Safety and Efficacy of an Anticancer Medication Combined... | NCT03474861

NCT03474861

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
The Second Hospital of Jia Xing	UNKNOWN

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combination therapy	Experimental	The subjects will be given combination therapy which consists of an anticancer medication (A01) and immune cells (IC01).	Biological: anticancer medication A01; immune cells IC01

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anticancer medication A01; immune cells IC01	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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.