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

Sponsor

Sulai Liu (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05546619

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: HIPEC+tislelizumab + targeted therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treating with a Design Protocol	Drug: HIPEC+tislelizumab + targeted therapy Patients with open liver lobe/segment resection, tumor excision, lymph node dissection will receive medication.

Arm

Intervention/Treatment

Experimental: Treating with a Design Protocol

Drug: HIPEC+tislelizumab + targeted therapy

Patients with open liver lobe/segment resection, tumor excision, lymph node dissection will receive medication.

Outcome Measures

Primary Outcome Measures

RFS [1 year]
Relapse free survival

Secondary Outcome Measures

OS [10 years]
Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)	Changsha	Hunan	China	410000

Sponsors and Collaborators

Sulai Liu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sulai Liu, Dc., Hunan Provincial People's Hospital

ClinicalTrials.gov Identifier:

NCT05546619

Other Study ID Numbers:

SLiu

First Posted:

Sep 21, 2022

Last Update Posted:

Sep 21, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sulai Liu, Dc., Hunan Provincial People's Hospital

High-risk hepatocellular carcinoma; Adjuvant therapy; HIPEC; Tislelizumab

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Sep 21, 2022