[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Cancer Center, Japan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":288},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,77,104,133,161,190,211,237,264],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053859","phase-2-perioperative-hlx10-serplulimab-with-s-1oxaliplatin-sox-in-locally-advanced-and-pd-l1-positive-gastric-or-esophagogastric-junction-adenocarcinoma-a-randomized-phase-2-investigator-initiated-trial-100053859",false,"NCT07699939","Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma: A Randomized Phase 2 Investigator-Initiated Trial","PLATANUS","Inclusion Criteria:\n\n1. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma at the study site. (For gastroesophageal junction adenocarcinoma, only patients classified as Siewert type II or type III who do not require surgery involving simultaneous thoracoabdominal incision are eligible.)\n2. Tumor tissue determined to be PD-L1 positive (CPS \\>= 5) based on pre-screening evaluation by the central laboratory. 3) Diagnosis of cT3-4N1-3M0 disease according to the AJCC\u002FUICC-TNM 8th edition based on assessments performed within 28 days prior to randomization (the same day of the week 4 weeks before the randomization date is acceptable; the same applies hereafter), with no prior systemic treatment. Pre-randomization laparoscopy is not mandatory, but if performed, no non-curative factors (including liver metastasis, peritoneal metastasis, other distant metastases, or positive peritoneal cytology (CY1)) should be observed.\n\n4\\) Judged by the investigator as capable of undergoing R0 resection. 5) Age between 18 years and 80 years on the day of enrollment. 6) ECOG performance status (PS) of 0 or 1. 7) The most recent laboratory values obtained within 14 days prior to randomization meet all of the following (however, transfusion, recombinant human thrombopoietin, and administration of granulocyte colony-stimulating factor (G-CSF) within 14 days prior to blood collection are not permitted): (1) Neutrophil count \\>= 1500\u002Fmm\\^3 (2) Hemoglobin \\>= 9.0 g\u002FdL (3) Platelet count \\>= 10 x 10\\^4\u002Fmm\\^3 (4) Total bilirubin \\\u003C= 1.5 mg\u002FdL (5) AST \\\u003C= 100 U\u002FL (6) ALT \\\u003C= 100 U\u002FL (7) Serum albumin \\>= 3.0 g\u002FdL (8) Serum creatinine \\\u003C= 1.5 mg\u002FdL (9) APTT \\\u003C= 60 s (10) PT-INR \\\u003C= 1.5 8) Females of childbearing potential should test negative for pregnancy test (serum or urine) within 7 days prior to randomization (the same day of the week is acceptable).\n\n9\\) Male patients and females of childbearing potential agree to use contraception from the time of provision of informed consent through a specified period after the last administration of study treatment (until at least 120 days after the last dose of HLX10 and at least 180 days after the last dose of study drug other than HLX10 (S-1 or oxaliplatin)).\n\n10\\) Written informed consent for study participation has been obtained from the patient.\n\nExclusion Criteria:\n\n1. Presence of another active malignancy within 5 years prior to enrollment or concurrently. Patients with cured, localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, non-invasive prostate cancer, non-invasive cervical cancer, and non-invasive breast cancer are permitted.\n2. Patients scheduled to undergo organ transplantation or bone marrow transplantation.\n3. Myocardial infarction and\u002For uncontrolled arrhythmia (including QTc interval \\>= 450 ms in males or \\>= 470 ms in females) occurring within 6 months prior to randomization (QTc interval calculated using Fridericia's formula).\n4. Cardiac dysfunction classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) \\\u003C 50 percent on echocardiography.\n5. Positive for any of the following: HIV antibody, HBs antigen, or HCV-RNA (HCV-RNA is measured only if HCV antibody is positive).\n6. HBs antigen negative, HBs antibody and\u002For HBc antibody positive, and quantitative HBV-DNA detectable (patients are not excluded if HBV-DNA is below the limit of detection).\n7. Active tuberculosis.\n8. Interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and\u002For severe pulmonary dysfunction that may interfere with evaluation and management of suspected drug-related pulmonary toxicity.\n9. Known active or suspected autoimmune disease, excluding patients whose disease is stable at randomization and who do not require systemic immunosuppressive therapy.\n10. Patients who received live vaccination within 28 days prior to randomization, except for inactivated virus vaccines used for seasonal influenza prophylaxis.\n11. Patients who require systemic corticosteroids (a therapeutic dose of \\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days prior to randomization or during the study period. However, in the absence of active autoimmune disease, patients are permitted to use steroids at a dose of \\\u003C= 10 mg\u002Fday prednisone or equivalent, or inhaled steroids, or adrenal hormone replacement therapy.\n12. Patients who have an active infection requiring systemic anti-infective treatment within 14 days prior to randomization, except for prophylactic antibiotic treatment (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease).\n13. Prior treatment with other antibody or drug therapies for immune checkpoint blockade, such as PD-1, PD-L1, or CTLA-4 therapy.\n14. Patients currently receiving other clinical study treatment, or for whom the planned start of treatment in this study is \\\u003C 14 days from completion of the prior clinical study treatment.\n15. History of severe hypersensitivity to the monoclonal antibody or any component of the study drug.\n16. History of psychotropic drug abuse or drug dependence.\n17. Patients with a disease that may increase the risk associated with study participation and use of the study drug, or with other severe acute or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the study.","ALL","18 Years","80 Years",{"count":20,"type":21},136,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To evaluate the clinical efficacy of perioperative treatment with S-1 + oxaliplatin (SOX)+ HLX10 compared with SOX as the control in patients with cT3-4N1-3M0 PD-L1-positive (CPS ≥ 5) locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, in a placebo-controlled, double-blind, randomized phase II investigator-initiated clinical study.",[27,28],"Gastric Adenocarcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma",[30,31,32,33,34],"SOX regimen","PD-1 inhibitor","Perioperative chemotherapy","serplulimab","Immuno-chemotherapy","NOT_YET_RECRUITING","2026-07-07",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":21},"2026-07-15",{"date":43,"type":21},"2029-06-30",{"name":45,"class":46},"National Cancer Center, Japan","OTHER_GOV",18,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100567856","phase-2-pembrolizumab-plus-lenvatinib-in-unresectable-cutaneous-angiosarcoma-patients-100567856","NCT06673628","Pembrolizumab Plus Lenvatinib in Unresectable Cutaneous Angiosarcoma Patients","The Phase II Study of Pembrolizumab Plus Lenvatinib in Patients With Unresectable Cutaneous Angiosarcoma","PLAS","Inclusion Criteria:\n\n1. Histologically diagnosed with cutaneous angiosarcoma.