Perioperative Treatment of High-risk Resectable CCA with HAIC Plus A+T: Neobrave CCA

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Intrahepatic Cholangiocarcinoma (Icc)Perihilar Cholangiocarcinoma
Interventions
COMBINATION_PRODUCT

Gemcitabine Oxaliplatin and 5FU

The perioperative treatment plan includes neoadjuvant therapy and adjuvant therapy. Neoadjuvant therapy consists of three cycles of HAIC combined with atezolizumab and bevacizumab (atezo/bev), while adjuvant therapy includes two cycles of HAIC combined with atezolizumab and bevacizumab (atezo/bev), along with additional capecitabine or tegafur as auxiliary maintenance treatment for three cycles. The total treatment duration for the perioperative period is six months. HAIC regimen: gemcitabine (1,000 mg/m2, 2h, d1) + oxaliplatin (35 mg/m2, 2h, d1-2) + 5-FU (0.75g/m2, 22h, d1-2); atezolizumab (PD-L1 inhibitor): 1200 mg, intravenous infusion, administered within 24 hours before HAIC treatment; bevacizumab: 7.5 mg/kg, intravenously infused before HAIC treatment (bevacizumab use is paused during the third neoadjuvant treatment). Each cycle lasts for three weeks.

Trial Locations (1)

100142

RECRUITING

Peing University Cancer Hospital, Beijing

All Listed Sponsors
lead

Peking University

OTHER