Clinical trial
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Patients With Potentially High Recurrence Risk After Liver Cancer Resection: a Prospective, Randomized, Controlled Clinical Study
Name
LHuanxian
Description
The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.
Trial arms
Trial start
2022-05-30
Estimated PCD
2023-12-30
Trial end
2024-12-30
Status
Recruiting
Phase
Early phase I
Treatment
TACE/HAIC
Within 1-3 days of lenvatinib and sintilimab, start Transarterial chemobolization treatment or FOLFOX-based chemotherapy infusion,after three months,patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection.
Arms:
TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
Lenvatinib
Participants received lenvatinib capsules 8mg for patients weight \<60kg, or 12mg for patients weight more than 60Kg.
Arms:
TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
Sintilimab
Sintilimab Injection will be administered every three weeks (200mg) until surgery or disease progression.
Arms:
TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
liver resection
liver resection is feasible after evaluation by the liver cancer surgery expert group
Arms:
Direct surgery group
Size
90
Primary endpoint
Recurrence-free Survival
12 months
Eligibility criteria
Inclusion Criteria:
* 1) Age 18-70 years old, gender is not limited.
* 2)The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
* 3)Patients must have at least one tumor lesion that can be accurately measured.
* 4)Conform to any of the following criteria (1) multiple nodules \>3; (2) ≥2 nodules, any of which is \>3 cm; (3) invasion of the portal vein or hepatic vein.
* 5)According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group
* 6)No previous anti-HCC treatment.
* 7)Eastern Co-operative Group performance status 2 or less.
* 8)Liver function: Child's A or B (score \< 7).
Exclusion Criteria:
* 1)Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava;
* 2) Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs;
* 3) Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-10-13
1 organization
2 products
1 indication
Product
LenvatinibIndication
Hepatocellular CarcinomaProduct
Sintilimab