Combining chemotherapy, immunotherapy, and targeted therapy for advanced cholangiocarcinoma
Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma
This study is testing a new combination of chemotherapy, immunotherapy, and targeted therapy to see if it helps people with advanced cholangiocarcinoma feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06718257 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the efficacy and safety of a treatment regimen combining gemcitabine with cisplatin or oxaliplatin, along with PD-1/L1 inhibitors and TKI agents, in patients diagnosed with advanced cholangiocarcinoma. It is a multicenter, retrospective study that will collect and analyze clinical data from patients who have received these therapies as initial treatment. The goal is to gather comprehensive clinical information to guide future clinical practice in managing this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically or radiologically confirmed advanced intrahepatic cholangiocarcinoma who have been treated with the specified chemotherapy and immunotherapy regimens.
Not a fit: Patients who have undergone direct surgery after hospitalization or received initial treatment involving local therapies or other comprehensive regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced cholangiocarcinoma.
How similar studies have performed: While this approach combines established therapies, the specific combination and its efficacy in cholangiocarcinoma is being explored, indicating a novel aspect of treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or radiologically confirmed intrahepatic cholangiocarcinoma * Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors Exclusion Criteria: * Direct surgery after hospitalization * Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.) * Initial treatment involving other comprehensive therapeutic regimens
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Weilin Wang, PHD
- Email: wam@zju.edu.cn
- Phone: +86 057187783820
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.