[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"first-line-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:first-line-treatment":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,77,100,126,150,180,209],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631409","phase-1-phase-1-study-of-sar445877-in-combination-with-folfox6-and-bevacizumab-as-first-line-treatment-for-microsatellite-stable-metastatic-colorectal-cancer-100631409",false,"NCT07500298","Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer","Eligibility Criteria\n\n1. Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.\n2. Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures.\n3. Age ≥18 years.\n4. Participants with histologically documented CRC with metastatic disease who have not received prior treatment in the metastatic setting. Participants who have received adjuvant FOLFOX must be 6 months from treatment at the time of enrollment.\n5. CRC documented as MSS by immunohistochemistry, next-generation sequencing, or polymerase chain reaction assay at any time prior to screening.\n6. Measurable disease per the RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Adequate organ and marrow function as defined below within 28 days of study treatment initiation:\n\n   * Hemoglobin \\>9.0 g\u002FdL\n   * Absolute neutrophil count ≥1500\u002FmL\n   * Platelets ≥100,000\u002FmL\n   * Total bilirubin ≤1.5 × institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.\n   * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤2.5 × institutional ULN. Transaminases up to 3 × ULN in the presence of liver metastases.\n   * Estimated glomerular filtration rate ≥50 mL\u002Fmin\u002F1.73 m² (Modification of Diet in Renal Disease Formula)\n   * For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen.\n9. Life expectancy ≥ 3 months.\n10. The effects of SAR445877 and FOLFOX\u002Fbevacizumab on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of the study treatment period, and for 9 months after completion of study treatment.\n\n    (Refer to Pregnancy Assessment Policy MD Anderson Cancer Center \\[MDACC\\] Institutional Policy # CLN1114). WOCBP includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n    * Postmenopausal (no menses in ≥12 consecutive months)\n    * History of hysterectomy or bilateral salpingo-oophorectomy\n    * Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy)\n    * History of bilateral tubal ligation or another surgical sterilization procedure\n    * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy, patient\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the duration of the study treatment period and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n11. Male participants must agree to use adequate contraception throughout the duration of the study treatment period and for 6 months after the last dose of study treatment\n12. WOCBP must have a negative serum pregnancy test within 3 days prior to first administration of study treatment.\n\nExclusion Criteria\n\n1. Pregnant or breastfeeding.\n2. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that requires\u002Frequired treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs. Participants with the following conditions are eligible: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.\n3. Participants who are receiving any other investigational agents.\n4. Receipt of a live-virus vaccination within 28 days prior to study treatment initiation. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).\n5. Participants with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 1 week prior to the first administration of study treatment. Physiologic replacement doses are allowed even if they are \\>10 mg of prednisone\u002Fday or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided they are not for the treatment of an autoimmune disorder. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are eligible to be enrolled in the study.\n6. Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome, unless most recent CD4 count exceeds 500 cells\u002Fmm3.\n7. Acute or chronic hepatitis B virus or hepatitis C virus infection.\n8. Previous solid organ or allogeneic hematopoietic stem cell transplant.\n9. Active brain or leptomeningeal metastases.\n10. Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.\n11. History of interstitial lung disease or severe obstructive pulmonary disease.\n12. Clinically significant cardiovascular\u002Fcerebrovascular disease.\n13. Left ventricular ejection fraction \\\u003C50% as measured by echocardiogram or multigated acquisition scan.\n14. Serious, non-healing wound, ulcer, or bone fracture.