Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Gastrointestinal Agents

Vitamins

Leucovorin

Fluorouracil

Irinotecan

Levoleucovorin

Folic Acid

Pancrelipase

Pancreatin

Vitamin B Complex

Camptothecin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Trace Elements

Folinic Acid

Folate

Vitamin B9

Cycle 1 (Crossover Phase) Day 1: One dose Onivyde® Reference product + 5-FU/LV.

Cycle 1 (Crossover Phase) Day 15: One dose Onivyde Test product + 5-FU/LV

Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV

Cycle 1 (Crossover Phase) Day 1: One dose Onivyde Test product + 5-FU/LV.

Cycle 1 (Crossover Phase) Day 15: One dose Onivyde® Reference product + 5-FU/LV.

Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV.

Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)

Irinotecan liposome injection

Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase)

Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase)

Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)

LV 400 mg/m2 intravenously over 30 minutes, on Day 1 and Day 15 of every 28-day cycle

5-FU 2,400 mg/m2 intravenously over 46 hours, on Day 1 and Day 15 every 28-day cycle

5-Fluorouracil

Ipsen Recruitment Enquiries

Ipsen Medical Director

The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas.

Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP) and Reference Product (RP) Onivyde in line with its approved indication. The order in which they receive them depends on the group to which they are randomly assigned, this will be referred to as the crossover phase.

The average study duration for each participant until end of crossover phase is estimated to be approximately 3 months. After completion of the crossover phase, participants who in the opinion of the investigator will benefit from the treatment will be offered to enter the extension phase where they will receive the commercial Onivyde (RP) until disease progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of the body.

Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with 5-fluorouracil (5-FU) and leucovorin (LV).

A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas

A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination With Anti-Cancer Agents in Adult Participants With Metastatic Pancreatic Adenocarcinoma

Including treatment-emergent serious adverse events

It includes clinically significant abnormal laboratory results, physical examination findings, Electrocardiogram (ECG) and vital signs

Ipsen

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Topotecan

A randomized, open label phase 3 study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy

The study was conducted in two parts:

1. Dose determination of irinotecan liposome injection
2. A randomized, efficacy study of irinotecan liposome injection versus topotecan

The study was conducted in two parts:

Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were planned to be enrolled.

Part 1 Primary Objectives:

* Describe the safety and tolerability of irinotecan liposome injection monotherapy administered every 2 weeks
* Determine the optimal irinotecan liposome injection monotherapy dose for Part 2 of this study

Part 2: A randomized, efficacy study of irinotecan liposome injection versus intravenous (IV) topotecan.

Approximately 450 patients were planned to be enrolled in part 2.

Part 2 objectives: To compare overall survival following treatment with irinotecan liposome injection with overall survival following treatment with IV topotecan.

Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Progressed on or After Platinum-based First-Line Therapy

An adverse event (AE) was any untoward medical occurrence in a participant following or during exposure to a study treatment, whether or not causally related to the study treatment. An undesirable medical condition could be symptoms, signs or abnormal results of an investigation. An SAE was any AE that: resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; resulted in congenital anomaly or birth defect; or was medically important. A TEAE was any AE that occurred or worsened on or after the day of first dose of study treatment and within 30 days after discontinuation of study treatment.

A TEAE was considered as DLT if it occurred during the safety evaluation period (i.e. first 28 days of treatment or 14 days after the second dose of study treatment if there was a treatment delay due to non-DLT related reasons) and were deemed related to the study treatment by the investigator. The determination of whether an Adverse Event was considered a Dose Limiting Toxicity was made by the Safety Review Committee (SRC) comprising the Part 1 Investigators and the Medical Monitor(s) of the Sponsor.

The OS was defined as the time from randomization date to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status.

The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) recorded from date of first dose of study treatment until documented PD or death. ORR analysis was based on BOR using RECIST v1.1 per investigator assessment. Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had computed tomography (CT)-scans and brain magnetic resonance imaging (MRI) every 6 weeks to measure tumor lesion size. This was continued throughout treatment until progressive disease (PD) or commencement of new anti-neoplastic therapy.

The PFS was defined as time from first dose of study treatment to the first documented objective PD using RECIST v1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, progression is defined as at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

The OS was defined as the time from first dose of study treatment to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status.

The PFS was defined as time from randomization to first documented objective PD using RECIST 1.1 (or response assessment in neuro-oncology brain metastases \[RANO-BM\] criteria for central nervous system \[CNS\] lesions) as assessed by blinded independent central review (BICR) or death due to any cause, whichever occurred first. Per RECIST 1.1, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

The ORR was defined as percentage of participants with a BOR characterized as either a CR or PR, recorded from randomization until documented PD or death relative to the total number of participants. ORR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

The DoR was defined as time from the first documented objective response (CR or PR, whichever was earlier) to the date of first documented PD or death due to any cause. The DoR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions and PR is \>=30% decrease in the sum of the longest diameter of target lesions. The DoR was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Time to OR as per RECIST v1.1 Criteria according to BICR was defined as time from the date of randomization to the date of first documented objective tumor response (CR or PR, whichever was first). Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesion. Participants with a new anti-cancer therapy prior to OR were censored at the last tumor assessment prior to new anti-cancer therapy. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Scores range from 0-100 and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in dyspnea scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy.