\n2. Unresectable primary or metastatic disease.\n3. No spinal metastases that require radiotherapy or surgical intervention.\n4. No pericardial effusion, pleural effusion, or ascites that require treatment.\n5. Age at enrollment: 18 years or older and 85 years or younger.\n6. The most recent performance status score (ECOG) within 14 days prior to enrollment is 0 or 1.\n7. A contrast-enhanced CT\u002FMRI (head, neck, chest, abdomen, pelvis: slice thickness 5 mm or less) performed within 14 days prior to enrollment or have at least one measurable lesion that can be confirmed to be present on the surface of the body by visual inspection (for patients with contrast allergy or renal function deterioration, plain CT is allowed).\n8. Cohort A (untreated patients): Cutaneous angiosarcoma without prior therapy. Cohort B (previously treated patients): Cutaneous angiosarcoma with prior therapy.\n9. Have adequately controlled BP with or without antihypertensive medications (of 2 or less counted by components), defined as BP \\\u003C=150\u002F90 mmHg with no change in antihypertensive medications within 7 days prior to enrollment.\n10. Wounds (e.g., those after a surgical procedure or trauma) have healed at enrollment.\n11. Did not have major surgery within 21 days prior to the first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.\n12. Laboratory tests performed within 14 days before the enrollment date meet the following criteria: (1) to (10). However, patients should not receive granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 14 days before the day of blood collection.\n\n(1) Neutrophil count \\>=1,500\u002Fmm3 (2) Platelet count \\>=10×104\u002Fmm3 (3) Hemoglobin \\>=9.0 g\u002FdL (4) AST \\\u003C=100 U\u002FL (5) ALT\\\u003C=100 U\u002FL (6) Total bilirubin \\\u003C=1.5 mg\u002FdL (7) Serum creatinine \\\u003C=1.5 mg\u002FdL (8) Creatinine\u002Fclearance \\>=30 mL\u002Fmin (Cockcroft-Gault). (Even if the calculated value is less than 30 mL\u002Fmin, it can be registered if the value is more than 30 mL\u002Fmin by the 24-hour urine collection method).\n\n(9) Urine protein \\\u003C1 g\u002F24 hours. Note: Participants with proteinuria \\>=2+ on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n\n(10) PT-INR \\\u003C=1.5 13) Male patients agree to use highly effective contraception and not donate sperm during treatment and for at least 120 days after the last dose of the investigational drugs.\n\nFemale patients agree to use contraception methods, are not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n* Is not a woman of childbearing potential (WOCBP).\n* Is a WOCBP tested negative by pregnancy test within 14 days prior to enrollment, and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last. A WOCBP must have a negative result of a highly sensitive pregnancy test within 24 hours before the first dose of study intervention.\n\n  14\\) Twenty-eight days have passed since the last day of prior chemotherapy if applicable, and the patient has recovered from all toxicities except alopecia and blood toxicity (below Grade 1 or to baseline).\n\n  15\\) Written informed consent for study participation has been obtained from the patient.\n\nExclusion Criteria:\n\n1. Persons previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).\n2. Individuals previously treated with lenvatinib or another angiogenesis inhibitor, including treatment for other cancer types.\n3. Patients who are likely to be cured with chemoradiotherapy, at the discretion of the treating physician.\n4. Patients who received radiation therapy within 14 days prior to enrollment or patients with radiation therapy-related toxicities at enrollment.\n5. Patients positive for either HIV antibody, HBs antigen, or HCV antibody.\n6. Patients of HBs antigen-negative, HBs antibody, or HBc antibody-positive, and HBV-DNA assay-positive.\n7. Patients receiving live or live attenuated vaccines within 30 days of enrollment.\n8. Patients who received other investigational products or used investigational medical devices within 28 days prior to enrollment.\n9. Patients diagnosed as being in an immunocompromised state or patients treated with long-term systemic steroidal therapy or other immunosuppressive therapies in the 14 days prior to enrollment.\n10. Patients with other malignancies requiring progressive or aggressive treatment within the past 3 years.\n11. Patients with active CNS metastases or carcinomatous meningitis.\n12. Patients with severe (\\>= Grade 3) hypersensitivity to pembrolizumab or lenvatinib additives.\n13. Patients with active autoimmune disease requiring systemic treatment, excluding replacement therapy within the past 2 years.\n14. Patients with a history of interstitial lung disease\u002Fpneumonitis complicated by interstitial lung disease\u002Fpneumonitis or interstitial lung disease\u002Fpneumonitis requiring steroid administration (non-infectious).\n15. Patients with active infections requiring systemic treatment at enrollment.\n16. Patients with preexisting \\>=Grade 3 gastrointestinal or non-gastrointestinal fistula at enrollment.\n17. Patients with gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n18. Patients with a history of acute coronary syndrome, coronary angioplasty, or stenting within 6 months prior to enrollment.\n19. Patients with clinically significant cardiovascular diseases within the 12 months prior to enrollment.\n20. Patients having left ventricular ejection fraction (LVEF) below 50% within 14 days before the date of enrollment.\n21. Patients with complications requiring hospitalization.\n22. Patients with radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n23. Patients with QTcF spacing prolongation beyond 480 msec within 14 days prior to enrollment.\n24. Patients with active hemoptysis in the 21 days prior to enrollment.\n25. Patients who have comorbid psychotic or psychiatric symptoms or substance use disorders that interfere with daily life.