Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-02 @ 4:16 AM
Study NCT ID:
NCT03175705
Status:
UNKNOWN
Last Update Posted:
2018-01-18
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}, {'id': 'D005641', 'term': 'Tegafur'}, {'id': 'C104201', 'term': 'gimeracil'}, {'id': 'C489337', 'term': 'potassium oxonate'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-17', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progress Free Survival (PFS)', 'timeFrame': '12 weeks or up to death', 'description': 'PFS is the time that passes from the date that patient enrolled in the clinical trial and the date on which HCC progresses or the date on which the patient dies. HCC progression was evaluated by imaging according to the irRC standard.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': '12 weeks or up to death', 'description': 'DCR is the proportion of patients who had a response rate including complete remission (CR), partial remission (PR) and disease stabilization (SD) evaluated by imaging according to the irRC standard.'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety]', 'timeFrame': '4 weeks', 'description': 'Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.'}], 'secondaryOutcomes': [{'measure': 'Biological activity of infused T cells', 'timeFrame': '4 weeks', 'description': 'To assess the biological activity of infused in vitro expanded and sorted HCC antigens-specific T cells.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses specific HCC antigens CD8+ T cells, a new experimental treatment.\n\nThe purpose of this study is to evaluate the safety and tolerance as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with human leukocyte antigen (HLA)-peptide multimers and specific for Glypican (GPC)-3 /New York Esophageal Squamous-1 (NY-ESO-1) /alpha-fetoprotein (AFP) antigens and cultured in vitro, to patients suffering from relapsed/advanced hepatocellular carcinoma (HCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Patients with relapsed/advanced HCC (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, proven GPC3/NY-ESO-1/AFP(+), relapsed after previous therapy and no effective therapies known at this time.\n* Life expectancy of ≥ 12 weeks.\n* WBC\\>3.5×10\\^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.\n* Able to understand and sign the informed consent.\n\nExclusion Criteria:\n\n* Any uncontrolled systematic disease: hypertension, heart disease, and et al.;\n* Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;\n* Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;\n* Unstable immune systematic diseases or Infectious diseases;\n* Combined with AIDS or syphilis;\n* Patients with history of stem cell or organ transplantation;\n* Patients with allergic history to related drugs and immunotherapy;\n* Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;\n* Pregnant or lactating subjects;\n* Unsuitable subjects considered by clinicians.'}, 'identificationModule': {'nctId': 'NCT03175705', 'briefTitle': 'Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC', 'organization': {'class': 'OTHER', 'fullName': 'Beijing YouAn Hospital'}, 'officialTitle': 'A Study of Specific HCC Antigens CD8+ T Cells Therapy for Treating Patients With Relapsed/Advanced Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'Beijing Youan Ethics[2017]06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)', 'description': 'Autologous in vitro expanded HCC antigens-specific CD8+ T lymphocytes in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with relapsed/advanced HCC.', 'interventionNames': ['Biological: HCC antigens-specific CD8+ T lymphocytes', 'Drug: IL-2', 'Drug: Tegafur']}], 'interventions': [{'name': 'HCC antigens-specific CD8+ T lymphocytes', 'type': 'BIOLOGICAL', 'description': 'Three different dosing schedules will be evaluated. Three patients will be evaluated on each dosing schedule.\n\nThe following dose levels will be evaluated:\n\nLoading Dose 1: 3x10\\^7/m2 Loading Dose 2: 6x10\\^7/m2 Loading Dose 3: 9x10\\^7/m2 The doses are calculated according to the actual number of GPC3/NY-ESO-1/AFP specific cytotoxic lymphocytes (CTLs)', 'armGroupLabels': ['Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)']}, {'name': 'IL-2', 'type': 'DRUG', 'otherNames': ['Human recombinated Interleukin-2'], 'description': 'IL-2 will be given at a dose of 25000 IU/kg/day for 5-14 days.', 'armGroupLabels': ['Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)']}, {'name': 'Tegafur', 'type': 'DRUG', 'otherNames': ['Gimeracil and Oteracil potassium Capsules'], 'description': 'Tegafur will be given at a dose of 40\\~60 mg bis in die (BID) 2 weeks.', 'armGroupLabels': ['Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuli Bao, Clinician', 'role': 'CONTACT', 'email': 'bxli2001@163.com', 'phone': '86-13161935299'}], 'facility': 'Beijing Youan Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Lu, Director', 'role': 'CONTACT', 'email': 'lujun98@ccmu.edu.cn', 'phone': '86-13661381489'}, {'name': 'Xuli Bao, Clinician', 'role': 'CONTACT', 'email': 'bxli2001@163.com', 'phone': '86-13161935299'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing YouAn Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Hepatology and Cancer Biotherapy Ward', 'investigatorFullName': 'LU JUN', 'investigatorAffiliation': 'Beijing YouAn Hospital'}}}}