Abstract 266TiP
Background
The Checkmate 577 study (NCT02743494) has demonstrated that adjuvant nivolumab significantly improves DFS and DMFS in patients with EC and GEJC who have received neoadjuvant chemoradiotherapy (NCRT) with residual pathological disease post-surgery. However, the study has several limitations. First, only 230 cases (29.0%) of ESCC were included, which is the major type of EC in East-Asia. Second, only 40% of pN0 patients were enrolled, and this subgroup did not reach statistical significance. Third, one of inclusion criteria is patients received NCRT before surgery, As known, with state-of-the-art evidence emerged for neoadjuvant immunochemotherapy (NICT) for local advanced EC, NCRT is less applied in clinical practice. Taken collectively, the results from Checkmate 577 need to be interpreted with caution because they are not fully applicable to ESCC patients without lymph node metastasis who received radio-free regimen preoperatively. Therefore, it is essential to conduct a study on adjuvant therapy for patients with ESCC who have not reached the PCR (residual primary tumors with node-negative) after NICT followed by curative resection.
Trial design
The PPIO-008 study (NCT06354140) is a single-arm, multicenter, prospective phase II clinical trial conducted across multiple centers in China. The study will enroll 45 ESCC patients aged 18-75 years who have undergone NICT followed by curative resection with a pathological stage of ypT1-4aN0M0. The treatment plan consists of Tislelizumab 200mg Q3W combined with S-1 80-120mg daily (Discontinuation of medication during the third week of each cycle), with a planned treatment duration of up to 1 year or until disease progression. The primary endpoint is the 1-year DFS rate; secondary objectives include OS, DFS, safety, and quality of life. Assuming an enrollment period of 1 year and a follow-up period of 3 years, the study aims to improve the 1-year DFS rate by 15%. Based on Brookmeyer-Crowley analysis, with a two-sided alpha of 0.05 and 80% power, considering 10% drop-out, 45 patients are required for enrollment.
Clinical trial identification
NCT06354140.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.