[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638659":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":29,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":29,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":44,"whyStopped":29,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"EDS01 1.0×10^11 VP + Toripalimab","EXPERIMENTAL","Participants receive intratumoral EDS01 1.0×10\\^11 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.",[13],"Drug: EDS01 1.0×10^11 VP + Toripalimab",{"label":15,"type":10,"description":16,"interventionNames":17},"EDS01 5.0×10^11 VP + Toripalimab","Participants receive intratumoral EDS01 5.0×10\\^11 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.",[18],"Drug: EDS01 1.0×10^12 VP + Toripalimab",{"label":20,"type":10,"description":21,"interventionNames":22},"EDS01 1.0×10^12 VP + Toripalimab","Participants receive intratumoral EDS01 1.0×10\\^12 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.",[23],"Drug: EDS01 5.0×10^11 VP + Toripalimab",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 1.0×10\\^11 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.",[9],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 5.0×10\\^11 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.",[20],{"type":26,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 1.0×10\\^12 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.",[15],[37],{"name":38,"role":39,"phone":40,"phoneExt":29,"email":41},"nan lin, MD","CONTACT","+8618708305692","nanishard@gmail.com",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Chengdu","China","610041","CN",{"type":50,"coordinates":51},"Point",[52,53],104.06667,30.66667,{"lat":53,"lon":52},[56],{"name":57,"role":39,"phone":58,"phoneExt":29,"email":59},"Xuelei ma","18708305692","drmaxuelei@gmail.com",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Xuelei Ma MD","Biotherapy Department, Deputy Director","100638659","phase-1-intratumoral-injection-of-recombinant-human-endostatin-adenovirus-eds01-for-the-treatment-of-recurrent-or-metastatic-head-and-neck-tumors-100638659",false,"NCT07625423","Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors","A Phase I Clinical Trial of Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) Combined With Toripalimab for the Treatment of Recurrent or Metastatic Head and Neck Tumors","EDS01 HN","Inclusion Criteria:\n\nAdults aged 18 to 65 years. Histologically or cytologically confirmed recurrent or metastatic head and neck tumor.\n\nPreviously received at least 1 standard platinum-based systemic chemotherapy regimen for recurrent\u002Fmetastatic disease, or had platinum-insensitive or platinum-intolerant disease after prior curative-intent treatment.\n\nNot suitable for surgery or radiotherapy. At least 1 target lesion suitable for intratumoral injection of recombinant human endostatin adenovirus injection.\n\nAt least 1 measurable lesion with diameter ≥2 cm on imaging, according to RECIST version 1.1.\n\nNo chemotherapy, radiotherapy, biologic antitumor therapy, or antiviral therapy within 4 weeks before enrollment.\n\nEstimated life expectancy of at least 12 weeks. ECOG performance status 0 to 1. Male or female participants of childbearing potential must agree to use reliable contraception during treatment and for at least 6 months after treatment.\n\nRecovery of prior treatment-related toxicities to NCI CTCAE grade 1 or baseline, with screening laboratory results within 1 week before enrollment meeting protocol requirements: ANC ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, total bilirubin ≤1.5 × ULN, ALT and AST ≤2 × ULN, and coagulation parameters ≤1.25 × ULN.\n\nWilling and able to provide written informed consent.\n\nExclusion Criteria:\n\nKnown allergy to the study drugs. Lesions involving major blood vessels or nerves and therefore unsuitable for local injection.\n\nReceiving radiotherapy to the study lesion at the same time. Prior anti-angiogenic therapy. Receiving immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes at a dose greater than prednisone 10 mg\u002Fday (or equivalent) within 2 weeks before enrollment.\n\nActive autoimmune disease or history of autoimmune disease. Congenital or acquired immunodeficiency. Risk of major nasopharyngeal hemorrhage or deep nasopharyngeal ulceration. Severe coagulation disorder or bleeding tendency. Severe uncontrolled medical disease or myocardial infarction within 3 months before enrollment.\n\nAcute infection. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","ALL","18 Years","65 Years",{"count":76,"type":77},9,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","This single-center, Phase 1 study is evaluating the safety, tolerability, and preliminary antitumor activity of recombinant human endostatin adenovirus injection (EDS01) given by intratumoral injection in combination with toripalimab in adults with recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma, whose disease has progressed after platinum-based systemic therapy or who are not suitable for further platinum treatment.\n\nA total of 9 participants will be enrolled in 3 planned dose groups of EDS01. EDS01 will be injected directly into an accessible tumor lesion on Days 0 and 7, and toripalimab 240 mg will be administered intravenously on Day 1 of each treatment cycle for up to 4 cycles, unless disease progression or unacceptable toxicity occurs. The study will evaluate treatment-related adverse events as well as preliminary efficacy outcomes, including tumor response, disease control, and time to progression, using clinical assessments, laboratory tests, imaging, and follow-up after treatment.",[83,84],"Head & Neck Cancer","Nasopharyngeal Cancinoma (NPC)",[86,87,88],"head and neck cancer","nasopharyngeal cancer","recombinant human endostatin adenovirus","2026-06-03",{"date":91,"type":92},"2026-06-04","ACTUAL",{"date":94,"type":92},"2026-03-27",{"date":96,"type":77},"2028-03-30",{"name":5,"class":6},1]