NCT04214730

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

December 30, 2019

Last Update Submit

March 26, 2023

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Combination of NK with chemotherapy group

EXPERIMENTAL

Patients will receive NK treatments combined with Chemotherapy.

Combination Product: NK combined with Chemotherapy

Chemotherapy group

ACTIVE COMPARATOR

Patients will only receive Chemotherapy.

Drug: Chemotherapy

Interventions

NK combined with ChemotherapyCOMBINATION_PRODUCT

Patients will receive 4 cycles of NK treatments combined with Chemotherapy within 8 months

Combination of NK with chemotherapy group
ChemotherapyDRUG

Patients will only receive Chemotherapy.

Chemotherapy group

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with treatment-refractory advanced solid cancer can not accept operation;
  • Age 10 to 90 years;
  • Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
  • estimate survival \> 3 months;
  • 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;
  • Without any other malignant disease;
  • With more than one scalable lesions;
  • Patients Voluntary attempt, and informed consent;
  • Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

You may not qualify if:

  • Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
  • Patients who were pregnant or lactating;
  • ECOG perform status ≥ 2;4.
  • Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Peiwen Lian, PhD

    Yantai Yuhuangding Hospital

    STUDY DIRECTOR

Central Study Contacts

Peiwen Lian, PhD

CONTACT

+0086 5356691999peiwen.lian@hotmail.com

Jian Chen, PhD

CONTACT

+0086 5356691999chenjianyt@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 2, 2020

Study Start

December 31, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

CN(1)