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Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody (PMMR/MSS)

Primary Purpose

Rectal Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring short course radiotherapy, furoquintinib, PD-1, low locally advanced rectal cancer

Eligibility Criteria

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

Inclusion Criteria: This study has been fully understood and voluntarily signed informed consent ; Age 18-75 years old ( including 18 and 75 years old ) ; rectal adenocarcinoma was histologically confirmed as pMMR / MSS type ( according to the detection criteria of the institutional testing center, it can be detected by immunohistochemistry, PCR or NGS ), and was staged as stage II ( T3-4N0 ) or stage III ( T1-4N1-2 ) by MRI and CT. 4.MRI was used to evaluate the middle and low rectal cancer below 10 cm from the anal margin of the tumor ; 5.Patients who were recommended for neoadjuvant therapy after evaluation by the Multidisciplinary Oncology Committee ; 6.ECOG physical condition 0-1 points ; 7.Expected survival ≥ 2 years ; 8.No previous anti-tumor treatment has been received ; the function of vital organs meets the following requirements ( not allowed to use any blood components and cell growth factors within * 14 days before enrollment ) : Absolute neutrophil count ≥ 1.5 × 109 / L ; platelet ≥ 100 × 109 / L ; hemoglobin ≥ 90g / L ; total bilirubin < 1.5 times ULN ; aLT and / or AST < 2.5 times ULN ; serum creatinine < 1.5 times ULN ; endogenous creatinine clearance rate ≥ 50ml / min ; 10. Women of childbearing age need to take effective contraceptive measures ; 11.good compliance, with follow-up. Exclusion Criteria: 1.Unable to comply with the research program or research procedures ; 2.Patients with surgical taboos ; 3.Patients with metastatic disease or recurrent rectal cancer ; 4.Patients with familial adenomatous polyposis ( FAP ), hereditary nonpolyposis colorectal cancer ( HNPCC ), active Crohn 's disease or active ulcerative colitis ; 5.Patients with other malignant tumors within 5 years before enrollment, except for basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ; 6.Severe cardiovascular diseases, including unstable angina or myocardial infarction, occurred within 6 months before enrollment ; 7.Subjects who were allergic to the study drug or any of its adjuvants ; 8.Participated in other domestic unapproved or unlisted drug clinical trials within 4 weeks before enrollment and received corresponding experimental drug treatment ; 9.International normalized ratio ( INR ) > 1.5 or activated partial thromboplastin time ( APTT ) > 1.5 × ULN ; 10.Investigators judged clinically significant electrolyte abnormalities ; 11.There was uncontrolled hypertension before enrollment, which was defined as : systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg ; 12.There were poorly controlled diabetes before enrollment ( after regular treatment, fasting glucose concentration ≥ CTCAE grade 2 ) ; 1.3.13.Before enrollment, there are any diseases or states that affect drug absorption, or patients cannot take oral drugs ; 14.Before entering the group, there were gastrointestinal diseases such as gastric and duodenal active ulcers and ulcerative colitis, or other conditions that may cause gastrointestinal bleeding and perforation determined by the researchers ; 15.Severe active bleeding, hemoptysis ( fresh blood > 5 mL within 4 weeks ) or thromboembolic events occurred within 12 months before enrollment ( package ).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody

    Arm Description

    Radiotherapy 5 * 5 Gy, once a day, 5 Gy each time, for 5 days.Two weeks after the end of radiotherapy, the patients were treated with furoquintinib combined with slurimab, furoquintinib 5 mg / time / day, d1-14, Q3 W ; combined with 300 mg of brucella, intravenous injection, d1, Q3W ; a total of 4 cycles of treatment.

