RecruitingPhase 2NCT06422858

Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

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

Sponsor

Zhejiang Cancer Hospital

Enrollment

37 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of S-1 (an oral chemotherapy pill) and serplulimab (an immunotherapy drug) given after chemoradiation for people with locally advanced esophageal squamous cell carcinoma (cancer of the food pipe) who cannot have or choose not to have surgery. **You may be eligible if...** - You are aged 18–70 with confirmed locally advanced esophageal squamous cell carcinoma - You are medically unable to have surgery, or you choose not to have surgery - You have not received any prior cancer treatment - You are in good health (ECOG 0–1) with expected survival of at least 6 months - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have received prior treatment for esophageal cancer - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - Your tumor has spread to distant organs beyond what the staging allows Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

Serplulimab will be administered as a fixed dose of 300 mg via intravenous infusion every three weeks, continuing for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent

DRUGTegafur-gimeracil-oteracil potassium capsule(S1)

S1 will be administered at a dose of 60 mg/m2 per day, taken orally in two divided doses on day 1 concurrent with radiotherapy, repeated every 28 days; and from day 1 to day 14 of each 21-day cycle, for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent

RADIATIONRadiotherapy

Radiotherapy will be delivered as a total dose of 50.4 Gy in 28 fractions over six weeks using techniques such as IGRT, IMRT, VMAT, or TOMO, targeting the primary tumor and associated lymph nodes

DRUGCisplatin

Cisplatin will be administered at a dose of 75 mg/m\^2 on day 1 concurrent with radiotherapy, repeated every 28 days

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06422858