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

NCT05023109 | Unknown Phase 2

• 1 other identifier: ZSAB-TOP
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Disease control rate (DCR)

  24 months

• Duration of response (DoR)

  24 months

• Progression-free survival (PFS)

  24 months

• 6-months/12-months PFS rate

  6 months/12 months

• Overall Survival (OS）

  24 months

Study Arms (1)

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

Interventions

GP+PD-1+Tight DRUG

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

GP+PD-1+Tight

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Jining Medical University: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator

Study Sites (1)

Zhongshan hospital

Shanghai, 200032, China

Location

Study Officials

• Jia Fan

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: February 1, 2021
• Primary Completion: January 18, 2023
• Study Completion: December 1, 2024
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)