    Outcomes

    Primary Outcome Measures

    cCR rate
    the clinical complete remission rate of short-course radiotherapy followed by sequential fruquintinib combined with PD1 monoantibody therapy for locally advanced rectal cancer.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2023
    Last Updated
    August 29, 2023
    Sponsor
    Changhai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06014944
    Brief Title
    Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody
    Acronym
    PMMR/MSS
    Official Title
    A Single-arm, Single-center, Prospective Clinical Study of Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody for Neoadjuvant Therapy of PMMR/MSS Type Middle and Low Locally Advanced Rectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2028 (Anticipated)
    Study Completion Date
    December 31, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Changhai 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
    The investigators conduct a single-arm, single-center, prospective clinical study enrolling patients diagnoses with pMMR / MSS type middle and low locally advanced rectal cancer who had not received systemic anti-tumor therapy to explore the efficacy and safety of short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody as neoadjuvant therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer
    Keywords
    short course radiotherapy, furoquintinib, PD-1, low locally advanced rectal 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
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
    Arm Type
    Experimental
    Arm Description
    Radiotherapy 5 * 5 Gy, once a day, 5 Gy each time, for 5 days.Two weeks after the end of radiotherapy, the patients were treated with furoquintinib combined with slurimab, furoquintinib 5 mg / time / day, d1-14, Q3 W ; combined with 300 mg of brucella, intravenous injection, d1, Q3W ; a total of 4 cycles of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
    Intervention Description
    neoadjuvant therapy for short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody for PMMR / MSS type middle and low locally advanced rectal cancer.
    Primary Outcome Measure Information:
    Title
    cCR rate
    Description
    the clinical complete remission rate of short-course radiotherapy followed by sequential fruquintinib combined with PD1 monoantibody therapy for locally advanced rectal cancer.
    Time Frame
    5 years

    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: This study has been fully understood and voluntarily signed informed consent ; Age 18-75 years old ( including 18 and 75 years old ) ; rectal adenocarcinoma was histologically confirmed as pMMR / MSS type ( according to the detection criteria of the institutional testing center, it can be detected by immunohistochemistry, PCR or NGS ), and was staged as stage II ( T3-4N0 ) or stage III ( T1-4N1-2 ) by MRI and CT. 4.MRI was used to evaluate the middle and low rectal cancer below 10 cm from the anal margin of the tumor ; 5.Patients who were recommended for neoadjuvant therapy after evaluation by the Multidisciplinary Oncology Committee ; 6.ECOG physical condition 0-1 points ; 7.Expected survival ≥ 2 years ; 8.No previous anti-tumor treatment has been received ; the function of vital organs meets the following requirements ( not allowed to use any blood components and cell growth factors within * 14 days before enrollment ) : Absolute neutrophil count ≥ 1.5 × 109 / L ; platelet ≥ 100 × 109 / L ; hemoglobin ≥ 90g / L ; total bilirubin < 1.5 times ULN ; aLT and / or AST < 2.5 times ULN ; serum creatinine < 1.5 times ULN ; endogenous creatinine clearance rate ≥ 50ml / min ; 10. Women of childbearing age need to take effective contraceptive measures ; 11.good compliance, with follow-up. Exclusion Criteria: 1.Unable to comply with the research program or research procedures ; 2.Patients with surgical taboos ; 3.Patients with metastatic disease or recurrent rectal cancer ; 4.Patients with familial adenomatous polyposis ( FAP ), hereditary nonpolyposis colorectal cancer ( HNPCC ), active Crohn 's disease or active ulcerative colitis ; 5.Patients with other malignant tumors within 5 years before enrollment, except for basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ; 6.Severe cardiovascular diseases, including unstable angina or myocardial infarction, occurred within 6 months before enrollment ; 7.Subjects who were allergic to the study drug or any of its adjuvants ; 8.Participated in other domestic unapproved or unlisted drug clinical trials within 4 weeks before enrollment and received corresponding experimental drug treatment ; 9.International normalized ratio ( INR ) > 1.5 or activated partial thromboplastin time ( APTT ) > 1.5 × ULN ; 10.Investigators judged clinically significant electrolyte abnormalities ; 11.There was uncontrolled hypertension before enrollment, which was defined as : systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg ; 12.There were poorly controlled diabetes before enrollment ( after regular treatment, fasting glucose concentration ≥ CTCAE grade 2 ) ; 1.3.13.Before enrollment, there are any diseases or states that affect drug absorption, or patients cannot take oral drugs ; 14.Before entering the group, there were gastrointestinal diseases such as gastric and duodenal active ulcers and ulcerative colitis, or other conditions that may cause gastrointestinal bleeding and perforation determined by the researchers ; 15.Severe active bleeding, hemoptysis ( fresh blood > 5 mL within 4 weeks ) or thromboembolic events occurred within 12 months before enrollment ( package ).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody

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