Status:
UNKNOWN
Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells
Lead Sponsor:
Beijing 302 Hospital
Collaborating Sponsors:
Chinese Academy of Medical Sciences
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma.
Detailed Description
This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, fresh...
Eligibility Criteria
Inclusion
- Patients should sign informed consent form voluntarily and comply with the requirements of this study.
- Gender unlimited, age 18 to 70 years old.
- Hepatocellular carcinoma histopathology proven by liver fresh biopsy.
- According to the 2018 edition of the EASL guidelines for primary liver cancer, patients were diagnosed with advanced HBV-related hepatocellular carcinoma (BCLC stage B and C) by pathology and imaging; all patients required antiviral therapy with nucleoside analogues; other treatments (e.g. interventional therapy) at least 2 weeks prior to γδT cell infusion; patients can take the first- or second-line targeted drugs recommended by the guidelines, such as lenvatinib or sorafenib.
- Liver function: Child-Pugh class A/B (5-9), Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Expected survival ≥ 6 months.
- Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study.
Exclusion
- Combine other viral liver diseases or other liver disease patients.
- Acute infection, gastrointestinal bleeding, etc. occurred within 30 days before screening.
- Pregnant or lactating women; patients after organ transplantation; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
- Dysfunction of major organs; patient white blood cell count \<1.0×10e9/L, platelet count \<60×10e9/L, hemoglobin \<86g/L, prothrombin time (INR) \>2.3, or prolonged clotting time \>6 seconds, serum albumin \<28g/L, total bilirubin \>51mmol/L, ALT/AST \>5 times the upper limit of normal, creatinine \>1.5 times the upper limit of normal.
- Combined with other serious organic diseases, mental illnesses, including any uncontrolled clinically significant systemic diseases such as urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune diseases.
- Allergic constitution, history of allergies to blood products, known to be allergic to test substances.
- Immunosuppressive or systemic cytotoxic drugs may require within six months prior to screening or during treatment; 6 months prior to screening accepted other cell therapies including NK, CIK, DC, CTL and stem cell therapy etc.; immunotherapy such as PD-1 and PD-L1 antibodies.
- Patients currently participating in other clinical trials who may violate this treatment plan and observations.
- Those who are unable or unwilling to provide informed consent or who are unable to comply with the research requirements.
- Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed: patients with any serious acute or chronic physical or mental illness, or laboratory abnormalities.
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04032392
Start Date
July 23 2019
End Date
July 30 2022
Last Update
July 25 2019
Active Locations (2)
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1
Beijing 302 Hospital of China
Beijing, Beijing Municipality, China, 100039
2
Beijing 302 hospital
Beijing, China, 100039