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

NCT ID: NCT03478488

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Biliary Tract Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KN035

KN035 plus Gemcitabine & oxaliplatin KN035 2.5 mg/Kg, administered as subcutaneous injection, weekly of each 21-day cycle.

Gemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.

Group Type: EXPERIMENTAL

KN035 plus Gemcitabine & oxaliplatin

Intervention Type: DRUG

KN035 a programmed death ligand immune check inhibitor Per Investigator decision

Gemcitabine & oxaliplatin

Gemcitabine 1000 mg/m\^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.

Group Type: ACTIVE_COMPARATOR

Gemcitabine & oxaliplatin

Intervention Type: DRUG

The standard of care for the patients with unresectable/metastatic biliary tract cancer

Interventions

KN035 plus Gemcitabine & oxaliplatin

KN035 a programmed death ligand immune check inhibitor Per Investigator decision

Intervention Type: DRUG

Gemcitabine & oxaliplatin

The standard of care for the patients with unresectable/metastatic biliary tract cancer

Intervention Type: DRUG

Other Intervention Names

Experimental; Active Comparator

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3D Medicines (Sichuan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shukui Qin

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

KN035-CN-005

Identifier Type: -

Identifier Source: org_study_id