- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04162158
Safety and Efficacy of Allogeneic NK Cells Therapy in Patients With Advanced Hepatocellular Carcinoma
November 11, 2019 updated by: Beijing 302 Hospital
This is a multicenter, open-label, paired control study to evaluate the safety and clinical efficacy of allogeneic NK cells combined with targeted drug in the treatment for advanced HCC.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Since killer cell immunoglobulin-like receptor (KIR) mismatch can inhibit the negative regulatory signal of autologous major histocompatibility complex (MHC) molecules and ensure sufficient NK cell activation, allogeneic NK cells therapy, as a potential therapeutic option for tumor, has achieved good results in patients with acute myeloid leukemia.
In this study, investigators evaluate the safety and efficacy of allogeneic NK cells in the treatment of advanced HCC. 200 patients from three hospitals will be enrolled in this study and followed up for 1 year.
Peripheral blood mononuclear cells (PBMCs) were isolated from patient-related donor and cultured in vitro for 15 days and infused to the patient in two consecutive days.
Clinical data and laboratory data were collected and analyzed, including survival, impact indicators, hematology, biochemical indicators, and immunological indicators to evaluate the safety and efficacy of the treatment.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Junliang Fu
- Phone Number: 010-66-933332
- Email: fjunliang@163.com
Study Contact Backup
- Name: Yunbo Xie
- Phone Number: 010-66-933331
- Email: 15110140963@163.com
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100039
- Recruiting
- The Fifth Medical Center of PLA General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- According to the 2010 edition of the diagnostic criteria for primary liver cancer BCLC, the patient was diagnosed as advanced hepatocellular carcinoma by pathology and imaging (BCLC C phase);
- Child-Pugh A/B (5-9), Eastern Cooperative Oncology Group (ECOG) PS score less than 2 points;
Laboratory criteria:
- Liver function: Child A/B, ALT < 200 U/L, AST < 200 U/L, Tbil <51μmol/L
- Renal function: Creatinine clearance ≥ 60ml/minute
- Hematologic function: PLT ≥40×10'9/L, WBC ≥2×10'9/L, HGB>80 g/L
- 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:
- Women who are pregnant or breast-feeding.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
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.
|
No Intervention: Targeted drug treatment group
Sorafenib, regolfinib or levabinib will be administered in addition to traditional symptomatic supportive care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events
Time Frame: From the date of enrollment to the end of two years of follow-up.
|
Incidence of Treatment-Emergent Adverse Events as assessed by [National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0]
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From the date of enrollment to the end of two years of follow-up.
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Overall survival
Time Frame: From the date of enrollment to the end of two years of follow-up.
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Overall Survival (OS) defined as the time from randomisation until death by any cause.
Participants will be followed up for survival follow up for at least five years.
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From the date of enrollment to the end of two years of follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate
Time Frame: From the date of enrollment to the end of two years of follow-up.
|
According to the RECIST criteria, patients with complete response (CR), partial response (PR), and stable disease (SD) were imaged.
|
From the date of enrollment to the end of two years of follow-up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Fusheng Wang, Beijing 302 Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2024
Study Registration Dates
First Submitted
August 6, 2019
First Submitted That Met QC Criteria
November 11, 2019
First Posted (Actual)
November 14, 2019
Study Record Updates
Last Update Posted (Actual)
November 14, 2019
Last Update Submitted That Met QC Criteria
November 11, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- beijing302-NK-HCC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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