\n26. Patients with a history of allogeneic transplantation.","85 Years",{"count":58,"type":21},38,[24],"Cutaneous angiosarcoma is a rare cancer for which effective treatment has not been developed sufficiently. Still, because it often occurs in elderly people, the number of patients is increasing due to the aging population. Cutaneous angiosarcoma is difficult to completely remove by surgery, and recurrence and metastasis after surgery are not uncommon. Therefore, chemotherapy, radiation therapy, and a combination of these are currently widely used as treatments. Traditionally, the anticancer drug used for cutaneous angiosarcoma was mainly doxorubicin. In recent years, it has been reported that cancer shrank in 18% of patients after two months of paclitaxel administration in a clinical trial. Therefore, paclitaxel has become more commonly used for cutaneous angiosarcoma. Other options include anthracycline anticancer drugs and gemcitabine. However, even with these anticancer drugs (and radiation therapy), cutaneous angiosarcoma progresses quickly, and some reports have said that the 5-year survival rate is 9%. This study is planned to develop a safer and more effective treatment for cutaneous angiosarcoma and will include 38 participants. In this study, eligible participants will receive combination chemotherapy with 200 mg of pembrolizumab (injection liquid, once every 3 weeks) and 20 mg of lenvatinib (capsule, once daily) for up to approximately two years as protocol treatment unless the criteria for termination meet. Before, during, and after the protocol treatment, participants will undergo many examinations and evaluations, including blood tests, urine tests, and imaging tests (e.g., x-ray, CT scan, or MRI) to assess the safety and efficacy of the protocol treatment.",[62,63],"Angiosarcoma of Skin","Angiosarcoma Metastatic",[65,66],"pembrolizumab","lenvatinib","RECRUITING","2026-06-22",{"date":70,"type":39},"2026-06-24",{"date":72,"type":39},"2024-12-01",{"date":74,"type":21},"2029-11-30",{"name":45,"class":46},6,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100619645","phase-2-enfortumab-vedotin-in-patients-with-advanced-small-bowel-adenocarcinoma-refractory-or-intolerant-to-platinum-based-combination-therapy-100619645","NCT07347314","Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy","Enfortumab Vedotin in Patients With Locally Advanced or Metastatic Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy: a Multicenter, Phase II Investigator-initiated Trial (ENVELOPE, NCCH2412\u002FMK015)","ENVELOPE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed small bowel adenocarcinoma (duodenum excluding the ampulla of Vater, jejunum, or ileum). If pathology was performed at another institution, slides\u002Fblocks must be reviewed by a pathologist at the study site before enrollment.\n2. One of the following:\n\n   1. unresectable locally advanced small bowel adenocarcinoma in which R0 resection would require combined resection of invaded organs and is judged infeasible\n   2. UICC-TNM stage IV small bowel adenocarcinoma with distant metastasis\n   3. postoperative recurrence of small bowel adenocarcinoma.\n3. No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiation or surgical intervention.\n4. No clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.\n5. Age ≥18 years at registration.\n6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.\n7. ≥1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, on contrast-enhanced CT (slice thickness ≤5 mm) obtained within 14 days before registration.\n8. Prior platinum-based chemotherapy for unresectable locally advanced or metastatic small bowel adenocarcinoma (FOLFOX or CapeOX) with documented progression, recurrence or treatment discontinuation due to toxicity.\n9. If prior testing (e.g., microsatellite instability, mismatch repair, or comprehensive genomic profiling) has identified alterations that qualify for tumor-agnostic approved therapies, the patient must be refractory, intolerant, or ineligible to such therapies. These tests are not mandatory; lack of testing does not preclude enrollment.\n10. Archival tumor tissue is available; if unavailable, the patient agrees to a pre-treatment biopsy to obtain tumor tissue.\n11. No anticancer chemotherapy or radiotherapy within 14 days before registration.\n12. No surgery under general anesthesia within 28 days before registration.\n13. Screening laboratory tests within 14 days before registration meet all of the following conditions:\n\n    1. absolute neutrophil count ≥1,500\u002Fmm³\n    2. platelet count≥100,000\u002Fmm³\n    3. hemoglobin ≥8.5 g\u002FdL\n    4. AST ≤100 U\u002FL (≤200 U\u002FL with liver metastases)\n    5. ALT ≤100 U\u002FL (≤200 U\u002FL with liver metastases)\n    6. total bilirubin ≤1.5 mg\u002FdL\n    7. serum creatinine ≤1.5 mg\u002FdL\n14. Contraception: Women of childbearing potential agree to use effective contraception and to refrain from oocyte donation from consent through ≥2 months after last dose; breastfeeding patients agree to withhold breastfeeding for ≥3 weeks after last dose; men agree to use effective contraception and to refrain from sperm donation from consent until ≥1 month after last dose.\n15. Written informed consent obtained from the patient.\n\nExclusion Criteria:\n\n1. Active second primary malignancy.\n2. Active infection requiring systemic therapy.\n3. Interstitial lung disease\u002Fpneumonitis, diagnosed by imaging or clinical findings, current or prior, irrespective of steroid use.\n4. Poorly controlled diabetes mellitus: HbA1c ≥8%, or HbA1c 7.0-\\\u003C8.0% with otherwise unexplained hyperglycemic symptoms (polyuria and\u002For polydipsia).\n5. Known hypersensitivity to enfortumab vedotin, its excipients (e.g., histidine, trehalose dihydrate, polysorbate 20).\n6. Ongoing grade ≥2 sensory or motor peripheral neuropathy.\n7. Cerebrovascular event, unstable angina, myocardial infarction, or severe heart failure within 6 months before registration.\n8. Ongoing grade ≥2 unresolved clinically significant toxicities from prior therapy, excluding alopecia.\n9. Ongoing grade ≥2 dermatologic disorders regardless of prior-treatment causality.\n10. Ongoing use of chronic systemic corticosteroids or other immunosuppressants.\n11. Active keratitis or corneal ulcer.\n12. Positive for HIV antibodies, HBs antigen, or HCV RNA\n13. Negative for HBs antigen, positive for HBs or HBc antibodies, and positive HBV DNA quantification (patients are not excluded if HBV DNA is detected but below the limit of quantification).\n14. Pregnant or possibly pregnant women.\n15. Psychiatric illness or psychiatric symptoms that interfere with activities of daily living and, in the investigator's judgment, preclude study participation.",{"count":86,"type":21},27,[24],"Small bowel adenocarcinoma is a rare cancer with a poor prognosis. For patients with locally advanced or metastatic disease, the usual first treatment is chemotherapy with platinum-based combinations such as FOLFOX or CapeOX. However, once the cancer grows after this treatment or the side effects become too severe, there is no widely accepted standard second-line therapy, and outcomes are generally poor. New treatment options are therefore urgently needed. Recent retrospective research from our group has shown that the majority of the small bowel adenocarcinomas strongly express a protein called Nectin-4 on the surface of cancer cells. High Nectin-4 expression was also associated with poorer survival, suggesting that Nectin-4 could be a crucial treatment target in this disease.