Status:
COMPLETED
Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC
Lead Sponsor:
Beijing YouAn Hospital
Collaborating Sponsors:
Beijing Shijitan Hospital, Capital Medical University
Beijing Ditan Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients receive a diagnosis when their tumors are too advanced for curative approaches and have a dismal prognosi...
Detailed Description
Patients with unresectable HCC will be enrolled and divided into two groups. Patients in trial group will be treated with combination of TAE/TACE and adoptive transfer of autologus iNKT cells. TAE/TAC...
Eligibility Criteria
Inclusion
- Age 18-80 years.
- Patients with hepatocellular carcinoma (BCLC, stageB/C) proved by histopathology or proved by CT or MRI imaging system, relapsed after previous therapy and no effective therapies known at this time.
- Life expectancy of ≥ 12 weeks.
- WBC\>3.0×10\^9/L, LYMPH\> 0.8×10\^9/L, Hb\>85g/L, PLT\>50×10\^9/L, Cre\<1.5×the upper limit of normal value.
- iNKT\>10 cell/mL in peripheral blood mononuclear cell (PBMC).
- Able to understand and sign the informed consent.
Exclusion
- Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
- Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
- Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
- Unstable immune systematic diseases or infectious diseases;
- Combined with AIDS or syphilis;
- Patients with history of stem cell or organ transplantation;
- Patients with allergic history to related drugs and immunotherapy;
- Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
- Pregnant or lactating subjects;
- Unsuitable subjects considered by clinicians.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04011033
Start Date
March 1 2018
End Date
October 1 2023
Last Update
October 8 2024
Active Locations (1)
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1
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100069