Clinical trial · Interventional
GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
NCT05215665CI-TRIAL-00083591unknownN/AClinicalTrials.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)
The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GEMOX Regimen | Drug | — | UNRESOLVED |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- group 1
- description
- GEMOX+Lenvatinib+Toripalimab
- interventionNames
- Drug: GEMOX Regimen
- Drug: Lenvatinib
- Drug: Toripalimab
- type
- EXPERIMENTAL
- label
- group 2
- description
- GEMOX+Toripalimab
- interventionNames
- Drug: GEMOX Regimen
- Drug: Toripalimab
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- up to 90 days after last treatment administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, 18 years old ≤ age ≤ 70 years old * ECOG PS scores 0-1 * Expected survival time \> 12 weeks * Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria) * Not received any previous systemic or local treatment for the tumor * Sufficient organ and bone marrow function 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.