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

Immunotherapy Clinical Trial

— RICE  

Official title:

A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05621707
• Other study ID #: drjunliu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 20, 2022
• Est. completion date: November 19, 2026

Study information

• Verified date: November 2022
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 19, 2026
• Est. primary completion date: November 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Chemotherapy
• Concurrent Chemoradiotherapy
• Esophageal Squamous Cell Carcinoma
• Esophageal Squamous Cell Carcinomas
• Immunotherapy
• Neoplasms, Squamous Cell

Intervention

Drug:
• chemotherapy combined with PD-1 inhibitors
Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival Rate	Overall survival rate is defined as the percentage of participants who are alive up to 3 years from enrollment	3 years after last patient enrolled
Secondary	progression-free Survival (PFS)	Progression-free survival is defined as the time between date of enrollment and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary tumor site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as PFS events.	3 years after last patient enrolled
Secondary	Treatment related complications	complications after treatment	During the procedure