Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06190639

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

Led by Zhejiang Cancer Hospital · Updated on 2024-01-05

31

Participants Needed

1

Research Sites

218 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed an Informed Consent Form
  • ECOG performance status 0-1
  • Histologically confirmed T1-3N+M0 thoracic esophageal squamous cell carcinoma according to AJCC 8th edition
  • Able to tolerate radical esophageal cancer surgery
  • Surgery performed within 4 to 12 weeks before enrollment
  • Confirmed disease-free by physical and imaging exams (CT/MRI scans of neck, chest, abdomen) within 4 weeks before enrollment
  • Baseline laboratory tests within 28 days before enrollment meeting all criteria: WBC 2000/bcL; neutrophils 1500/bcL; platelets 100 x 10b3/bcL; hemoglobin 9.0 g/dL; serum creatinine 1.5 x ULN or creatinine clearance >50 mL/min; AST 3 x ULN; ALT 3 x ULN; total bilirubin 1.5 x ULN (except <3 x ULN for Gilbert syndrome)
  • Age 18 years or older
  • Women of childbearing potential must have a negative pregnancy test within 24 hours before starting treatment
  • Women must not be breastfeeding
Not Eligible

You will not qualify if you...

  • Presence of locally advanced unresectable or metastatic disease
  • Tumors located in cervical or abdominal esophagus
  • Prior treatment after surgery for esophageal cancer such as chemotherapy, targeted therapy, radiation, or biotherapy
  • Grade 2 or higher peripheral neuropathy
  • Active, known, or suspected autoimmune diseases (except type I diabetes, hypothyroidism requiring only hormone replacement, and certain non-systemic skin conditions)
  • Use of systemic glucocorticoids (>10 mg prednisone daily) or other immunosuppressive drugs within 14 days before treatment
  • Known HIV infection or AIDS
  • Serious or uncontrolled medical conditions
  • Prior radiotherapy, chemotherapy, immunotherapy, esophagectomy, or related surgeries before trial
  • Severe cardiovascular or pulmonary diseases, interstitial pneumonia, or history of interstitial pneumonia
  • Active malignancy within last 3 years except certain locally curable cancers
  • Active hepatitis B or positive hepatitis C RNA test
  • History of allergy or severe hypersensitivity to study drug or monoclonal antibodies
  • Active infection needing systemic treatment within 28 days prior to dosing
  • Any condition preventing understanding or compliance with trial requirements
  • Other diseases judged by researchers as exclusionary for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

C

Changchun Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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