NCT06363006

Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer

Evaluation of the Efficacy and Safety of Cardonilimab Injection Combined With TKI as Second-line Treatment for Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Multicenter Real-world Clinical Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma. The main questions it aims to answer are: * Objective response rate (ORR) for evaluation * Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。

Detailed description

Have received at least one prior systemic treatment progression or intolerance for HCC. Cardonilizumab was administered every 2 weeks on the first day of each cycle for up to 24 months in the absence of investigator judgment that there is no longer a clinical continuation benefit, intolerable toxicity, initiation of a new antitumor therapy, withdrawal of informed consent, loss of follow-up, death, or other protocol requirements for treatment termination. Cardonilizumab will complete infusion within 60 minutes (± 10 minutes). Continuous monitoring of potential infusion reactions and allowing pre-treatment of hypersensitivity reactions or infusion rate adjustment according to protocol guidelines. For subjects who cannot tolerate a 60-minute infusion, the infusion time can be extended up to 120 minutes. Dose adjustment of cardonilizumab is not allowed during treatment, but delayed dosing is allowed for up to 12 weeks (since the last dosing time). If glucocorticoids are used in the treatment of irAE, In both cases where the glucocorticoid reduction process resulted in the suspension of cardonilizumab for more than 12 weeks, or in the treatment of AE that may or may not be related to cardonilizumab, and where the investigator determined that the patient would benefit from continued treatment, permission to continue treatment was required after discussion with the sponsor medical Ombudsman.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	TKI+Cardunilimab	Cardonilizumab 6mg/kg, IV, Q2W + lenvatinib 8mg (body weight \< 60kg) or 12mg(body weight ≥60kg) PO, QD, / Sorafenib 400mg, PO, BID/ Regorafenib 160mg, PO, QD/ Donafenib 200mg, PO, BID。 omniscience

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: China