Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04814069
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2021-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-year disease free survival', 'timeFrame': '1 year', 'description': 'from date of enrollment until date of first documented disease progression or from date of enrollment until date of first documented disease progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'from date of enrollment until death from any cause'}, {'measure': 'Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment', 'timeFrame': 'up to 3 months after completion of radiotherapy', 'description': 'Acute toxicity profiles, graded according to the NCI CTCAE version 4.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Radiation', 'PD-1']}, 'descriptionModule': {'briefSummary': 'To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically confirmed squamous cell carcinoma of the head and neck. Site of tumor origin in the oral cavity, oropharynx (p16-), larynx, or hypopharynx\n2. With at least one high risk factor after radical surgery ①positive margin; ②close margin（\\<5mm); ③ENE.\n3. No distant metastases\n4. No synchronous or concurrent head and neck primary tumors\n5. ECOG PS 0-1\n6. Adequate organ function including the following:\n\nAbsolute neutrophil count (ANC) \\>= 1.5 \\* 10\\^9/l Platelets count \\>= 80 \\* 10\\^9/l Hemoglobin \\>= 80 g/dl AST and ALT \\<= 2.5 times institutional upper limit of normal (ULN) Total bilirubin \\<= 1.5 times institutional ULN Creatinine clearance \\>30 ml/min 8. Signed written informed consent\n\nExclusion Criteria:\n\n1. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region\n2. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma\n3. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures\n4. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia\n5. Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n6. Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;"}, 'identificationModule': {'nctId': 'NCT04814069', 'briefTitle': 'A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study', 'orgStudyIdInfo': {'id': '2021HNRT01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'description': 'Tislelizumab 200mg q3w'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Guopei Zhu', 'investigatorAffiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}}}}