Clinical trial NCT05251662: Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: Intrahepatic Cholangiocarcinoma
First-line Therapy
Sintilimab
IBI305
GEMOX
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate ( ORR)
timeFrame: up to 90 days after last treatment administration
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: up to 90 days after last treatment administration
measure: Progression free survival (PFS)
timeFrame: up to 3 years
measure: Overall survival (OS)
timeFrame: up to 3 years
measure: Adverse event
timeFrame: up to 30 days after last treatment administration
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Wei Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: