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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

January 1, 2028

Conditions
CholangiocarcinomaHilar CholangiocarcinomaBile Duct Cancer
Interventions
RADIATION

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.

DRUG

Tislelizumab

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.

DRUG

Gemcitabine

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

DRUG

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 three to six cycles.

All Listed Sponsors
lead

Jinbo Yue

OTHER