Sintilimab plus Lenvatinib conversion therapy for intermediate/locally advanced hepatocellular carcinoma: A phase 2...

Area of Science:

• Hepatobiliary Surgery
• Medical Oncology
• Clinical Trials

Background:

• Intermediate or locally advanced hepatocellular carcinoma (HCC) often carries a poor prognosis for patients ineligible for radical treatment.
• Conversion therapy aims to transform unresectable HCC into a resectable state, potentially improving survival rates.

Purpose of the Study:

• To evaluate the efficacy and safety of Sintilimab in combination with Lenvatinib as a conversion therapy for patients with intermediate to locally advanced HCC.
• To assess the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), event-free survival (EFS), and surgical conversion rate.

Main Methods:

• A single-arm, single-center phase 2 trial (NCT04042805) involving 36 adult patients with Barcelona Clinic Liver Cancer (BCLC) Stage B or C HCC.
• Patients received Sintilimab intravenously plus Lenvatinib orally, with resectability determined by imaging and liver function.
• Primary endpoint was ORR assessed by RECIST v1.1; secondary endpoints included DCR, PFS, EFS, surgical conversion rate, and safety.

Main Results:

• The objective response rate (ORR) was 36.1% and the disease control rate (DCR) was 94.4%.
• Eleven patients underwent radical surgery, and one received other ablative therapies; all 12 remained alive at a median follow-up of 15.9 months.
• Median PFS was 14.3 months for the 24 patients who did not undergo surgery; treatment was generally well tolerated with no treatment-related deaths.

Conclusions:

• Sintilimab plus Lenvatinib demonstrates safety and feasibility as a conversion therapy for intermediate to locally advanced HCC.
• This combination regimen offers a potential strategy to improve outcomes for patients initially unsuitable for surgical resection.