Safety and Efficacy of Allogeneic NK Cells Therapy in Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT04162158
Last Updated: 2019-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2019-03-01
2024-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Targeted drug combined with allogeneic NK cell treatment group
In addition to traditional symptomatic supportive treatment, Sorafenib, regolfinib or levabinib will be administered in combination with allogeneic NK cells (3 cycles).
allogeneic NK cells therapy
PBMC was isolated from the peripheral blood of the donors and infused to the patient after 14 days incubation. In each cycle, patients will be infused 4.0-5.0×10'9 allogeneic NK cells. All patients in the experimental group received a total of three cycles of treatment with one month interval between each treatment.
Targeted drug treatment group
Sorafenib, regolfinib or levabinib will be administered in addition to traditional symptomatic supportive care.
No interventions assigned to this group
Interventions
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allogeneic NK cells therapy
PBMC was isolated from the peripheral blood of the donors and infused to the patient after 14 days incubation. In each cycle, patients will be infused 4.0-5.0×10'9 allogeneic NK cells. All patients in the experimental group received a total of three cycles of treatment with one month interval between each treatment.
Eligibility Criteria
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Inclusion Criteria
* Child-Pugh A/B (5-9), Eastern Cooperative Oncology Group (ECOG) PS score less than 2 points;
* Laboratory criteria:
1. Liver function: Child A/B, ALT \< 200 U/L, AST \< 200 U/L, Tbil \<51μmol/L
2. Renal function: Creatinine clearance ≥ 60ml/minute
3. Hematologic function: PLT ≥40×10'9/L, WBC ≥2×10'9/L, HGB\>80 g/L
4. Cardiac function: No abnormality in cardiac enzyme and ECG
* Survival expectation is greater than 6 months;
* Patients with active hepatitis B or C were treated with the appropriate NA or DAA medication, and all patients enrolled in the group were treated with targeted drugs.
* The patient has a donor who meets the donor enrollment criteria and all patients and donors sign the Informed Consent Form;
Exclusion Criteria
* Co-infected with hepatitis A, hepatitis E, AIDS or other infectious diseases.
* Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days.
* Patients with other serious systemic and psychiatric diseases.
* Exposure to any cell therapy such as, but not limited to CIK, DC, CTL , PD-1 and stem cells therapy 6 months prior to study drug administration.
* Other conditions that researchers believe may increase the risk of subjects or lead to affected study results, such as the presence of mental illness in subjects.
18 Years
65 Years
ALL
Yes
Sponsors
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Shenzhen Third People's Hospital
OTHER
The first People's Hospital of Zhengzhou
UNKNOWN
Beijing 302 Hospital
OTHER
Responsible Party
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Principal Investigators
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Fusheng Wang
Role: STUDY_CHAIR
Beijing 302 Hospital
Locations
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The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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beijing302-NK-HCC
Identifier Type: -
Identifier Source: org_study_id
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