\n15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to first administration of study treatment.\n16. Evidence of bleeding or coagulopathy.\n17. Uncontrolled hypertension (\\>150\u002F100 mmHg).\n18. Urine dipstick of proteinuria \\>2+. Participants with \\>2+ proteinuria on dipstick analysis will undergo a 24-hour urine collection and must demonstrate \\\u003C1.0 g protein\u002F24 hours to be eligible.\n19. Known severe hypersensitivity reactions to monoclonal antibodies, any history of or recent (within 6 months) anaphylaxis.\n20. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.\n21. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n\n    \\-","ALL","18 Years",{"count":18,"type":19},41,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.",[25,26,27,28,29,30,31],"Phase 1","SAR445877","FOlfox6","Bevacizimab","First Line Treatment","Metastatic Colorectal Cancer (CRC)","Microsatellite Stable","RECRUITING","2026-05-29",{"date":35,"type":36},"2026-06-01","ACTUAL",{"date":38,"type":36},"2026-05-20",{"date":40,"type":19},"2032-12-27",{"name":42,"class":43},"M.D. Anderson Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100591507","phase-2-evaluation-of-efficacy-and-safety-of-cemiplimab-as-first-line-treatment-for-advanced-basal-cell-carcinoma-bcc-patients-100591507","NCT06981325","Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients","Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (CEMI-first) - An Open Label, Single Arm, Prospective Phase II Trial of the DeCOG Network","CEMI-first","Inclusion Criteria:\n\n1. Signed informed consent form available\n2. Patient\\* 18 years or older at time of signing informed consent form\n3. Centrally confirmed histological diagnosis of BCC\n\n   NOTE: Tumor tissue to be sent to Central Pathology during screening procedure:\n   * Formalin-fixed, parrafin-embedded (FFPE) tumor specimen in a paraffin block (preferred) OR\n   * approximately 10 sections (5µm thickness) on uncoated slides and 10 sections (5µm thickness) on Superfrost Ultra slides containing unstained, freshly cut, serial sections to be submitted along with associated pathology report (please refer to section 11.1.1 for details)\n4. Locally advanced stage without distant metastases, not amenable for surgery or radiotherapy or surgery\u002Fradiotherapy contraindicated or refused by patient (as evidenced in source data)\n5. Expected survival of at least 6 months\n6. ECOG performance status 0 or 1\n7. Adequate laboratory parameters particularly for the blood count, renal and liver function parameters.\n\n   1. Absolute number of neutrophils ≥ 1.5 x 109\u002FL\n   2. Platelets ≥ 75 x 109\u002FL\n   3. Hemoglobin ≥ 9 g\u002FdL\n   4. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), (patients with Gilbert´s Disease and total bilirubin up to 3x ULN may be eligible after approval from trial's medical expert)\n   5. AST (SGOT) and ALT (SGPT) ≤ 3x ULN\n   6. AP ≤ 2.5x ULN\n   7. Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL\u002Fmin\n8. Absence of other severe comorbidities\n9. Resolution of any acute, clinically significant treatment-related adverse events from prior therapy\u002Fprocedure to Grade ≤ 1 prior to study entry, with the exception of alopecia.\n10. Negative serum pregnancy test done less than or equal to 7 days prior to enrollment, for females of childbearing potential only.\n11. Sexually active women of childbearing potential (WOCBP) and men with WOCBP partners must be prepared to use suitable contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the last dose of Cemiplimab\n\n    * There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently\n\nExclusion Criteria:\n\n1. Pretreatment with systemic immunotherapy (such as PD-1\u002FPD-L1 or CTL4) or targeted therapy (such as hedgehog inhibitor) NOTE: Prior treatment with imiquimod or other topical or intralesional immune modulators will not be exclusionary\n2. Any other non-radiation anti-cancer therapy (e.g. imiquimod, photodynamic therapy; neither investigational nor standard of care) within 30 days (from date of last administration) of initial Cemiplimab administration or if planned during the study duration\n3. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required systemic immunosuppressive therapy, excluding: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment\n4. Other neoplasia, in particular hematologic diseases that might impair immune response, such as chronic lymphocytic leukemia, myelodysplastic or myeloproliferative disease and patients with Gorlin-Goltz syndrom\n5. Immunosuppressive corticosteroid doses (\\> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of Cemiplimab NOTE: Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are eligible for participation. Furthermore, patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or replacement in case of adrenal or hypophysis insufficiency are eligible for participation.