Abstract 175P
Background
BCLC staging classifies HCC with PVTT as progressive stage (stage C) and recommends systemic treatment for these patients. Multidisciplinary treatment may improve long-term survival. Tislelizumab (Tisle) alone or plus lenvatinib have shown promising efficacy, and HAIC has a favorable tumor shrinkage effect. This trial aims to explore the safety and feasibility of tisle plus HAIC in the treatment of HCC with PVTT.
Methods
HCC patients with PVTT with Child-Pugh A, ECOG PS 0-1, no prior systemic therapy were eligible. Patients start treatment with 2 cycles of tisle (200mg, d1, Q3W) combined with HAIC (mFOLFOX6), surgical feasibility was then assessed. Patients who are resectable will receive adjuvant treatment of tisle for up to 1 year. Unresectable patients will receive tisle plus lenvatinib (8mg/kg, PO, qd) and HAIC until disease progression or intolerance of adverse reactions. Primary endpoint was event free survival (EFS), the secondary endpoints were major pathologic response rate (MPR, ≥70% tumor regression), surgical resection rate, ORR, OS and safety.
Results
Between Apr. 26, 2020 and Nov. 3, 2023, 17 patients (median age, 53 years) were enrolled, with 88.2% were males and 82.4% had HBV infection. PVTT types were Vp1 (n=7), Vp2 (n=4) and Vp3 (n=6). All 17 patients have completed the treatment of tisle plus HAIC, ORR was 82.4%, DCR reached 100% (mRECIST: 5 CR, 9 PR, 3 SD). Among them, 14 patients underwent surgical resection, start the adjuvant therapy. pCR was confirmed in 4 tumors (28.6%), and MPR rate was 50%. By Jan. 10, 2024, the median follow-up time was 11.70 months (95%CI 4.34-16.82) and no deaths occurred. 4 patients developed recurrence, and postoperative mEFS was 25.04 months (95%CI 5.98-NR). For 3 patients who were not able to undergo surgery, the ORR was 66.7%, DCR was 100% (mRECIST: 1 CR, 1 PR, 1 SD). The safety was satisfied, 4 Grade 1-2 TRAEs occurred (2 rash, 4 thrombocytopenia, 1 hand-foot syndrome).
Conclusions
Multimodal therapies of Tisle, HAIC and hepatectomy was well tolerated and showed promising postoperative EFS for HCC patients with PVTT, and longer follow up are needed.
Clinical trial identification
ChiCTR2200057978.
Legal entity responsible for the study
H. Zhang.
Funding
This work was supported by grants from the Natural Science Foundation of China (No. 82172880) and the Fund of Education Key Laboratory on Signaling Regulation and Targeting Therapy of Liver Cancer, Eastern Hepatobiliary Surgery Hospital/National Center for Liver Cancer (No. 2022-MEKLLC-MS-004).
Disclosure
All authors have declared no conflicts of interest.