1522P - Camrelizumab plus chemotherapy versus concurrent chemoradiotherapy as neoadjuvant therapy for resectable thoracic oesophageal squamous cell cancer (REVO): A multicenter, randomized, open-label, phase II trial

Background

Preoperative chemoradiotherapy (CRT) is the current standard treatment for locally advanced oesophageal cancer in the world. In previous single-arm clinical trials, neoadjuvant camrelizumab (anti-PD-1 antibody) plus chemotherapy showed durable antitumor activity with a manageable safety profile in patients with locally advanced oesophageal squamous cell carcinoma (ESCC). In this multicenter, randomized, open-label, phase II REVO trial, we compared immunochemotherapy (ICT) with concurrent CRT as neoadjuvant therapy in patients with resectable thoracic ESCC using a non-inferiority design.

Methods

Patients were randomly assigned to two to four 21-day cycles of intravenous camrelizumab (200 mg, day 1) plus albumin-bound paclitaxel (125 mg/m², days 1 and 8) and cisplatin (75 mg/m², day 1), or two 21-day cycles of albumin-bound paclitaxel and cisplatin combined with concurrent radiotherapy (36-40Gy in 20 fractions, 5 days per week), followed by surgery. The primary endpoint was pathological complete response (pCR) rate.

Results

Between September 2021 and March 2023, 85 patients had been enrolled, and the enrolment is still ongoing. As of April 6, 2023, 32 of 41 and 28 of 44 patients underwent surgery in the ICT and CRT groups, respectively. All patients achieved R0 resection. The pCR (ypT0N0) and major pathological response (MPR) rates were 40.6% (13/32) and 62.5% (20/32) in the ICT group and 35.7% (10/28) and 71.4% (20/28) in the CRT group, respectively. The incidence of grade ≥3 treatment-related adverse events (TRAEs) was 22.0% in the ICT group and 31.8% in the CRT group. The most common grade ≥3 TRAE was decreased lymphocyte count (14.6%) in the ICT group, and decreased lymphocyte count (18.2%) and decreased platelet count (6.8%) in the CRT group. One patient in the CRT group died due to pneumonia after surgery.

Conclusions

The current results suggest that neoadjuvant camrelizumab plus chemotherapy is non-inferior to concurrent CRT for patients with locally advanced ESCC, with better safety. The final results and long-term survival will be reported in the future.

Clinical trial identification

NCT05007145.

Editorial acknowledgement

Legal entity responsible for the study

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Funding

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.