Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-04 @ 6:24 PM
Study NCT ID:
NCT06422858
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2024-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma
Sponsor:
Zhejiang Cancer Hospital
Organization:
Study Overview
Official Title:
Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Stars
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: