RecruitingPhase 2Phase 3NCT06138028

Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

The Prospective Study of Sintilimab Combination With Chemotherapy Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma

Sponsor

Qingdao Central Hospital

Enrollment

90 participants

Start Date

Sep 20, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Esophageal Squamous Cell Carcinoma

Summary

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining an immunotherapy drug (sintilimab) with chemotherapy, followed by radiation therapy, can improve outcomes for people with Stage IV esophageal squamous cell carcinoma — a type of advanced throat/esophageal cancer. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of Stage IV esophageal squamous cell carcinoma - You have at least one tumor that can be measured on scans - Your overall health is good (ECOG 0 or 1) - Your expected survival is at least 3 months - Your blood counts, liver, and kidney function meet the required levels **You may NOT be eligible if...** - Your cancer is not squamous cell type - Your general health is too poor to receive combination chemotherapy and immunotherapy - Your organ function is insufficient - You have previously received treatment for Stage IV esophageal cancer 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

DRUGTP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）

TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）for 4 cycles, then irradiation of the residual lesions for 50Gy/2Gy/25f. After complete irradiation, sintilimab is administered every 21 days a cycle for additional 13 cycles.