GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC

Biliary Tract Carcinoma Clinical Trial

Official title:

A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Participants With Unresectable Advanced Biliary Tract Carcinoma (BTC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05023109
• Other study ID #: ZSAB-TOP
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• 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) has an 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: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 1, 2024
• Est. primary completion date: January 18, 2023
• 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 a 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

Related Conditions & MeSH terms

• Biliary Tract Carcinoma
• Carcinoma

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	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Cancer Hospital of Guangxi Medical University, Jining Medical 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.	6 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.	6 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