NCT06417606

Lenvatinib and Adebrelimab Combined With GEMOX in the Perioperative Treatment of Potentially Resectable Intrahepatic Cholangiocarcinoma

A Single-arm, Prospective Clinical Study of Lenvatinib and Adebrelimab Combined With GEMOX in the Perioperative Treatment of Potentially Resectable Intrahepatic Cholangiocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhiyong Huang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, prospective clinical study was conducted to enroll 20 subjects. Each subject was treated with oral Lenvatinib + Adebrelimab + GEMOX (gemcitabine + oxaliplatin). The treatment phase before surgery was 3 cycles, and the evaluation was performed every 2 cycles. The evaluation was repeated before surgery, and the decision of surgery was made according to the evaluation results. To evaluate the efficacy and safety of Lenvatinib and Adebrelimab combined with GEMOX in the perioperative treatment of potentially resectable intrahepatic cholangiocarcinoma.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib（oral，12mg once daily if body weight ≥60Kg; Body weight \< 60Kg, 8mg/ day）； Adebrelimab（intravenous drip，1200mg once every 3 weeks）； GEMOX（intravenous drip，Gemcitabine 1000mg/m2, 2 times every 3 weeks d1+d8; intravenous drip，Oxaliplatin, 100mg/m2, was given every 3 weeks）

Timeline

• Start date: 2024-05-30
• Primary completion: 2025-04-20
• Completion: 2025-05-30
• First posted: 2024-05-16
• Last updated: 2024-05-22

Locations

1 site across 1 country: China