Study of NK Combined With Chemotherapy for Advanced Solid Tumor

Not Applicable

Recruiting

• Conditions: Solid Tumor
• Interventions: Combination Product: NK combined with Chemotherapy; Drug: Chemotherapy

• Registration Number: NCT04214730
• Lead Sponsor: Yantai Yuhuangding Hospital

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 Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study Start: 2019-12-31
• Study First Posted: 2020-01-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-26
• Last Update Posted: 2023-03-28
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of NK with chemotherapy group	NK combined with Chemotherapy	Patients will receive NK treatments combined with Chemotherapy.
Chemotherapy group	Chemotherapy	Patients will only receive Chemotherapy.

Primary Outcome Measures

Name	Time	Method
Disease Control Rates (DCR)	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).

Trial Locations

Locations (1)

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China