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

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05251662

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Drug: Sintilimab Drug: IBI305 Drug: GEMOX	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 13, 2022

Anticipated Primary Completion Date :

Jan 13, 2024

Anticipated Study Completion Date :

Jan 13, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group1 Sintilimab Combined With GEMOX + IBI305	Drug: Sintilimab 200mg IV d1 Q3W Drug: IBI305 7.5mg/kg IV d1 Q3W Other Names: Bevacizumab Biosimilar Drug: GEMOX Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
Experimental: experimental group2 Sintilimab Combined With GEMOX	Drug: Sintilimab 200mg IV d1 Q3W Drug: GEMOX Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
Active Comparator: Comparator GEMOX	Drug: GEMOX Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

Arm

Intervention/Treatment

Experimental: experimental group1

Sintilimab Combined With GEMOX + IBI305

Drug: Sintilimab

200mg IV d1 Q3W

Drug: IBI305

7.5mg/kg IV d1 Q3W

Other Names:

Bevacizumab Biosimilar

Drug: GEMOX

Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

Experimental: experimental group2

Sintilimab Combined With GEMOX

Drug: Sintilimab

200mg IV d1 Q3W

Drug: GEMOX

Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

Active Comparator: Comparator

GEMOX

Drug: GEMOX

Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

Outcome Measures

Primary Outcome Measures

Overall response rate ( ORR) [up to 90 days after last treatment administration]
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.