What question did this study set out to answer?

This trial aims to evaluate the effectiveness of adding sintilimab to standard neoadjuvant chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

May 30, 2026

Chemoradiotherapy plus sintilimab versus chemoradiotherapy as neoadjuvant treatment in locally advanced esophageal squamous cell carcinoma (NEOCRTEC2101): A multicenter, randomized, phase III trial.

Key Points

This trial aims to evaluate the effectiveness of adding sintilimab to standard neoadjuvant chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma.
Multicenter, open-label, randomized phase III trial with 422 patients.
Patients with resectable thoracic ESCC were randomly assigned (1:1) to receive either sintilimab plus chemoradiotherapy or chemoradiotherapy alone.
Neoadjuvant therapy included concurrent radiotherapy and chemotherapy, followed by surgical resection 6-8 weeks later.
Primary endpoint of overall survival will be assessed; secondary endpoints include progression-free survival and pCR rate.
Previous phase II trial showed promising pCR rates with sintilimab combined with NCRT.
Safety profile was acceptable in earlier stages with the use of sintilimab.

Abstract

TPS4248 Background: Neoadjuvant chemoradiotherapy (NCRT) followed by surgery is the current standard of care for resectable locally advanced esophageal squamous cell carcinoma (ESCC). The integration of immunotherapy is now challenging this established therapeutic paradigm. Our previous phase II trial demonstrated that combining PD-1 inhibitor and NCRT yielded an encouraging pathological complete response (pCR) rate with an acceptable safety profile in ESCC. Therefore, this multicenter, randomized phase III trial (NEOCRTEC2101) aims to compare the efficacy and safety of NCRT combined with sintilimab (a IgG4 anti-PD-1 monoclonal antibody) versus NCRT alone in patients with resectable locally advanced ESCC. Methods: This was a multicenter, open-label, randomized, phase III trial. Key eligibility criteria included previously untreated, histologically confirmed, resectable thoracic ESCC clinically staged as T1-4aN1-3M0 or T3-4aN0M0 according to the 8th edition of the UICC staging system, age 18–75 years, Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate hematologic and organ function. Key exclusion criteria included a history of other malignancies, previous antitumor therapy, severe comorbidities, active autoimmune disease, prior non-infectious pneumonitis, or interstitial lung disease. Eligible patients were randomly assigned (1:1) to sintilimab plus NCRT group or NCRT group. All patients received NCRT consisting of concurrent radiotherapy (40 or 45 Gy in 20 fractions) and chemotherapy (paclitaxel 50 mg/m² + cisplatin 25 mg/m² administered on days 1, 8, 15, and 22). Patients randomized to the sintilimab plus NCRT group additionally received sintilimab 200 mg via intravenous infusion on days 1 and 22. Surgical resection was performed 6-8 weeks following the completion of neoadjuvant therapy. The primary endpoint was overall survival, and the secondary endpoints were progression-free survival, pCR rate, R0 resection rate, and treatment-related adverse events. The planned sample size is 422 patients. This study opened to accrual in October 2022 and is currently recruiting patients. Clinical trial information: NCT05357846 .

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