[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ak112\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ak112":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100605453","phase-2-scrt-followed-by-ak112-in-pmmrmss-mid-low-rectal-cancer-100605453",false,"NCT07162714","SCRT Followed by AK112 in pMMR\u002FMSS Mid-low Rectal Cancer","Short-Course Radiotherapy Followed by Ivonescimab (AK112) in pMMR\u002FMSS Mid-Low Rectal Cancer: An Exploratory Phase II Clinical Study.","STAR","Inclusion Criteria:\n\n1. Aged between 18 and 75 years old;\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1;\n3. Histopathologically confirmed rectal adenocarcinoma, without any prior anti - tumor treatment; The status of MMR\u002FMSI is detected by IHC\u002FPCR in pathological biopsy to clarify that the patient's classification is pMMR\u002FMSS;\n4. The lower border of the lesion is ≤ 7 cm from the anal verge as determined by fibrocolonoscopy or digital rectal examination;\n5. Baseline magnetic resonance staging is cT2 - 4 and\u002For N+, excluding any of cT4b, N2, positive mesorectal fascia (MRF+), extramural venous invasion (EMVI+), lateral lymph node metastasis, and distant metastasis (according to the 8th edition of the AJCC Cancer Staging Manual);\n6. Able to accept the treatment plan during the study period;\n7. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Uncontrolled epilepsy, history of central nervous system disorders or psychiatric conditions that, in the investigator's judgment, may interfere with the ability to provide informed consent or affect compliance with oral medication.\n2. Prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies.\n3. Clinically significant active cardiac disease, including symptomatic coronary artery disease, congestive heart failure (New York Heart Association \\[NYHA\\] Class II or higher), severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.\n4. Immunosuppressive therapy following organ transplantation.\n5. History of other malignancies within the past 5 years (excluding adequately treated non-melanoma skin cancer or carcinoma in situ).\n6. Severe uncontrolled recurrent infections or other significant uncontrolled comorbidities.\n7. Baseline laboratory values failing to meet the following criteria:Hemoglobin ≥80 g\u002FL; Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelets ≥100×10\\^9\u002FL; ALT\u002FAST ≤2.5×upper limit of normal (ULN); Alkaline phosphatase (ALP) ≤2.5×ULN; Total bilirubin \\\u003C1.5×ULN; Serum creatinine \\\u003C1×ULN\n8. Active gastrointestinal diseases (e.g., gastric\u002Fduodenal ulcers, ulcerative colitis), unresected tumors with active bleeding, or other conditions deemed by the investigator to pose risks of gastrointestinal bleeding or perforation.\n9. Active bleeding or bleeding predisposition.\n10. Pregnancy or lactation.\n11. Hypersensitivity to any component of the investigational drug(s).","ALL","18 Years","75 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Primary Objectives： Evaluate the complete response rate (CR rate) and safety of short - course radiotherapy combined with ivonesimab (AK112) in patients with pMMR\u002FMSS mid - low rectal cancer.\n\nSecondary Objectives： Evaluate treatment - related toxic reactions, the quality of life, long - term prognosis (local control \\[LC\\], disease - free survival \\[DFS\\] and overall survival \\[OS\\]).\n\nPatients will :\n\nReceive Radiotherapy: Pelvic IMRT or VMAT, DT 25Gy\u002F5Fx. One week after radiotherapy, begin treatment with Ivorsimab (AK112) at a dose of 20mg\u002Fkg by intravenous drip on day 1. One cycle is 21 days, and a total of 6 cycles are to be carried out.