Actively Recruiting
Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
Led by Jinbo Yue · Updated on 2026-05-01
38
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 tislelizumab plus GP chemotherapy. Patients with resectable disease after evaluation may undergo surgery and receive postoperative treatment as recommended by the multidisciplinary team. Those who remain unresectable will receive three additional cycles of systemic therapy. The primary endpoint is overall survival (OS); secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, progression-free survival (PFS), local control rate, and treatment-related safety.
CONDITIONS
Official Title
Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Histologically or cytologically confirmed hilar cholangiocarcinoma
- Borderline resectable or unresectable disease based on imaging and multidisciplinary team evaluation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate blood, liver, and kidney function
- No prior anti-tumor therapy for the current diagnosis
- Expected survival of at least 3 months
- Signed informed consent
You will not qualify if you...
- Evidence of distant metastasis
- Prior treatment with immune checkpoint inhibitors
- Uncontrolled infection or serious medical conditions
- Active autoimmune disease requiring systemic treatment
- History of organ transplantation or immunodeficiency
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
J
Jinbo Yue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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