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Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tislelizumab
Irinotecan Hydrochloride
cetuximab
SBRT
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria: Aged 18-75 years Physical Condition Score (ECOG PS) of the Eastern Cancer Cooperative Group (USA) 0 or 1; Colorectal cancer diagnosed histologically and/or cytologically has metastases or relapses that are not curable by surgery Have received first - and second-line systemic antitumor therapy for mCRC (chemotherapy drugs may include fluorouracil, oxaliplatin, irinotecan, e.g. XELOX, FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; Can be combined with or without targeted drugs, such as cetuximab, bevacizumab);And disease progression after second-line treatment; Evaluation of lung or liver metastases can be evaluated, with stereotactic radiotherapy maneuverability; At least one measurable lesion as defined in RECIST version 1.1; Fertile patients must be willing to take effective pregnancy avoidance measures during the study period and ≥120 days after the last dose; Female patients with negative urine or serum pregnancy test results within 7 days or less before the first administration of the study drug; Have fully understood this study and voluntarily signed informed consent. Adequate organ and bone marrow function, meeting the following definitions: Blood routine (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no other drug correction within 14 days before treatment);Absolute count of neutrophils (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥80×109/L; Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min;Serum albumin ≥2.8g/dL, for patients with poor nutritional status before neoadjuvant therapy, patients who met the requirements through parenteral nutrition could also be included in the group;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN; Exclusion Criteria: 1. Pregnant or lactating women; Patients with a known history of allergy to any investigative drug, similar drug or excipient; Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction; Patients with a history of thromboembolism, except thrombosis caused by PICC; There are patients with active infection; Patients with unmanageable hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90mmHg); Patients with brain metastases with clinical symptoms or imaging evidence; Contraindications exist in treatment with other chronic diseases; Patients with a history of immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, nephritis, etc., with current AE ≥ grade 2; According to the evaluation criteria of NCI CTCAE version 5.0, there are patients with all kinds of toxicities ≥ grade 2 due to previous treatment; Other conditions that the researchers determined were not suitable for inclusion in the study. Received any antitumor therapy and participated in other clinical studies within 4 weeks before enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SBRT followed by tislelizumab plus cetuximab and irinotecan

    Arm Description

    Outcomes

    Primary Outcome Measures

    Objective response rate(ORR)
    ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR

    Secondary Outcome Measures

    Progression-Free Survival(PFS)
    PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first
    Overall Survival (OS)
    Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death.

    Full Information

    First Posted
    March 23, 2023
    Last Updated
    March 23, 2023
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05799443
    Brief Title
    Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer
    Official Title
    Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer: a Phase II, Single-arm Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 5, 2023 (Anticipated)
    Primary Completion Date
    April 5, 2024 (Anticipated)
    Study Completion Date
    April 5, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy and safety of SBRT followed by tislelizumab plus cetuximab and irinotecan in patients with previously treated RAS wild-type advanced refractory colorectal cancer

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SBRT followed by tislelizumab plus cetuximab and irinotecan
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Tislelizumab
    Intervention Description
    Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Irinotecan Hydrochloride
    Intervention Description
    Irinotecan will be administered on day 1 of each cycle at 180 mg/m2 once every 14 days.
    Intervention Type
    Drug
    Intervention Name(s)
    cetuximab
    Intervention Description
    cetuximab will be administered on day 1 of each cycle at 500 mg/m2 once every 14 days.
    Intervention Type
    Radiation
    Intervention Name(s)
    SBRT
    Intervention Description
    8-10Gy×5F,QOD
    Primary Outcome Measure Information:
    Title
    Objective response rate(ORR)
    Description
    ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR
    Time Frame
    From enrollment to 12 month
    Secondary Outcome Measure Information:
    Title
    Progression-Free Survival(PFS)
    Description
    PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first
    Time Frame
    From enrollment to 12 month
    Title
    Overall Survival (OS)
    Description
    Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death.
    Time Frame
    From enrollment to 12 month

    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: Aged 18-75 years Physical Condition Score (ECOG PS) of the Eastern Cancer Cooperative Group (USA) 0 or 1; Colorectal cancer diagnosed histologically and/or cytologically has metastases or relapses that are not curable by surgery Have received first - and second-line systemic antitumor therapy for mCRC (chemotherapy drugs may include fluorouracil, oxaliplatin, irinotecan, e.g. XELOX, FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; Can be combined with or without targeted drugs, such as cetuximab, bevacizumab);And disease progression after second-line treatment; Evaluation of lung or liver metastases can be evaluated, with stereotactic radiotherapy maneuverability; At least one measurable lesion as defined in RECIST version 1.1; Fertile patients must be willing to take effective pregnancy avoidance measures during the study period and ≥120 days after the last dose; Female patients with negative urine or serum pregnancy test results within 7 days or less before the first administration of the study drug; Have fully understood this study and voluntarily signed informed consent. Adequate organ and bone marrow function, meeting the following definitions: Blood routine (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no other drug correction within 14 days before treatment);Absolute count of neutrophils (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥80×109/L; Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min;Serum albumin ≥2.8g/dL, for patients with poor nutritional status before neoadjuvant therapy, patients who met the requirements through parenteral nutrition could also be included in the group;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN; Exclusion Criteria: 1. Pregnant or lactating women; Patients with a known history of allergy to any investigative drug, similar drug or excipient; Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction; Patients with a history of thromboembolism, except thrombosis caused by PICC; There are patients with active infection; Patients with unmanageable hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90mmHg); Patients with brain metastases with clinical symptoms or imaging evidence; Contraindications exist in treatment with other chronic diseases; Patients with a history of immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, nephritis, etc., with current AE ≥ grade 2; According to the evaluation criteria of NCI CTCAE version 5.0, there are patients with all kinds of toxicities ≥ grade 2 due to previous treatment; Other conditions that the researchers determined were not suitable for inclusion in the study. Received any antitumor therapy and participated in other clinical studies within 4 weeks before enrollment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer

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