1541P - Neoadjuvant therapy of camrelizumab combined with chemotherapy in patients (pts) with resectable esophageal squamous cell cancer (ESCC)

Background

The study aimed to evaluate the efficacy and safety of neoadjuvant therapy of camrelizumab, combined with chemotherapy in resectable ESCC pts.

Methods

In this single-center, single-arm, exploratory clinical trial (ChiCTR2100050057), treatment naïve pts with histologically identified resectable ESCC were included. Eligible pts was treated with camrelizumab (200 mg, d1) combined with nab-paclitaxel (100 mg/m², d1 and d8) and nedaplatin (75 mg/m², d1) for 2 cycles (21 days per cycle). Radical surgery was conducted in the following 4-6 weeks. Primary endpoints were pathological complete response (pCR) rate, and major pathologic response (MPR).

Results

From Aug 13, 2021, to Jul 9, 2022, a total of 70 pts were enrolled in this study. Sixty-eight pts completed the two-cycle neoadjuvant therapy, with two pts discontinued the 2^nd cycle therapy for intolerable toxicity. As of March 15, 2023, 61 pts were available for efficacy evaluation, with 6 complete responses (CR), 35 partial responses (PR), and 20 stable diseases (SD) based on RECIST 1.1 criteria, resulting in an objective response rate (ORR) of 67.2%. Then 59 pts underwent surgery, as 11 pts refused. Overall, surgery-related complications occurred in 53 (89.8%) pts after resection. Pulmonary complications occurred in forty-nine pts (83.1%) and cardiac complications were observed in four pts (6.8%). The rate of anastomotic leakage was 20.3%. Vocal cord paralysis and wound infection occurred in 2 pts, respectively. The pCR and MPR rate were 27.1% and 59.3%, respectively. According to tumor regression grade, 19/59 (32.2%) pts had TRG0, 16/59 (27.1%) TRG1, 14/59 (23.7%) TRG2, and 10/59 (16.9%) TRG3. We analyzed the correlation between PD-L1 expression and pathological tumor regression and found no significant correlation between PD-L1 status and pathological reactions in ESCC. The most common AEs were anemia (70.0%) lymphocyte count decreased (67.1%) white blood cell count decreased (52.9%) and neutrophil count decreased (50%). Most AEs were grade 1-2. No grade 4/5 AEs occurred.

Conclusions

Neoadjuvant therapy of camrelizumab combined with chemotherapy has promising efficacy and good safety in ESCC pts.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Affiliated Cancer Hospital of Shandong First Medical University.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.