Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
Recruiting
Phase 2
Interventional Study
Cholangiocarcinoma
Hilar Cholangiocarcinoma
Bile Duct Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 38 (estimated)
- Sponsor
- Jinbo Yue · Other
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About This Trial
This is a phase II, single-arm, prospective clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy combining stereotactic body radiotherapy (SBRT), GP chemotherapy (gemcitabine and cisplatin/oxaliplatin), and tislelizumab in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Eligible patients will receive SBRT followed by three cycles of tisle…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 18-75 years, histologically or cytologically confirmed hilar cholangiocarcinoma
* Borderline resectable or unresectable disease based on imaging and MDT evaluation
* ECOG performance status 0-1
* Adequate hematologic, hepatic, and renal function
* No prior anti-tumor thera…
Contacts