Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 8:10 PM
Study NCT ID:
NCT07154108
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '* Cohort A (Head and Neck Cancer): Patients with recurrent or metastatic head and neck cancer; single-arm, open-label; N ≈ 20\n* Cohort B (Esophageal Squamous Cell Carcinoma): Patients with superficial lymph node metastasis of ESCC; single-arm, open-label; N ≈ 20'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-related adverse effects (TRAEs)', 'timeFrame': 'Through study completion, an average of 1.5 year', 'description': 'This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment related adverse events as assessed by CTCAE v5.0.'}, {'measure': 'Incidence of Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'During the first cycle of treatment （21 days）', 'description': 'DLTs are defined as treatment-related adverse events occurring during the DLT evaluation period that meet protocol-specified criteria for severity and duration, as assessed by NCI CTCAE v5.0.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 12 months', 'description': 'It is defined as the proportion of patients with complete response (CR) or partial response (PR), as assessed by RECIST 1.1.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'up to 12 months', 'description': 'DCR refers to the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) for a specified minimum duration after treatment, based on RECIST 1.1.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'up to 12 months', 'description': 'Time from the start of treatment to the first documentation of disease progression based on RECIST 1.1.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'up to 24 months', 'description': 'Time from the start of treatment to death from any cause'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal cancer', 'Esophageal squamous cell carcinoma', 'Head and neck cancer', 'Endostatin Adenovirus', 'safety', 'Clinical efficacy'], 'conditions': ['Esophageal Cancer', 'Head and Neck Cancer (H&Amp;Amp;Amp;N)']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open-label, dual-cohort clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of intratumoral injection of recombinant human endostatin adenovirus in combination with a PD-1 inhibitor in patients with recurrent or metastatic head and neck cancer, or in patients with esophageal squamous cell carcinoma (ESCC) with superficial lymph node metastasis.', 'detailedDescription': 'Cohort A will enroll patients with recurrent or metastatic head and neck cancer. Cohort B will enroll patients with ESCC with superficial lymph node metastasis. Both cohorts will receive intratumoral injection of recombinant human endostatin adenovirus combined with intravenous an immune checkpoint inhibitor.\n\nThe primary objectives are to assess the safety profile, incidence of dose-limiting toxicities (DLTs), and treatment-related adverse events (TRAEs) of the combination therapy. The secondary objectives include evaluation of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Each cohort plans to enroll approximately 20 patients, with a total of 40 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Cohort A (Head and Neck Cancer)\n* Cohort B (Esophageal Squamous Cell Carcinoma)\n\nInclusion Criteria:\n\n1. Age ≥18 years\n\n * Cohort A (Head and Neck Cancer): ≤70 years\n * Cohort B (Esophageal Squamous Cell Carcinoma): ≤75 years\n2. Histologically or cytologically confirmed recurrent or metastatic:\n\n * Cohort A: Head and Neck Cancer\n * Cohort B: ESCC, AJCC 9th edition stage IV\n3. Prior treatment:\n\n * Cohort A: ≥1 prior platinum-based chemotherapy regimen or platinum-refractory/intolerant\n * Cohort B: Prior immune checkpoint inhibitor (ICI) therapy with documented acquired resistance after prior PR or SD\n4. At least one lesion accessible for intratumoral injection\n\n * Cohort A: measurable lesion ≥2 cm by RECIST 1.1\n * Cohort B: superficial metastatic lymph nodes (cervical or supraclavicular)\n5. ECOG performance status\n\n * Cohort A: 0-2\n * Cohort B: 0-1\n6. Adequate organ function\n7. Life expectancy ≥12 weeks (Cohort A)\n8. No anti-tumor therapy (chemotherapy, radiotherapy, biotherapy, antiviral) within 4 weeks prior to enrollment (Cohort A)\n9. Availability of fresh tumor tissue specimen or pathological slides from the injection target lesion (Cohort B)\n10. Male/female patients of childbearing potential must use effective contraception during study and for at least 6 months after treatment\n11. Voluntary participation with signed informed consent\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to study drugs\n2. Lesions unsuitable for injection due to proximity to major blood vessels, nerves, or hollow organs, or with extensive necrosis\n3. Deeply located lesions with high procedural difficulty (Cohort B)\n4. Concurrent radiotherapy to target lesion(s) (Cohort A)\n5. Prior anti-angiogenic therapy (Cohort A)\n6. Immunosuppressive therapy or systemic corticosteroids \\>10 mg/day prednisone (or equivalent) within 2 weeks prior to enrollment\n7. Active autoimmune disease or history of autoimmune disease\n8. Congenital or acquired immunodeficiency\n9. Severe coagulopathy, bleeding tendency, or high-risk lesions (Cohort B)\n10. Poor nutritional status (Cohort B)\n11. Interstitial lung disease with symptoms or radiographic evidence (Cohort B)\n12. Severe uncontrolled systemic disease or recent myocardial infarction (\\<3 months)\n13. Acute infection\n14. Pregnancy or breastfeeding\n15. Other malignancy besides ESCC (Cohort B)\n16. Patients unlikely to comply with follow-up or participation requirements\n17. Any condition deemed unsuitable for enrollment by the investigator'}, 'identificationModule': {'nctId': 'NCT07154108', 'briefTitle': 'Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'A Phase I, Open-label, Two-cohort Study of Recombinant Human Endostatin Adenovirus in Combination With Immune Checkpoint Inhibitors in Patients With Recurrent or Metastatic Head and Neck Cancer or Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'AdEndo-PD1-P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostatin Adenovirus+PD-1 inhibitor', 'description': 'Recombinant Human Endostatin Adenovirus: Administered via intratumoral injection twice every 3 weeks for a total of eight doses, or until disease progression, the occurrence of unacceptable toxicity, or death from any cause, whichever occurs first. Immune checkpoint inhibitor: Administered via intravenous infusion once every 3 weeks.\n\n(This study includes two parallel cohorts: Cohort A (recurrent/metastatic head and neck cancer) and Cohort B (esophageal squamous cell carcinoma). Both cohorts will receive the same intervention.)', 'interventionNames': ['Biological: recombinant human endostatin adenovirus', 'Drug: PD-1 Inhibitor']}], 'interventions': [{'name': 'recombinant human endostatin adenovirus', 'type': 'BIOLOGICAL', 'description': 'Recombinant Human Endostatin Adenovirus: Administered via intratumoral injection twice every 3 weeks for a total of eight doses, or until disease progression, the occurrence of unacceptable toxicity, or death from any cause, whichever occurs first.', 'armGroupLabels': ['Endostatin Adenovirus+PD-1 inhibitor']}, {'name': 'PD-1 Inhibitor', 'type': 'DRUG', 'description': 'PD-1 inhibitor: Administered via intravenous infusion once every 3 weeks.', 'armGroupLabels': ['Endostatin Adenovirus+PD-1 inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Zhenyu Ding, MD', 'role': 'CONTACT', 'email': 'dingzhenyu@scu.edu.cn', 'phone': '+862885422562'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Zhenyu Ding, MD', 'role': 'CONTACT', 'email': 'dingzhenyu@scu.edu.cn', 'phone': '+862885422562'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zhen-Yu Ding', 'investigatorAffiliation': 'Sichuan University'}}}}