Sintilimab for Esophageal Squamous Cell Carcinoma

A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive ESCC

Recruiting Phase 2 Interventional Study
Esophageal Squamous Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
31 (estimated)
Sponsor
Zhejiang Cancer Hospital · Other
Who this trial is looking for

This trial is looking for adults who have recently had surgery for esophageal cancer. Participants will receive a medication called sintilimab to see how well it works in preventing cancer from returning.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with esophageal squamous cell carcinoma.
  • I am between 18 and 100 years old.
  • I have had surgery to remove my esophageal cancer within the last 4 to 12 weeks.
  • I have been confirmed as disease-free by tests within the last 4 weeks.
  • I can tolerate the surgery I had.
  • I have a good performance status (ECOG PS 0-1).
  • I am not pregnant and not breastfeeding.

You may not be able to join if

  • I have advanced or metastatic esophageal cancer.
  • I have had any treatment for my esophageal cancer after surgery.
  • I have a serious or uncontrolled medical condition.
  • I have active autoimmune disease, unless specific criteria are met.
  • I have had an active infection requiring treatment in the past 28 days.
  • I have a known history of HIV or AIDS.
  • I have severe heart or lung disease.
  • I have a history of severe allergies to monoclonal antibodies.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The goal of this clinical trial is to evaluate the efficacy and safety of sintilimab as adjuvant therapy in node-positive esophageal squamous cell carcinoma after radical surgery without neoadjuvant therapy. The main question it aims to answer is: • Efficacy of sintilimab as adjuvant therapy Participants will receive sintilimab 200 mg once on day 1, every 21 days(Q3W).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Signed an Informed Consent Form 2. Participant type and target disease characteristics: * ECOG PS 0-1 * Histologically confirmed T1-3N+M0 thoracic esophageal squamous cell cancer (AJCC 8th) * can tolerate radical resection of esophageal cancer * Resection must be…
Contacts

Changchun Wang, MD

13606520363

wangcc@zjcc.org.cn

CONTACT