Intrahepatic Cholangiocarcinoma Clinical Trial
Official title:
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
Verified date | August 2021 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
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 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 |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
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. | 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. | 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 |
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