Loading clinical trials...

ACTIVE_NOT_RECRUITINGPHASE3

Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC

Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study

NCT03478488•3D Medicines (Sichuan) Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eighteen years and older;
•Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma;
•Previously untreated with systemic therapy; Subjects who developed recurrent disease \>6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.
•Liver function Child-Pugh A or B;
•Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
•Life expectancy of at least 12 weeks;
•At least one measurable lesion per RECIST 1.1;
•Adequate organ function

Exclusion Criteria

•Specific anti-tumor treatment prior to 4 weeks;
•more than 50% liver metastasis ;
•Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc;
•History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;
•Women who are pregnant or in the period of lactation;
•Patients with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement;

Locations (1)

The Chinese people's liberation army (PLA) 81hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

April 16, 2018

Primary Completion Date

September 10, 2024

Completion Date

December 31, 2026

Last Updated

May 29, 2025

Enrollment

480

ESTIMATED participants

Conditions

Biliary Tract Neoplasms

Interventions

KN035 plus Gemcitabine & oxaliplatin

DRUG

Gemcitabine & oxaliplatin

DRUG

Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

NCT07146646

Biliary Tract CancerBiliary Tract Neoplasms+3 more

View study

RECRUITINGPHASE2

Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

NCT06230471

Biliary Tract Neoplasms Immunotherapy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC

Inclusion Criteria

Exclusion Criteria

Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics