Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Lenvatinib

Cisplatin

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Single-arm trial whereby all consented, enrolled, eligible patients receive Envofolimab, Lenvatinib, Gemcitabine and Cisplatin

400mg by subcutaneous injection every 3 weeks

Envofolimab

1000mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

25mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

Ming Kuang, PhD

Ming Kuang, Ph.D.

This is a phase 2, single-arm, open label study. The purpose is to investigate both the efficacy and safety of Envofolimab and Lenvatinib in combination with Gemcitabine plus Cisplatin for treatment of advanced biliary tract cancer as first-line treatment.

The trial will recruit 43 patients. At the first step, 10 patients will be recruited. Only when at least 4 patients achieve objective response will the trial enter the second step and continue to recruit other patients. After being enrolled, all patients giving written informed consent will receive treatment until progression of disease, unacceptable toxicity or death. The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN)

Envofolimab and Lenvatinib in Combination With Gemcitabine Plus Cisplatin for Patients With Advanced Biliary Tract Cancer as First-Line Treatment: A Single-arm, Open-label, Phase II Study

ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

OS is defined as the time from first treatment to death, regardless of disease recurrence.

PFS is defined as the time from the first dose of administration to progression or death.

DCR is defined as the percentage of patients who have achieved CR, PR or stable disease(SD), as measured by RECIST 1.1 criteria.

The percentage of patients who suffer grade 3 or worse adverse events from the first dose of administration to last follow-up, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Sun Yat-sen University

Professor

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Irinotecan

Docetaxel

Leucovorin

Levoleucovorin

Calcium

Calcium, Dietary

Tubulin Modulators

Antimitotic Agents

Hormones

Topoisomerase I Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）

Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）+Docetaxel(75mg/m2，Q3W)

Envofolimab（200mg，Q2W）+BD0801（2mg/kg，Q2W）+FOLFIRI（Irinotecan 180 mg/m2，Leucovorin 400mg/m2，5-Fluorouridine 2400 mg/m2，Q2W）

300mg，Q3W (arm A,B and C)or 200mg, Q2W(arm D)

2mg/kg，Q3W(armA, B and C) or 2mg/kg，Q2W

BD0801

Leucovorin calcium

5-Fluorouridine

Zhengguang Lv

This is an open label, multi-cohort, multicenter Phase II study, the purpose of this study is to assess the efficacy and safety of envofolimab in combination with BD0801 injection with/without chemotherapy for the treatment of advanced solid tumors

The efficacy of immune checkpoint inhibitors combined with antivascular agents has been preliminarily demonstrated in a variety of solid tumors. Based on the huge clinical needs, the efficacy of envofolimab combined with BD0801 in patients with advanced hepatocellular carcinoma, non-small cell lung cancer and advanced colorectal cancer deserves further exploration.

A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors

An Open Label, Multi-cohort, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Envofolimab in Combination With BD0801 Injection With/Without Chemotherapy in Patients With Advanced Solid Tumors

Plasma concentrations of envofolimab an BD0801 will be measured.

MTD: A maximum dose of acceptable safety, at least 6 patients treated with this dose, and less than 1/3 of patients experienced DLT(Dose limited toxicity).

RD:The following will be taken into account to make decision about RD: MTD, if is reached; PK characteristics, efficacy and safety results.

Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria

Measured from the date of partial or complete response to therapy until the disease progression based on RECIST v1.1criteria.

PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigator according to the RECIST1.1 criteria

Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria

OS is the time interval from the date of randomization to death from any cause.

Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0

Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria in subgroup of different TMB、PDL-1 and MSI status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN)	NCT05410197	Advanced Biliar...	Envofolimab Lenvatinib Gemcitabine Cisplatin	18 Years -	Sun Yat-sen University
A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors	NCT05148195	Advanced Solid ...	Envofolimab BD0801 Docetaxel Irinotecan Leucovorin calc... 5-Fluorouridine	18 Years -	Jiangsu Simcere Pharmaceutical Co., Ltd.
A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors	NCT05148195	Advanced Solid ...	Envofolimab BD0801 Docetaxel Irinotecan Leucovorin calc... 5-Fluorouridine	18 Years -	Jiangsu Simcere Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for envofolimab

Every month we try and update this database with for envofolimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for envofolimab

Every month we try and update this database with for envofolimab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for envofolimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.