\n\nEvaluate the curative effect after 3 cycles of treatment. Patients with progressive disease (PD) will withdraw from the study, and other treatment plans will be adjusted in a timely manner. Patients with CR\u002FPR\u002FSD will continue treatment for another 3 cycles. Conduct a comprehensive assessment after 6 cycles of treatment. Patients who achieve cCR can choose the watch - and - wait approach. For patients who do not achieve cCR, TME surgery is recommended. Decide whether to perform adjuvant chemotherapy based on the postoperative pathological findings.",[28,29,30],"Rectal Cancer","Radiation","AK112","NOT_YET_RECRUITING","2025-09-06",{"date":34,"type":35},"2025-09-09","ACTUAL",{"date":37,"type":22},"2025-09-01",{"date":39,"type":22},"2028-12-31",{"name":41,"class":42},"Zhejiang Cancer Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100599579","phase-2-a-phase-ii-randomized-trial-of-neoadjuvant-ivonescimab-or-penpulimab-plus-chemotherapy-in-resectable-nsclc-100599579","NCT07086326","A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC","A Prospective, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Ivonescimab Combined With Chemotherapy Versus Penpulimab Combined With Chemotherapy for Neoadjuvant Treatment of Non-small Cell Lung Cancer (NSCLC)","NEOINSPIRE","Inclusion Criteria:\n\n1. Voluntarily sign the written Informed Consent Form (ICF) and consent to receive curative surgical treatment.\n2. Participants must be aged ≥ 18 years, regardless of gender.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status Score is 0-1.\n4. Histologically confirmed resectable Stage IIA-IIIB (N2) non-small cell lung cancer (NSCLC) according to the 9th edition of the TNM staging system for lung cancer by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).\n5. Prior to study enrollment, subjects must be evaluated by an attending thoracic surgeon responsible for the surgery to verify eligibility for R0 resection with curative intent.\n6. NSCLC appears solid or subsolid (not purely ground-glass opacity \\[GGO\\]) on CT scan. For subsolid lesions, tumor size (i.e., clinical T stage) should be based solely on the solid component without measuring the GGO portion.\n7. Normal pulmonary function test results.\n8. At least one measurable lesion according to RECIST v1.1, amenable to repeated accurate measurements.\n9. Adequate cardiac function.\n10. Laboratory values obtained during screening or within ≤14 days prior to randomization indicate adequate organ function.\n11. For patients planned to receive cisplatin: No hearing impairment.\n12. Women of childbearing potential must have a negative pregnancy test result within 3 days before first treatment; all subjects (male and female) must agree to use appropriate contraceptive methods during the study.\n\nExclusion Criteria:\n\n1. Patients with large cell neuroendocrine carcinoma (LCNEC) or NSCLC mixed with small cell lung cancer components;\n2. Presence of locally advanced unresectable disease (any stage) or metastatic disease (Stage IV). Subjects with contralateral mediastinal lymph node involvement confirmed by PET-CT scan.\n3. NSCLC diagnosed with EGFR-sensitive mutations or ALK gene translocation. For non-squamous cell carcinoma subjects (including NSCLC with unclear pathology), tumor tissue-based EGFR and ALK testing results must be provided. If EGFR\u002FALK status is unknown, testing must be performed prior to enrollment. For squamous NSCLC subjects, EGFR\u002FALK testing is not required during screening if status is unknown.\n4. Any prior systemic or local anti-tumor therapy for NSCLC;\n5. Concurrent enrollment in another clinical trial;\n6. History of other malignancies (excluding NSCLC) within 3 years prior to randomization;\n7. Active autoimmune disease requiring systemic treatment within 2 years prior to randomization;\n8. History of major diseases within 1 year prior to randomization;\n9. Severe cardiovascular risk factors;\n10. History of significant bleeding diathesis or coagulation disorders; clinically significant bleeding symptoms (including but not limited to gastrointestinal hemorrhage, hemoptysis ≥1 teaspoon of fresh blood\u002Fclots or pure hemoptysis without sputum, minor blood-tinged sputum allowed; excluding epistaxis and retracted blood-tinged nasal discharge) within 4 weeks prior to randomization;\n11. Any other conditions deemed unsuitable for enrollment by the investigator.",{"count":52,"type":22},164,[25],"This is a randomized, open-label, multicenter phase II study. The trial plans to enroll 164 subjects with resectable stage IIA-IIIB (N2) NSCLC. Participants will be randomized 1:1 into either the ivonescimab plus chemotherapy or penpulimab plus chemotherapy treatment arm. After 3-4 cycles of neoadjuvant therapy, surgical resection will be performed. The primary objective is to compare the pathological complete response (pCR) rate assessed by local pathologists between ivonescimab-based and