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Study of NK Combined With Chemotherapy for Advanced Solid Tumor

Sponsor
Yantai Yuhuangding Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04214730
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
47
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of Natural Killer Cell Combined With Chemotherapy for Advanced Solid Tumor
Actual Study Start Date :
Dec 31, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Active Comparator: Chemotherapy group

Patients will only receive Chemotherapy.

Drug: Chemotherapy
Patients will only receive Chemotherapy.

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yantai Yuhuangding Hospital Yantai Shandong China 264000

Sponsors and Collaborators

  • Yantai Yuhuangding Hospital

Investigators

  • Study Director: Peiwen Lian, PhD, Yantai Yuhuangding Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peiwen Lian, Principle Investigator, Yantai Yuhuangding Hospital
ClinicalTrials.gov Identifier:
NCT04214730
Other Study ID Numbers:
  • 2019-009
First Posted:
Jan 2, 2020
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Feb 9, 2022