Clinical trial · Interventional
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer: A Single Center, Single Arm, Phase II Trial
NCT05820906CI-TRIAL-00072021unknownPhase 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)
To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy in advanced biliary tract Cancer
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 |
|---|---|---|---|
| Advanced Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab+Regorafenib+GC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cadonilimab+rego+Gem/Cis
- interventionNames
- Drug: Cadonilimab+Regorafenib+GC
Primary outcomes (1)
- measure
- Overall response rate ( ORR) per RECIST 1.1
- timeFrame
- Up to 1 year
- description
- Defined as proportion of patients who have a best response of CR or PR
Secondary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- Up to two years
- description
- Defined as the time from enrollment to death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Main Inclusion Criteria: 1. subjects with a histopathological or cytologically diagnosis of BTC 2. The participants must be required to sign an informed consent 3. At least one measurable lesion (RECIST 1.1) 4. No previous systematic treatment for BTC 5. Child-Pugh Score, Class A 6. ECOG performance status 0 or 1 7. Adequate organ function 8. Life expectancy of at least 3 months Exclusion Criteria: 1. Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma 2. Known history of serious allergy to any monoclonal antibody 3. Known central nervous system metastases and/or leptomeningeal disease prior to treatment 4. Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment 5. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment 6. Any active malignancy prior to the start of treatment 7. Active or history of autoimmune disease 8. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation 9. Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.