Study of Natural Killer Cell Combined With Chemotherapy for Advanced Solid Tumor
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Yantai Yuhuangding Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Disease Control Rates (DCR)
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)
Arms & Interventions
Combination of NK with chemotherapy group
Patients will receive NK treatments combined with Chemotherapy.
Intervention: NK combined with Chemotherapy (Combination Product)
Chemotherapy group
Patients will only receive Chemotherapy.
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
Disease Control Rates (DCR)
Time Frame: 1 year
Disease Control Rates (Complete Remission + Partial Remission + Stable Disease), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST).
Secondary Outcomes
No secondary outcomes reported
Investigators
Peiwen Lian
Principle Investigator
Yantai Yuhuangding Hospital