Study of NK Combined With Chemotherapy for Advanced Solid Tumor

Yantai Yuhuangding Hospital

Status: Enrolling

Conditions: Solid Tumor

Treatments: Drug: Chemotherapy; Combination Product: NK combined with Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04214730

2019-009

Details and patient eligibility

About

Combinations Natural Killer Cell (NK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with treatment-refractory advanced solid cancer can not accept operation;
2. Age 10 to 90 years;
3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
4. estimate survival > 3 months;
5. 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;
6. Without any other malignant disease;
7. With more than one scalable lesions;
8. Patients Voluntary attempt, and informed consent;
9. 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

1. Patients who do not conform to the inclusion criteria;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;4.
5. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Combination of NK with chemotherapy group

Experimental group

Description:

Patients will receive NK treatments combined with Chemotherapy.

Treatment:

Combination Product: NK combined with Chemotherapy

Chemotherapy group

Active Comparator group

Description:

Patients will only receive Chemotherapy.

Treatment:

Drug: Chemotherapy