Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT05397769
Status:
RECRUITING
Last Update Posted:
2022-08-10
First Post:
2022-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718749', 'term': 'envafolimab'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year progression free survival', 'timeFrame': '3-year', 'description': 'time from the randomization to the first disease progression or death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Nasopharyngeal Carcinoma', 'Envafolimab', 'Induction Chemotherapy', 'PD-L1']}, 'descriptionModule': {'briefSummary': 'Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG 0-1\n* histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx\n* stage III-IVa （AJCC/UICC 8th ）, untreated NPC patients\n* NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L\n* ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN\n* creatinine\\<1.5×ULN\n\nExclusion Criteria:\n\n* recurrent or metastatic NPC patients\n* histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx\n* already received radiation or chemotherapy\n* pregnant or lactating women, or women of childbearing age without birth control\n* HIV (+)\n* had other cancers before\n* used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before\n* complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose\n* with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included)\n* use of massive dose of glucocorticoids within 4 weeks before enrollment\n* laboratory test values do not meet relevant standards within 7 days before enrollment\n* significantly lower functions of heart, liver, lung, kidney and bone marrow\n* serious or uncontrolled medical diseases or infections\n* participating other clinical trial in the same time\n* HBsAg (+) and HBV DNA \\>1×10E3 copiers /mL\n* HCV (+) unless HCV RNA PCR(-)\n* with any other treatment contraindications'}, 'identificationModule': {'nctId': 'NCT05397769', 'briefTitle': 'Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.', 'orgStudyIdInfo': {'id': 'B2022-203-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Envafolimab group', 'description': 'Envafolimab is a PD-L1 antibody by hypodermic injection. Envafolimab will be administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.', 'interventionNames': ['Drug: Envafolimab Plus Chemoradiotherapy']}], 'interventions': [{'name': 'Envafolimab Plus Chemoradiotherapy', 'type': 'DRUG', 'description': 'Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.', 'armGroupLabels': ['Envafolimab group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Han', 'role': 'CONTACT', 'email': 'hanfei@sysucc.org.cn', 'phone': '13822113698', 'phoneExt': '86'}, {'name': 'Fei Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Fei Han', 'role': 'CONTACT', 'email': 'hanfei@sysucc.org.cn', 'phone': '13822113698', 'phoneExt': '86'}, {'name': 'Xiaohui Wang', 'role': 'CONTACT', 'email': 'wangxh@sysucc.org.cn', 'phone': '18826260661', 'phoneExt': '86'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Fei Han', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}