Abstract 187P
Background
The recurrence rate of hepatocellular carcinoma (HCC) remains high and multinodular HCC is a well-defined high-risk factor. This trial is to evaluate the safety and efficacy of cadonilimab plus HAIC as a neoadjuvant management for the resectable multinodular HCC with CNLC stage Ⅰb/Ⅱa.
Methods
In this ongoing single-center, phase 2, open label, prospective cohort clinical trial, eligible patients (pts) were randomly assigned (1:1:1) to 3 arms and receive neoadjuvant therapy: (A) 2 cycles of cadonilimab (6mg/kg Q2W); (B) once HAIC with FOLFOX regimen followed by 2 cycles of cadonilimab; (C) once FOLFOX-HAIC. Pts receive scheduled surgery on day 21-28 and adjuvant HAIC one month after surgery. Primary endpoints were major pathologic response (MPR defined as ≤50% residual living tumor) and 1-year RFS rate. Secondary endpoints included ORR, DCR and TRAEs.
Results
From January 4 to August 20, 2023, 18 pts were enrolled and 16 pts have received scheming hepatectomy (5 pts in Arm A, 9 pts in Arm B, 2 pt in Arm C). Remarkably, almost all (8/9) pts in Arm B achieved MPR and some pts demonstrated focal heterogeneity—one lesion achieved pathologic complete response, while another got non-/partial response. No obvious tumor necrosis in Arm A and C, but the inflammatory infiltrating and fibrosis area seemed to increase in some HCC lesions. 3 pts in Arm B (3/9) achieved PR and DCR was 100% per RECIST 1.1. The most common TRAEs in Arm B and C were increased ALT, AST (Grade 1-3) and bilirubin (Grade 1), which mainly resulted from HAIC and can be improved by routine liver protection treatment. Main TRAEs observed in Arm A was increased AST (Grade 3). Two pts in Arm A and B delayed scheduled surgery for 3 weeks due to increased ALT/AST. One pt experienced postoperative controllable pneumonia which may relate to novel coronavirus (2019-nCoV) and cadonilimab. One pt experienced postoperative severe but curable bacterial hepatic abscess related to bilioenteric anastomosis and diabetes mellitus.
Conclusions
This study preliminarily demonstrated that neoadjuvant cadonilimab plus FOLFOX-HAIC had a promising antitumor activity and a manageable safety for the resectable multinodular HCC.
Clinical trial identification
ChiCTR2200067161; Chinese Clinical Trial Registry; 2022-12-28.
Editorial acknowledgement
The authors acknowledge to Akeso Biopharma Ltd. for their drugs and writing supports.
Legal entity responsible for the study
Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangxi Medical University.
Funding
Akeso Biopharma Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
281P - 10-year treatment outcome of prostate cancer patients with 3D conformal radiation: Experience of a single cancer institution in Iran
Presenter: Reyhane Bayani
Session: Poster Display
Resources:
Abstract
282P - Predictors of outcomes in patients with clinically lymph node-positive prostate cancer after definitive radiotherapy
Presenter: Jae-Sung Kim
Session: Poster Display
Resources:
Abstract
283P - Radiotherapy utilization rate and treatment patern of protate cancer at Cipto Mangunkusumo Central General Hospital (RSCM): What we learn from pre-pandemic era
Presenter: Riyan Apriantoni
Session: Poster Display
Resources:
Abstract
284TiP - CYCLONE 3: A phase III, randomized, double-blind, placebo-controlled study of abemaciclib in combination with abiraterone plus prednisone in men with high-risk metastatic hormone-sensitive prostate cancer
Presenter: Nobuaki Matsubara
Session: Poster Display
Resources:
Abstract
292P - Comparative characteristics of early cervical cancer diagnosis methods for Tashkent women
Presenter: Gulnoza Goyibova
Session: Poster Display
Resources:
Abstract
293P - Carboplatin in locally advanced cervical cancer treated with chemoradiation: An alternative to cisplatin
Presenter: Natalia Isabel Valdiviezo Lama
Session: Poster Display
Resources:
Abstract
294P - Concurrent chemoradiation with cisplatin every 3 weeks in locally advanced cervical cancer: A single arm phase II clinical trial
Presenter: Long Nguyen
Session: Poster Display
Resources:
Abstract
295P - A prospective study of dose escalated simultaneous integrated boost in node-positive cervical cancer
Presenter: Ritusha Mishra
Session: Poster Display
Resources:
Abstract
296P - Safety, efficacy, and immunogenicity of therapeutic vaccines for patients with high-grade cervical intraepithelial neoplasia (CIN 2/3) associated with human papillomavirus: A systematic review
Presenter: Caroline Amélia Gonçalves
Session: Poster Display
Resources:
Abstract
297P - The utilization rate of radiotherapy and chemotherapy for cervical cancer in Indonesia: Optimal versus actual, how far the gap?
Presenter: Charity Kotambunan
Session: Poster Display
Resources:
Abstract