Abstract 215P
Background
PVTT is one of the main factors for poor prognosis of HCC, leading to intrahepatic or extrahepatic metastasis, portal hypertension, jaundice, and ascites in a short period of time. The survival time is around only 2.7 ∼ 4.0 months, and the prognosis of pts with Vp4 is worse. VIC-TRIPLET study supported that Camrelizumab and Apatinib plus FOLFOX chemotherapy showed promising antitumor activity and acceptable safety for advanced HCC. Here, we further report the efficacy and safety of combination regimens for advanced HCC pts with PVTT from this study.
Methods
The VIC-TRIPLET study enrolled 35 unresectable HCC pts. Pts were administrated with systemic chemotherapy of FOLFOX regimens (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, 5-fluorouracil bolus 400 mg/m2, and 5-fluorouracil infusion 2400 mg/m2 in 46 hours; q3w, up to 6 cycles), plus camrelizumab (200 mg q3w) and apatinib (250 mg qd) until disease progression or intolerable toxicity occurred or for a year. The primary endpoint is overall response rate (ORR) per RECIST v1.1.
Results
24 pts with PVTT were enrolled, and 12 pts were with Vp4. As of June 2024, confirmed ORR of pts with Vp1-3 was 58.3% (7/12, RECIST v1.1). The median progression-free survival (PFS) and overall survival (OS) of these pts were 10.8 months and 14.3 months, respectively. Confirmed ORR of pts with Vp4 was 66.7% (8/12, RECIST v1.1). The median PFS of these pts was 13.7 months, while the median OS is not reached. 12 pts accepted surgical resection, all of them achieved R0 resection. The postoperative pathological complete response was 41.7% (5/12). The most common TEAEs was platelet count decreased (10 [41.7%]), and Grade ≥3 TEAEs occurred in 13 pts (54.2%). Table: 215P
| ALL (n=35) | PVTT-Vp0 (n=11) | PVTT-Vp1-3 (n=12） | PVTT-Vp4 (n=12） | |
| Response evaluation (Per RECIST v 1.1) | ||||
| ORR (%) | 60.0 | 54.5 | 58.3 | 66.7 |
| DCR (%) | 97.1 | 100.0 | 91.7 | 100.0 |
| PFS-6 incidence (%) | 88.5 | 90.9 | 83.3 | 91.7 |
| PFS-9 incidence (%) | 76.1 | 80.8 | 74.1 | 74.1 |
| PFS-12 incidence (%) | 55.1 | 80.8 | 28.2 | 55.6 |
| the median time for PFS (mon) | 15.5 | NR | 10.8 | 13.7 |
| OS-12 incidence (%) | 76.6 | 90.0 | 67.5 | 73.3 |
| the median time for OS (mon) | NR | NR | 14.3 | NR |
| Response evaluation (Per mRECIST) | ||||
| ORR (%) | 68.6 | 54.5 | 66.7 | 83.3 |
| DCR (%) | 100.0 | 100.0 | 100.0 | 100.0 |
| Safety evaluation (Per CTCAE v5.0) | ||||
| Grade <3 TEAEs incidence (%) | 100.0 | 100.0 | 100.0 | 100.0 |
| Grade ≥3 TEAEs incidence (%) | 48.6 | 36.4 | 33.3 | 75.0 |
Conclusions
In pts for HCC with PVTT, especially Vp4, better survival can be achieved through combination therapy, which is worthy of clinical application.
Clinical trial identification
NCT05412589.
Editorial acknowledgement
Jiahui Liu, Xiaoqiang Fang (Jiangsu Hengrui Pharmaceuticals Co., Ltd.) provided editorial assistance.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.