Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-29 @ 4:29 PM
Study NCT ID:
NCT01781520
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2013-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment toxicity', 'timeFrame': '4 years', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v3.0'}], 'secondaryOutcomes': [{'measure': 'The disease control rate', 'timeFrame': '4 years', 'description': 'the proportion of patients who had a best response rating of complete response, partial response, or stable disease.'}, {'measure': 'Progression free survival（PFS）', 'timeFrame': '4 years', 'description': 'From starting date of enrollment to this study until date of first documented disease progression or date of death from any cause, whichever comes first.'}, {'measure': 'Overal survival(OS)', 'timeFrame': '4 years', 'description': 'From starting date of enrollment to this study until date of death from any cause'}, {'measure': 'Changing trend of tumor biomarkers', 'timeFrame': '4 years', 'description': 'The changing of CEA and CA-199 levels among different groups before the treatment and at the end of the first cycle of therapy'}, {'measure': 'Phenotypic analysis of peripheral blood immune cells', 'timeFrame': '4 years', 'description': 'Phenotypic analysis of peripheral blood mononuclear cells before the treatment and at the end of the first cycle of therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'S1', 'DC-CIK'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '28611200', 'type': 'RESULT', 'citation': 'Jiang N, Qiao G, Wang X, Morse MA, Gwin WR, Zhou L, Song Y, Zhao Y, Chen F, Zhou X, Huang L, Hobeika A, Yi X, Xia X, Guan Y, Song J, Ren J, Lyerly HK. Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined with S-1 in Patients with Advanced Pancreatic Cancer: A Prospective Study. Clin Cancer Res. 2017 Sep 1;23(17):5066-5073. doi: 10.1158/1078-0432.CCR-17-0492. Epub 2017 Jun 13.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=Dendritic+Cell%2FCytokine-Induced+Killer+CellImmunotherapy+Combined+with+S-1+in+Patients+with+Advanced+Pancreatic+Cancer%3AA+Prospective+Study', 'label': 'Published article for this study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for unresectable locally advanced pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.\n* Capable of oral intake\n* Between 18 and 80 years old\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n* Karnofsky Performance Status (KPS) ≥ 70%\n* Normal functions of heart, lung and bone marrow\n* Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3\n* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN\n* Adequate renal function(normal serum creatinine level)\n* A life expectancy≥ 2 months\n* Informed consent signed\n\nExclusion Criteria:\n\n* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study\n* Any radiotherapy or surgery within the previous 3 weeks\n* Symptomatic brain metastasis not controlled by corticosteroids\n* Bone marrow metastasis\n* Active infection\n* Serious complications\n* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.\n* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy'}, 'identificationModule': {'nctId': 'NCT01781520', 'briefTitle': 'Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.', 'orgStudyIdInfo': {'id': 'S1+DC CIK-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-1 plus DC-CIK', 'description': 'Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks.\n\nDC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles.', 'interventionNames': ['Biological: DC-CIK Treatment', 'Drug: S1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DC-CIK alone', 'description': 'DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles.', 'interventionNames': ['Biological: DC-CIK Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'S-1 alone', 'description': 'Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks.', 'interventionNames': ['Drug: S1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best supportive care', 'interventionNames': ['Other: Best supportive care']}], 'interventions': [{'name': 'DC-CIK Treatment', 'type': 'BIOLOGICAL', 'description': 'The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.', 'armGroupLabels': ['DC-CIK alone', 'S-1 plus DC-CIK']}, {'name': 'S1', 'type': 'DRUG', 'description': 'The dose of S-1 is determined according to the body surface area as follows: \\<1.25 m2, 40 mg; 1.25-\\<1.5 m2, 50 mg; and \\>1.5 m2, 60 mg, given twice daily after meals for 14 days followed by a 7-day rest. Cycles is repeated every 21 days. Treatment is continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.', 'armGroupLabels': ['S-1 alone', 'S-1 plus DC-CIK']}, {'name': 'Best supportive care', 'type': 'OTHER', 'description': 'Best supportive care', 'armGroupLabels': ['Best supportive care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Capital Medical University Cancer Center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director,Capital Medical University (CMU)Cancer Center', 'investigatorFullName': 'Jun Ren MD, PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}