Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT05524168
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2022-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631724', 'term': 'camrelizumab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'up to 12 months', 'description': 'Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'up to 12 months', 'description': 'Defined as the time from randomization to death from any cause.'}, {'measure': 'Objective Response Rate', 'timeFrame': 'up to 12 months', 'description': 'The percentage of patients with CR and PR assessed according to RECIST v1.1.'}, {'measure': 'Disease Control Rate', 'timeFrame': 'up to 12 months', 'description': 'The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1.'}, {'measure': 'Adverse Events', 'timeFrame': 'up to 12 months', 'description': 'All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03'}, {'measure': 'QoL', 'timeFrame': 'up to 12 months', 'description': 'Assessed by EQ-5D-5L questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SBRT', 'PD-1 antibody', 'Chemotherapy', 'Efficacy', 'Safety', 'Oligometastasis'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT combined with programmed death 1 (PD-1) antibody and chemotherapy in nasopharyngeal carcinoma patients with oligometastasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed as metastatic NPC with no more than 3 metastatic lesions;\n* Histopathological diagnosis of NPC;\n* ECOG 0-1 point;\n* Has not received prior systemic treatment, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;\n* No contraindications to immunotherapy and chemoradiotherapy;\n* Every metastatic lesions could receive SBRT safely;\n* Subject must have a measurable target lesion based on RECIST v1.1;\n* Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;\n* Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;\n* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);\n* Take effective contraceptions during and three months after treatment;\n* Patients must be informed of the investigational nature of this study and give written informed consent.\n\nExclusion Criteria:\n\n* Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;\n* Unexplained fever \\> 38.5 ℃, except for tumor fever;\n* Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);\n* Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;\n* Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;\n* Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; Have known allergy to large molecule protein products or any compound of study therapy;\n* Pregnant or breastfeeding;\n* Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;\n* Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;\n* Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results."}, 'identificationModule': {'nctId': 'NCT05524168', 'briefTitle': 'SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'SBRT Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Nasopharyngeal Carcinoma With Oligometastasis: A Prospective, Multicenter, Single-arm, Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'SBRT+PD-1+Chemo for mNPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBRT+PD-1+Chemotherapy', 'description': 'Patients will receive SBRT first, then PD-1 antibody (Camrelizumab 200mg/Q3W) and chemotherapy (cisplatin 80mg/m2 on d1, gemcitabine 1000mg/m2, d1 and d8, Q3W, maximum 6 cycles), followed by Camrelizumab (200mg/Q3W) until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 1 year treatment.', 'interventionNames': ['Radiation: SBRT', 'Drug: Camrelizumab', 'Drug: Gemcitabine', 'Drug: Cisplatin']}], 'interventions': [{'name': 'SBRT', 'type': 'RADIATION', 'description': 'SBRT for metastatic lesions', 'armGroupLabels': ['SBRT+PD-1+Chemotherapy']}, {'name': 'Camrelizumab', 'type': 'DRUG', 'otherNames': ['SHR-1210'], 'description': 'Maximum 6 cycles for combined therapy. Camrelizumab maintenance for 1 year.', 'armGroupLabels': ['SBRT+PD-1+Chemotherapy']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Maximum 6 cycles for combined therapy.', 'armGroupLabels': ['SBRT+PD-1+Chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Maximum 6 cycles for combined therapy.', 'armGroupLabels': ['SBRT+PD-1+Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingjing Miao, MD.', 'role': 'CONTACT', 'email': 'miaojj@sysucc.org.cn', 'phone': '13631355201'}, {'name': 'Chong Zhao, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jingjing Miao, MD.', 'role': 'CONTACT', 'email': 'miaojj@sysucc.org.cn', 'phone': '13631355201'}, {'name': 'Chong Zhao, MD. PhD.', 'role': 'CONTACT', 'email': 'zhaochong@sysucc.org.cn', 'phone': '+8687342638'}], 'overallOfficials': [{'name': 'Chong Zhao, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': "Shenzhen People's Hospital", 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': 'Jiangxi Provincial Cancer Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Chongqing University Cancer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Prof.', 'investigatorFullName': 'Zhao Chong', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}