Abstract 190P
Background
Perioperative chemotherapy(CT) for resectable locally advanced gastric or gastroesophageal junction(G/GEJ) adenocarcinoma has favourable outcomes. Immune checkpoint inhibitors(ICIs) combined with CT have some efficacy in advanced G/GEJ adenocarcinoma. However, the application of ICIs in resectable locally advanced G/GEJ adenocarcinoma remains to be explored. Here, this clinical trial evaluates efficacy and safety of perioperative ICI(Camrelizumab) +CT(XELOX) in resectable locally advanced G/GEJ adenocarcinoma.
Methods
Treatment-naive patients(pts) with cT3-4aN1-3M0 resectable locally advanced G/GEJ adenocarcinoma were recruited to receive Camrelizumab(200mg, iv) on D1, Oxaliplatin(130 mg/m2, iv) on D1 and Capecitabine(1000 mg/m2, po, bid) on D1∼14 Q3W for 4 cycles, followed by surgery and adjuvant Camrelizumab+CT Q3W for 4 cycles. The primary endpoint was pCR rate. The secondary endpoints were MPR rate, ORR, EFS, DFS, safety and feasibility of surgery. The exploratory endpoint was correlation between PD-L1 and TMB expression and efficacy.
Results
From 9/2020 to 1/2023, 46 pts were enrolled, received and completed neoadjuvant treatment, 43 of which had underwent D2 resection. 38 pts received, but 35 pts completed adjuvant treatment. In the ITT analysis set, pCR(TRG1a) occurred in 9 pts(19.6%, 95%CI: 9.9%-34.4%), and MPR(TRG1a/b) occurred in 25 pts(54.3%, 95%CI: 39.2%-68.8%). TRG1b, TRG2 and TRG3 were observed in 16(34.8%), 12 (26.1%) and 6(13.0%) pts, respectively. ORR was 69.6%(95%CI: 54.1%-81.2%), of which 12 pts achieved CR and 20 pts achieved PR. 1-year EFS and DFS achieved 93.101% and 93.108% respectively. Treatment-related adverse events(TRAE) occurred in 91.3% pts, and grade 3 TRAE occurred in 19.6% pts. No grade 4–5 TRAEs were observed. The toxicity and post-surgery complications were limited. Surgical feasibility was not affected.
Conclusions
Among patients with resectable locally advanced G/GEJ adenocarcinoma, neoadjuvant Camrelizumab combined with CT followed by surgery and adjuvant treatment demonstrated good efficacy and safety, providing a new treatment option for locally advanced G/GEJ adenocarcinoma.
Clinical trial identification
NCT05715632.
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