This study will enroll 664 patients who had completed induction chemotherapy combined with the PD-1 antibody sintilimab treatment followed by concurrent cisplatin-based chemoradiotherapy (no concurrent sintiliamb). Patients will be randomly divided into two groups. One group will receive 9 cycles of sintilimab therapy, while the other group will receive an additional year of capecitabine chemotherapy on top of the sintilimab treatment. The primary endpoints will be event-free survival and overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
664
Sintilimab 200 mg, administered on Day 1, every 3 weeks for a total of 9 cycles
Capecitabine 650 mg/m², taken orally twice daily, continuously from Day 1 to Day 21, every 3 weeks, for a maximum of 1 year.
Sun Yat-sen University Cancer Center
Guangzhou, China, China
Event-free survival (EFS)
Time frame: 3-years
Overall survival (OS)
Time frame: 5-years
Distant metastasis-free survival (DMFS)
Time frame: 3-years
Locoregional recurrence-free survival (LRFS)
Time frame: 3-years
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: 5-years
Quality of life (QoL)
The change of QoL from randomization to 9 weeks (at the 3rd cycle of adjuvant sintilimab treatment), 1 year, 2 years, 3 years, 4 years, and 5 years after randomization. The EORTC QoL questionnaire-C30 (EORTC QLQ-C30) version 3.0 will be used. This questionnaire comprises 30 questions, 24 aggregated into nine multi-question scales: five functioning scales (e.g., physical), three symptom scales (e.g., fatigue), and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual of EORTC QLQ-C30.
Time frame: 5-years
Event-free survival (EFS) within different subgroups
analyses for EFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (=0 vs. \>0copies/ml after radiotherapy), different PD-L1 CPS (0 vs. ≥1), tertiary lymphoid structure (+ vs. -), age, sex, performance status, T category, N category, and stage (II vs. III).
Time frame: 3-years
Overall survival (OS) within different subgroups
analyses for OS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (=0 vs. \>0copies/ml after radiotherapy), different PD-L1 CPS (0 vs. ≥1), tertiary lymphoid structure (+ vs. -), age, sex, performance status, T category, N category, and stage (II vs. III).
Time frame: 5-years
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