127P - A prospective phase II clinical trial exploring neoadjuvant immunotherapy combined with chemotherapy in resectable thoracic esophageal squamous cell cancer (TESCC) with multi-station lymph node metastases (NICE study): Preliminary results

Background

Patients (pts) with resectable TESCC with multi-station lymph node metastases derive unoptimistic overall survival benefit with neoadjuvant or postoperative adjuvant therapy. Camrelizumab (anti-PD-1) is standard of care as second-line therapy for advanced TESCC in China. We hypothesize that the addition of camrelizumab to neoadjuvant chemotherapy agents (albumin paclitaxel and carboplatin) will increase the pathological complete response (pCR) rate compared with historical controls.

Methods

This was an investigator-initiated trial for pts with newly diagnosed AJCC 8th resectable TESCC with multi-station lymph node metastases with a plan to have surgery. Pts received 2 courses of camrelizumab 200mg IV q3w added to carboplatin AUC=5 IV q3w plus albumin paclitaxel 100 mg/m² IV qwk with surgery 4 wks after the last dose. The primary objective was pCR. Our primary endpoint will be reached if 5/52 (9.6%) planned pts have pCR.

Results

From 11/2019 to 6/2020, 11 pts were enrolled all of whom had surgery. Median age was 65 (55-72), 9.1% women, and 36.4% PD-L1 positive (≥1%, 22C3). Pre-surgical grade 3/4 toxicity occurred in 8/11pts, and treatment was delayed by an average of 5.7 days due to toxicities. Grade 3/4 toxicities were neutropenia (8/11), thrombocytopenia (2/11). All pts recovered well from pre-surgical toxicities.Our primary endpoint was met; the pCR (pT0N0M0) was achieved in 45.4% (5/11) and pT0 was 54.5% (6/11). Radiologic response rate was 90.9% (PR10,CR0). Pts with either PD-L1+ or PD-L1- had pCRs. R0 resection rate was 100% (11/11). The average intraoperative blood loss was 172ml and the average hospitalization time after operation was 9 days (7-12days).No patient developed anastomotic leak and died due to treatment-related toxicity.

Conclusions

The addition of camrelizumab to neoadjuvant chemotherapy agents (albumin paclitaxel and carboplatin) was well tolerated. The primary endpoint of pCR in at least 5/52 pts was surpassed with pCR in 5/11 pts post-surgery. The pCR was seen independent of PD-L1 score. The surprisingly good preliminary results have encouraged us to keep this phase II study ongoing.

Clinical trial identification

ChiCTR1900026240.

Editorial acknowledgement

Legal entity responsible for the study

Shanghai Chest Hospital.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.