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PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

Primary Purpose

Gastrointestinal Neoplasms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PTC drug screening
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gastrointestinal Neoplasms focused on measuring neoadjuvant, chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosed of gastrointestinal adenocarcinoma by biopsy
  • existence of initially resectable lesions evaluated by investigators
  • indications of neoadjuvant chemotherapy including: 1) locally advanced gastric cancer cT1-2N1-3M0 & cT3-4N0-3M0; 2) locally advanced colorectal cancer cT3-4 or N+; 3)colorectal carcinoma with synchronous liver metastases: CRS≤2; 4)other patients who are considered to be appropriate to receive neoadjuvant chemotherapy determined by MDT
  • never receive any tumor related treatment including chemotherapy, radiotherapy, and immune therapy
  • never diagnosed of other malignancies
  • able to tolerate chemotherapy
  • ECOG≤2
  • life expectance >6 months
  • at least 1 measurable lesions(according to RECIST 1.1)
  • informed consent

Exclusion Criteria:

  • pregnant or lactating women
  • participating in other clinical trials within 6 months
  • MSI-H or dMMR or EBER(+)
  • lesion located within 10cm from anal margin
  • severe liver dysfunction
  • severe renal dysfunction
  • cognitive disorder, mental disease or poor compliance
  • allergic to known chemotherapeutic agents
  • other conditions not suitable to participate in this trial determined by investigators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Neoadjuvant therapy based on PTC drug screening

    Neoadjuvant therapy based on clinical experience

    Arm Description

    Patients will receive neoadjuvant therapy based on PTC drug screening. The regimen is complied with NCCN and CSCO guidelines. PD-1 inhibitor will be used if effective in drug screening.

    Patients will receive neoadjuvant therapy based on clinical experience. The regimen is complied with NCCN and CSCO guidelines.

    Outcomes

    Primary Outcome Measures

    pathological complete response rate(pCR)
    having no invasive cancer left in the resected sample

    Secondary Outcome Measures

    pathological response rate
    tumor regression grade 0-2
    objective response rate(ORR)
    CR+PR according to RECIST 1.1
    disease control rate(DCR)
    CR+PR+SD according to RECIST 1.1
    R0 resection rate
    microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
    prediction accuracy of PTC
    consistency between the effect of neoadjuvant chemotherapy and the result of PTC assay

    Full Information

    First Posted
    March 4, 2022
    Last Updated
    March 4, 2022
    Sponsor
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05280210
    Brief Title
    PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor
    Official Title
    Patient-derived Tumor-like Cell Clusters (PTC) in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor: A Prospective, Open-label and Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University

    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
    To explore the value of PTC drug screening technique in selecting neoadjuvant therapy for advanced gastrointestinal cancer.
    Detailed Description
    In this study, patients diagnosed with advanced gastrointestinal cancer including locally advanced gastric cancer, locally advanced colorectal cancer and colorectal cancer with liver metastasis. Tumor sample will be collected by endoscopy biopsy, needle biopsy or surgery, which will used for PTC drug screening. Patients will be randomized to two groups. Patients in experiment group will receive neoadjuvant therapy based on PTC drug screening, and patients in control group will receive neoadjuvant therapy based on clinical experience. 2-4 cycles of neoadjuvant therapy will be administered. Patients appropriate for surgery will receive radical surgery after neoadjuvant therapy. Pathological response will be compared primarily between these two groups. This is a randomized controlled, open-label and sequential designed clinical trial. All neoadjuvant therapy used in this study or for PTC drug screening comply with NCCN (National comprehensive cancer network) or CSCO (Chinese Society of Clinical Oncology) guidelines.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Neoplasms
    Keywords
    neoadjuvant, chemotherapy

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    420 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neoadjuvant therapy based on PTC drug screening
    Arm Type
    Experimental
    Arm Description
    Patients will receive neoadjuvant therapy based on PTC drug screening. The regimen is complied with NCCN and CSCO guidelines. PD-1 inhibitor will be used if effective in drug screening.
    Arm Title
    Neoadjuvant therapy based on clinical experience
    Arm Type
    No Intervention
    Arm Description
    Patients will receive neoadjuvant therapy based on clinical experience. The regimen is complied with NCCN and CSCO guidelines.
    Intervention Type
    Other
    Intervention Name(s)
    PTC drug screening
    Intervention Description
    PTC is an in vitro tumor model, which serves as a structural and functional unit recapitulating the original tumors in genotype, phenotype, and drug response. PTC will be used in drug screening.
    Primary Outcome Measure Information:
    Title
    pathological complete response rate(pCR)
    Description
    having no invasive cancer left in the resected sample
    Time Frame
    immediately evaluated after surgery
    Secondary Outcome Measure Information:
    Title
    pathological response rate
    Description
    tumor regression grade 0-2
    Time Frame
    immediately evaluated after surgery
    Title
    objective response rate(ORR)
    Description
    CR+PR according to RECIST 1.1
    Time Frame
    evaluated by imaging before surgery
    Title
    disease control rate(DCR)
    Description
    CR+PR+SD according to RECIST 1.1
    Time Frame
    evaluated by imaging before surgery
    Title
    R0 resection rate
    Description
    microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
    Time Frame
    immediately evaluated after surgery
    Title
    prediction accuracy of PTC
    Description
    consistency between the effect of neoadjuvant chemotherapy and the result of PTC assay
    Time Frame
    immediately evaluated after surgery

    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: diagnosed of gastrointestinal adenocarcinoma by biopsy existence of initially resectable lesions evaluated by investigators indications of neoadjuvant chemotherapy including: 1) locally advanced gastric cancer cT1-2N1-3M0 & cT3-4N0-3M0; 2) locally advanced colorectal cancer cT3-4 or N+; 3)colorectal carcinoma with synchronous liver metastases: CRS≤2; 4)other patients who are considered to be appropriate to receive neoadjuvant chemotherapy determined by MDT never receive any tumor related treatment including chemotherapy, radiotherapy, and immune therapy never diagnosed of other malignancies able to tolerate chemotherapy ECOG≤2 life expectance >6 months at least 1 measurable lesions(according to RECIST 1.1) informed consent Exclusion Criteria: pregnant or lactating women participating in other clinical trials within 6 months MSI-H or dMMR or EBER(+) lesion located within 10cm from anal margin severe liver dysfunction severe renal dysfunction cognitive disorder, mental disease or poor compliance allergic to known chemotherapeutic agents other conditions not suitable to participate in this trial determined by investigators
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aiwen Wu, M.D.
    Phone
    +8613911577190
    Email
    wuaw@sina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aiwen Wu, M.D.
    Organizational Affiliation
    Peking University Cancer Hospital & Institute
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

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