\n\nEnfortumab vedotin is a targeted anticancer drug called an antibody-drug conjugate. It combines an antibody that recognizes Nectin-4 with vedotin, a cytotoxic anticancer agent (payload). After enfortumab vedotin binds to Nectin-4 on the tumor cell surface, it is taken up into the cell and releases the anticancer payload, which damages the cell's internal structure and leads to cell death and apoptosis. Enfortumab vedotin has already shown meaningful antitumor activity and an acceptable safety profile in patients with advanced urothelial carcinoma and is approved over the world. However, its efficacy has never been formally evaluated in patients with small bowel adenocarcinoma.\n\nENVELOPE is a multicenter, single-arm, phase II investigator-initiated trial designed to evaluate the efficacy and safety of enfortumab vedotin in patients with locally advanced or metastatic small bowel adenocarcinoma that has progressed during or after, or is intolerant to, platinum-based combination chemotherapy (FOLFOX or CapeOX). Eligible patients are adults (aged 18 years or older) with histologically or cytologically confirmed small bowel adenocarcinoma, a good performance status, adequate organ function, and at least one measurable lesion on a CT scan. Patients who have genomic alterations that make them candidates for previously approved \"tumor-agnostic\" targeted drugs (for example, high microsatellite instability or high tumor mutational burden) must already have tried and not benefited from, or not tolerated, those treatments. Testing positive for Nectin-4 is not required to take part in this study.\n\nParticipants will receive enfortumab vedotin as an intravenous infusion at a dose of 1.25 mg\u002Fkg on days 1, 8, and 15 of each 28-day treatment cycle. Treatment will continue as long as the cancer does not grow and side effects remain manageable. Tumor scans with contrast-enhanced CT will be performed every 8 weeks up to week 24 and every 12 weeks thereafter to monitor the response of the enfortumab vedotin. The primary objective is to determine the proportion of patients achieving a tumor response to enfortumab vedotin, as assessed by independent radiologic review. Key secondary objectives include progression-free survival, overall survival, duration of response, and safety profiling.\n\nIn addition, this study includes a prespecified translational research program. Tumor samples will be examined for Nectin-4 expression using immunohistochemistry, and researchers will investigate the relationship between Nectin-4 levels and the effects of enfortumab vedotin. Blood and tissue samples will also be collected before treatment, during treatment, and at the time of cancer progression, when possible, for detailed \"multi-omics\" analyses. These translational studies aim to elucidate why some patients respond whereas others do not, and to identify biomarkers that could inform future treatment strategies for small bowel adenocarcinoma.\n\nThe ENVELOPE trial has been approved by the Institutional Review Board of the National Cancer Center, Japan, as well as by the ethics committees at participating sites. The study is funded by the Japan Agency for Medical Research and Development (AMED), and enfortumab vedotin is supplied by Astellas Pharma. Enrollment began in October 2025 and is planned to continue through October 2027, with patients followed for at least 12 months after the last participant is enrolled.",[90],"Advanced Small Bowel Adenocarcinoma",[92,93,94],"enfortumab vedotin","small bowel adenocarcinoma","advanced","2026-03-10",{"date":97,"type":39},"2026-03-11",{"date":99,"type":39},"2025-11-04",{"date":101,"type":21},"2028-09-30",{"name":45,"class":46},3,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100436409","phase-2-ncch2006mk010-trial-fortune-trial-100436409","NCT04962867","NCCH2006\u002FMK010 Trial (FORTUNE Trial)","Multicenter Investigator-initiated Phase II Trial of E7090 in Patients With Advanced or Recurrent Solid Tumor With Fibroblast Growth Factor Receptor (FGFR) Gene Alteration (FORTUNE Trial)","Inclusion Criteria:\n\n1. Participants with histologically or cytologically confirmed metastatic, unresectable, or recurrent solid tumor who agree to provide an archival tumor sample, a residual biopsy sample, or a fresh tumor biopsy sample\n2. Ineffective to or intolerant to initial treatment, or for which standard treatment is no longer available\n3. Participants with an FGFR gene alteration detected by NGS panel, who fall under one of the categories of groups A to C and E defined as below\n\n   Group A: FGFR1-3 fusion\n\n   Group B and E: FGFR1-3 specific activating mutations as below;\n\n   FGFR1: P150S, T340M, R445W, N546K, K656E\n\n   FGFR2: C62Y, A67V, N82K, D101Y, E160K, E163K, M186T, R203H, R210Q, Q212K, R251Q, S252W, P253R, P253L, A264T, W290C, K310R, Y328N, G364E, Y375C, C382R, A389T, V392A, R399Q, H416R, I422V, H544Q, N549H, N549K, N549D, N549S, L560F, K659E, K659N, R664W, E718K, S791T\n\n   FGFR3: G380E, G380R, A391E, K650T, K650E, K650Q, K650N\n\n   Group C: FGFR1-3 activating mutation not applicable to group B, or FGFR1, 2 gene amplification\n4. For Group D, participants with cholangiocarcinoma who have previously received a selective FGFR inhibitor other than E7090 and have demonstrated progressive disease or resistance\n5. Karnofsky Performance Status (KPS) \\>= 70 for patients with primary CNS tumors. Performance Status (ECOG) 0-1 for patients with non-primary CNS tumors\n6. For patients with non-primary CNS tumors, they have at least 1 lesion of \\>= 10 millimeter (mm) in the longest diameter for a non-lymph node or \\>= 15 mm in the short-axis diameter for a lymph node that is considered as serially measurable according to RECIST v1.1 using computerized tomography or magnetic resonance imaging (CT or MRI) within 28 days of enrollment. However, lesions that have received local treatment such as external-beam radiation therapy (EBRT) or radiofrequency ablation (RFA) must have progressed after these local treatment to count as measurable lesion\n7. Participants with primary CNS tumors must meet all of the following criteria:\n\n   1. Have received prior treatment including radiation and\u002For chemotherapy, as recommended or appropriate for the CNS tumor type\n   2. Have \\>= 1 site of bi-dimensionally measurable disease (confirmed by magnetic resonance imaging (MRI) and evaluable by RANO criteria), with the size of at least one of the measurable lesions \\>= 1 cm in each dimension and noted on more than one imaging slice. Imaging study performed within 28 days before enrollment\n   3. Must be neurologically stable based on neurologic exam at least for the last 7 days prior to enrollment. (based on medical