51P - A phase II trial of camrelizumab in combination with hepatic arterial infusion chemotherapy (HAIC) for initially unresectable advanced extrahepatic cholangiocarcinoma (eCCA) and gallbladder cancer (GBC): An interim report

Background

Conversion therapy for biliary tract cancer has attracted increasing interest in recent years. Camrelizumab plus oxaliplatin-based chemotherapy has shown clinical activity as the first-line treatment for patients (pts) with advanced BTC. HAIC with oxaliplatin and 5-fluorouracil (HAIC-FO) could improve the objective response rate (ORR) in advanced perihilacholangiocarcinoma and GBC. This study aims to evaluate the efficacy and safety of camrelizumab in combination with HAIC-FO as conversion therapy in pts with initially unresectable advanced eCCA and GBC.

Methods

This ongoing phase II study enrolled pts with pathologically confirmed initially unresectable advanced eCCA or GBC to receive intravenous camrelizumab (200 mg, day 1, q2w) plus HAIC with oxaliplatin (40 mg/m² for 2 h, days 1-3, q4w) and 5-fluorouracil (800 mg/m² for 22 h, days 1-3, q4w). Treatment was continued until potential resectability could be achieved, disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was ORR per RECIST v1.1.The secondary endpoint was organ-specific ORR and safety.

Results

Between June 15, 2021 and April 15, 2024, 42 pts were enrolled and treated. Of these, 34 pts completed at least 4 cycles of conversion therapy and 7 pts still under treatment. The median follow-up time was 12.8 months. The ORR was 47.0% and the disease control rate was 61.8%. 14 pts underwent surgery after successful conversion therapy. The conversion rate was 41.2% and the R0 resection rate was 92.8%. 5(11.9%) of 42 pts had treatment-related adverse event (TRAEs) that were Grade 3 or 4. No Grade 3 or 4 TRAEs occurred after surgery. Table: 51P

Conclusions

These promising preliminary results may suggest camrelizumab in combination with HAIC-FO as an effective therapeutic regimen for initially unresectable advanced eCCA and GBC.

Clinical trial identification

ChiCTR2100044629.

Editorial acknowledgement

Legal entity responsible for the study

W. Zhai.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.