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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05019677
Other study ID # zs-BTC
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date September 1, 2021
Est. completion date December 1, 2024

Study information

Verified date August 2021
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GP+PD-1+Tight
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

Locations

Country Name City State
China Zhongshan hospital, Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs. 24 months
Secondary Disease control rate (DCR) DCR is defined as the proportion of subjects with CR or PR or SD to study drugs. 24 months
Secondary 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. 24 months
Secondary 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. 24 months
Secondary 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. 12 months
Secondary Overall Survival (OS) OS is defined as the time from the treatment until death due to any cause. 24 months
Secondary 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. 12 months
Secondary Adverse Events (AEs) The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0 24 months
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