Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT06422858
Brief Summary:
This Phase II trial evaluates the efficacy and safety of Serplulimab combined with S1 chemotherapy in patients with inoperable, locally advanced esophageal squamous cell carcinoma after concurrent chemoradiation. The primary endpoint is the one-year progression-free survival rate. Secondary measures include clinical response rates, overall survival, duration of response, and safety profiles. Exploratory goals focus on the potential of biomarkers like PD-L1 and ctDNA to predict treatment outcomes. Treatment involves initial chemoradiation followed by consolidation with Serplulimab and S1, continuing for up to 12 months or until disease progression or unacceptable toxicity.
Detailed Description:
Detailed Description:
This single-arm, Phase II study is designed to assess the efficacy and safety of the combination of Serplulimab (an anti-PD-1 antibody) and S1 (an oral fluoropyrimidine derivative) in patients with locally advanced, inoperable esophageal squamous cell carcinoma (ESCC), following concurrent chemoradiation therapy.
Study Treatment Regimen:
Patients enrolled in the study will first undergo concurrent chemoradiation, which includes a total radiation dose of 50.4 Gy delivered in 28 fractions over six weeks. Radiation will be administered using modern techniques such as image-guided radiation therapy (IGRT), intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), or helical tomotherapy (TOMO), ensuring precise targeting of the tumor and surrounding lymph nodes. Concurrent chemotherapy consists of cisplatin (75 mg/m2 on day 1) and S1 (60 mg/m2 per day, given in two divided doses from day 1 to day 14, repeated every 28 days).
Following chemoradiation, patients will receive consolidation therapy with Serplulimab administered at a fixed dose of 300 mg every three weeks via intravenous infusion, alongside S1 (60 mg/m2 per day, on days 1-14 of a 21-day cycle). This consolidation phase will continue for up to 12 months or 17 cycles, unless there is disease progression, patient withdrawal, onset of unacceptable toxicity, or initiation of new anti-cancer treatment.
Study:
NCT06422858
Study Brief:
Protocol Section:
NCT06422858