Status:
UNKNOWN
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
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 patient...
Detailed Description
For patients with hepatocellular carcinoma staged BCLC B/C(intermediate hepatocellular carcinoma)，TACE is a widely used treatments .However ,The efficacy of TACE in intermediate hepatocellular carcino...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05250843
Start Date
May 30 2022
End Date
December 30 2024
Last Update
October 13 2023
Active Locations (1)
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1
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510630