Clinical trial NCT05023109: GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Biliary Tract Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Jining Medical University
name: Cancer Hospital of Guangxi Medical University
First posted: 2021-08-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: 24 months
measure: Duration of response (DoR)
timeFrame: 24 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: 6-months/12-months PFS rate
timeFrame: 6 months/12 months
measure: Overall Survival (OS）
timeFrame: 24 months
measure: 6-months/12-months OS rate
timeFrame: 6 months/12 months
measure: Adverse Events (AEs)
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jia Fan
role: PRINCIPAL_INVESTIGATOR
References: