Study of NK Combined With Chemotherapy for Advanced Solid Tumor

Study Overview
=================
Brief Summary
-----------------
Combinations Natural Killer Cell (NK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

Detailed Description
-----------------
Patients in group A will receive 4 cycles of NK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of NK with chemotherapy in patients with treatment-refractory solid tumors

Official Title
-----------------
Study of Natural Killer Cell Combined With Chemotherapy for Advanced Solid Tumor

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Combination Product: NK combined with Chemotherapy
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with treatment-refractory advanced solid cancer can not accept operation; Age 10 to 90 years; Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points; estimate survival > 3 months; Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value; Without any other malignant disease; With more than one scalable lesions; Patients Voluntary attempt, and informed consent; Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus. Exclusion Criteria: Patients who do not conform to the inclusion criteria; Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis ); Patients who were pregnant or lactating; ECOG perform status ≥ 2;4. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of NK with chemotherapy group<br>Patients will receive NK treatments combined with Chemotherapy. | Combination Product: NK combined with Chemotherapy<br>* Patients will receive 4 cycles of NK treatments combined with Chemotherapy within 8 months<br>|
| Active Comparator: Chemotherapy group<br>Patients will only receive Chemotherapy. | Drug: Chemotherapy<br>* Patients will only receive Chemotherapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rates (DCR) | Disease Control Rates (Complete Remission + Partial Remission + Stable Disease), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST). | 1 year |