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

Gastrointestinal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03474861
• Other study ID #: CVD20180401002
• Status: Not yet recruiting
• Phase: Phase 1
• First received: March 7, 2018
• Last updated: March 23, 2018
• Start date: April 2018
• Est. completion date: April 2019

Study information

• Verified date: March 2018
• Source: Hangzhou Converd Co., Ltd.
• Contact: Lin Chen, PhD
• Phone: +86 18005817715
• Email: chenlin[@]converd.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hangzhou Converd Co., Ltd.	The Second Hospital of Jia Xing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 to 4 months after the end of the trial
Secondary	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.	Before treatment and Day 28 to 4 months after the end of the treatment