Intrahepatic Cholangiocarcinoma
Conditions
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) 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.
Interventions
DRUGGP+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
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 24 months | ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DoR) | 24 months | 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. |
| Progression-free survival (PFS) | 24 months | 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. |
| 6-months/12-months PFS rate | 12 months | 6-months/12-months PFS rate is defined as the proportion of patients alive and free of disease progression at 6 months/12 months. |
| Disease control rate (DCR) | 24 months | DCR is defined as the proportion of subjects with CR or PR or SD to study drugs. |
| 6-months/12-months OS rate | 12 months | OS rate is defined as the proportion of patients who have not experienced death from any cause at 6 months/12 months. |
| Adverse Events (AEs) | 24 months | The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0 |
| Overall Survival (OS） | 24 months | OS is defined as the time from the treatment until death due to any cause. |
Countries
China
Outcome results
None listed