Cambrelizumab plus chemotherapy as conversion therapy for unresectable metastatic gastric cancer: A single-arm, multicenter, prospective clinical trial.

Authors

null

Shuang Li

Department of Gastric & Colorectal Surgery, The First Hospital of Jilin University, Changchun, China

Shuang Li , Liang He , Meng Li , Quan Wang

Organizations

Department of Gastric & Colorectal Surgery, The First Hospital of Jilin University, Changchun, China

Research Funding

No funding received

Background: Although anti-PD-1 antibody in combination with chemotherapy has shown promising antitumor activity in advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC), the evidence of conversion therapy for initially unresectable GC/GEJC is limited. Camrelizumab combined chemotherapy as conversion therapy for unresectable GC/GEJC was a prospective, single-arm, phase 2 study we conducted. Here, we updated the results of efficacy and safety of this study. Methods: Patients with HER-2 negative and PD-L1+ (CPS≥1) or MSI-H/dMMR, or EBV (+) unresectable gastric cancer were enrolled. Eligible patients must meet one of the following criteria: 1) peritoneal metastasis (CY1P0 or P1a, P1b or PCI < = 10); 2) liver metastasis (H1), < 3 metastatic sites; 3) para-aortic lymph node metastasis. For patients with lymph node metastasis or liver metastasis, they received 6 cycles of camrelizumab (200mg ivgtt on day1, q3w) plus SOX (Oxaliplatin, 130mg/m² ivgtt, d1, q3w, S-1 40/50/60 mg based on BSA, po, bid, d1-14, q3w) as conversion therapy. For patients with peritoneal metastasis, they received 6 cycles of camrelizumab (200mg ivgtt on day1, q3w) plus IP (Paclitaxel, 50mg/m², ivgtt, d1, d8, q3w. Paclitaxel, 20mg/m², intraperitoneal administration, d1, d8, q3w. S-1 40/50/60 mg based on BSA, po, bid, d1-14, q3w) as conversion therapy. Then patients without disease progression evaluated by imaging underwent gastrectomy of D2 lymph node dissection. The primary endpoint was R0 resection rate and 2 years survival rate, the secondary endpoints were objective response rate (ORR), pathological complete response (pCR) rate and overall survival. Results: Between December 30, 2020 and January 5, 2022, 31 patients were enrolled. 19 patients received SOX plus camrelizumab, 12 patients received IP plus camrelizumab. Unfortunately, 7 of them were confirmed PD by imaging. In addition, two patients refused gastrectomy and withdrew from the study. 12 patients underwent gastrectomy and 8 patients are in the process of conversion therapy. Among the 12 patients were evaluable, 9 of them gained R0 resection (75%), 1 patient (8.3%) achieved pCR and 2 patient (16.6%) reached TRG1. The most common grade 3 adverse events (AEs) were neutropenia (27.6%). No serious AEs resulted in termination of treatment or death. Conclusions: Camrelizumab combined with chemotherapy was an effective and safe conversion therapy strategy for patients with unresectable GC/GEJC. Furthermore, the analysis of biomarkers with clinical benefits is undergoing. Clinical trial information: NCT04694183.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT04694183

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr e16032)

DOI

10.1200/JCO.2022.40.16_suppl.e16032

Abstract #

e16032

Abstract Disclosures