Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-01 @ 5:15 PM
Study NCT ID:
NCT04778956
Status:
RECRUITING
Last Update Posted:
2021-03-04
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'C000711728', 'term': 'spartalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2033-03-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-28', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '2 years', 'description': 'Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '3-5 weeks', 'description': 'Defined as the proportion of patients with radiologically confirmed complete or partial response according to RECIST 1.1.'}, {'measure': 'Major Pathological Response Rate', 'timeFrame': '4-6 weeks', 'description': 'Defined as the proportion of patients with no more than 10% viable tumor cells which is identified on routine hematoxylin and eosin staining within the recurrent nasopharyngeal tumor and/or regional lymph node after neoadjuvant PD-1 treatment.'}, {'measure': 'Overall Survival', 'timeFrame': '2 years', 'description': 'Defined as the time interval from randomization to death due to any cause.'}, {'measure': 'Distant Metastasis-Free Survival', 'timeFrame': '2 years', 'description': 'Defined as the time interval from randomisation to the date of first distant metastases.'}, {'measure': 'Locoregional Relapse-Free Survival', 'timeFrame': '2 years', 'description': 'Defined as the time from randomisation to the date of first locoregional relapse.'}, {'measure': 'Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)', 'timeFrame': 'up to 2 years', 'description': 'Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.'}, {'measure': 'Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)', 'timeFrame': 'up to 2 years', 'description': 'Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\\&N35) before treatment, during treatment, after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal carcinoma', 'Recurrent', 'Salvage surgery', 'Anti-programmed death-1 antibody', 'Disease free survival'], 'conditions': ['Nasopharyngeal Carcinoma', 'PD-1', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.', 'detailedDescription': 'Through multicenter, open-label, randomised clinical trials, patients with resectable locally recurrent nasopharyngeal carcinoma are randomized into salvage surgery plus PD-1 treatment group and salvage surgery alone group. The efficacy and safety of patients between these two groups are compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The recurrence time is more than 6 months from the end of radiotherapy.\n2. Histologically confirmed recurrent nasopharyngeal carcinoma.\n3. Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)\n4. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)\n5. Given written informed consent.\n\nExclusion Criteria:\n\n1. Karnofsky Performance Status (KPS) ≤70.\n2. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.\n3. Has known subjects with other malignant tumors.\n4. Has participated in other drug trials within 3 months of planned start of study treatment.\n5. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.\n6. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.\n7. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.\n8. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.\n9. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.\n10. Has received a live vaccine within 4 weeks of planned start of study treatment.\n11. Pregnancy or breast feeding.\n12. Cannot complete regular follow-up."}, 'identificationModule': {'nctId': 'NCT04778956', 'briefTitle': 'Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SYSUCC-CMY-2020-2302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toripalimab plus salvage surgery', 'description': '1. Toripalimab: Toripalimab treatment before and after salvage surgery.\n2. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.', 'interventionNames': ['Drug: Toripalimab', 'Procedure: salvage surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salvage surgery alone', 'description': '1\\. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.', 'interventionNames': ['Procedure: salvage surgery']}], 'interventions': [{'name': 'Toripalimab', 'type': 'DRUG', 'otherNames': ['PD-1 antibody'], 'description': 'Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.', 'armGroupLabels': ['Toripalimab plus salvage surgery']}, {'name': 'salvage surgery', 'type': 'PROCEDURE', 'description': 'Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.', 'armGroupLabels': ['Salvage surgery alone', 'Toripalimab plus salvage surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming-Yuan Chen, MD, PhD', 'role': 'CONTACT', 'email': 'chmingy@mail.sysu.edu.cn', 'phone': '86-20-8734-3624'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei-Ping Wen, MD, PhD', 'role': 'CONTACT', 'email': 'wenwp@mail.sysu.edu.cn', 'phone': '86-13802966937'}], 'facility': 'The First Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao-Cheng Tang, MD.PhD', 'role': 'CONTACT', 'email': 'hctang2006@qq.com', 'phone': '86-15920115552'}], 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510700', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian-Zhong Zhang, MD', 'role': 'CONTACT', 'email': '525567166@qq.com', 'phone': '86-15820279737'}], 'facility': 'The Fifth Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '528000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Tang, MD', 'role': 'CONTACT', 'email': 'tjun@fsyyy.com', 'phone': '86-18038860199'}], 'facility': "The First People's Hospital of Foshan", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '528403', 'city': 'Zhongshan', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min-Yi Fu', 'role': 'CONTACT', 'email': '503498362@qq.com', 'phone': '86-13924933366'}], 'facility': "Zhongshan People's Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'zip': '330008', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming-Yuan Chen, MD, PhD', 'role': 'CONTACT', 'email': 'chmingy@mail.sysu.edu.cn', 'phone': '86-13903052650'}], 'facility': 'The Tenth Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Ming-Yuan Chen, MD, PhD', 'role': 'CONTACT', 'email': 'chmingy@mail.sysu.edu.cn', 'phone': '86-20-87343624'}, {'name': 'You-Ping Liu, MD, PhD', 'role': 'CONTACT', 'email': 'liuyoup@sysucc.org.cn', 'phone': '86-20-87343379'}], 'overallOfficials': [{'name': 'Ming-Yuan Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, {'name': 'Tenth Affiliated Hospital, Sun Yat-sen University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief Doctor', 'investigatorFullName': 'Ming-Yuan Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}