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

Sponsor
Jinbo Yue
Study ID
NCT07030140
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bile Duct Cancer
  • Cholangiocarcinoma
  • Hilar Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Body Radiotherapy (SBRT) — RADIATION
    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 — DRUG
    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.
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m² administered intravenously on Days 1 and 8 of each 21-day cycle, for three to six cycles.
  • Cisplatin or Oxaliplatin — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jun 22, 2025
Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Jul 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tislelizumab + SBRT + GP Chemotherapy
    Participants will receive neoadjuvant stereotactic body radiotherapy (SBRT) followed by three cycles of combination therapy with tislelizumab and GP chemotherapy. SBRT: 5 Gy × 5-8 fractions or 4 Gy × 15 fractions to the primary tumor. Tislelizumab: 200 mg intravenously every 3 weeks (Day 1 of each cycle). Gemcitabine: 1000 mg/m² IV on Days 1 and 8 of each 21-day cycle. Cisplatin: 25 mg/m² IV on Days 1 and 8 OR Oxaliplatin: 100 mg/m² IV on Day 1 (based on clinical condition). After three cycles, patients will undergo re-evaluation. Those deemed resectable will undergo surgery and receive postoperative therapy based on multidisciplinary assessment. Patients remaining unresectable will receive an additional three cycles of the same systemic therapy.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 36 months ]

Central Contacts

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