Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT03559803
Status:
UNKNOWN
Last Update Posted:
2019-01-22
First Post:
2018-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Study of Monitoring Immune Response in Locally Advanced Cervix Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-21', 'releaseDate': '2021-03-25'}, {'resetDate': '2022-02-17', 'releaseDate': '2021-12-02'}, {'resetDate': '2023-03-30', 'releaseDate': '2022-06-19'}, {'resetDate': '2024-01-24', 'releaseDate': '2023-05-10'}, {'resetDate': '2024-08-14', 'releaseDate': '2024-03-19'}], 'estimatedResultsFirstSubmitDate': '2021-03-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of expression of PD-L1+ on cervix biopsies', 'timeFrame': 'From baseline,3 weeks,2 months', 'description': 'The biopsy was collected at baseline,3 weeks,2 months'}], 'secondaryOutcomes': [{'measure': 'The change of expression of PD1 on the non-regulatory CD4+ and CD8+ lymphocytes and Treg cells', 'timeFrame': 'baseline,3 weeks,2 months', 'description': 'The blood was collected at baseline,3 weeks,2 months'}, {'measure': 'The diversity of T-cell Repertoire in cervix biopsies and blood, respectively', 'timeFrame': 'baseline,3 weeks,2 months', 'description': 'The blood and biopsies were collected at baseline,3 weeks,2 months'}, {'measure': 'The change of expression of CD8+PD1+ lymphocytes infiltrate on cervix biopsies', 'timeFrame': 'baseline,3 weeks,2 months', 'description': 'The biopsy was collected at baseline,3 weeks,2 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical Cancer', 'PD-L1', 'Concurrent Chemoradiotherapy'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '19901438', 'type': 'BACKGROUND', 'citation': 'Jayshree RS, Sreenivas A, Tessy M, Krishna S. Cell intrinsic & extrinsic factors in cervical carcinogenesis. Indian J Med Res. 2009 Sep;130(3):286-95.'}, {'pmid': '19931186', 'type': 'BACKGROUND', 'citation': 'Folkl A, Bienzle D. Structure and function of programmed death (PD) molecules. Vet Immunol Immunopathol. 2010 Mar 15;134(1-2):33-8. doi: 10.1016/j.vetimm.2009.10.006. Epub 2009 Oct 14.'}, {'pmid': '19188168', 'type': 'BACKGROUND', 'citation': 'Gao Q, Wang XY, Qiu SJ, Yamato I, Sho M, Nakajima Y, Zhou J, Li BZ, Shi YH, Xiao YS, Xu Y, Fan J. Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma. Clin Cancer Res. 2009 Feb 1;15(3):971-9. doi: 10.1158/1078-0432.CCR-08-1608.'}, {'pmid': '24548766', 'type': 'BACKGROUND', 'citation': 'Yang CY, Lin MW, Chang YL, Wu CT, Yang PC. Programmed cell death-ligand 1 expression in surgically resected stage I pulmonary adenocarcinoma and its correlation with driver mutations and clinical outcomes. Eur J Cancer. 2014 May;50(7):1361-9. doi: 10.1016/j.ejca.2014.01.018. Epub 2014 Feb 15.'}, {'pmid': '25477049', 'type': 'BACKGROUND', 'citation': 'Madore J, Vilain RE, Menzies AM, Kakavand H, Wilmott JS, Hyman J, Yearley JH, Kefford RF, Thompson JF, Long GV, Hersey P, Scolyer RA. PD-L1 expression in melanoma shows marked heterogeneity within and between patients: implications for anti-PD-1/PD-L1 clinical trials. Pigment Cell Melanoma Res. 2015 May;28(3):245-53. doi: 10.1111/pcmr.12340. Epub 2014 Dec 22.'}, {'pmid': '24842267', 'type': 'BACKGROUND', 'citation': 'Muenst S, Schaerli AR, Gao F, Daster S, Trella E, Droeser RA, Muraro MG, Zajac P, Zanetti R, Gillanders WE, Weber WP, Soysal SD. Expression of programmed death ligand 1 (PD-L1) is associated with poor prognosis in human breast cancer. Breast Cancer Res Treat. 2014 Jul;146(1):15-24. doi: 10.1007/s10549-014-2988-5. Epub 2014 May 20.'}, {'pmid': '20473887', 'type': 'BACKGROUND', 'citation': 'Shi F, Shi M, Zeng Z, Qi RZ, Liu ZW, Zhang JY, Yang YP, Tien P, Wang FS. PD-1 and PD-L1 upregulation promotes CD8(+) T-cell apoptosis and postoperative recurrence in hepatocellular carcinoma patients. Int J Cancer. 2011 Feb 15;128(4):887-96. doi: 10.1002/ijc.25397.'}, {'pmid': '27056074', 'type': 'BACKGROUND', 'citation': 'Heeren AM, Punt S, Bleeker MC, Gaarenstroom KN, van der Velden J, Kenter GG, de Gruijl TD, Jordanova ES. Prognostic effect of different PD-L1 expression patterns in squamous cell carcinoma and adenocarcinoma of the cervix. Mod Pathol. 2016 Jul;29(7):753-63. doi: 10.1038/modpathol.2016.64. Epub 2016 Apr 8.'}, {'pmid': '26623522', 'type': 'BACKGROUND', 'citation': 'Lim SH, Hong M, Ahn S, Choi YL, Kim KM, Oh D, Ahn YC, Jung SH, Ahn MJ, Park K, Zo JI, Shim YM, Sun JM. Changes in tumour expression of programmed death-ligand 1 after neoadjuvant concurrent chemoradiotherapy in patients with squamous oesophageal cancer. Eur J Cancer. 2016 Jan;52:1-9. doi: 10.1016/j.ejca.2015.09.019. Epub 2015 Nov 26.'