Abstract 494TiP
Background
Neoadjuvant chemotherapy is the standard treatment for locally advanced gastric cancer. Immunotherapy together with chemotherapy showed a better prognosis for late GC than chemotherapy alone in multiple large-scale clinical trials. However, several recent studies demonstrated that neoadjuvant chemoimmunotherapy could increase the ratio of pathological complete recovery (pCR) but did not promote prognosis. Thus, it is rational to continue to explore and optimize the application of immunotherapy for locally advanced resectable GC. AK104/Cadonilimab is a PD-1/CTLA-4 bispecific antibody, and a study of AK104 combined with chemotherapy as the first-line therapy for advanced GC (NCT03852251) is ongoing. COX-2 inhibitor is a great regulator for the immune environment of tumors and increased pCR ratio in locally advanced MSI-H colorectal cancer in PICC study, which indicated that regulation of the tumor environment might be a great option to promote the efficacy of neoadjuvant treatment.
Trial design
This is an open-label, single-center, randomized, phase II study designed to evaluate the efficacy and safety of Cadonilimab and COX-2 inhibitor combined with Oxaliplatin and Capecitabine (XELOX) in perioperative treatment for locally advanced resectable GC. Patients with locally advanced resectable GC/GEJC and ECOG of 0 or 1 are eligible. Patients enrolled are randomized 1:1 to receive three cycles of XELOX alone or the combination of XELOX, Cadonilimab (10mg/kg, Q3W) and celecoxib (200mg daily oral administration), followed by D2 radical gastrectomy. After surgery, patients receive 3-5 cycles of adjuvant treatment consistent with preoperative treatment. The primary endpoint is pCR, and the secondary endpoints include R0 resection rate, 1- and 3-year OS rate, 1-&3-year DFS rate, and incidence rate of adverse events. pCR is assessed by blinded pathologists according to the AJCC 8th Edition TRG scoring system. Adverse events are graded per NCI CTCAE v4.0. Archival tumor tissues and blood samples are collected for further exploration. Recruitment for this study is ongoing.
Clinical trial identification
ChiCTR2300076761.
Legal entity responsible for the study
The authors.
Funding
Akesobio.
Disclosure
Y. Qian, E. Zhai, J. Ye, S. Chen, K. Yuan, Z. Wang, J. Xu, X. Zhang, J. Ma, C. Chen, J. Chen, S. Cai: Non-Financial Interests, Institutional, Sponsor/Funding, Akesobio provides Capecitabine freely in this study: Akesobio. J. Peng: Financial Interests, Institutional, Sponsor/Funding, Akesobio provides Capecitabine freely in this study: Akesobio.