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
About this trial
This is an interventional treatment trial for Gastrointestinal Cancer
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.
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
NCT ID
NCT03474861
First Posted
March 7, 2018
Last Updated
March 23, 2018
Sponsor
Hangzhou Converd Co., Ltd.
Collaborators
The Second Hospital of Jia Xing
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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