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

Phase 2

Withdrawn

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Drug: GP+PD-1+Tight

• Registration Number: NCT05019677
• Lead Sponsor: Fudan University

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-25
• Study Start: 2021-09-01
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GP+PD-1+Tight	GP+PD-1+Tight	Experimental: Tislelizumab 200mg IV Q3W + Ociperlimab 900mg IV Q3W + GP (gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W) Gemcitabine/Cisplatin will be administered on D1/D8 in every three weeks cycle and up to 8 cycles. Tislelizumab and Ociperlimab will be administered on D1 in every three weeks cycle, until the disease progression, intolerable toxicity, death, withdrawal of consent.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	24 months	ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs.

Secondary Outcome Measures

Name	Time	Method
6-months/12-months PFS rate	12 months	6-months/12-months PFS rate is defined as the proportion of patients alive and free of disease progression at 6 months/12 months.
Overall Survival (OS）	24 months	OS is defined as the time from the treatment until death due to any cause.
Disease control rate (DCR)	24 months	DCR is defined as the proportion of subjects with CR or PR or SD to study drugs.
Duration of response (DoR)	24 months	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.
Progression-free survival (PFS)	24 months	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.
6-months/12-months OS rate	12 months	OS rate is defined as the proportion of patients who have not experienced death from any cause at 6 months/12 months.
Adverse Events (AEs)	24 months	The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0

Trial Locations

Locations (1)

Zhongshan hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China