RecruitingPhase 3NCT05495152

Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma: a Multi-Centre, Open-Label, Randomized, Controlled, Clinical Trial (HCHTOG2203)

Sponsor

Henan Cancer Hospital

Enrollment

219 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

Summary

No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing sintilimab — an immunotherapy drug — as an additional treatment after surgery in patients with locally advanced esophageal squamous cell carcinoma (ESCC), a type of cancer of the food pipe. The goal is to reduce the risk of cancer coming back after surgery. **You may be eligible if...** - You are between 18 and 70 years old - You have squamous cell carcinoma in the chest portion of the esophagus confirmed by biopsy - You had a complete (R0) surgical removal of your cancer - Your cancer was at an advanced or node-positive stage, or had residual disease after neoadjuvant chemotherapy - You did not receive prior cancer treatment for other cancers - Your blood counts and liver function are within required ranges - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have active autoimmune disease - You have metastatic cancer - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGSintilimab

Patients in adjuvant arm receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks.

Locations(2)

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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