penpulimab-based chemo-immunotherapy regimens in the neoadjuvant treatment of resectable NSCLC.",[56,57,58,30,59],"NSCLC","Neoadjuvant Therapy","Immunotherapy","Bispecific Antibody","2025-07-17",{"date":62,"type":35},"2025-07-25",{"date":64,"type":22},"2025-07-31",{"date":66,"type":22},"2027-12-30",{"name":68,"class":42},"Yang Fan, MD",5,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100575000","ivonescimab-combined-with-chemotherapy-for-the-treatment-of-leptomeningeal-metastases-failed-to-egfr-tkis-100575000","NCT06766591","Ivonescimab Combined With Chemotherapy for the Treatment of Leptomeningeal Metastases Failed to EGFR-TKIs","Ivonescimab Combined With Chemotherapy for EGFR Mutant NSCLC With Leptomeningeal Metastasis After EGFR TKIs Resistance: A Multicenter Observational Study.","Inclusion Criteria:\n\n* Age range: 18-75y\n* EGFR mutation NSCLC\n* LM was diagnosed through head enhanced MRI or (and) CSF cytology\n* EGFR activation mutations were positive\n* Patients who have failed to first or second-generation EGFR-TKI treatment，without T790M mutation; or failed to third-generation EGFR-TKI treatment\n* Hematological, coagulation, renal and liver function is sufficient\n* Women of childbearing age must undergo a pregnancy test and the result must be negative\n\nExclusion Criteria:\n\n* Patients with squamous cell carcinoma, large cell carcinoma, mixed cell lung cancer\n* The patient has other driver genes that can be treated with targeted drugs\n* Subjects who have previously received immunotherapy with a discontinuation time of less than 3 months\n* Received EGFR-TKI treatment within one week prior to the first administration\n* Received non-specific immunomodulatory therapy\n* Clinical manifestations of neurological failure\n* Non malignant neurological disorders\n* Radiotherapy for the chest and whole brain should be completed within 4 weeks before enrollment\n* Tumor surrounded important blood vessels or had obvious necrosis or cavities\n* Tumor has invaded important surrounding organs and blood vessels\n* History of severe bleeding tendency or coagulation dysfunction\n* The risk of developing esophagotracheal fistula or esophageal pleural fistula",{"count":78,"type":22},36,[80],"NA","Research objective Main purpose Exploring the real-world effectiveness of Ivonescimab combined with chemotherapy for EGFR mutant NSCLC with leptomeningeal metastasis after EGFR-TKIs resistance. Outcome measure: Real world intracranial disease-free survival time (iPFS).\n\nSecondary purpose Federation patterns: describing different treatment modes in the real world; Outcome measures: Combination chemotherapy regimen and duration of chemotherapy.\n\nEfficacy: Further explore the effectiveness of Ivonescimab combined with chemotherapy for EGFR mutant NSCLC with leptomeningeal metastasis failed with EGFR-TKI treatment; Outcome measures: Objective response rate (LM-ORR), duration of intracranial response (iDoR), overall progression free survival (PFS), overall survival (OS), improvement in neurological function, CSF response rate based on CSF cytology.\n\nSafety: Explore the safety of Ivonescimab combined with chemotherapy for NSCLC patients with leptomeningeal metastases who have failed EGFR-TKI treatment; Outcome measures: incidence of adverse events (TEAEs), laboratory test outliers, and serious adverse events (SAEs).\n\nResearch endpoint Primary endpoint\n\n* iPFS (intracranial progression free survival). Secondary endpoint\n* Efficacy: leptomeningeal ORR (LM-ORR), intracranial duration of response (iDoR), overall progression free survival (PFS), overall survival (OS), improvement in neurological function, and CSF response rate based on CSF cytology;\n* Safety: Determine the incidence and severity of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE5.0 standards; Changes in vital signs, laboratory abnormalities, and quality of life scores.\n\nExploratory endpoint: efficacy related biomarkers",[56,83,84,85,30],"Chemotherapy","Leptomeningeal Metastases","EGFR-TKI",[87,56,88,85,89,90],"Ivonescimab","leptomeningeal metastases","VEGF","PD-1\u002FVEGF bispecific antibody","2025-01-05",{"date":93,"type":35},"2025-01-09",{"date":95,"type":22},"2025-01-01",{"date":97,"type":22},"2025-10-31",{"name":99,"class":42},"Jiangsu Province Nanjing Brain Hospital"]