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

NCT ID: NCT03474861

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-04-30

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination therapy

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

Group Type: EXPERIMENTAL

anticancer medication A01; immune cells IC01

Intervention Type: BIOLOGICAL

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.

Interventions

anticancer medication A01; immune cells IC01

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Jia Xing

UNKNOWN

Sponsor Role: collaborator

Hangzhou Converd Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lin Chen, PhD

Role: CONTACT

chenlin@converd.com.cn

+86 18005817715

Other Identifiers

CVD20180401002

Identifier Type: -

Identifier Source: org_study_id