Clinical trial · Interventional
Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma
A Phase II Study of Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX as First-line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma
NCT05251662CI-TRIAL-00056683unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GEMOX | Drug | — | UNRESOLVED |
| IBI305 | Drug | Bevacizumab | ALIAS |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- experimental group1
- description
- Sintilimab Combined With GEMOX + IBI305
- interventionNames
- Drug: Sintilimab
- Drug: IBI305
- Drug: GEMOX
- type
- EXPERIMENTAL
- label
- experimental group2
- description
- Sintilimab Combined With GEMOX
- interventionNames
- Drug: Sintilimab
- Drug: GEMOX
- type
- ACTIVE_COMPARATOR
- label
- Comparator
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.