1544P - Camrelizumab plus albumin-bound paclitaxel and S-1 as first-line treatment of advanced gastric/gastroesophageal junction cancer: A phase II clinical trial

Background

Patients (pts) with advanced gastric/gastroesophageal junction cancer that progresses on chemotherapy have poor outcomes. We investigated the safety and efficacy of camrelizumab combined with albumin-bound paclitaxel and S-1 in first-line treatment of HER-2-negative advanced gastric/gastroesophageal junction cancer.

Methods

This study was a single-arm, open-label, phase II clinical study. Eligible pts were adults with histologically confirmed HER-2 -negative advanced gastric/ gastroesophageal junction cancer. Pts participating in this study were required to detect PD-L1 expression, MSI/MMR status, and EBV virus content. Pts received camrelizumab (200 mg, day 1), S-1 (60mg/m² bid, days 1-14), and albumin-bound paclitaxel (125mg/m², days 1, 8) every 3 weeks. The maintenance therapy of camrelizumab (200 mg, day 1, every 3 weeks) was given to pts who did not progress after 4-6 cycles of chemotherapy until disease progression or unacceptable toxicity. Response was assessed every 6 weeks in accordance with RECIST1.1. The primary endpoint was overall response rate (ORR), and secondary endpoints included safety profile, progression free survival (PFS), overall survival (OS), and disease control rate (DCR).

Results

Between December 2020 and March 2023, a total of 28 pts were enrolled in this study. Median age was 57.5 (range: 35-71) years, and most pts were male (75.0%). Among 21 pts who were evaluated, the ORR was 71.4% (15/21) and the DCR was 95.2% (20/21). The median PFS was 9.3 months (95% Cl: 7.0-11.6), the Median follow-up time was 14.3 months (95% Cl: 9.9-18.7), and the one-year survival rate was 85.7%. The most common treatment-related adverse events of grade 3 or 4 included neutropenia (22.2%), leukopenia (22.2%), erythra (3.7%). There were no treatment-related deaths.

Conclusions

Camrelizumab plus albumin-bound paclitaxel and S-1 demonstrated promising activity and manageable safety in first-line treatment of HER-2- negative advanced gastric/gastroesophageal junction cancer.

Clinical trial identification

NCT04675866.

Editorial acknowledgement

Legal entity responsible for the study

Henan Cancer Hospital.

Funding

Jiangsu Hengrui Pharmaceutical Co. LTD.

Disclosure

All authors have declared no conflicts of interest.