An Open, Single-arm, Single-centre Clinical Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Intermediate to Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy

NCT05644379 Phase 1 ACTIVE_NOT_RECRUITING

To evaluate the efficacy and safety of Cadonilimab Injection in combination with Regorafenib in the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy .

Details

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	30
Start date	2022-11-24
Completion	2026-11

Conditions

• Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy

Interventions

• Cadonilimab Injection
• Regorafenib

Primary outcomes

• Overall response rate ( ORR) — up to 1 years
  Defined as proportion of patients who have a best response of CR or PR
• Overall survival (OS) — up to 3 years
  OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
• Progress Free Survival （PFS） — up to 3 years
  Defined as the time from enrollment to disease progression or death (whichever occurs first)
• Adverse Events (AEs) — up to 3 years
  Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

Countries

China