Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)

Last updated: November 17, 2022
Sponsor: Shanghai Chest Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Cancer

Squamous Cell Carcinoma

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT05621707
drjunliu
  • Ages 18-75
  • All Genders

Study Summary

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age:18-75 years of age;
  2. Histologically confirmed squamous cell carcinoma;
  3. locally-advanced ,medical inoperability, technical irresectability, or patient refusalto surgery;
  4. Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
  5. Able to eat a semi-liquid diet;
  6. Less than 20% weight loss within 6 months;
  7. Adequate hepatic function, renal function, hematologic function and coagulationfunction;
  8. Documented informed consent.

Exclusion

Exclusion Criteria:

  1. Distant metastasis;
  2. Known malignancy diagnosed or require active treatment in the last 5 years, except forcancers that can be cured by surgery including cervical cancer in situ, basal orsquamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
  3. Prior thoracic irradiation, chemotherapy, or lobectomy
  4. Known diseases or conditions that are contraindicated for radiotherapy or surgery;
  5. Allergy to the research medications;
  6. Pregnant women or women preparing for pregnancy;
  7. Diagnosis of autoimmune disease or history of chronic autoimmune disease
  8. Absence of informed consent because of psychological, family, social and otherfactors;
  9. Patients with comorbidities (chronic pulmonary disease, poorly controlledhypertension, unstable angina, myocardial infarction within 6 months, unstable mentaldisorders requiring therapy).

Study Design

Total Participants: 50
Study Start date:
November 20, 2022
Estimated Completion Date:
November 19, 2026