Study of NK Combined With Chemotherapy for Advanced Solid Tumor

Solid Tumor Clinical Trial

— NK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04214730
• Other study ID #: 2019-009
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2019
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Yantai Yuhuangding Hospital
• Contact: Peiwen Lian, PhD
• Phone: +0086 5356691999
• Email: peiwen.lian[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 90 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Combination Product:
• NK combined with Chemotherapy
Patients will receive 4 cycles of NK treatments combined with Chemotherapy within 8 months

Drug:
• Chemotherapy
Patients will only receive Chemotherapy.

Locations

Country	Name	City	State
China	Yantai Yuhuangding Hospital	Yantai	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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