Combination treatment for advanced biliary tract cancer
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer: A Single Center, Single Arm, Phase II Trial
This study is testing a new combination of treatments for advanced biliary tract cancer to see if it works better than the usual options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | Cadonilimab, chemotherapy |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05820906 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy for patients with advanced biliary tract cancer. The study aims to determine how well this combination therapy works in treating the disease compared to standard treatments. Participants must have a measurable lesion and meet specific health criteria to be eligible for the trial. The study is designed to provide insights into a potentially effective treatment option for this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed diagnosis of advanced biliary tract cancer who have not received prior systemic treatment.
Not a fit: Patients with mixed ampullary, hepatocellular, or cholangiocarcinoma diagnoses, or those with certain serious health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced biliary tract cancer.
How similar studies have performed: While this specific combination has not been widely tested, similar approaches in treating biliary tract cancer have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin, Tianjin
- Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.