The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Score ranges from 0-100 scale and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in cough scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy.

Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. Part 2: Safety population included all randomized participants who were treated with at least 1 dose of study treatment. The AEs are coded using MedDRA version 24.0 for Part 1 and MedDRA version 25.0 for Part 2. During all study visits, participants were asked to report any adverse events/symptoms since prior study visit.

Participants received irinotecan liposome injection 85 mg/m\^2 intravenously (i.v.) over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.

Part 1: Irinotecan Liposome Injection 85 mg/m^2

Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.

Part 1: Irinotecan Liposome Injection 70 mg/m^2

Eligible participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes, every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.

Part 2: Irinotecan Liposome Injection 70 mg/m^2

Eligible participants received topotecan 1.5 mg/m\^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.

Part 2: Topotecan 1.5 mg/m^2

Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.

Total

<65 years

>=65 years

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. Part 2: Intent-to-Treat (ITT) population included all randomized participants.

Medical Director

Any TEAE

Serious TEAEs

Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)

Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)

Part 2: The ITT population included all randomized participants.

Part 2: Overall Survival (OS)

Part 1: Objective Response Rate (ORR)

Part 1: Progression-Free Survival (PFS)

Part 1: OS

Part 2: PFS

Part 2: ORR

Eligible participants received topotecan 1.5 mg/m2 i.v. over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle for 6 weeks.

Part 2: Topotecan 1.5 mg/m2 IV

Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed.

Part 2: Median Duration of Response (DoR)

Part 2: Median Time to Objective Response (OR)

Part 2: The ITT population included all randomized participants. Only participants analyzed at Week 12 are reported.

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)/Lung Cancer Supplement (LC13) Dyspnea Scale at Week 12

Change From Baseline in EORTC QLQ-LC13 Cough Scale at Week 12

Participants received irinotecan liposome injection 85 mg/m\^2 intravenously (i.v.) over 90 minutes every 2 weeks in a 6-week cycle until disease progression (PD), death, unacceptable study treatment-related toxicity or withdrawal of consent.

Part 1: Irinotecan Liposome Injection 85 Milligrams/Meter Square (mg/m^2)

Part 1: Dose Evaluation (Up to Week 172)

Part 2: Randomized Study (Upto Week 197)

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Oxaliplatin

Patients receive 8 cycles of NALIRIFOX. Then undergo surgery and receive 4 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV

Patients receive 12 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.

2400 mg/m² continuous IV infusion in 46 h

5-FU

Guo Shiwei, Professor

Jin Gang, Professor

This multicentric randomized trial will compare the efficacy and safety of neoadjuvant chemotherapy + surgery + adjuvant chemotherapy or surgery + adjuvant chemotherapy in patients with high-risk resectable pancreatic cancer. NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) will be used as the chemotherapy regimen.

Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose,improve the efficacy and reduce the toxic side effects. The aim of this study is to compare the efficacy and safety of NALIRIFOX + surgery + NALIRIFOX or surgery + NALIRIFOX in high-risk patients with resectable pancreatic cancer.

Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer : a Multicenter, Randomized, Open-label Trial

Defined as the percentage of patients who are alive at 2 years after randomization (proportion of patients alive will estimated by the survival curve)

Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1

Defined as the percentage of patients that underwent a R0/R1 resection

Defined as the proportion of patients who have achieved R0 resection

Defined as the time between signing the informed consent form to the first documentation of event where events considered are 1) disease progression (local recurrence, new lesions or distant metastasis), 2) a second malignant tumor occurs, or 3) death due to any cause

Defined as the time between signing the informed consent form and death due to various causes

Use NCI-CTCAE version 5.0 for classification and grading

Changhai Hospital

Cholangiocarcinoma

Biliary Tract Neoplasms

Biliary Tract Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Antibodies

Antibodies, Monoclonal

Immunoglobulins

The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or termination of the study for other reasons.

The patients in cohort 1 will receive irinotecan liposome injection combined with SG001, 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or until 24 months is reached, or the study is terminated for other reasons.

Irinotecan Liposome Injection, intravenously, over 90 min on days 1 of every 14-day cycle, 43mg/10mL

Irinotecan Liposome Injection

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, intravenously, over 60 min on days 1 of every 14-day cycle, 100mg/10mL

SG001

5-Fluorouracil (5-Fu), intravenously, over 46 h on days 1 of every 14-day cycle

Leucovorin (LV), intravenously, over 30 min on days 1 of every 14-day cycle

Xiangdong Cheng, Ph.D

Xiangdong Cheng

This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced biliary tract cancer.

