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Trial Title:
Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)
NCT ID:
NCT05621707
Condition:
Esophageal Squamous Cell Carcinomas
Concurrent Chemoradiotherapy
Immunotherapy
Chemotherapy
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Squamous Cell
Immune Checkpoint Inhibitors
Conditions: Keywords:
esophageal cancer
chemoradiotherapy
immunotherapy
chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
chemotherapy combined with PD-1 inhibitors
Description:
Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent
chemoradiotherapy
Arm group label:
experimental arm
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age:18-75 years of age;
2. Histologically confirmed squamous cell carcinoma;
3. locally-advanced ,medical inoperability, technical irresectability, or patient
refusal to 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 coagulation
function;
8. Documented informed consent.
Exclusion Criteria:
1. Distant metastasis;
2. Known malignancy diagnosed or require active treatment in the last 5 years, except
for cancers that can be cured by surgery including cervical cancer in situ, basal or
squamous 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 other
factors;
9. Patients with comorbidities (chronic pulmonary disease, poorly controlled
hypertension, unstable angina, myocardial infarction within 6 months, unstable
mental disorders requiring therapy).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 20, 2022
Completion date:
November 19, 2026
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05621707
