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

A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab(Anti-PD-1) and Ociperlimab(Anti-TIGIT) as First-line Treatment in Participants With Unresectable Advanced BTC

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).

Study Overview

• Status: Withdrawn
• Conditions: Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Drug: GP+PD-1+Tight

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: zs-BTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No