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

Phase 3Active Not RecruitingNCT03478488

3D Medicines (Sichuan) Co., Ltd.480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

480

Conditions

Biliary Tract Neoplasms

Interventions

KN035 plus Gemcitabine & oxaliplatinDRUG

KN035 a programmed death ligand immune check inhibitor Per Investigator decision

Gemcitabine & oxaliplatinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival (OS)

was defined as the time from randomization to death due to any cause.

Time frame: Observed by 12 weeks after progressive disease or end of treatment

Secondary Outcomes

Progression Free Survival (PFS)

was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent Review Committee (BIRC) review.

Time frame: Observed by 6 weeks

Objective response rate (ORR)

was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on BIRC evaluation.

Time frame: Observed by 6 weeks

Disease control rate (DCR)

was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response or stable disease and was assessed using RECIST 1.1 based on BIRC evaluation

Time frame: Observed by 6 weeks

Duration of Response (DOR)

was defined as the time from the first met for complete response/partial response (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study)

Time frame: Observed by 6 weeks

Time to progression (TTP)

was defined as the time from randomization to the first date that progressive disease was objectively documented

Data from ClinicalTrials.gov

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