GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC

Phase 2WithdrawnNCT05019677

Fudan University

Overview

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).

Biliary Tract Carcinoma (BTC) have insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. For patients with advanced BTC, systemic therapy is currently the main choice, and gemcitabine/cisplatin (GP) is currently the "gold standard" for first-line treatment of advanced BTC, but the efficacy is still unsatisfactory, and more and more clinical practice has found that GP-based combination therapy may have better efficacy. Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody (Tislelizumab) and anti-TIGIT antibody (Ociperlimab) as first-line treatment in participants with unresectable advanced BTC.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Intrahepatic Cholangiocarcinoma

Interventions

GP+PD-1+TightDRUG

Drug: Tislelizumab Tislelizumab 200mg IV Q3W Other Name: BGB-A317 Anti-PD-1 therapy Drug: Ociperlimab Ociperlimab 900mg IV Q3W Other Name: BGB-A1217 Anti-TIGIT therapy Drug: GP chemotherapy gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * • Subjects with a histopathological or cytologically diagnosis of BTC * The participants must be required to sign an informed consent * At least one measurable lesion (RECIST 1.1) * No previous systematic treatment for BTC * Child-Pugh Score, Class A * ECOG performance status 0 or 1 * Adequate organ function * Life expectancy of at least 3 months Exclusion Criteria: * • Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma * Known history of serious allergy to any monoclonal antibody * Known central nervous system metastases and/or leptomeningeal disease prior to treatment * Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment * Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment * Any active malignancy prior to the start of treatment * Active or history of autoimmune disease * Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation * Pregnant or lactating women

Locations (1)

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Objective response rate (ORR)

ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs.

Time frame: 24 months

Secondary Outcomes

Disease control rate (DCR)

DCR is defined as the proportion of subjects with CR or PR or SD to study drugs.

Time frame: 24 months

Duration of response (DoR)

DoR is defined as the time interval from first meeting response criteria (CR or PR) to confirmed progressive disease (PD) or death, whichever occurs first.

Time frame: 24 months

Progression-free survival (PFS)

PFS is defined as the time from the date of treatment to the first documented disease progression or death due to any cause, whichever occurs first.

Time frame: 24 months

6-months/12-months PFS rate

6-months/12-months PFS rate is defined as the proportion of patients alive and free of disease progression at 6 months/12 months.

Time frame: 12 months

Overall Survival (OS）

OS is defined as the time from the treatment until death due to any cause.

Time frame: 24 months

6-months/12-months OS rate

OS rate is defined as the proportion of patients who have not experienced death from any cause at 6 months/12 months.

Time frame: 12 months

Adverse Events (AEs)

Data from ClinicalTrials.gov

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