Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy in advanced biliary tract Cancer

Official Title
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Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer: A Single Center, Single Arm, Phase II Trial

Conditions
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Advanced Biliary Tract Cancer

Intervention / Treatment
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* Drug: Cadonilimab+Regorafenib+GC


Participation Criteria
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Eligibility Criteria
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Main 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cadonilimab+rego+Gem/Cis<br> | Drug: Cadonilimab+Regorafenib+GC<br>* Cadonilimab:10mg/kg, iv,q3w,D1 Regorafenib: 80mg, po, orally once daily Gemcitabine:1000 mg/m2, iv, Q3W，D1,D8 Cisplatin:25 mg/m2, iv, Q3W, D1,D8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate ( ORR) per RECIST 1.1 | Defined as proportion of patients who have a best response of CR or PR | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Defined as the time from enrollment to death from any cause | Up to two years | 
| Progress Free Survival (PFS) | Defined as the time from enrollment to disease progression or death (whichever occurs first) | Up to two years | 
| Adverse Events (AEs) | Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 | Up to two years | 
| Disease control rate (DCR) per RECIST 1.1 | Defined as proportion of patients who have CR or PR or SD | Up to 1 year |