\n6. Known allergic\u002Fhypersensitive reaction to the study drug and any of its excipients or history of documented allergic\u002Fhypersensitive reactions to antibody treatments\n7. Active infection requiring systemic therapy, including uncontrolled HIV, HBV and HCV infection or diagnosis of immunodeficiency.\n\n   NOTE: Patients are eligible if:\n   * Patients have controlled HIV infection with CD4 counts is \\> 350 cells\u002FµL and viral load is undectable \\[HIV RNA PCR\\]\n   * Patients positive for HBV surface antigen have controlled HBV infection receiving anti-viral therapy and with undectable serum viral load \\[HBV DNA PCR\\]. Patients must remain on anti-viral therapy for at least 6 months after last dose of Cemiplimab\n   * Patients positive for HCV antibody have controlled HCV infection with undectable viral load \\[HCV RNA PCR\\]\n8. History of pneumonitis within the last 3 years\n9. Patients with history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the Lead Investigator)\n10. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n11. Receipt of live vaccines (including attenuated) within 30 days of first administration of Cemiplimab\n12. Pregnancy or lactation period.\n13. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.\n14. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n15. Legal incapacity or limited legal capacity.\n16. On-treatment participation in another clinical trial in the period 30 days prior to start of the study treatment and during the study",{"count":54,"type":19},34,[56],"PHASE2","The study is an open-label, singel arm, prospective, multicenter phase II trial evaluating the efficacy and safety of Cemiplimab when applied as first-line therapy in patients with locally advanced basal cell carcinoma (BCC), which were not pretreated with hedgehog inhibitors (HHI).",[59,29],"Basal Cell Carcinoma (BCC)",[61,62,63,64,65,66],"BCC","Skin Cancer","Basal Cell Carcinoma","anti-PD-1 monoclonal antibody","HHI naïve","Cemiplimab","2026-03-10",{"date":69,"type":36},"2026-03-11",{"date":71,"type":36},"2025-08-07",{"date":73,"type":19},"2029-07",{"name":75,"class":43},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest",7,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":20,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":44},"100601971","phase-1-paclitaxel-cationic-liposome-hepatic-arterial-infusion-in-combination-with-systemic-therapy-as-first-line-treatment-in-colorectal-liver-metastases-100601971","NCT07117435","Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases","A Phase Ib\u002FIII Study to Evaluate the Safety and Efficacy of Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases","Inclusion Criteria:\n\n* 1\\. Age range: 18 - 75 years old (inclusive), gender not limited.\n* 2\\. For patients with colorectal liver metastases have been histologically or cytologically confirmed and who are assessed by multidisciplinary team (MDT) to be inoperable for radical surgical resection:\n\n  1. Have not received systemic treatment for the metastatic or recurrent disease;\n  2. For patients who have received neoadjuvant\u002Fadjuvant therapy before, the time interval between the last administration and disease progression must be ≥ 6 months;\n  3. Allow patients who have received local treatment and progressed.\n* 3\\. According to RECIST v1.1, at least one measurable lesion in the hepatic arterial infusion area (long diameter ≥ 1 cm and no previous local treatment).\n* 4\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* 5\\. Life expectancy of at least 3 months.\n* 6\\. Adequate organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factors within 14 days)\n* 7\\. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the study and for at least 6 months after the last dose of study intervention. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n* 8\\. Fully understand the clinical study and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Patients known to have microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR), and have been evaluated by the investigators to be eligible for immune checkpoint inhibitor therapy.\n* 2\\. Patients known to have wild-type RAS and BRAF, and have been evaluated by the investigators to be eligible for anti-epidermal growth factor receptor (EGFR) drug therapy.\n* 3\\. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigators).\n* 4\\. Central nervous system metastasis with clinical symptoms, or meningeal metastasis, or there are other evidences indicating that the patient's central nervous system metastasis or meningeal metastatic lesions have not been controlled, and the investigators judges that the patient is not suitable for enrollment.\n* 5\\. Patients with contraindications for transcatheter arterial infusion.\n* 6\\. Patients with active infections within 2 weeks prior to administration (NCI CTC AE v5.0 ≥ grade 2) (Defined as requiring intravenous administration of antibacterial, antifungal or antiviral drugs for treatment).\n* 7\\. Patients with grade 2 or above peripheral neuropathy (NCI CTC AE v5.0).\n* 8\\. Patients with a history of autoimmune diseases, immunodeficiency disorders, including HIV positive test results, or suffering from other acquired or congenital immune deficiencies, or those currently using immunosuppressive agents.\n* 9\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with HBV DNA ≥ 2×103 IU\u002FmL (can use continuous antiviral treatment); or anti-hepatitis C virus antibody (HCV-Ab) positive with HCV RNA above the measurable limit; or active syphilis.\n* 10\\. Patients with known contraindications to capecitabine or oxaliplatin, paclitaxel or cationic liposome, or have severe allergic reactions; note: If the subject has contraindications to bevacizumab or has severe allergic reactions to any component of bevacizumab, it will not affect the enrollment but should not use bevacizumab in the study, and the specific reasons need to be recorded.\n* 11\\. Patients need to receive strong inducers and strong inhibitors of CYP2C8 and CYP3A4 within 2 weeks before the first study treatment or during the treatment.\n* 12\\. Patients had or have non-infectious pneumonia\u002Finterstitial lung disease that requires systemic glucocorticoid treatment.\n* 13\\. Severe cardiovascular disease history, including but not limited to:\n\n  * Long QT syndrome;\n  * High-degree atrioventricular block;\n  * Severe arrhythmia that is not well controlled by medication;\n  * Chronic heart failure history and NYHA cardiac function classification ≥ 3;\n  * Severe valvular regurgitation or stenosis that requires treatment;\n  * Acute coronary syndrome or severe myocardial disease within 6 months before screening;\n  * Uncontrolled hypertension;\n  * Echocardiography suggests LVEF \\\u003C 50%;\n* 14\\. Patients with a previous history of severe neurological or mental disorders (including epilepsy or dementia) lead to compliance issues.\n* 15\\. Patients with ultrasound-detected limb vascular thrombosis with potentially serious consequences during screening, or who with thromboembolic events within 3 months prior to enrollment.\n* 16\\. Patients with a history of severe bleeding, or who experienced major bleeding events such as intracranial hemorrhage, gastrointestinal bleeding, or purpura within the last 3 months.\n* 17\\. Any other reasons deemed by the investigators.","75 Years",{"count":76,"type":19},[22],"This is a phase Ib\u002FIII, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.",[89,90],"Colorectal Liver Metastases","First-line Treatment","2025-08-05",{"date":93,"type":36},"2025-08-12",{"date":95,"type":36},"2025-05-13",{"date":35,"type":19},{"name":98,"class":99},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":20,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":44},"100585820","phase-2-testing-a-functional-precision-medicine-approach-to-select-chemotherapy-for-metastatic-colorectal-cancer-cosense-1-100585820","NCT06907342","Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1)","COSENSE-1: A Feasibility Study for Using a Functional Precision Medicine Platform to Select Oxaliplatin-based Versus Irinotecan-based Chemotherapy Regimens for Patients With Metastatic Colorectal Cancer","COSENSE-1","Inclusion Criteria:\n\nGeneral conditions:\n\n1. Age 18 or older\n2. ECOG performance status 0 or 1\n3. Obtained informed consent\n4. Acceptable organ function (defined in publicly available protocol)\n5. Women of child-bearing potential and men must agree to use highly effective contraception (defined in publicly available protocol)\n\n   Disease and treatment specific conditions:\n6. Histologically confirmed pMMR\u002FMSS adenocarcinoma originating from the colon or rectum\n7. Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion)\n8. Patient has metastatic or primary lesion available for biopsy\n9. Patient has measurable or evaluable disease per RECIST (version 1.1)\n10. The oxaliplatin-based regimen FOLFOX (+\u002F- antibody) versus the irinotecan-based regimen FOLFIRI (+\u002F- antibody), are evaluated by an experienced physician, independent of inclusion in the trial, to be equally recommended for the participant as standard of care first-line therapy in the treatment of mCRC, following the Norwegian national guideline on the treatment of colorectal cancer (https:\u002F\u002Fwww.helsedirektoratet.no\u002Fretningslinjer\u002Fkreft-i-tykktarm-og-endetarm-handlingsprogram)\n11. Patient is eligible for full (100%) chemotherapy doses at first treatment cycle\n12. Treatment with chemotherapy can be scheduled within 28 days from referral\n\nExclusion Criteria:\n\n1. Patient has metastatic MMR deficient\u002FMSI adenocarcinoma\n2. Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle\n3. Patient is not equally eligible for FOLFOX (+\u002F- antibody) and FOLFIRI (+\u002F- antibody) chemotherapy regimens, according to the Norwegian national guideline on the treatment of colorectal cancer\n4. ECOG performance status 2 or worse\n5. Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus\n6. Breastfeeding\n7. Patients with psychological, geographical, familial or sociological conditions that can prevent compliance with the study protocol\n8. Inability to understand study procedures and comply with them, or disorder that compromises the patient's ability to provide informed consent and\u002For comply with study procedures\n9. Patient fulfils any of the contraindications listed in the SmPC of the relevant IMP\n10. Treatment cannot be scheduled within 28 days from referral\n\n    Medical history:\n11. Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency\n12. Evidence of CNS metastasis\n13. Unresolved toxicities of a previous systemic treatment that, in the opinion of the physician, make the patient unfit for inclusion\n14. Antitumoural treatment ≤ 30 days before inclusion. Hormonal substitutive treatment is allowed\n15. Preexisting significant cardiovascular disease including uncontrolled\u002Funstable or symptomatic angina, uncontrolled atrial or ventricular arrythmias, LVEF known to be \\\u003C 40% or symptomatic congestive heart failure\n16. Stroke (including TIA) or acute myocardial infarction within 6 months before the first dose of study treatment\n17. Clinically significant peripheral sensory neuropathy\n18. Recent (\\\u003C6 months before the start of study treatment) pulmonary embolism, deep vein thrombosis, or another significant thromboembolic event\n19. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on chest computed tomography (CT)\n20. Evidence of previous acute hypersensitivity reaction to any component of the treatment\n21. History of any disease that may increase the risks associated with study participation",{"count":109,"type":19},148,[56],"COSENSE-1 is an unblinded, phase II, single-armed, single center feasibility study for using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens, for male and female participants aged 18 and older, with microsatellite stable (MSS)\u002Fproficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC), that is incurable or not resectable with curative intent.",[113,114,115,116,117,90],"Tumor, Colorectal","Organoids","Tumoroid","Metastatic Colorectal Cancer","Core Needle Biopsy","2025-05-23",{"date":120,"type":36},"2025-05-25",{"date":118,"type":36},{"date":123,"type":19},"2040-09",{"name":125,"class":43},"St. Olavs Hospital",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":20,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100573797","phase-2-ivonescimab-combined-with-chemotherapy-as-first-line-treatment-of-relapsed-or-metastatic-thymic-cancer-a-prospective-single-arm-phase-ii-trial-100573797","NCT06750952","Ivonescimab Combined with Chemotherapy As First-line Treatment of Relapsed or Metastatic Thymic Cancer: a Prospective, Single Arm, Phase II Trial","Ivonescimab Combined with Chemotherapy As First-line Treatment of Relapsed or Metastatic Thymic Cancer: a Prospective, Single Arm, Phase II Trial (iTHYM)","iTHYM","Inclusion Criteria:\n\n1. Untreated metastatic or recurrent inoperable thymic cancer patients at the initial stage; All patients need to undergo baseline PET\u002FCT (or neck, chest, upper abdominal CT+cranial MR) for clinical staging.\n2. The patient's age is ≥ 18 years old, with no gender restrictions.\n3. Pathological diagnosis of thymic carcinoma through cytology\u002Fhistology.\n4. Expected survival period ≥ 3 months.\n5. ECOG (Performance Status, PS) score is 0-1 points.