[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cadonilimab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cadonilimab":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,76,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100544300","phase-2-cadonilimab-combined-with-chemotherapy-as-first-or-second-line-treatment-in-recurrent-or-metastatic-triple-negative-breast-cancer-100544300",false,"NCT06367088","Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer","Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Inclusion Criteria:\n\n* Recurrent or metastatic TNBC patients;\n* TNBC defined by immunohistochemistry as ER\\\u003C1%, PR\\\u003C1%, Her2=0\\~1+, or 2+ while HER2 Fish test shows no amplification；\n* Previous received no or only first line chemotherapy treatment for recurrent or metastatic TNBC；When the time between cancer metastasis and the end of adjuvant chemotherapy exceeds 1 year, the systemic chemotherapy for metastasis treatment is recorded as first-line treatment; When less than 1year, the systemic chemotherapy for metastasis treatment is recorded as second-line treatment；\n* ages 18 to 75 years at the time of signing the informed consent form (ICF);\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n* expected survival of ≥3 months; at least one measurable lesion per RECIST (version1.1);\n* acceptable renal and liver function;\n\nExclusion Criteria:\n\n* They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.)；\n* Patients with active central nervous system (CNS) metastatic lesions or meningeal metastases；\n* Patients with an active autoimmune disease that requires systemic treatment in the past two years；\n* A known history of primary immunodeficiency；\n* Pregnant or lactating women；\n* Previous or current abnormalities of any disease, treatment, laboratory tests may confuse the study results, affect the subject's participation in the study","ALL","18 Years","70 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.",[27,28],"Triple-negative Breast Cancer","Cadonilimab",[30,28,31],"triple negative breast cancer","chemotherapy","RECRUITING","2025-05-14",{"date":35,"type":36},"2025-05-20","ACTUAL",{"date":38,"type":36},"2024-05-01",{"date":40,"type":21},"2027-04-30",{"name":42,"class":43},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":44},"100547247","phase-2-naliri-xeloxak104-for-first-line-treatment-of-advanced-pdac-100547247","NCT06405490","NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC","Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study","Inclusion Criteria:\n\n1. Age ≥18, male or female;\n2. Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);\n3. Has not received prior systemic treatment for their locally advanced or metastatic PDAC;\n4. Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);\n5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;\n6. Has a life expectancy of at least 3 months;\n7. Has adequate organ function;\n8. If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;\n9. If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.\n\nExclusion Criteria:\n\n1. Untreated active CNS metastasis or leptomeningeal metastasis.\n2. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;\n3. Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;\n4. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and\u002For if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;\n5. Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;\n6. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \\\u003C 10 mg prednisone daily, inhaled steroids and topical use of steroids);\n7. Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);\n8. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;\n9. History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；\n10. Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody\u002Fdrug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；\n11. Is pregnant or breastfeeding;\n12. Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.",{"count":53,"type":21},30,[24],"This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.",[57,28,58,59,60,61,62,63],"Nanoliposomal Irinotecan","Oxaliplatin","Capecitabine","First-Line","Advanced Cancer","Pancreatic Adenocarcinoma","Drug Use",[62,57,28,65,66],"First-Line Treatment","Advanced Pancreatic Adenocarcinoma","2024-12-19",{"date":69,"type":36},"2024-12-24",{"date":71,"type":36},"2024-04-17",{"date":73,"type":21},"2026-12-30",{"name":75,"class":43},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100536478","cryoablation-combined-with-cardonilizumab-and-bevacizumab-in-hepatocellular-carcinoma-with-pulmonary-metastases-100536478","NCT06265350","Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases","Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases: A Single-center, Prospective, Randomized Controlled Phase II Study","Inclusion Criteria:\n\n1. primary or recurrent HCC;\n2. synchronous metastases (within one month after diagnosing of HCC) or asynchronous metastases (more than one month after diagnosis of HCC);\n3. pulmonary-only metastases \\>5 and ≤10;\n4. metastases diameter ≤ 5 cm;\n5. intrahepatic tumors ≤5, and tumor burden ≤1\u002F2 liver volume;\n6. PVTT type Vp≤3;\n7. patients underwent first-line system therapy failure, the first-line system included tyrosine kinase inhibitor (TKI), such as Sorafenib or Lenvatinib, with or without PD-1 or PDL1 inhibitor;\n8. the intrahepatic tumors were effectively controlled and pulmonary metastases were no progression, and the controlled intrahepatic tumors were defined as partial or stable response according to modified Response Evaluation Criteria in Solid Tumors (mRECIST);\n9. locoregional therapy (including TACE or HAIC) were also included;\n10. Child-Pugh class A or B;\n11. PS 0 or 1;\n12. no history of other malignancies.