Solid TumorNKNCT04214730
Study of NK Combined With Chemotherapy for Advanced Solid Tumor
A study testing NK combined with Chemotherapy and Chemotherapy in people with Solid Tumor, run by Yantai Yuhuangding Hospital at 1 site in China.
Trial summary
Combinations Natural Killer Cell (NK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- NK combined with Chemotherapy and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2019to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Patients who do not conform to the inclusion criteria;
- 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.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Peiwen Lian, PhD, +0086 5356691999 ext. 82708, peiwen.lian@qq.com
About this study
Official title: 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.
Read the 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
- Conditions
- Solid Tumor
- Being tested
- NK combined with Chemotherapy, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK combined with ChemotherapyCombination product
Patients will receive 4 cycles of NK treatments combined with Chemotherapy within 8 months
ChemotherapyDrug
Patients will only receive Chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Combination of NK with chemotherapy group | Experimental | Patients will receive NK treatments combined with Chemotherapy. Receives: Combination Product: NK combined with Chemotherapy |
| Chemotherapy group | Active comparator | Patients will only receive Chemotherapy. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start31 Dec 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiwen Lian, Yantai Yuhuangding Hospital
- Investigators
- Peiwen Lian, PhD, Study director, Yantai Yuhuangding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214730
- Sponsor's protocol ID
- 2019-009
- Acronym
- NK
- Status last verified
- Mar 2023
- First submitted
- 30 Dec 2019
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Natural Killer Cell Combined With Chemotherapy for Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04214730
- Acronym / sponsor ID
- NK / 2019-009
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of NK with chemotherapy group | Experimental | Combination Product: NK combined with ChemotherapyPatients will receive NK treatments combined with Chemotherapy. |
| Chemotherapy group | Active comparator | Drug: ChemotherapyPatients will only receive Chemotherapy. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (5 listed)
- Patients who do not conform to the inclusion criteria;
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK combined with ChemotherapyPatients will receive 4 cycles of NK treatments combined with Chemotherapy within 8 months | Combination product | Combination of NK with chemotherapy group |
| ChemotherapyPatients will only receive Chemotherapy. | Drug | Chemotherapy group |
Primary outcome
Disease Control Rates (DCR)
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peiwen Lian, PhD study director
Yantai Yuhuangding Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NK combined with Chemotherapy and Chemotherapy in people with Solid Tumor, run by Yantai Yuhuangding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peiwen Lian, PhD (+0086 5356691999 ext. 82708, peiwen.lian@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rates (DCR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.