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
957P - Interim report of Notable-HCC: A phase Ib study of neoadjuvant PD-1 with stereotactic body radiotherapy in patients with resectable hepatocellular carcinoma (HCC)
Presenter: Mingming Li
Session: Poster session 18
959P - Combination therapy of envafolimab and suvemcitug in patients with hepatocellular carcinoma (HCC): Results from a phase II clinical trial
Presenter: Lixia Ma
Session: Poster session 18
960P - Personalized circulating tumor DNA (ctDNA) monitoring for recurrence detection and treatment response assessment in hepatocellular carcinoma (HCC)
Presenter: Maen Abdelrahim
Session: Poster session 18
961P - Blood circulating Galectin-3 is a prognostic biomarker in hepatocellular carcinoma
Presenter: Shadi Chamseddine
Session: Poster session 18
962P - SBRT improves the efficacy of immuno-checkpoint inhibitors for hepatocellular carcinoma through the activation of IL-6/JAK1-STAT3/PD-L1 axis mediated by MBD3 degradation
Presenter: Weiwei Yan
Session: Poster session 18
963P - Discovery and validation of cfDNA methylation, AFP and ctDNA mutation for the early detection of hepatocellular carcinoma: A multicenter prospective study (ASCEND-Hep)
Presenter: Mingxin Pan
Session: Poster session 18
966P - Potential role of neuropilin-1 in the prognosis, development and risk of invasion in hepatocellular carcinoma patients
Presenter: Tania Payo-Serafín
Session: Poster session 18
967P - The effect of prognosis value of EZH2 (Enhancer Of Zeste Homologue) staining in hepatocellular cancer
Presenter: Mehmet Kidi
Session: Poster session 18