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The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

Primary Purpose

Rectal Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PD-1
SCRT
Bevacizumab
Oxaliplatin
Calcium folinate
5-fluorouracil
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed adenocarcinoma of the rectum； The clinical stage evaluated by MRI was T3-4 and/or N+ and M1a(only liver metastasis)； ECOG PS 0-2； CHild Pugh A； Estimated survival ≥3 months; Women of childbearing age should comply with contraceptive measures if pregnancy test is negative; Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy; Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability. Exclusion Criteria: Pregnant or lactating women; No previous antitumor therapy； No previous liver local therapy； No contraception during the reproductive period; patients known to have a history of allergy to any study drug, similar drug or excipient; Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction; Patients with a history of thromboembolism, except those caused by PICC; Patients with active infection; Other conditions that the investigator determines are not suitable for inclusion in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    (SCRT) followed by PD-1+ standard therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    progression free survival
    The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

    Secondary Outcome Measures

    objective response rate
    Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).

    Full Information

    First Posted
    November 25, 2022
    Last Updated
    December 6, 2022
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05640726
    Brief Title
    The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy
    Official Title
    The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2026 (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 explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    (SCRT) followed by PD-1+ standard therapy
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    PD-1
    Intervention Description
    Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
    Intervention Type
    Radiation
    Intervention Name(s)
    SCRT
    Intervention Description
    Radiotherapy dose: 5×5 Gy
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Intervention Description
    Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Oxaliplatin
    Intervention Description
    Participants will receive Oxaliplatin，85mg/m2，day1
    Intervention Type
    Drug
    Intervention Name(s)
    Calcium folinate
    Intervention Description
    Participants will receive calcium folinate ，400mg/m2，day1
    Intervention Type
    Drug
    Intervention Name(s)
    5-fluorouracil
    Intervention Description
    Participants will receive 5-fluorouracil ，400mg/m2，day1
    Primary Outcome Measure Information:
    Title
    progression free survival
    Description
    The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
    Time Frame
    up to 36 months
    Secondary Outcome Measure Information:
    Title
    objective response rate
    Description
    Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
    Time Frame
    every 3 months (up to 36 months）

    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: Histologically confirmed adenocarcinoma of the rectum； The clinical stage evaluated by MRI was T3-4 and/or N+ and M1a(only liver metastasis)； ECOG PS 0-2； CHild Pugh A； Estimated survival ≥3 months; Women of childbearing age should comply with contraceptive measures if pregnancy test is negative; Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy; Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability. Exclusion Criteria: Pregnant or lactating women; No previous antitumor therapy； No previous liver local therapy； No contraception during the reproductive period; patients known to have a history of allergy to any study drug, similar drug or excipient; Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction; Patients with a history of thromboembolism, except those caused by PICC; Patients with active infection; Other conditions that the investigator determines are not suitable for inclusion in the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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