NCT06187961

Combined HAIC, Lenvatinib and Cadonilimab As Conversion Therapy for Unresectable Hepatocellular Carcinoma

A Phase 2, Open-label, Single Arm Study of Combined HAIC, Lenvatinib and Cadonilimab As Conversion Therapy for Unresectable Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of hepatic arterial infusion chemotherapy combined with lenvatinib and cadonilimab as conversion therapy for unresectable hepatocellular carcinoma.

Detailed description

Cadonilimab is the world's first PD-1/CTLA-4 bispecific antibody tumor immunotherapy new drug, a tetrameric PD-1/CTLA-4 bispecific antibody, which can only bind to TIL tetravalent co-expressing PD-1 and CTLA-4. This design not only retains the efficacy observed in the combination therapy of PD-1 plus CTLA-4 inhibitors, but also reduces the risk of activated T cells attacking healthy tissues, thereby alleviating the toxicity problem outside the tumor. On June 29, 2022, the National Medical Products Administration of China approved the new drug Cadonilimab for the treatment of recurrent or metastatic cervical cancer patients who have failed platinum-based chemotherapy. Currently, a phase II clinical study of lenvatinib combined with Cadonilimab systemic treatment for advanced hepatocellular carcinoma is underway, and preliminary results reveal that in 30 enrolled patients, the ORR was 44.4%, the DCR was 77.8%, the treatment-related adverse reaction rate was 83.3%, but the incidence of grade 3 or above adverse reactions was only 26.7%. The safety of this antibody in patients is generally good. This study intends to evaluate the safety and efficacy of HAIC combined with lenvatinib and cadonilimab as a conversion regimen in unresectable hepatocellular carcinoma.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
PROCEDURE	HAIC	administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.
DRUG	Lenvatinib plus cadonilimab	lenvatinib (8mg, qd) plus cadonilimab (10mg/kg, q3w)

Timeline

• Start date: 2023-12-07
• Primary completion: 2025-12-31
• Completion: 2027-06-30
• First posted: 2024-01-03
• Last updated: 2024-12-12

Locations

1 site across 1 country: China