Camrelizumab plus albumin-bound paclitaxel and S-1 as first-line treatment for patients with human epidermal growth factor receptor 2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial.

BACKGROUND

Current first-line treatment options for human epidermal growth factor receptor 2 (HER2)-negative advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma have limited efficacy. This study aimed to evaluate the efficacy and safety of camrelizumab plus albumin-bound paclitaxel and S-1 as first-line treatment for this population.

METHODS

In this phase 2 trial (NCT04675866), patients received albumin-bound paclitaxel (125 mg/m2, days 1 and 8) and S-1 (40-60 mg per body surface area, twice daily on days 1-14) for 4-6 cycles of 21 days each. Camrelizumab (200 mg every 3 weeks) was concurrently initiated and continuously administered until disease progression, intolerable toxicity, or completion of 2-year treatment. The primary endpoint was objective response rate (ORR).

RESULTS

Between December 2020 and December 2024, 47 patients were enrolled. By the data cutoff date (January 6, 2025), the median follow-up duration was 16.7 months (range, 1.6-42.2 months). Among the 40 patients with evaluable efficacy, the ORR was 67.5% (95% CI: 52.3%-82.7%). The disease control rate was 95.0%. Median progression-free survival was 7.8 (95% CI: 6.2-9.4) months, and median overall survival was 23.8 (95% CI: 15.2-32.4) months. Grade 3-4 treatment-related adverse events(TRAEs) occurred in 18 patients (38.3%), with the most common being decreased neutrophil count (12 [25.5%]) and anemia (four [8.5%]).

CONCLUSION

The combination of camrelizumab, albumin-bound paclitaxel, and S-1 as first-line treatment for patients with HER2-negative advanced G/GEJ adenocarcinoma showed promising efficacy and an acceptable safety profile. Randomized controlled clinical trials are required to further demonstrate its efficacy and optimal application scenario.

CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04675866?term=Hou%20Xinfang&rank=1, identifier NCT04675866.