examination\u002Finterview)\n8. Corrected calcium \\\u003C= 10.1 mg\u002FdL\n9. Phosphate \\\u003C= 4.6 mg\u002FdL\n10. Required treatment washout period, from the last day of prior treatment until enrollment of this trial, is as follows:\n\n    1. Antibody and other investigational drugs: \\>= 28 days\n    2. Prior chemotherapy (excluding small-molecule targeted therapy), surgical therapy, radiation therapy: \\>= 21 days (\\>= 90 days from the date of the last radiation therapy for primary CNS tumors)\n    3. Endocrine therapy, immunotherapy, small-molecule targeted therapy: \\>=14 days\n\nExclusion Criteria:\n\n1. Participants with brain, subdural or leptomeningeal metastases\n2. Participants with primary CNS tumor located in either cerebellum, brainstem, spinal cord, pituitary gland, optic nerve or olfactory nerve\n3. Positive for either human immunodeficiency virus (HIV) antibody, HBs antigen, or HCV antibody (patients with positive HCV antibody but no detectable HCV-RNA are not excluded)\n4. Negative for HBs antigen, but positive for HBs antibody or HBc antibody, and also positive for HBV-DNA quantification (not excluded if HBV-DNA is below detection sensitivity)\n5. Child-Pugh score B or C\n6. Participants with pericardial effusion, pleural effusion, or ascites requiring treatment\n7. Have any of the following ocular diseases\n\n   1. Grade 2 or higher corneal disorders\n   2. Active retinopathy (e.g., age-related macular degeneration, central serous chorioretinal disease, retinal tear)\n8. Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower per Common Terminology Criteria for Adverse Events (CTCAE v5.0), except for alopecia, infertility, and the laboratory test results listed in the inclusion criteria\n9. Participants who received a prior selective FGFR inhibitor in the recurrent\u002Fmetastatic disease setting; except for patients with cholangiocarcinoma harboring FGFR2 fusion (Group D). Note that prior use of a multi-kinase inhibitor which includes anti-FGFR activity is acceptable after review by the lead investigator\n10. Participants who need the use of drugs that strongly inhibits or induces the metabolizing enzyme cytochrome P450 (CYP) 3A\n11. The presence of FGFR gatekeeper mutations as follows: FGFR1 V561, FGFR2 V564\u002F565, FGFR3 V555\u002F557, FGFR4 V550\n12. The presence of any of the following coexisting driver gene abnormalities:\n\n    1. Genetic mutations (excluding VUS): KRAS, NRAS, EGFR, or BRAF V600\n    2. Gene translocations: ALK, ROS1, or NTRK","20 Years",{"count":113,"type":21},75,[24],"This is a single-arm, open-label, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of E7090 in patients with advanced or recurrent solid tumors harboring FGFR genetic alterations (including fusion, mutation, amplification).",[117,118],"Advanced or Recurrent Solid Tumors","FGFR Gene Alterations",[120,121,122,123],"E7090","Solid tumor","Fibroblast Growth Factor Receptor (FGFR)","FGFR inhibitor","2025-09-29",{"date":126,"type":39},"2025-10-03",{"date":128,"type":39},"2021-06-15",{"date":130,"type":21},"2028-03-31",{"name":45,"class":46},7,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100387762","phase-3-a-randomized-controlled-trial-evaluating-of-prophylactic-irradiation-in-crt-for-ct1bn0m0-escc-100387762","NCT04328948","A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC","A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer","ARMADILLO","Inclusion criteria:\n\n1. Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.\n2. All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR\u002FESD) may not be confined to the thoracic esophagus.\n3. Clinical N0M0 with cervical to abdominal contrast-enhanced CT.\n4. The deepest lesion is diagnosed as cT1b (SM1 \u002F SM2 \u002F SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.\n5. Aged 20 years and older.\n6. ECOG Performance status 0 or 1.\n7. No previous therapy against esophageal cancer except for complete resection by EMR\u002FESD with either pT1a-LPM (pM2) \u002F pT1a-MM (M3) disease or pT1a-MM (M3) disease without vascular infiltration.\n8. No history of radiotherapy for the neck, chest, and upper abdomen for any cancers. No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.\n9. Major organ function is preserved. 1) WBC\\\u003C=12,000\u002Fmm3 2) ANC\\>=1,500\u002Fmm3 3) Hb\\>=10.0 g \u002FdL 4) PLT\\>=10,000\u002Fmm3 5) T-bil\\\u003C=1.5 mg \u002FdL 6) AST\\\u003C=100 IU\u002FL 7) ALT\\\u003C=100 IU\u002FL 8) SpO2\\>=95% 9) Ccr\\>=60 mL\u002Fmin\n10. Patients do not have a preference to receive a surgical resection as an initial therapy after receiving explanations.\n11. Written informed consent is obtained.\n\nExclusion criteria:\n\n1. Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.\n2. Active infection requiring systemic therapy.\n3. Fever over 38 degrees Celsius\n4. Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.\n5. Psychological disorder, which is difficult to participate in this clinical study.\n6. Receiving continuous systemic corticosteroid or immunosuppressant treatment.\n7. Positive for HBs antigen or HIV antigen.\n8. Diabetes mellitus, which is uncontrollable with continuous use of insulin or hypoglycemic agents.\n9. Uncontrolled arterial hypertension.\n10. History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.\n11. Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.\n12. Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.\n13. With a history of cerebrovascular disorder within 6 months.\n14. Drug allergy for iodic drugs.",{"count":142,"type":21},280,[144],"PHASE3","This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.",[147],"Esophageal Squamous Cell Carcinoma",[149,150,151],"Esophageal squamous cell carcinoma","chemoradiotherapy","Radiation Field","2025-05-19",{"date":154,"type":39},"2025-05-22",{"date":156,"type":39},"2020-07-01",{"date":158,"type":21},"2030-03-31",{"name":45,"class":46},1,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":171,"studyType":172,"phases":4,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":160},"100581794","a-prospective-study-investigating-the-relationship-between-minimal-residual-disease-detection-monitoring-frequency-and-prognosis-in-non-small-cell-lung-cancer-patients-eligible-for-curative-treatment-100581794","NCT06854939","A Prospective Study Investigating the Relationship Between Minimal Residual Disease Detection, Monitoring Frequency, and Prognosis in Non-small Cell Lung Cancer Patients Eligible for Curative Treatment.","Prospective Observational Study Using Personalized Minimal Residual Disease Assay (Signatera) to Evaluate the Kinetics and Detection Rate in Patients with Non-small Cell Lung Cancer","MRDSEEKER","Inclusion Criteria:\n\n1. A histopathologically confirmed diagnosis of non-small cell lung cancer (NSCLC)\n\n   The diagnosis (by cytology or biopsy) must be one of the following: \"adenocarcinoma,\" \"squamous cell carcinoma,\" \"non-small cell carcinoma consistent with adenocarcinoma,\" \"non-small cell carcinoma consistent with squamous cell carcinoma,\" or \"non-small cell carcinoma not otherwise specified (NOS).