Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma

Summary

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.

Eligibility

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 therapy for current diagnosis
* Expected survival ≥ 3 months
* Signed informed consent

Exclusion Criteria:

* Evidence of distant metastasis
* Prior treatment with immune checkpoint inhibitors
* Uncontrolled infection or serious medical comorbidities
* Active autoimmune disease requiring systemic therapy
* History of organ transplantation or immunodeficiency
* Pregnancy or lactation

Conditions4

Interventions3

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