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

Primary Purpose

Esophageal Squamous Cell Carcinomas, Concurrent Chemoradiotherapy, Immunotherapy

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
chemotherapy combined with PD-1 inhibitors
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinomas focused on measuring esophageal cancer, chemoradiotherapy, immunotherapy, chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age:18-75 years of age; Histologically confirmed squamous cell carcinoma; locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery; Eastern Cooperative Oncology Group (ECOG) performance status:0-2; Able to eat a semi-liquid diet; Less than 20% weight loss within 6 months; Adequate hepatic function, renal function, hematologic function and coagulation function; Documented informed consent. Exclusion Criteria: Distant metastasis; 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; Prior thoracic irradiation, chemotherapy, or lobectomy Known diseases or conditions that are contraindicated for radiotherapy or surgery; Allergy to the research medications; Pregnant women or women preparing for pregnancy; Diagnosis of autoimmune disease or history of chronic autoimmune disease Absence of informed consent because of psychological, family, social and other factors; Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    experimental arm

    Arm Description

    Two cycles of induction chemotherapy (nab-paclitaxel, 200 mg/m2/day, day1; carboplatin, area under the curve of 5 mg/ml/min, day 1) combined with PD-1 inhibitors （Sintilimab, 200 mg/day, day 1）every 3 weeks followed by concurrent chemoradiotherapy. Patients without progressive disease（PD） will proceed to receive immunotherapy (Sintilimab, 200 mg/day, every 3 weeks) as maintenance treatment for at least 1 year.

    Outcomes

    Primary Outcome Measures

    Overall Survival Rate
    Overall survival rate is defined as the percentage of participants who are alive up to 3 years from enrollment

    Secondary Outcome Measures

    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.
    Treatment related complications
    complications after treatment

    Full Information

    First Posted
    November 5, 2022
    Last Updated
    November 17, 2022
    Sponsor
    Shanghai Chest Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05621707
    Brief Title
    Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)
    Acronym
    RICE
    Official Title
    A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 20, 2022 (Anticipated)
    Primary Completion Date
    November 19, 2024 (Anticipated)
    Study Completion Date
    November 19, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Chest Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Squamous Cell Carcinomas, Concurrent Chemoradiotherapy, Immunotherapy, Chemotherapy
    Keywords
    esophageal cancer, chemoradiotherapy, immunotherapy, chemotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental arm
    Arm Type
    Experimental
    Arm Description
    Two cycles of induction chemotherapy (nab-paclitaxel, 200 mg/m2/day, day1; carboplatin, area under the curve of 5 mg/ml/min, day 1) combined with PD-1 inhibitors （Sintilimab, 200 mg/day, day 1）every 3 weeks followed by concurrent chemoradiotherapy. Patients without progressive disease（PD） will proceed to receive immunotherapy (Sintilimab, 200 mg/day, every 3 weeks) as maintenance treatment for at least 1 year.
    Intervention Type
    Drug
    Intervention Name(s)
    chemotherapy combined with PD-1 inhibitors
    Intervention Description
    Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy
    Primary Outcome Measure Information:
    Title
    Overall Survival Rate
    Description
    Overall survival rate is defined as the percentage of participants who are alive up to 3 years from enrollment
    Time Frame
    3 years after last patient enrolled
    Secondary Outcome Measure Information:
    Title
    progression-free Survival (PFS)
    Description
    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.
    Time Frame
    3 years after last patient enrolled
    Title
    Treatment related complications
    Description
    complications after treatment
    Time Frame
    During the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age:18-75 years of age; Histologically confirmed squamous cell carcinoma; locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery; Eastern Cooperative Oncology Group (ECOG) performance status:0-2; Able to eat a semi-liquid diet; Less than 20% weight loss within 6 months; Adequate hepatic function, renal function, hematologic function and coagulation function; Documented informed consent. Exclusion Criteria: Distant metastasis; 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; Prior thoracic irradiation, chemotherapy, or lobectomy Known diseases or conditions that are contraindicated for radiotherapy or surgery; Allergy to the research medications; Pregnant women or women preparing for pregnancy; Diagnosis of autoimmune disease or history of chronic autoimmune disease Absence of informed consent because of psychological, family, social and other factors; Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).

    12. IPD Sharing Statement

    Learn more about this trial

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

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