\" If the histological subtype differs between cytology and biopsy specimens, the subtype determined by the biopsy specimen shall be used.\n\n   At the time of enrollment, diagnoses of \"squamous cell carcinoma\" or \"non-small cell carcinoma consistent with squamous cell carcinoma\" are classified as squamous cell carcinoma, whereas \"adenocarcinoma,\" \"non-small cell carcinoma consistent with adenocarcinoma,\" and \"non-small cell carcinoma NOS\" are classified as non-squamous cell carcinoma.\n2. Meets one of the following criteria (1-3):\n\n1\\. Stage IB-III (preoperative clinical stage) deemed resectable, with no planned neoadjuvant therapy.\n\n2\\. Stage III disease deemed amenable to curative-intent chemoradiotherapy. 3. Stage II-III (preoperative clinical stage) deemed resectable, with planned neoadjuvant therapy.\n\n3\\) Age ≥ 18 years at the time of enrollment. 4) The attending physician has determined that tissue and blood samples can be provided.\n\n5\\) Written informed consent has been obtained from the patient.\n\nExclusion Criteria:\n\n* Presence of active multiple primary malignancies (defined as synchronous multiple cancers\u002Ftumors or metachronous multiple cancers\u002Ftumors with a disease-free interval of 3 years or less). However, even if the disease-free interval is less than 3 years, a history of clinical stage I prostate cancer or a completely resected cancer with any of the pathological stages specified below is not considered \"active multiple primary malignancies.",{"count":170,"type":21},350,"18 Months","OBSERVATIONAL","Adding immune checkpoint inhibitors or molecularly targeted drugs as adjuvant therapy to curative treatments-such as surgery or chemoradiotherapy-for stage I-III non-small cell lung cancer (NSCLC) has been established as a standard of care and has improved treatment outcomes. However, there is currently no adequate method to determine which patients should receive these adjuvant therapies. Identifying those with a good prognosis without adjuvant therapy could reduce the risk of adverse events, lessen the burden of clinic visits, and reduce healthcare costs.\n\nAmong various approaches, ctDNA-based MRD (minimal residual disease) analysis is highly anticipated and has already been introduced into clinical practice for hematologic malignancies. However, solid tumors' development as a companion diagnostic has been limited, and regulatory approval is mainly being considered based on performance evaluation data. In this study, we will conduct a performance evaluation of MRD analysis using Signatera™ in patients with stage I-III NSCLC while also collecting other prognostic factors based on clinicopathological information and survival data.",[175],"NSCLC, Stage I, II, III",[177,178,179,180,181],"Signatera™","minimal residual disease","MRD","lung cancer","NSCLC","2025-02-25",{"date":184,"type":39},"2025-03-03",{"date":186,"type":21},"2025-03-01",{"date":188,"type":21},"2029-09-30",{"name":45,"class":46},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":4,"enrollmentInfo":197,"targetDuration":199,"studyType":172,"phases":4,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":160},"100472582","asian-multicenter-prospective-study-in-her2-positive-early-breast-cancer-for-detecting-mrd-by-ctdnaharmony-study-100472582","NCT05433753","Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study","Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting Minimal Residual Disease by Circulating Tumor DNA Analysis With Neoadjuvant Chemotherapy; HARMONY Study","Inclusion Criteria:\n\n1. Age of 20 years or older at the date of registration.\n2. Histological diagnosis of HER2-positive invasive breast carcinoma.\n3. Patients scheduled for neoadjuvant chemotherapy followed by surgery.\n4. Clinical Stage IIA-IIIC.\n5. Known hormone receptor status.\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.\n2. Bilateral synchronous breast cancer.\n3. History of breast cancer.\n4. Pregnancy at registration.",{"count":198,"type":21},60,"3 Years","This study will assess minimal residual disease (MRD) in HER2-positive early breast cancer patients in Asian countries. The purpose is to evaluate the relation between the detection rate of MRD and recurrence.",[202],"HER2-positive Breast Cancer","2024-03-21",{"date":205,"type":39},"2024-03-25",{"date":207,"type":39},"2022-05-24",{"date":209,"type":21},"2027-09-30",{"name":45,"class":46},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":219,"targetDuration":199,"studyType":172,"phases":4,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":236,"locationsCount":47},"100455964","marker-assisted-selective-therapy-in-rare-cancers-knowledge-database-establishing-registry-asia-100455964","NCT05217407","Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia","A Prospective Clinical Registry Study of Genetic Profiling and Targeted Therapies in Patients With Rare Cancers in ASIA","MASTERKEY ASIA","Inclusion Criteria:\n\n1. Patients with a histological diagnosis of rare cancer, cancer of unknown primary origin, or cancer of rare tissue subtypes of common cancers. (Defined in protocol.)\n2. Patients with Advanced stage cancer.\n\nExclusion Criteria:\n\n1\\. Patients with complications of cognitive impairment.",{"count":220,"type":21},1000,"This is a registry study that aims to collect patients' data with advanced-stage rare cancer in Asia-Pacific region. Data includes clinical information, details of treatment, prognosis, pathological diagnosis and genetic biomarkers by next-generation sequencing.\n\nThe relationship between cancer types and prognosis, the effect of treatments, and the cancer type-specific incidence of genomic alterations will be investigated to discover more specific and effective treatment.",[223],"Rare Malignant Neoplasm",[225,226,227,228,229],"Rare cancer","Rare subtype","Registry","Asia","Next-generation sequencing","2024-03-20",{"date":232,"type":39},"2024-03-22",{"date":234,"type":39},"2021-11-30",{"date":158,"type":21},{"name":45,"class":46},{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":245,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":263,"locationsCount":76},"100528339","phase-2-binimetinib-in-patients-with-braf-fusion-positive-low-grade-glioma-or-pancreatic-cancer-perfume-100528339","NCT06159478","Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)","Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)","Perfume","Inclusion Criteria:\n\nInclusion criteria for both cohort A and B\n\n1. BRAF fusion or rearrangement is detected by reimbursed NGS-based cancer gene panel tests, cancer gene panel tests performed under advanced medical treatment, or clinical study (including liquid biopsy).