Research on Effectiveness and Safety of the Treatment, Hyperthermic Intraperitoneal Chemotherapy Combined With Tislelizumab and Targeted Therapy, That is Used for High-risk Hepatocellular Carcinoma After R0 Resection

Not Applicable

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: HIPEC+tislelizumab + targeted therapy

• Registration Number: NCT05546619
• Lead Sponsor: Sulai Liu

Brief Summary

There are limited treatment options for HCC with high recurrence risk, and there is no consistent plan for adjuvant therapy after surgery. Hence an unmet clinical need. Based on previous studies on unresectable HCC patients combined with targeted and immunotherapy, it has been found that the effect is significant, but the effect of combined with HIPEC is not clear, and no similar studies have been reported. Therefore, this project intends to carry out a single-arm clinical study on the efficacy and safety of HIPEC + tislelizumab combined with targeted therapy for high recurrence risk HCC. And observe the clinical benefits, to provide new ideas and evidence-based basis for the treatment of HCC with high recurrence risk.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• (1) In line with the diagnostic criteria of Western medicine, the pathological section was diagnosed as HCC; imaging and intraoperative exploration of HCC patients with high risk of recurrence: multiple tumors or satellite lesions, tumor diameter>5cm, HCC rupture and bleeding, combined with vascular invasion, and serum AFP>32ng/ml.

(2)18-70 years (3) Liver function: Child-Pugh A、B (4) Patients voluntarily receive treatment with this program.

Exclusion Criteria

• (1) Patients did not meet the inclusion criteria. (2) Use of other antineoplastic drugs during the follow-up period (3) Severe heart and kidney damage. (4) Failure to follow the prescription for medication, and unable to judge the efficacy or incomplete information (5) Not suitable for targeted therapy and anti-PD1 immunotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treating with a Design Protocol	HIPEC+tislelizumab + targeted therapy	-

Primary Outcome Measures

Name	Time	Method
RFS	1 year	Relapse free survival

Secondary Outcome Measures

Name	Time	Method
OS	10 years	Overall survival

Trial Locations

Locations (1)

Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University); 🇨🇳 Changsha, Hunan, China