Abstract 181P
Background
Hepatocellular carcinoma (HCC) is an extremely aggressive tumor, and surgical resection is the primary curative treatment. However, the high rate of early recurrence results in a poor prognosis. This study aims to evaluate the efficacy and safety of TQB2450 plus anlotinib as a perioperative regimen for the treatment of resectable HCC with a high risk of recurrence.
Methods
This single-arm, phase Ib study enrolled pts with primary resectable HCC who were at high risk of recurrence. High-risk features include tumor size >5 cm, multiple tumors (≤ 3), satellite nodules, and macrovascular invasion (MVI). Before surgery, pts received 3 cycles of TQB2450 (1200 mg, IV, d1, Q3W) plus 2 cycles of anlotinib (10 mg, PO, d1-d14, Q3W). The feasibility of resection was assessed by radiographic imaging. After 30 days of surgery, patients continued combination therapy for 24 weeks. The primary endpoints were pCR and ORR (mRECIST). Secondary endpoints were PFS, OS, and safety. CRAFITY was derived from serum CRP and AFP values at baseline by adding one point each for CRP ≥1 mg/dL and AFP ≥100 ng/mL resulting in three categories: CRAFITY-low, 0 points; CRAFITY-intermediate, 1 point; CRAFITY-high, 2 points.
Results
As of July 15, 2023, 20 pts were enrolled (median age 61y [31-68], 95% male), 80% had HBV infection. All pts had Child-Pugh class A and ECOG PS 0. 11 (55%) had single (>5 cm) and 9 (45%) had multiple tumors. While n=10 (50%), n=8 (40%), and n=2 (10%) had CRAFITY-low, intermediate and high, respectively. Of 17 evaluable pts, ORR was 29.4% (5/17), 2 PR pts had low and 3 had intermediate CRAFITY scores. 13 pts completed preoperative therapy and underwent hepatic resection, the R0 resection rate was 100% and the pCR rate was 23.1% (3/13). Among the 3 pCR pts, 1 had low and 2 had intermediate CRAFITY scores; 2 had multiple tumors and no pts had MVI. 13 pts had TRAEs and grade 3/4 TRAEs (10%) including one hypertension (grade 3) and one liver damage (grade 4).
Conclusions
Neoadjuvant therapy combining TQB2450 and anlotinib shows promising results, with a tolerable safety profile. The predictive role of the CRAFITY score for HCC prognosis is worth further exploration.
Clinical trial identification
Clinical trial information: NCT04888546.
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
153P - IMbrave150: Exploratory analyses for investigating associations between overall survival (OS) and depth of response (DpR) or duration of response (DoR) in patients (pts) with unresectable hepatocellular carcinoma (HCC)
Presenter: Masatoshi Kudo
Session: Poster Display
Resources:
Abstract
154P - Adverse events (AEs) as potential predictive factors of activity in patients with advanced hepatocellular carcinoma (HCC) treated with atezolizumab plus bevacizumab (AB)
Presenter: Mara Persano
Session: Poster Display
Resources:
Abstract
155P - Penpulimab combined with anlotinib and nab-paclitaxel plus gemcitabine (PAAG) as first-line treatment for advanced metastatic pancreatic cancer: A prospective, multicenter, single-arm, phase II study
Presenter: Juan Du
Session: Poster Display
Resources:
Abstract
156P - Phase II trial of second-line regorafenib in patients with unresectable hepatocellular carcinoma after progression on first-line atezolizumab plus bevacizumab: REGONEXT trial
Presenter: Jaekyung Cheon
Session: Poster Display
Resources:
Abstract
157P - T/N ratio and radiation dose delivered do not correlate with the development of Radioembolization-Induced Liver Disease (REILD) in Hepatocellular Carcinoma (HCC) following Y90 selective internal radiation therapy (Y90-SIRT): A retrospective, single tertiary centre cohort study
Presenter: Daniel Yang Yao Peh
Session: Poster Display
Resources:
Abstract
158P - Single-cell RNA sequencing via Endoscopic Ultrasoundguided Fine-Needle Biopsy (EUS-FNB) Pancreatic Biopsies uncovered an aggressive subclone with a poor prognosis
Presenter: Yung-yeh Su
Session: Poster Display
Resources:
Abstract
159P - Classical computer vision and modern deep-learning of pancreatic stroma histology features to diagnose cancer
Presenter: Abdelhakim Khellaf
Session: Poster Display
Resources:
Abstract
160P - Interim analysis of the NAPOLEON-2 study: Safety evaluation of nano-liposomal irinotecan with fluorouracil and folinic acid for advanced pancreatic cancer
Presenter: Wataru Kusano
Session: Poster Display
Resources:
Abstract
161P - Screening and COnsensus based on Practices and Evidence (SCOPE): Real-world survey on Japanese and rest-of-world practice patterns in resectable pancreatic cancer
Presenter: Elizabeth Smyth
Session: Poster Display
Resources:
Abstract
162P - Recurrence pattern of hepatocellular carcinoma patients receiving curative surgery of RFA: An update
Presenter: Long Chan
Session: Poster Display
Resources:
Abstract