Study of NK Combined With Chemotherapy for Advanced Solid Tumor (NK)

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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Chemotherapy; Combination product: NK combined with Chemotherapy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Yantai, Shandong, China, 264000
      • Recruiting
      • Yantai Yuhuangding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chemotherapy group; Patients will only receive Chemotherapy.	Drug: Chemotherapy; Patients will only receive Chemotherapy.
Experimental: Combination of NK with chemotherapy group; Patients will receive NK treatments combined with Chemotherapy.	Combination product: NK combined with Chemotherapy; Patients will receive 4 cycles of NK treatments combined with Chemotherapy within 8 months

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

Collaborators and Investigators

• Sponsor: Yantai Yuhuangding Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2019-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No