\n6. Organ function meets:\n\n   Hematology: I. neutrophils ≥ 1500\\*109\u002FL;II. Platelet ≥ 100\\*109\u002FL; iii、 Hemoglobin \\>90g\u002FL; Renal function: I. serum creatinine ≤ 1.5\\*ULN or creatinine clearance rate (CrCl) ≥ 50mL\u002Fmin; II. Urinary protein \\\u003C 2+ or 24h urinary protein quantitation \\\u003C 1.0g; Liver function: I, AST or ALT ≤ 3\\*ULN; For patients with liver metastasis, it can be ≤ 5\\*ULN; ii. Total bilirubin ≤ 1.5ULN, liver metastasis patients can be ≤ 3\\*ULN; Iii: serum albumin (ALB) ≥ 28g\u002FL.\n\n   Coagulation function: NR or APTT ≤ 1.5ULN. Cardiac function: left ejection fraction (levf) ≥ 50%. Thyroid function: thyroid stimulating hormone (TSH), free thyroxine (FT4), or free triple Iodothyronine (FT3) was within ± 10% of normal values.\n7. There were measurable lesions (according to irecist criteria).\n8. Subjects must understand and voluntarily sign an informed Consent form, and voluntarily comply with other requirements of the study.\n9. Female subjects with reproductive function must have urine or serum within 3 days before the first medication Pregnancy test (if the urine pregnancy test result cannot be confirmed as negative, serum pregnancy test is required Check, the serum pregnancy results shall prevail). If a female with fertility is different from a male without sterilization The partner had sex, and the subject agreed to continue to use contraception and avoid breastfeeding during the medication period Milk.\n10. The male subject agreed to continue using contraceptive methods during the medication period.\n\nExclusion Criteria:\n\n1. Patients with thymoma component suspected by pathological diagnosis (only thymic cancer patients were enrolled).\n2. The patient has or is suspected of having autoimmune disease. Note: Patients with vitiligo, type I diabetes, or Hashimoto's thyroiditis who have hypothyroidism but only need hormone replacement therapy can be included in the study when there is no obvious sign of recurrence.\n3. Patients need to receive systemic cortisol treatment (\\>10mg prednisolone \\[or equivalent dose\\] \u002F day) or use other immunosuppressive drugs within 14 days after enrollment. Note: inhaled or topical corticosteroids, or adrenal hormone replacement therapy (\\>10mg prednisolone \\[or equivalent dose\\] \u002F day) can be accepted for patients without obvious autoimmune disease.\n4. Patients with grade 3-4 interstitial lung disease.\n5. At the same time, the patient has other malignant tumors and need anti-tumor treatment.\n6. Patients with other malignant tumors in the past (excluding skin malignant tumors other than non melanoma, and carcinoma in situ in the following parts \\[bladder, stomach, colorectal, endometrial, cervical, melanoma or breast\\]) cannot be included in this study. However, if the malignant tumor has achieved complete remission for five years or more and does not need to receive additional anti-tumor treatment during this study, it can be included in the study.\n7. Received live attenuated vaccine within 4 weeks before the first dose or planned during the study.\n8. Major surgical operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks before the first administration.\n9. The investigator believes that the patient is medically, psychologically, or physiologically unable to complete the study or understand the information in the patient manual.\n10. Previously received anti-PD-1, anti-PD-L1, anti-CTLA4, other drugs targeting T cell costimulation or immune regulatory pathways, and anti vascular drugs.\n11. Myocardial infarction and poorly controlled arrhythmia occurred within 6 months before the first administration (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) (QTc interval was calculated according to fridericia formula); Or according to NYHA criteria for grade III-IV cardiac insufficiency or left ventricular ejection fraction \\\u003C50% by cardiac color Doppler ultrasound.\n12. The subject had grade ≥ 2 CTCAE peripheral neuropathy.\n13. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. Only a small amount of pleural fluid, ascites and pericardial effusion without clinical symptoms revealed by imaging can be enrolled.\n14. There are active patients with hepatitis B, C, tuberculosis, syphilis or other serious infections with poor clinical control.\n15. HIV test positive or have been diagnosed with acquired immune deficiency disease (AIDS).\n16. Allergic to the study drug or known history of severe allergy to any monoclonal antibody (NCI-CTCAE 5.0 grade \\> 3).\n17. Those who received live or attenuated vaccines within 28 days before the first dose or had plans to receive such vaccines during the study; However, inactivated viral vaccines for seasonal influenza are permitted.