Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06173986

Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer

Led by Shanghai Chest Hospital · Updated on 2023-12-18

50

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.

CONDITIONS

Official Title

Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Clinical stage T1N+M0 or T2-4aN0-3M0 according to the 8th UICC-TNM classification
  • Unresectable esophageal cancer due to unwillingness for surgery, technical unresectability, or medical unfitness
  • No prior anti-tumor treatment including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy
  • Adequate blood, lung, heart, liver, kidney, and thyroid function
  • Willing to use effective contraception throughout the study
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • History of malignant disease within 5 years before enrollment or presence of other malignant tumors or non-squamous cell carcinoma components
  • High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation
  • Weight loss greater than 20% within 90 days before starting treatment
  • Presence of long-lasting unhealed wounds or fractures or major surgery within 60 days before treatment
  • Severe or uncontrolled coexisting diseases including uncontrolled hypertension, interstitial lung disease or non-infectious pneumonia, active hepatitis B or C, syphilis, or other uncontrolled infections, cardiac insufficiency NYHA 2, renal dysfunction requiring dialysis, active autoimmune disease, or history of immunodeficiency diseases
  • Serious arterial or venous blood clots within 6 months before treatment
  • History of psychotropic substance abuse or psychotic disorders
  • Allergy to study drugs
  • Any other conditions judged by investigators to make participation unsuitable

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

Shanghai Chest Hospital

Shanghai, China

Actively Recruiting

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Research Team

W

Wen Yu, M.D

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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Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer | DecenTrialz