This is an open-label, parallel, multicentre, phase II study to evaluate the efficacy and safety of irinotecan liposome injection. Eligible patients will be divided into two cohorts according to the criteria for the corresponding cohort. The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV). The patients in cohort 2 will receive irinotecan liposome injection combined with a PD-1 inhibitor, 5-Fluorouracil and Leucovorin.

Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

An Open-label, Multicentre, Phase II Study to Evaluate the Safety and Efficacy of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

The percentage of patients who achieve a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Time from date of the first dose to date of recorded disease progression or death, whichever occurs first

Time from date of the first dose to date of death from any cause

The percentage of patients who achieve a CR, PR or stable disease (SD) based on the RECIST 1.1

Time from first documented response (CR or PR whichever occurs first, based on investigator's assessment per RECIST 1.1) to date of disease progression or death due to any cause, whichever occurs first

The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0

CSPC Ouyi Pharmaceutical Co., Ltd.

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

The patients in cohort 1 will receive irinotecan liposome injection combined with 5-fluorouracil (5-FU), leucovorin(LV) and oxaliplatin intravenously on day 1 and day 15 of every 28-day cycle until disease progression or unacceptable toxicity, or termination of the study due to other reasons.

The patients in cohort 2 will receive nab-paclitaxel and gemcitabine intravenously on day 1、day 8 and day 15 of every 28-day cycle until disease progression or unacceptable toxicity, or termination of the study due to other reasons.

Irinotecan Liposome Injection, intravenously, over 90 min on day 1and day 15 of every 28-day cycle

5-Fluorouracil (5-Fu), intravenously, over 46 h on day 1 and day 15 of every 28-day cycle

Leucovorin (LV), intravenously, over 30 min on day 1 and day 15 of every 28-day cycle

Oxaliplatin, intravenously, over 2 h on day 1 and day 15 of every 28-day cycle

Paclitaxel (albumin bound), intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle

Nab paclitaxel

Gemcitabine, intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle

Jihui Hao, Ph.D

This is a multicenter, randomized, open-lable, parallel-controlled phase II study of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma. The purpose of this study is to evaluate the differences of safety and efficacy of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma.

This is a multicentre randomized, open-label, parallel-controlled, phase II study to evaluate the efficacy and safety of irinotecan liposome injection-containing regimens. Eligible patients will be randomly divided into two cohorts at a ratio of 2:1. The patients in cohort 1 (the experimental group) will receive irinotecan liposome injection combined with 5-fluorouracil (5-FU), leucovorin (LV) and oxaliplatin.The patients in cohort 2 (the control group) will receive nab-paclitaxel plus gemcitabine.

Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase II Study to Evaluate the Differences of Safety and Efficacy of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Time from date of the first dose to date of recorded disease progression or death, whichever occurs first.

Time from date of the first dose to date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas	NCT05383352	Metastatic Panc...	Irinotecan lipo... Irinotecan lipo... Irinotecan lipo... Irinotecan lipo... Folinic Acid 5-Fluorouracil	18 Years -	Ipsen
Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer	NCT03088813	Small Cell Lung...	Irinotecan lipo... Topotecan	18 Years -	Ipsen
Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX	NCT06210360	Pancreatic Canc...	Irinotecan lipo... Oxaliplatin 5-FU LV	18 Years -	Changhai Hospital
Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer	NCT05009953	Advanced Biliar... Intrahepatic Ch... Extrahepatic Ch... Gallbladder Car...	Irinotecan Lipo... SG001 Fluorouracil Leucovorin	18 Years -	CSPC Ouyi Pharmaceutical Co., Ltd.
Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma	NCT05047991	Pancreatic Canc... Pancreatic Canc...	Irinotecan Lipo... Fluorouracil Leucovorin Oxaliplatin Nab paclitaxel Gemcitabine	18 Years - 70 Years	CSPC Ouyi Pharmaceutical Co., Ltd.
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment	NCT06370754	Pancreatic Canc...	JS001 JS004 JS007 JS015 Irinotecan Lipo... 5-Fluorouracil ... Leucovorin (LV) Nab paclitaxel Gemcitabine	18 Years - 75 Years	Fudan University
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment	NCT06370754	Pancreatic Canc...	JS001 JS004 JS007 JS015 Irinotecan Lipo... 5-Fluorouracil ... Leucovorin (LV) Nab paclitaxel Gemcitabine	18 Years - 75 Years	Fudan University
Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma	NCT05047991	Pancreatic Canc... Pancreatic Canc...	Irinotecan Lipo... Fluorouracil Leucovorin Oxaliplatin Nab paclitaxel Gemcitabine	18 Years - 70 Years	CSPC Ouyi Pharmaceutical Co., Ltd.
Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC)	NCT04727853	Small Cell Lung...	irinotecan lipo...	18 Years -	CSPC Ouyi Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for irinotecan liposome injection