RecruitingPhase 2NCT07030140

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

A Phase II, Single-arm, Prospective Clinical Study of Neoadjuvant Therapy With Tislelizumab Combined With Radiotherapy and Gemcitabine-Platinum Chemotherapy for Borderline Resectable or Unresectable Hilar Cholangiocarcinoma

Sponsor

Jinbo Yue

Enrollment

38 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma Bile Duct Cancer 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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria6

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

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Interventions

RADIATIONStereotactic Body Radiotherapy (SBRT)

SBRT to the primary tumor and metastatic lymph node at a dose of either 5 Gy × 5-8 fractions or 4 Gy × 15 fractions, delivered prior to systemic therapy.

DRUGTislelizumab

Tislelizumab 200 mg administered intravenously every 3 weeks (on Day 1 of each 21-day cycle), for three to six cycles depending on surgical eligibility.

DRUGGemcitabine

Gemcitabine 1000 mg/m² administered intravenously on Days 1 and 8 of each 21-day cycle, for three to six cycles.

DRUGCisplatin or Oxaliplatin

Cisplatin 25 mg/m² on Days 1 and 8 or oxaliplatin 100 mg/m² on Day 1 of each 21-day cycle, selected based on patient condition, for three to six cycles.