Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

All Patients will receive liposomal paclitaxel (starting at a dose of 190mg/m2,3h,ivgtt,at d1)each cycle for 1 cycle.

Liposomal paclitaxel

Jin Li, Dr.

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.

There are clinical trials show that paclitaxel is common option for the treatment of solid tumors. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional paclitaxel. However,the tolerance of this new dosage form of paclitaxel (liposomal paclitaxel) has never been studied in Chinese cancer patients. This study is designed to find the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese cancer patients.

Clinical Study of Liposomal Paclitaxel in Chinese Patients

Dose Escalation Study of Liposomal Paclitaxel in Chinese Patients With Advanced Solid Tumors

Nanjing Sike Pharmaceutical Co., Ltd.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Micronutrients

Hematinics

Vitamins

Carboplatin

Antibodies

Pemetrexed

Immunoglobulins

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

In this arm, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.

In this arm, patients with tumors resectable after chemoimmunotherapy will receive radiotherapy in department of medical oncology.

In this arm, patients with tumors still unresectable after chemoimmunotherapy will receive therapy in department of medical oncology.

Serplulimab

Nab-paclitaxel

Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.

Surgery

Radiotherapy

Peng Zhang, PhD

Suyu Wang

For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.

Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer

Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial

The researchers will consider whether IPD is available to other researchers only after the paper is published.

Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.

MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery

It refers to the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.

It refers to the time (months) from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).

It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.

It is defined as the time from the first time of partial response or complete response to progressive disease via RECIST1.1.

It is defined as the rate of stable disease, partial response, or complete response via RECIST1.1.

It is defined as the rate of complete resection with no residual tumor cell in the resection margin.

It is defined as the frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.

The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.

Shanghai Pulmonary Hospital, Shanghai, China

Professor

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Adenocarcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Esophageal Squamous Cell Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

liposomal paclitaxel

David H. Ilson, MD, PhD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of PNU-93914 in treating patients who have locally advanced or metastatic cancer of the esophagus.

OBJECTIVES: I. Determine the antitumor activity and duration of activity of PNU-93914 in patients with locally advanced or metastatic esophageal carcinoma. II. Determine the objective tumor response rate and tumor response duration in patients treated with this drug. III. Determine the survival of patients treated with this drug. IV. Determine the safety profile of this drug in these patients. V. Determine the effect of this drug on the quality of life of these patients. VI. Determine the time to tumor response, time to tumor progression, and time to treatment failure in patients treated with this drug. VII. Evaluate the change in dysphagia score in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive PNU-93914 IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 1 of each course, and then at the final study visit. Patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study.

PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

A Phase II Multicenter Study of the Efficacy and Safety Study of PNU-93914 (Liposome Encapsulated Paclitaxel) in Patients With Advanced Esophageal Cancer Previously Exposed to Chemotherapy

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Stomach Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Diseases

Stomach Cancer

Capecitabine

Antimetabolites

Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2、185mg/m2、195mg/m2、 200mg/m2、205mg/m2 and so on ,at the first day of chemotherapy. Capecitabine will be given on d1 to d14 with the dose of 185mg/m2、200mg/m2 or d8 to d21 with the dose of 175mg/m2、195mg/m2、205mg/m2 .Cycle duration will be 21 days. Each patient will receive 2 cycles of therapy. Only in the first cycle blood samples will be taken on 16 points in 48 hours after the infusion of liposomal paclitaxel.

Liposomal paclitaxel and capecitabine

Jinwan Wang, Doctor

Chi Yihebali, Doctor

The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.

The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.

Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma

A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.

Prof. Jinwan Wang

Taxane

Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.

Patients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.

Jin Li, Doctor

The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.

The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study of Liposomal Paclitaxel in Chinese Patients	NCT00881101	Solid Tumor	Liposomal pacli...	18 Years - 70 Years	Nanjing Sike Pharmaceutical Co., Ltd.
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer	NCT05766800	Locally Advance... Non-small Cell ...	Serplulimab Carboplatin Pemetrexed Nab-paclitaxel Liposomal pacli... Surgery Radiotherapy	18 Years -	Shanghai Pulmonary Hospital, Shanghai, China
PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus	NCT00016900	Esophageal Canc...	liposomal pacli...	18 Years -	Memorial Sloan Kettering Cancer Center
Clinical Study of Liposomal Paclitaxel in Chinese Patients	NCT00881101	Solid Tumor	Liposomal pacli...	18 Years - 70 Years	Nanjing Sike Pharmaceutical Co., Ltd.
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma	NCT00639522	Gastric Carcino...	Liposomal pacli...	18 Years - 65 Years	Nanjing Sike Pharmaceutical Co., Ltd.
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma	NCT00639522	Gastric Carcino...	Liposomal pacli...	18 Years - 65 Years	Nanjing Sike Pharmaceutical Co., Ltd.
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma	NCT00639522	Gastric Carcino...	Liposomal pacli...	18 Years - 65 Years	Nanjing Sike Pharmaceutical Co., Ltd.
Pharmacokinetics Study of Liposomal Paclitaxel in Humans	NCT00606515	Cancer	Liposomal pacli... Paclitaxel	18 Years - 75 Years	Shandong Luye Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for liposomal paclitaxel