A Phase 2/3 interventional study of TACE/HAIC and Lenvatinib in Hepatocellular Carcinoma, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Phase 2/3, Interventional, and Treatment
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.
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 carcinoma is not very satisfactory.A series of study demonstrated that direct hepatectomy has better prognosis compared with TACE for these intermediate hepatocellular carcinoma patients.Despite of this ,The high recurrence risk, high probability of surgical complications, and poor treatment effect after recurrence of intermediate hepatocellular carcinoma after direct surgical treatment is a still a tough problem to be solved.Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver .In addition, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma.In this context，for those patients with potentially high recurrence risk after liver resection, the investigators carried out this prospective randomized control to demonstrate the superiority of TACE/HAIC combined with PD-1 antibody and lenvatinib as a neoadjuvant therapy before liver resection over direct hepatectomy.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 90 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
For patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection
Procedure: TACE/HAIC · Drug: Lenvatinib · Drug: Sintilimab
After being diagnosed with hepatocellular carcinoma, surgery will be immediately performed.
Procedure: liver resection
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.
Participants received lenvatinib capsules 8mg for patients weight \<60kg, or 12mg for patients weight more than 60Kg.
Sintilimab Injection will be administered every three weeks (200mg) until surgery or disease progression.
liver resection is feasible after evaluation by the liver cancer surgery expert group
Recurrence-free Survival
Time from the start of liver resection until tumor recurrence or death (from any cause).
Time frame: 12 months
Adverse effects
Frequency and severity of adverse effects as defined by CTCAE version 5
Time frame: 12 months
Plan to share: No
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Third Affiliated Hospital, Sun Yat-Sen University