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AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)

Resectable Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05578430
Study type Interventional
Source Sun Yat-sen University
Contact Kuang Ming, Ph.D.
Phone 008687755766
Email kuangm@mail.sysu.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date January 1, 2023
Completion date January 1, 2025
View Details
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