Hepatocellular Carcinoma
Conditions
Keywords
High-risk hepatocellular carcinoma; Adjuvant therapy; HIPEC; Tislelizumab
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.
Interventions
DRUGHIPEC+tislelizumab + targeted therapy
Patients with open liver lobe/segment resection, tumor excision, lymph node dissection will receive medication.
Sponsors
Sulai Liu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RFS | 1 year | Relapse free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 10 years | Overall survival |
Countries
China
Outcome results
None listed