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
16P - Patient and healthcare practitioner preferences in early-stage triple-negative breast cancer treatment: A discrete choice experiment
Presenter: Jiun-I Lai
Session: Poster Display
Resources:
Abstract
17P - Initial outcomes of the ACT Now PRIME CARE for breast cancer: Prevention of Breast canceR (screening/ stage shifting) utilizing Integrated MobilE Clinics and pAtient Reported online Evaluations and Education
Presenter: Herdee Gloriane Luna
Session: Poster Display
Resources:
Abstract
18P - Optimizing premenopausal HR+ HER2–ve eBC management in India: Insights from expert consensus
Presenter: Anitha Ramesh
Session: Poster Display
Resources:
Abstract
19P - Referral patterns among breast cancer patients in county-level hospitals in China
Presenter: Ping Lu
Session: Poster Display
Resources:
Abstract
20P - Real-world treatment of HER2+ and HR+/HER2- early breast cancer in county areas of China
Presenter: Ping Lu
Session: Poster Display
Resources:
Abstract
21P - Duration of breast cancer trials: Analysis of predicted versus actual completion date
Presenter: Daniëlle Verschoor
Session: Poster Display
Resources:
Abstract
22P - Impact of an online Asian genetic risk calculator on risk perception: Cancer-related distress and uptake of genetic counselling among Malaysian breast cancer patients (The ARiCa Study)
Presenter: HEAMANTHAA Padmanabhan
Session: Poster Display
Resources:
Abstract
23P - Consensus statements and expert recommendations for BRCAm breast cancer in the Asia-Pacific region (STREAM-AP)
Presenter: Soo Chin Lee
Session: Poster Display
Resources:
Abstract
24P - Germline genetic testing for hereditary cancer: A retrospective analysis in a single site referral centre in Malaysia
Presenter: Vivian Lee
Session: Poster Display
Resources:
Abstract
25P - Clinical presentations and prognostication of HER2-low breast cancer in Taiwan
Presenter: Bo-Fang Chen
Session: Poster Display
Resources:
Abstract