\n2. Unresectable or recurrent\n3. No symptomatic brain metastasis, carcinomatous meningitis or spinal metastasis requiring surgical intervention or radiotherapy\n4. No cardiac effusion, pleural effusion, or ascites requiring treatment\n5. Not received anti-cancer drug within 14 days before registration, nor received other study drug (molecular targeting drug, immune therapy) within 21 days before registration\n6. Not received operation under general anesthesia within 28 days before registration\n7. Not received radiation therapy (including gamma knife, cyber knife) within 14 days before registration\n8. Left ventricular ejection fraction \\>= 50% by echocardiography or MUGA (multigated acquisition scan) within 28 days before registration\n9. Having all laboratory tests performed within 14 days before registration and the values are within the following range. Patients should not receive administration of G-CSF and\u002For blood transfusion within 14 days before the blood collection (1) Absolute neutrophil count \\>= 1.500\u002Fmm3 (2) Platelet count \\>= 10.0 X 10(4))\u002Fmm3 (3) Hemoglobin \\>= 8.0 g\u002FdL (4) Total bilirubin \\\u003C= 1.5 g\u002FdL (5) Aspartate aminotransferase (AST) \\\u003C= 100 U\u002FL (6) Alanine aminotransferase (ALT) \\\u003C= 100 U\u002FL (7) Serum creatinine \\\u003C= 1.5 mg\u002FdL\n10. Patients who are able to swallow orally administered medication.\n11. Consent to at least 30 days of contraception and limited egg donation (including egg retrieval for future egg transfer) after last administration of study drug for child-bearing status women. Consent to 90 days of contraception and limited sperm donation after last administration of study drug for men.\n12. Written informed consent (When registering patient under 18, a signed consent form must be obtained from both the patient and the parent or legal guardian.)\n\n    Cohort A\n13. Histopathologically diagnosed as low-grade glioma, based on WHO classification of 2007, 2016 and 2021. The grade is WHO grade 1 or 2.\n14. Age at the time of registration is 12 years or older (When registering a patient under 18, a signed consent form must be obtained from both the patient and the parent or legal guardian), and patients who are 12-17 years old have to be 40 kg or over in body weight. There is no limitation in body weight for patients who are 18 years or older.\n15. Lansky Performance Status (LPS) \\>= 70 for patients 12-15 years old Karnofsky Performance Status (KPS) \\>= 70 for patients 16 years or older\n16. Having measurable disease within 28 days before registration\n17. Patients suffice the following. (1) Having adequate initial treatment depending on the primary central nervous tumor including surgery if recommended treatment is available. (2) Neurologically stable.\n\n(3) Multiple lesion or dissemination is not detected with MRI at the registration.\n\n18\\) Not increased steroid for low-grade glioma within 14 days before registration and the dosage of steroid in equivalent to 50 mg prednisolone or less.\n\nCohort B 19) Histopathologically diagnosed as pancreatic cancer (histologically not specified).\n\n20\\) Having progression after at least one regimen of chemotherapy excluding adjuvant therapy.\n\n21\\) Age at the time of registration is 18 years or older. 22) Performance Status (ECOG) is 0 or 1 23) Having measurable disease within 28 days before registration detected by enhanced CT (Head, chest, abdominal, pelvic: under 5 mm in slice)\n\nExclusion Criteria:\n\n1. Active double primary cancer (but not \\[1\\]-\\[3\\]): \\[1\\] completely resected following cancers: basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, \\[2\\] gastrointestinal cancer curatively resected with ESD or EMR, and \\[3\\] other cancers with no recurrence for more than 5 years.\n2. Patients with symptomatic congestive heart failure of NYHA class II-IV or arrythmia (over grade 2) occurring in less than 6 months before registration.\n3. Patients with myocardial infarction or unstable angina occurring in less than 6 months before registration.\n4. Patients with corrected QT interval (QTcF) \\> 480 ms in ECG performed within 14 days before enrollment.\n5. Patients with infections requiring systemic treatment.\n6. Patients with uncontrolled hypertension (systolic blood pressure: over 150 mmHg or diastolic blood pressure: over 100 mmHg).\n7. Patients with history or findings of retinal vein occlusion (RVO) or having RVO risk factor (unstable glaucoma, ocular hypertension, hyperviscosity syndrome, hypercoagulability syndrome, etc.)\n8. Patients with history or complication of retinal degenerative disease other than RVO (central serous chorioretinopathy, retinal detachment, age-related macular degeneration, etc.)\n9. Patients with uncontrolled diabetes mellitis.\n10. Patients with venous thrombus (transient ischemic attack, stroke, massive deep vein thrombosis, pulmonary embolism, etc.) occurring in less than 3 months\n11. Patients who have neuromuscular disease with CK elevation (inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, etc.).\n12. Prior treatment with MEK inhibitors.\n13. Previous severe hypersensitive reaction to ingredient including binimetinib.\n14. Patients who are positive for either HIV antibody, HBs antigen, or HCV-RNA.\n15. Negative for HBs antigen, positive for HBs antibody or HBc antibody, and positive for HBV-DNA assay. (If it is less than or equal to the detection sensitivity, patients are not excluded)\n16. Patients with concomitant diseases that affect gastrointestinal function.\n17. Women who are pregnant, breastfeeding and need to continue breastfeeding in the future, and women who may be pregnant.\n18. Patients with psychiatric diseases or psychological symptoms interfering with participation in the trial.\n19. Patients who are deemed inappropriate for participation in the trial by the principal investigator or sub-investigator.","12 Years",{"count":247,"type":21},32,[24],"This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer harboring BRAF fusion\u002Frearrangement.",[251,252],"Low-grade Glioma","Pancreatic Cancer",[254,255,256],"BRAF fusion","BRAF rearrangement","Binimetinib","2023-12-06",{"date":259,"type":39},"2023-12-13",{"date":261,"type":39},"2023-03-29",{"date":209,"type":21},{"name":45,"class":46},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":160},"100503251","phase-2-first-line-cbdcaptxlenpembrolizumab-combination-for-previously-untreated-advanced-or-recurrent-thymic-carcinomas-artemis-100503251","NCT05832827","First-line CBDCA\u002FPTX\u002FLEN\u002FPembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)","First-line Carboplatin\u002FPaclitaxel\u002FLenvatinib\u002FPembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas","Artemis","Inclusion Criteria:\n\n1. Patients aged 18 years or older at the time of informed consent, who are pathologically (histologically or cytologically) diagnosed with thymic carcinoma for primary or metastatic thymic lesions, are included. They are preferred to be positive for CD5 or c-KIT by immunohistochemical staining. For those with non-squamous epithelial carcinoma negative for p40 or p63, non-primary cases should be excluded based on their clinical and pathological findings. In addition, those with thymoma are excluded.