\n\nExclusion Criteria:\n\n1. under 18 years or over 75 years;\n2. metastases \\>10\n3. non-lung metastases;\n4. incomplete clinical data;\n5. metastases diameter \\> 5 cm;\n6. intrahepatic tumors \\> 5, and tumor burden \\> 1\u002F2 liver volume;\n7. PVTT type Vp 4;\n8. lost to follow-up within 3 months.","75 Years",{"count":85,"type":21},80,[87],"NA","This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases.",[90,91,92,28,93,94],"Hepatocellular Carcinoma","Liver Cancer Stage IV","Pulmonary Metastases","Bevacizumab","Cryoablation","2024-02-09",{"date":97,"type":36},"2024-02-20",{"date":99,"type":36},"2024-02-02",{"date":101,"type":21},"2027-01-30",{"name":103,"class":43},"Sun Yat-sen University",2,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":44},"100532899","phase-2-cadonilimab-in-combination-with-bevacizumab-and-folfox-regimen-for-the-first-line-treatment-of-advanced-unresectable-mss-type-ras-mutated-metastatic-colorectal-cancer-100532899","NCT06218810","Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer","Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer: A Single-Arm, Open-Label, Multicenter Phase II Study","Inclusion Criteria:\n\n1. Voluntarily sign a written ICF.\n2. Age at enrollment: ≥ 18 years old, ≤ 75 years old, both male and female.\n3. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.\n4. The expected survival period is ≥ 3 months.\n5. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.\n6. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past and are not suitable for radical surgical resection or local treatment.\n7. Genetic testing results indicate pMMR or MSS; RAS mutation;\n8. According to RECIST v1.1, there is at least one measurable lesion that is suitable for repeated and accurate measurements. Note: Brain metastases cannot be used as target lesions; For lesions that have received radiation therapy before, it is not recommended to select them as target lesions. If there are no other lesions that meet the target lesion criteria, and the lesion can be measured according to RECIST v1.1 and there is objective evidence to prove significant progression after radiation therapy, the irradiated lesion can be considered as a target lesion.\n\nExclusion Criteria:\n\n1. Patients with known MSI-H or dMMR.\n2. Participants of RAS wild-type.\n3. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).\n4. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.\n5. Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration; Palliative local treatment was performed on non target lesions within 2 weeks prior to the first administration; Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first administration; Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications was received within 1 week before the first administration.\n6. Have received any immunotherapy against tumors in the past, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any treatment targeting the immune mechanism of tumors.\n7. Patients with active autoimmune diseases that require systematic treatment within the past two years (such as using medication to improve the condition, corticosteroids, immunosuppressive agents), and replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) are not considered as systematic treatment.\n8. A history of active or previous inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).\n9. History of immunodeficiency; HIV antibody test positive individuals; Currently using systemic corticosteroids or other immunosuppressants for a long time.\n10. Subjects who are known to have active pulmonary tuberculosis (TB) and suspected to have active TB need to undergo clinical examination to exclude them; Known active syphilis infection.\n11. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n12. Previous or current non infectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid treatment.",{"count":113,"type":21},53,[24],"The dual immunotherapy regimen significantly outperformed previous chemotherapy or immunomonotherapy for MSS type advanced CRC in two key efficacy indicators, ORR and PFS. Researchers have also conducted in-depth analysis of patient transcriptomics, immune microenvironment characteristics, and other related information, which is expected to guide more accurate immune combination therapy for CRC in the future. Our team plans to conduct a multicenter, prospective, single arm clinical trial in patients with RAS mutant MSS unresectable metastatic colorectal cancer, with a focus on observing the 1-year progression free survival rate of the combination of two chemotherapy drugs, bevacizumab and Cadonilimab, as well as ORR, perioperative safety, and long-term survival.",[117,118,119,28],"Metastatic Colorectal Cancer","Microsatellite Stable Colorectal Carcinoma","RAS Mutation","2024-01-20",{"date":122,"type":36},"2024-01-23",{"date":124,"type":36},"2024-01-01",{"date":126,"type":21},"2026-12-31",{"name":128,"class":43},"Fudan University"]