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

Condition(s) studied

Investigational drug(s) / intervention(s)

Stereotactic 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.

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

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

Cisplatin 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 six cycles.

Study 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

Primary outcome measure(s)

• Overall Survival (OS) — Up to 36 months
  Defined as the time from initiation of treatment to death from any cause.

Trial sites (1)

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