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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP+PD-1+Tight | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR or PR or SD to study drugs. | 24 months |
| 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. |
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Inclusion Criteria:
• Subjects with a histopathological or cytologically diagnosis of BTC
Exclusion Criteria:
• Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Jia Fan | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 24 months |
| 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 |
| 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 |
| Overall Survival (OS） | OS is defined as the time from the treatment until death due to any cause. | 24 months |
| 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 |
| Adverse Events (AEs) | The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0 | 24 months |
| D009369 | Neoplasms |