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

Hangzhou ConVerd

Status and phase: Unknown; Phase 1

Conditions: Gastrointestinal Cancer

Treatments: Biological: anticancer medication A01; immune cells IC01

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03474861

CVD20180401002

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Combination therapy

Experimental group

Description:

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

Treatment:

Biological: anticancer medication A01; immune cells IC01