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Trial 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
NCT ID:
NCT05546619
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Tislelizumab
Conditions: Keywords:
High-risk hepatocellular carcinoma; Adjuvant therapy; HIPEC; Tislelizumab
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HIPEC+tislelizumab + targeted therapy
Description:
Patients with open liver lobe/segment resection, tumor excision, lymph node dissection
will receive medication.
Arm group label:
Treating with a Design Protocol
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)
Address:
City:
Changsha
Zip:
410000
Country:
China
Start date:
August 1, 2022
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Sulai Liu
Agency class:
Other
Source:
Hunan Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05546619
