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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-13

Study Completion Date

2025-01-13

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.

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Detailed Description

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Conditions

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Intrahepatic Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Sintilimab

200mg IV d1 Q3W

Intervention Type DRUG

IBI305

7.5mg/kg IV d1 Q3W

Intervention Type DRUG

GEMOX

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

Intervention Type DRUG

Other Intervention Names

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Bevacizumab Biosimilar

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No