[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604791":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":33,"responsibleParty":49,"collaborators":21,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":21,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":21,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":80,"whyStopped":21,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Sichuan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endostatin Adenovirus+PD-1 inhibitor","EXPERIMENTAL","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\u002Fmetastatic head and neck cancer) and Cohort B (esophageal squamous cell carcinoma). Both cohorts will receive the same intervention.)",[13,14],"Biological: recombinant human endostatin adenovirus","Drug: PD-1 Inhibitor",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","recombinant human endostatin adenovirus","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.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","PD-1 Inhibitor","PD-1 inhibitor: Administered via intravenous infusion once every 3 weeks.",[9],[28],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Zhenyu Ding, MD","CONTACT","+862885422562","dingzhenyu@scu.edu.cn",[34],{"facility":35,"status":21,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041","China","CN",{"type":42,"coordinates":43},"Point",[44,45],104.06667,30.66667,{"lat":45,"lon":44},[48],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Zhen-Yu Ding","Clinical Professor","100604791","phase-1-endostatin-adenovirus-with-checkpoint-inhibitor-in-advanced-head-and-neck-or-esophageal-cancer-100604791",false,"NCT07154108","Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer","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","* 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\u002Fintolerant\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\u002Ffemale 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\u002Fday 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 (\\\u003C3 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","ALL","18 Years","75 Years",{"count":64,"type":65},40,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","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.",[71,72],"Esophageal Cancer","Head and Neck Cancer (H&Amp;Amp;Amp;N)",[74,75,76,77,78,79],"Esophageal cancer","Esophageal squamous cell carcinoma","Head and neck cancer","Endostatin Adenovirus","safety","Clinical efficacy","NOT_YET_RECRUITING","2025-08-27",{"date":83,"type":84},"2025-09-04","ACTUAL",{"date":86,"type":65},"2025-09-01",{"date":88,"type":65},"2027-08-01",{"name":5,"class":6},1]