Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT07188103
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months', 'description': 'progression free survival'}, {'measure': 'Advese Events', 'timeFrame': 'Assessed every 8 weeks up to 36 months from the date of enrollment', 'description': 'Advese Events'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'From date of enrollment until the date of death from any cause, assessed up to 36 months', 'description': 'overall survival'}, {'measure': 'ORR', 'timeFrame': 'From enrollment to the time of the second radiological evaluation', 'description': 'Objective Response Rate'}, {'measure': 'DOR', 'timeFrame': 'the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death.', 'description': 'Duration of Response'}, {'measure': 'DCR', 'timeFrame': 'From enrollment to the time of second radiological evaluation', 'description': 'Disease Control Rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal cancer', 'Hypofractionated Radiotherapy', 'Ivonescimab'], 'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'In the era of immunotherapy, the standard second-line treatment regimen for locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced/metastatic ESCC. The study plans to enroll 37 patients who have failed first-line treatment, without grouping, all of whom will receive Ivonescimab combined with short-course hypofractionated radiotherapy. The primary endpoints are progression-free survival (PFS) and safety, while the secondary endpoints include overall survival (OS), duration of response (DOR), and objective response rate (ORR). The study duration is 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years;\n* b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure;\n* c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station;\n* d. Adequate major organ function, defined as:\n\n 1. Hematology:\n\n 1. Hemoglobin (Hb) ≥ 90 g/L\n 2. White blood cell (WBC) count ≥ 1.5 × 10⁹/L\n 3. Platelet count ≥ 60 × 10⁹/L\n 2. Serum biochemistry:\n\n 1. Albumin ≥ 25 g/L\n 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)\n 3. Total bilirubin ≤ 1.5 × ULN\n 4. Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min\n 3. Echocardiography:\n\nLeft ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)\n\n* e. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2;\n* f. Expected survival ≥ 3 months;\n* g. Voluntarily enrolled, with signed informed consent, and willing to comply with study protocols and follow-up.\n\nExclusion Criteria:\n\n* a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;\n* b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;\n* c. Patients with esophagotracheal or esophagomediastinal fistulas;\n* d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;\n* e. Patients with esophageal primary/metastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;\n* f. Patients with esophageal primary/metastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of esophagotracheal fistula;\n* g. Patients not suitable for short-course hypofractionated radiotherapy, as evaluated by the responsible physician;\n* h. Pregnant or lactating women;\n* i. Patients with mental disorders, or those with a history of psychotropic drug abuse and unable to quit;\n* j. Patients who have participated in other drug clinical trials within the past 4 weeks;\n* k. Patients or their families who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07188103', 'briefTitle': 'Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Anhui Provincial Hospital'}, 'officialTitle': 'Efficacy and Safety of Ivonescimab Combined With Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Single-Arm Phase II Clinical Study', 'orgStudyIdInfo': {'id': '2025KY-296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivonescimab+Radiotherapy', 'description': 'Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal.', 'interventionNames': ['Drug: Ivonescimab+Radiotherapy']}], 'interventions': [{'name': 'Ivonescimab+Radiotherapy', 'type': 'DRUG', 'description': 'Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal.', 'armGroupLabels': ['Ivonescimab+Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Anhui Provincal Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Huiquan Liu', 'role': 'CONTACT', 'email': '759821691@qq.com', 'phone': '+86 15005518171'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}