\n2. Patients with unresectable advanced thymic carcinoma (equivalent to stage IVa or IVb of Masaoka-Koga classification), metastatic or recurrent, who have not been treated with systemic cancer chemotherapy.\n\n   Or, in the case of stage III Masaoka-Koga classification, patients who are judged to be incapable of radical resection (R0 resection is not possible due to the combined resection of invasive lesions in surrounding organs (pericardial sac, lung, great vessels, etc.) or who are not eligible for curative treatment with chemoradiotherapy. A history of adjuvant chemotherapy and radiation therapy is acceptable for perioperative adjuvant therapy prior to the finding of recurrence. If platinum-containing cancer chemotherapy has been administered as adjuvant therapy, it is eligible if there is an interval of at least 24 weeks before registration.\n3. No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiotherapy or surgery\n4. No prior history of an antiangiogenetic agent targeting VEGFR for thymic carcinoma\n5. Not receiving radiotherapy within 14 days before registration Male participants\n6. A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 135 days after the last dose of study treatment and refrain from donating sperm during this period.\n\n   Female participants:\n7. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n   2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment.\n8. The participant provides written informed consent for the trial\n9. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n10. Meet the following criteria for Hepatitis B and C Patients with no history of HBV or HCV infection or who meet the following criteria 10.1 Hepatitis B positive subjects Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have an undetectable HBV viral load prior to registration.\n\n    Participants should remain on anti-viral therapy throughout the study intervention and follow local guidelines for HBV anti-viral therapy post-completion of the study intervention.\n\n    10.2 Participants with a history of HCV infection Participants are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to registration.\n11. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n12. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days before registration.\n13. Have adequate organ function as defined in the following table (Table 8). Specimens must be collected within 14 days prior to registration.\n14. Have a predicted life expectancy of \\>12 weeks\n\nExclusion Criteria:\n\n1. Has diagnosed as thymomas\n2. Has related immune-related complications such as myasthenia gravis, pure red cell aplasia, or hypogammaglobulinemia\n3. Patients with ECG QT correction interval prolongation or history of such prolongation (patients with QTcF \\> 480 ms)\n4. Has a LVEF below the institutional normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)\n5. A WOCBP who has a positive urine pregnancy test within 72 hours prior to registration (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n6. Has urine protein ≥1 g\u002F24 hours Note: Participants with proteinuria ≥2+ (≥100 mg\u002FdL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria\n7. Has had major surgery within 3 weeks prior to the first dose of study interventions\n8. Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability\n9. Has any of the following a) to i):\n\n   1. History of interstitial pneumonia or evidence of interstitial lung disease\n   2. Uncontrollable autoimmune disease receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy\n   3. History or complications of hypertensive crisis or hypertensive encephalopathy\n   4. Surgery under general anesthesia within 28 days before registration\n   5. History of total gastrectomy\n   6. Complication of congenital bleeding predisposition or abnormal coagulation\n   7. Complication of Grade 3 or higher gastrointestinal or non-gastrointestinal fistula with CTCAE v5.0\n   8. History of Grade 3 or higher bleeding (site not specified) with CTCAE v5.0 within 28 days prior to registration\n   9. Blood pressure is not well controlled (with 2 or fewer antihypertensive drugs\\* 2, systolic blood pressure is 150 mmHg or less and diastolic blood pressure is 90 mmHg or less) \\*Antihypertensive drugs are counted by the number of compounds\n10. Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n11. Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib\n12. Active hemoptysis (bright red blood of at least 0.5 teaspoons) within 3 weeks prior to the first dose of the study drug\n13. Has received prior radiotherapy within 14 days before registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease\n14. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed. Approved COVID-19 vaccines (excluding live vaccines and\u002For live-attenuated vaccines) are allowed\n15. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent\n16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug\n17. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n18. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening),clinically stable and without the requirement of steroid treatment for at least 14 days prior to the first dose of the study intervention\n19. Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n20. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n21. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n22. Has an active infection requiring systemic therapy\n23. Has a known history of Human Immunodeficiency Virus (HIV) infection\n24. Concurrent active Hepatitis B ( defined as HBsAg positive and detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection\n25. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n26. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n27. Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. Is expecting to father children within 135 days after the last dose of trial treatment\n28. Has had an allogeneic tissue\u002Fsolid organ transplant",{"count":273,"type":21},35,[24],"A phase II, investigator-initiated, non-randomized, open-label, single-arm, multicenter study to evaluate the efficacy and safety of Carboplatin\u002FPaclitaxel\u002FLenvatinib\u002FPembrolizumab combination for previously untreated advanced or recurrent thymic carcinomas",[277],"Untreated Advanced or Recurrent Thymic Carcinomas",[279,65,66],"thymic carcinoma","2023-10-18",{"date":282,"type":39},"2023-10-23",{"date":284,"type":39},"2023-09-04",{"date":286,"type":21},"2028-06-30",{"name":45,"class":46},""]