NCT06925516

A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC

Efficacy and Safety of Apatinib Combined With Adebrelimab and GEMOX Regimen Chemotherapy as the First-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma (ICC): A Single-arm, Multicenter, Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)

Detailed description

The investigators are conducting a clinical research study to evaluate the effectiveness and safety of a novel combination therapy for patients with advanced, unresectable intrahepatic cholangiocarcinoma (ICC). The study hypothesizes that combining three treatments, apatinib (an oral TKI selectively targeting VEGFR2) and adebrelimab (an immune checkpoint inhibitor) plus GEMOX chemotherapy (a standard chemotherapy regimen of gemcitabine and oxaliplatin), will significantly improve outcomes compared to traditional chemotherapy alone. The primary goal is to measure how many patients experience tumor response (objective response rate, ORR), with historical data suggesting a 16% response rate for chemotherapy alone, while this study aims to achieve a 40% response rate. Secondary goals include assessing how long patients live without cancer worsening (progression-free survival), overall survival, and monitoring side effects. The trial will enroll 38 participants across multiple hospitals, all of whom will receive the combination therapy for up to two years or until the cancer progresses or side effects become unmanageable. Researchers will also explore whether specific biological markers, such as tumor protein levels or genetic changes, predict better responses to the treatment. By testing this three-drug combination, the study seeks to provide a more effective and tolerable first-line option for a cancer type with limited treatment choices and poor survival rates.

Conditions

• Intrahepatic Cholangiocarcinoma (Icc)

Interventions

Type	Name	Description
DRUG	Apatinib and Adebrelimab in Combination With chemotherapy	Patients would receive Adebrelimab (IV 1200mg q3w) and apatinib (PO 250mg qd) plus GEMOX (up to 6 cycles) in 21day cycles. Apatinib and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.

Timeline

• Start date: 2025-01-22
• Primary completion: 2026-06-01
• Completion: 2027-10-01
• First posted: 2025-04-13
• Last updated: 2025-11-28

Locations

1 site across 1 country: China