190P - Perioperative camrelizumab combined with chemotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma: A single-arm, single-center, phase II clinical trial

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 cT_3-4aN_1-3M₀ 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.