\n18. Have a history of severe bleeding tendency or coagulation dysfunction. Those who had deep vein thrombosis, were using anticoagulant or platelet therapy, or had deep vein thrombosis or serious bleeding caused by the use of antiangiogenic drugs in the past 3 months before enrollment; Or any other history of severe thromboembolism (implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis is not considered \"severe\" thromboembolism).\n19. Vascular events occurred in the past 6 months, including cerebrovascular accidents (including transient ischemic attack), any arterial thromboembolic events, including myocardial infarction, pulmonary embolism, unstable angina pectoris, etc.\n20. A history of hereditary bleeding prone disease or coagulation dysfunction is known.\n21. Poorly controlled blood pressure (defined as blood pressure ≥ 160\u002F100mmHg under the optimal treatment of hypertension).\n22. Pregnant or lactating women.\n23. Have a history of alcohol or drug abuse.",{"count":135,"type":19},24,[56],"This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer.",[139,90],"Relapsed or Metastatic Thymic Cancer","NOT_YET_RECRUITING","2024-12-25",{"date":143,"type":36},"2024-12-27",{"date":145,"type":19},"2024-12-20",{"date":147,"type":19},"2028-12-20",{"name":149,"class":43},"Sun Yat-sen University",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":160,"phases":4,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":44},"100527516","can-digitally-delivered-first-line-osteoarthritis-treatment-improve-equal-access-to-care-100527516","NCT06148779","Can Digitally Delivered First-line Osteoarthritis Treatment Improve Equal Access to Care","Can Digitally Delivered First-line Osteoarthritis Treatment Improve Equal Access to Care in Urban and Rural Areas of Sweden","Access","\\* Patients in the Joint Academy database that had participated in the Joint Academy treatment program for OA and given their informed consent to participate in research.\n\nInclusion criteria for the treatment program:\n\n* Radiographic and or clinical diagnosis of hip or knee OA from a physical therapist or physician (95% of all patients in previously published studies). Individuals without a prior diagnosis had clinical OA confirmed by an orthopaedic surgeon or physiotherapist via telephone (diagnosis according to National Institute for Health and Care Excellence (NICE) criteria and Swedish National Guidelines, and confirming the absence of any red flag symptoms), or if deemed necessary were recommended to seek face-to-face care before inclusion in the programme.\n* From October 1st 2021, all patients should have undergone a physical examination by doctor or physiotherapists before being able to enter the treatment.",{"count":159,"type":19},50000,"OBSERVATIONAL","To improve chronically ill patients' health and quality of life, long-standing and continuous treatment is needed at an acceptable cost. The purpose of this study was to compare utilization of digital versus face-to-face delivered osteoarthritis (OA) treatment in the 21 different county councils of Sweden that are responsible for providing healthcare to the residents.",[163,90,164],"Health Services Accessibility","Osteoarthritis",[164,166,167,168,169,170],"Digitally delivered","Tele-health","Physiotherapy","Access to care","Exercise","2024-09-26",{"date":173,"type":36},"2024-09-27",{"date":175,"type":36},"2022-01-01",{"date":177,"type":19},"2025-07-31",{"name":179,"class":99},"Joint Academy",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":20,"phases":190,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":44},"100544843","exercise-in-patients-with-advanced-non-small-cell-lung-cancer-100544843","NCT06374160","Exercise in Patients With Advanced Non-small Cell Lung Cancer","Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer","BREATH","Inclusion Criteria\n\n* Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV\n* First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention\n* Age ≥ 18 years\n* Signed informed consent\n\nExclusion Criteria\n\n* Severe cardiopulmonary disease (EF\\\u003C30%)\n* Newly occurring or progressive uncontrolled CNS (central nervous system) metastases\n* Expected life expectancy \\\u003C 3 months\n* Bone metastases with acute risk of fracture\n* ECOG (Eastern Cooperative Oncology Group) performance status \\> 2\n* Acute pulmonary embolism\n* Acute myocardial infarction\n* Requiring surgery for aortic aneurysm\n* Tension pneumothorax\n* Lack of proficiency in the German language\n* Active infection",{"count":189,"type":19},104,[191],"NA","Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.