Spots Global Cancer Trial Database for AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)

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Trial Identification

Brief Title: AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)

Official Title: Neoadjuvant Immune-Checkpoint Blockade Therapy Combining With TACE For Resectable Hepatocellular Carcinoma With High Recurrence Risk: A Phase II, Single-arm Clinical Trial

Study ID: NCT05578430

Conditions

Resectable Hepatocellular Carcinoma

Interventions

Cadonilimab

TACE

Surgery

Study Description

Brief Summary: This is a Phase 2, open-label, single-arm study of neoadjuvant immune-checkpoint blockade therapy (AK104) combining with TACE for resectable hepatocellular carcinoma. The purpose is to investigate the efficacy and safety of this therapeutic regimen to reduce the risk of postoperative recurrence in resectable HCC patients with a high risk of recurrence.

Detailed Description: The trial will recruit 54 patients. At the first step, 26 patients will be recruited. Only when at least 10 patients achieve major pathological response after surgery will the trial enter the second step and continue to recruit other patients. After being enrolled, all patients giving written informed consent will receive TACE plus 2-cycle of Cadonilimab treatment before surgery. Four weeks later after surgery, Cadonilimab treatment will be followed up to 16 cycles. The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.