Intrahepatic Cholangiocarcinoma
Conditions
Keywords
Intrahepatic Cholangiocarcinoma, First-line Therapy, Sintilimab, IBI305, GEMOX
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.
Interventions
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWei Lu, MD
Backup ContactNingning Zhang, MD
Outcome results
None listed