Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma

Study Overview
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Brief Summary
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A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.

Official Title
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A Phase II Study of Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX as First-line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma

Conditions
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Intrahepatic Cholangiocarcinoma

Intervention / Treatment
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* Drug: Sintilimab
* Drug: IBI305
* Drug: GEMOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent should be signed before implementing any trial-related procedures Male or female, 18 years old ≤ age ≤ 75 years old Histopathologically or cytologically diagnosed as locally advanced intrahepatic cholangiocarcinoma No previous systemic treatment, More than 6 months after the end of postoperative adjuvant therapy was allowed Expected survival time > 3 months At least ≥ 1 measurable lesions per RECIST 1.1 ECOG PS scores 0-2 Sufficient organ and bone marrow function Urine or serum pregnancy test is negative Exclusion Criteria: Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ) Ampullary tumor Received treatment from other clinical trials within 4 weeks before the first dose Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction Uncontrollable pleural effusion, pericardial effusion or ascites Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment Allergic reactions to the drugs used in this study HIV antibody positive, active hepatitis B or C (HBV, HCV) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation other conditions that the investigator deems inappropriate for enrollment.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group1<br>Sintilimab Combined With GEMOX + IBI305 | Drug: Sintilimab<br>* 200mg IV d1 Q3W<br>Drug: IBI305<br>* 7.5mg/kg IV d1 Q3W<br>* Other names: Bevacizumab Biosimilar;Drug: GEMOX<br>* Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W<br>|
| Experimental: experimental group2<br>Sintilimab Combined With GEMOX | Drug: Sintilimab<br>* 200mg IV d1 Q3W<br>Drug: GEMOX<br>* Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W<br>|
| Active Comparator: Comparator<br>GEMOX | Drug: GEMOX<br>* Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate ( ORR) | Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR | up to 90 days after last treatment administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD | up to 90 days after last treatment administration | 
| Progression free survival (PFS) | the time period from randomization of the participants to objective tumor progression or death | up to 3 years | 
| Overall survival (OS) | the time period from the randomization of the participants to the death event due to any reason | up to 3 years | 
| Adverse event | All grades of adverse events, all grades of treatment related adverse events, serious of adverse events | up to 30 days after last treatment administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrahepatic Cholangiocarcinoma, First-line Therapy, Sintilimab, IBI305, GEMOX