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Clinical Trials in China / NCT03478488
Active, not recruiting Phase 3

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

NCT03478488 · tracked via the Priya Life Science China tracker
Sponsor
3D Medicines (Sichuan) Co., Ltd.
Phase
Phase 3
Started
2018-04-16
Last updated
2025-05-29

Condition(s) studied

Biliary Tract Neoplasms

Investigational drug(s) / intervention(s)

KN035 plus Gemcitabine & oxaliplatinGemcitabine & oxaliplatin

KN035 plus Gemcitabine & oxaliplatin: KN035 a programmed death ligand immune check inhibitor Per Investigator decision

Gemcitabine & oxaliplatin: The standard of care for the patients with unresectable/metastatic biliary tract cancer

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

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

More 3D Medicines (Sichuan) Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03478488 on ClinicalTrials.gov ↗ ← All trials in China