Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT06235203
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2023-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
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': 'D004724', 'term': 'Endoscopy'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EFS', 'timeFrame': 'From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year', 'description': 'Event free survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'Time interval of randomization and death of any cause, up to 5 years', 'description': 'Overall Survival'}, {'measure': 'DFS', 'timeFrame': 'From randomization to recurrence, metastasis or death, up to 1 year', 'description': 'Disease free survival'}, {'measure': 'LRFS', 'timeFrame': 'From randomization to local recurrence or death, up to 1 year', 'description': 'Local recurrence free survival'}, {'measure': 'DMFS', 'timeFrame': 'From randomization to distant metastasis or death, up to 1 year', 'description': 'Distant metastasis free survival'}, {'measure': 'pCR', 'timeFrame': 'Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery', 'description': 'pathologic complete response'}, {'measure': 'ORR', 'timeFrame': 'Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year', 'description': 'Objective response rate,Proportion of CR, PR in all patients.'}, {'measure': 'DCR', 'timeFrame': 'Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year', 'description': 'Disease Control Rate,Proportion of CR, PR and SD in all patients.'}, {'measure': 'DoR', 'timeFrame': 'First date of response to the date of progression, up to 5 years', 'description': 'Duration of response,the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first).'}, {'measure': '1-and 2-year PFS rate', 'timeFrame': 'one- and two-year', 'description': 'one- and two-year progression free survival rate'}, {'measure': '1-and 2-year OS rate', 'timeFrame': 'one- and two-year', 'description': 'one- and two-year overall survival rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy', 'detailedDescription': 'Eligible patients are randomized into the control group and the experimental group.\n\nPatients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.\n\nPatients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;\n2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;\n3. Cervical lymph node metastasis can be controlled locally;\n4. Aged 18 to 75 years;\n5. Informed consent forms signed to participate in the trial;\n6. Without distant metastasis;\n7. ≥6months from the accomplishment of radical radiation to recurrence\n8. previously only 1 course of radiotherapy;\n9. Sufficient organ function;\n10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.\n\nExclusion Criteria:\n\n1. Participate in other interventional clinical trials;\n2. Uncontrolled illnesses that interfere with the therapy;\n3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);\n4. Any contradiction to surgery;\n5. With serious autoimmune disease;\n6. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;\n7. Severe allergic reactions to other monoclonal antibodies;\n8. History of radioactive particle planting;\n9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;\n10. Female patients who are at pregnancy or lactation;\n11. Other situations that the researchers believe not suitable for enrollment'}, 'identificationModule': {'nctId': 'NCT06235203', 'briefTitle': 'Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC', 'organization': {'class': 'OTHER', 'fullName': 'Eye & ENT Hospital of Fudan University'}, 'officialTitle': 'Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'adv-rNPC-RCT-Neo-V1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The control group', 'description': 'Endoscopic surgery + adjuvant therapy', 'interventionNames': ['Procedure: endoscopic surgery', 'Drug: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy']}, {'type': 'EXPERIMENTAL', 'label': 'The experimental group', 'description': 'Neoadjuvant therapy +endoscopic surgery + adjuvant therapy', 'interventionNames': ['Procedure: endoscopic surgery', 'Drug: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy', 'Drug: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy']}], 'interventions': [{'name': 'endoscopic surgery', 'type': 'PROCEDURE', 'description': 'The tumor was resected by endoscopic nasopharyngectomy.', 'armGroupLabels': ['The control group', 'The experimental group']}, {'name': 'Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy', 'type': 'DRUG', 'description': 'Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.', 'armGroupLabels': ['The experimental group']}, {'name': 'Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy', 'type': 'DRUG', 'description': 'Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.', 'armGroupLabels': ['The experimental group']}, {'name': 'Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy', 'type': 'DRUG', 'description': 'Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.', 'armGroupLabels': ['The control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaole Song', 'role': 'CONTACT', 'email': 'jxfxsxl@163.com', 'phone': '15821388769'}, {'name': 'Hongmeng Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaole Song', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Li Yan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yuting Lai', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Eye& ENT Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Fuzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Desheng Wang', 'role': 'CONTACT'}, {'name': 'Desheng Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Haichun Lai', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Nanning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shenhong Qu', 'role': 'CONTACT'}, {'name': 'Shenhong Qu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jingjin Weng', 'role': 'SUB_INVESTIGATOR'}], 'facility': "The People's Hospital of Guangxi Zhuang Autonomous Region", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haihong Tang', 'role': 'CONTACT'}, {'name': 'Haihong Tang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hongliang Zheng', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Haopu Li', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fengya Pan', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weitian Zhang', 'role': 'CONTACT'}, {'name': 'Weitian Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ru Tang', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Shanghai Sixth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinsheng Huang', 'role': 'CONTACT'}, {'name': 'Xinsheng Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xianhui Ning', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lei Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenzhen', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongtian Lu', 'role': 'CONTACT'}, {'name': 'Yongtian Lu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jing Tao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shenzhen Second People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Xiaole Song', 'role': 'CONTACT', 'email': 'jxfxsxl@163.com', 'phone': '+8621 64377134'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye & ENT Hospital of Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}, {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, {'name': "People's Hospital of Guangxi Zhuang Autonomous Region", 'class': 'OTHER'}, {'name': "Shenzhen Second People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}