}, {'pmid': '25702326', 'type': 'BACKGROUND', 'citation': 'Zhang J, Fang W, Qin T, Yang Y, Hong S, Liang W, Ma Y, Zhao H, Huang Y, Xue C, Huang P, Hu Z, Zhao Y, Zhang L. Co-expression of PD-1 and PD-L1 predicts poor outcome in nasopharyngeal carcinoma. Med Oncol. 2015 Mar;32(3):86. doi: 10.1007/s12032-015-0501-6. Epub 2015 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'Perspectives:\n\nTo analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy.\n\nTo evaluate the specific immune response throughout monitor the change of the programmed death-1(PD-1) in CD8 T cell and CD4 T cell and Treg cell in blood at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.\n\nTo use immunohistochemistry (IHC) technique to monitor the change of programmed death-ligand 1 (PD-L1),CD68,CD8,CD4,PD1 and Treg expression in biopsy at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.\n\nTo detect the change of T cell receptor(TCR) repertoire and Tumor mutation burden (TMB) at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.', 'detailedDescription': "Cervical cancer is the fourth most common cancer among women worldwide. At present, patients with cervical cancer are treated with radical hysterectomy and pelvic lymphadenectomy or chemoradiation. To improve the prognosis of cervical cancer patients, novel immunotherapeutic strategies need to be developed. Now there are some clinical phase I/II trials ongoing to assess the effects of ipilimumab, pembrolizumab and nivolumab in advanced cervical cancer,but information on the clinical significance of PD-L1 expression in cervical cancer is largely lacking.In this study, the investigator's primary objective:\n\nTo analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy.\n\nTo evaluate the specific immune response throughout monitor the change of PD-1 in CD8 T cell and CD4 T cell and Treg cell in blood at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.\n\nTo use IHC technique to monitor the change of PD-L1, CD68,CD8,CD4,PD1 and Treg expression in biopsy at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.\n\nTo detect the change of TCR repertoire and TMB at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age:18-70 years.\n2. All FIGO stages cervical cancers which are the matter for radiochemotherapy and exclusive brachytherapy indications.\n3. ECOG:0-1.\n4. Ability to give informed consent.\n\n4\\. Patients must be affiliated to a Social Security System. 6. Patient information and written informed consent form signed.\n\nExclusion Criteria:\n\n1. Known autoimmune disorder.\n2. History of HIV and/ or active hepatitis infection.\n3. History of pelvic radiation or radio-chemotherapy.\n4. Recurrent or metastatic cervical cancer.\n5. Contra-indication for cisplatin.\n6. Patient pregnant and/or breastfeeding.\n7. Patients with psychological or familial disease potentially hampering compliance with the study protocol and follow-up schedule'}, 'identificationModule': {'nctId': 'NCT03559803', 'briefTitle': 'A Prospective Study of Monitoring Immune Response in Locally Advanced Cervix Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'A Prospective Study of Dynamic Monitoring Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy', 'orgStudyIdInfo': {'id': 'GHR-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cisplatin', 'description': 'Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory.', 'interventionNames': ['Drug: Cisplatin']}], 'interventions': [{'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['radiotherapy'], 'description': "Drug: Cisplatin injection Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory.\n\nCombination Product: radiotherapy A total dose of 45Gy in 25 fractions to the PTV is considered standard but simultaneous integrated boost or two steps boost to specific volumes (positive lymph nodes for example) are accepted and left to the investigator's discretion).", 'armGroupLabels': ['Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guizhou', 'state': 'Guizhou', 'country': 'China', 'facility': "Guizhou Province People's Hospital"}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'You Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Department of Thoracic Oncology', 'investigatorFullName': 'You Lu', 'investigatorAffiliation': 'Sichuan University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-25', 'type': 'RELEASE'}, {'date': '2021-04-21', 'type': 'RESET'}, {'date': '2021-12-02', 'type': 'RELEASE'}, {'date': '2022-02-17', 'type': 'RESET'}, {'date': '2022-06-19', 'type': 'RELEASE'}, {'date': '2023-03-30', 'type': 'RESET'}, {'date': '2023-05-10', 'type': 'RELEASE'}, {'date': '2024-01-24', 'type': 'RESET'}, {'date': '2024-03-19', 'type': 'RELEASE'}, {'date': '2024-08-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'You Lu, Chair of Department of Thoracic Oncology, Sichuan University'}}}}