Abstract 946P
Background
Hepatocellular carcinoma (HCC) patients (pts) with major vascular invasion (MVI) or extrahepatic metastases were generally recommended systemic treatment by guidelines, and pts have missed the opportunity for curative resection. Conversion therapy that can convert unresectable HCC into resectable HCC may improve patient survival. Here we report the Sintilimab plus Lenvatini as a conversion therapy for unresectable HCC.
Methods
Briefly, the main inclusion criteria of the study was: Aged 18 to 75 years unresectable HCC pts diagnosed pathologically and/or radiologically, with at least one measurable lesion (mRECIST). The criteria for Successful Conversion: 1. Child-Pugh score < 7. 2. ECOG PS score ≤1. 3. Downstaging to BCLC-A or PR according to mRECIST, and extrahepatic lesions can be resected at the same time. 4. Intact vascular structure of the reserved liver and sufficient FLR.
Results
A total of 137 pts were enrolled in the study by April 10, 2023 and accepted the Sintilimab plus Lenvatinib as conversion therapy,100 pts were finally included for evaluation, in which 58 pts with PVTT (39 pts were classified as VP4), 4 with IVCTT and 7 with both. 26 pts had extrahepatic metastases, and 92 pts were HBV-positive. According to mRECIST, the ORR was 54% and DCR was 77%. Successful conversion rate based on radiology was 51%, and 47% pts received hepatectomy. With a median follow-up of 17 months (range, 1-43), the median OS was 25 months (95% CI, 15.9–34.1) among all pts, the median OS of the pts was not reached [95% CI not reached] in the surgical group and 15 months (95% CI, 10.3–19.7) in the non-surgical group. The median RFS was 25 months (95% CI, 13.6–36.4) in the surgical group and the median PFS was 7 months (95% CI, 3.5–10.5) in the non-surgical group. All pts were evaluable for toxicity, and 83 (83%) pts had at least one treatment-related AE (TRAE). TRAEs occurring in ≥10% of pts were rash (27%), hypertension (18%), hand foot syndrome (17%), and diarrhoea (16%). 28 pts had grade 3 TRAEs.
Conclusions
The combination therapy of Sintilimab plus Lenvatinib can be reviewed as a reasonable and promising conversion therapy option for unresectable HCC with safety and effectiveness.
Clinical trial identification
ChiCTR1900023914.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1000P - Real-world clinical outcomes of cabozantinib (cabo) as a second-line (2L) treatment for advanced hepatocellular carcinoma (aHCC)
Presenter: Daniel Ahn
Session: Poster session 18
1001P - Patients’ prioritization of treatment goals in hepatocellular carcinoma (HCC): A global qualitative observational study (PERIDOT)
Presenter: Marcus-Alexander Wörns
Session: Poster session 18
1002P - Efficacy and safety of tislelizumab combined with TKIs and FOLFOX4-HAIC in conversion therapy of unresectable hepatocellular carcinoma
Presenter: Kai Tan
Session: Poster session 18
1003P - Efficacy and safety of triple combination therapy with transarterial chemoembolization (TACE), tyrosine kinase inhibitor (TKI), and immune checkpoint inhibitor (ICI) versus dual combination therapy in unresectable hepatocellular carcinoma (uHCC): A systematic review and meta-analysis
Presenter: Omar Maaño
Session: Poster session 18
1004P - Comparative efficacy of systemic sequential regorafenib after sorafenib or lenvatinib treatment failure for advanced hepatocellular carcinoma: A retrospective, multi-center, real-world study
Presenter: Danjun Song
Session: Poster session 18
1005P - Atezolizumab plus bevacizumab combined with transarterial chemoembolization and hepatic arterial infusion chemotherapy for unresectable hepatocellular carcinoma with high tumor burden
Presenter: Jiliang Qiu
Session: Poster session 18
1006P - Associations of online search trends and prescription trends for hepatocellular carcinoma drugs
Presenter: Philipp Berning
Session: Poster session 18
1007P - Network meta-analysis (NMA) of lenvatinib vs key comparators in first-line unresectable hepatocellular carcinoma (uHCC)
Presenter: David Trueman
Session: Poster session 18