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Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Gastrointestinal Cancer

Primary Purpose

Gastrointestinal Cancer

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
anticancer medication A01; immune cells IC01
Sponsored by
Hangzhou Converd Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent form must be obtained prior to any research procedures;
  2. Age: 18 Years to 70 Years;
  3. The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (200 ml) for the treatment, and who signs the informed consent form independently;
  4. Histologically confirmed diagnosis of gastrointestinal cancer;
  5. Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
  6. Karnofsky Performance Status (KPS) score ≥ 70
  7. Expected survival ≥ 3 months
  8. Adequate organ function defined as: ANC≥3.5×10^9/L, PLT≥50×10^9/L, ALB≥25g/L, AST≤2.5×ULN, ALT≤2.5×ULN, TBIL≤1.5×ULN
  9. If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result.

Exclusion Criteria:

  1. Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment;
  2. Patients who have not recovered from adverse reactions related to above-mentioned procedures;
  3. Patients with two types of primary solid tumors;
  4. Patients with brain metastases or bone metastases;
  5. Patients with poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association Class II or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on treatment;
  6. Patients with other serious organic diseases or mental disorders;
  7. Patients with systemic or active infection;
  8. Patients with positive HIV test result;
  9. Patients who have received an organ transplant;
  10. Patients who are breastfeeding or pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Combination therapy

    Arm Description

    The subjects will be given combination therapy which consists of an anticancer medication (A01) and immune cells (IC01).

    Outcomes

    Primary Outcome Measures

    The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed.
    Incidence and duration of all the adverse events will be recorded. The severity of adverse events will be evaluated according to NCI-CTCAE v4.03 criteria.

    Secondary Outcome Measures

    Tumor Response of the treatment in patients with advanced gastrointestinal cancer.
    Response Evaluation Criteria in Solid Tumors (RECIST) from the NCI will be used for assessment of radiographic response.

    Full Information

    First Posted
    March 7, 2018
    Last Updated
    March 23, 2018
    Sponsor
    Hangzhou Converd Co., Ltd.
    Collaborators
    The Second Hospital of Jia Xing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03474861
    Brief Title
    Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Gastrointestinal Cancer
    Official Title
    A Combination Study to Evaluate the Safety and Efficacy of an Anticancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Gastrointestinal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2018 (Anticipated)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hangzhou Converd Co., Ltd.
    Collaborators
    The Second Hospital of Jia Xing

    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
    This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) combined with immune cells (IC01) in subjects with advanced Gastrointestinal cancer.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Combination therapy
    Arm Type
    Experimental
    Arm Description
    The subjects will be given combination therapy which consists of an anticancer medication (A01) and immune cells (IC01).
    Intervention Type
    Biological
    Intervention Name(s)
    anticancer medication A01; immune cells IC01
    Intervention Description
    The administration of the anticancer medication A01 and immune cells IC01 will be performed in The Second Hospital of Jiaxing, Zhejiang, China. The subjects will be observed for any side effects during this time and all the adverse events will be recorded.
    Primary Outcome Measure Information:
    Title
    The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed.
    Description
    Incidence and duration of all the adverse events will be recorded. The severity of adverse events will be evaluated according to NCI-CTCAE v4.03 criteria.
    Time Frame
    Day 0 to 4 months after the end of the trial
    Secondary Outcome Measure Information:
    Title
    Tumor Response of the treatment in patients with advanced gastrointestinal cancer.
    Description
    Response Evaluation Criteria in Solid Tumors (RECIST) from the NCI will be used for assessment of radiographic response.
    Time Frame
    Before treatment and Day 28 to 4 months after the end of the treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent form must be obtained prior to any research procedures; Age: 18 Years to 70 Years; The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (200 ml) for the treatment, and who signs the informed consent form independently; Histologically confirmed diagnosis of gastrointestinal cancer; Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments; Karnofsky Performance Status (KPS) score ≥ 70 Expected survival ≥ 3 months Adequate organ function defined as: ANC≥3.5×10^9/L, PLT≥50×10^9/L, ALB≥25g/L, AST≤2.5×ULN, ALT≤2.5×ULN, TBIL≤1.5×ULN If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result. Exclusion Criteria: Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment; Patients who have not recovered from adverse reactions related to above-mentioned procedures; Patients with two types of primary solid tumors; Patients with brain metastases or bone metastases; Patients with poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association Class II or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on treatment; Patients with other serious organic diseases or mental disorders; Patients with systemic or active infection; Patients with positive HIV test result; Patients who have received an organ transplant; Patients who are breastfeeding or pregnant.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lin Chen, PhD
    Phone
    +86 18005817715
    Email
    chenlin@converd.com.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Gastrointestinal Cancer

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