\n\nThe BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise\u002Fonly endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.\n\nThe primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.",[194,29,195,196,197,198,199],"Advanced Lung Carcinoma","Second Line Treatment","NSCLC Stage IV","NSCLC Stage IIIB","Palliative Treatment","NSCLC Stage IIIC","2024-04-15",{"date":202,"type":36},"2024-04-18",{"date":204,"type":19},"2024-05-01",{"date":206,"type":19},"2026-08-31",{"name":208,"class":43},"University Hospital, Essen",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":216,"minAge":16,"maxAge":84,"enrollmentInfo":217,"targetDuration":4,"studyType":20,"phases":219,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":44},"100537518","phase-3-disitamab-vedotin--pyrotinib-versus-thp-in-the-first-line-treatment-for-her2-advanced-breast-cancer-clinical-trial-100537518","NCT06278870","Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial","Disitamab Vedotin in Combination With Pyrotinib Versus THP in the First-line Treatment for HER2-positive Advanced Breast Cancer, a Multicentre, Randomized, Double-blind Controlled, Phase III Trial","Inclusion Criteria:\n\n1. Adult female patients (age 18-75 years) with metastatic breast cancer confirmed by pathology or imaging;\n2. Pathologically confirmed HER2 positive (definition: Immunohistochemistry(IHC) 3+, or IHC 2+ and Fluorescent In Situ Hybridization(FISH) amplification);\n3. No previous chemotherapy regimen for metastatic breast cancer;\n4. At least one measurable lesion exists (Response Evaluation Criteria in Solid Tumors(RECIST) 1.1);\n5. Eastern Cooperative Oncology Group(ECOG) performance status score ≤ 2 and expected survival of not less than 3 months;\n6. Prior treatment-related toxicity at enrollment must have resolved to National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) (version 5.0) ≤ 1 degree (except for alopecia or other toxicity that, in the judgment of the investigator, is not considered a risk to the safety of the patient);\n7. Patients with adequate organ function before enrollment:\n\n   1. White Blood Cell (WBC) ≥ 3.0 x 10\\^9\u002FL;\n   2. Neutrophil granulocyte (ANC) ≥1.5 x 10\\^9\u002FL;\n   3. Platelet (PLT) ≥70×10\\^9\u002FL;\n8. Liver, kidney, and cardiac function tests are essentially normal (based on the normal values in the laboratory of each study center):\n\n   1. Total bilirubin (TBIL) ≤ 3 x Upper Limit of Normal (ULN);\n   2. Alanine aminotransferase (ALT\u002FAST) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases);\n   3. serum creatinine ≤ 1.5 x ULN or creatinine clearance (Ccr) ≥ 60 ml\u002Fmin;\n9. . Normal cardiac function;\n\n   1. Left ventricular ejection fraction (LVEF) ≥ 55%;\n   2. QT-interval corrected with Fridericia (QTcF) ≤ 470ms;\n10. Hormone receptor status is clear;\n11. Female patients of childbearing potential who have a negative pregnancy test and agree to use an effective non-hormonal method of contraception during treatment and for at least 6 months after the last dose of the test drug;\n12. Able to understand the study process, voluntarily participate in this study, and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Pathology suggestive of HER2 negativity (IHC 2+ and FISH-, or IHC 1+);\n2. Patients with known hypersensitivity to the active ingredient or other components of the study drug;\n3. Patients during pregnancy or lactation, patients with childbearing potential tested positive in a baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial;\n4. Patients not eligible for this study judged by the investigator, a pre-existing disease or condition that may interfere with participation in the study or any serious medical disorder that may interfere with the safety of the subject (e.g., uncontrolled heart disease, high blood pressure, active or uncontrolled infections, active hepatitis B virus infection).","FEMALE",{"count":218,"type":19},312,[220],"PHASE3","The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent\u002Fmetastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are:\n\n* Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP.\n* Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment.\n\nParticipants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab.\n\nResearchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer.",[223,90],"HER2-positive Metastatic Breast Cancer","2024-02-22",{"date":226,"type":36},"2024-02-26",{"date":228,"type":36},"2023-09-06",{"date":230,"type":19},"2031-06-30",{"name":232,"class":43},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]