[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Cancer Center Hospital East\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":212},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,56,89,114,153,185],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":4},"100640951","phase-1-a-multicenter-phase-ibii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-concurrent-combination-therapy-of-s-531011-plus-fruquintinib-or-s-531011-plus-fruquintinib-plus-pembrolizumab-in-patients-with-msspmmr-colorectal-cancer-100640951",false,"NCT07591597","A Multicenter, Phase Ib\u002FII Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS\u002FpMMR Colorectal Cancer","IGNITE-CRC","Inclusion Criteria:\n\n1. Patients with histologically confirmed unresectable adenocarcinoma of the colon or rectum.\n2. Confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) status.\n3. Prior treatment with standard systemic chemotherapy and refractory or intolerant\\* to such therapies. Standard chemotherapy must include all of the following:\n\n   \\- Fluoropyrimidine, irinotecan, and oxaliplatin (with or without anti-VEGF antibody therapy)\n\n   \\- For patients with RAS and BRAF wild-type tumors: prior treatment with anti-EGFR monoclonal antibody (cetuximab or panitumumab)\n\n   \\- For patients with BRAF V600E mutation: prior treatment with a BRAF inhibitor (encorafenib)\n\n   \\*For patients who relapse during adjuvant chemotherapy or within 6 months after the last dose of postoperative adjuvant chemotherapy, that adjuvant therapy counts as prior systemic therapy.\n4. Presence of measurable disease according to RECIST version 1.1.\n5. Age ≥ 18 years at the time of informed consent.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Laboratory values within 14 days prior to enrollment meeting all of the following (tests performed on the same weekday 2 weeks before the enrollment date are acceptable):\n\n\u003C!-- -->\n\n1. Absolute neutrophil count ≥ 1,500\u002Fmm³\n2. Hemoglobin ≥ 9.0 g\u002FdL\n3. Platelet count ≥ 75,000\u002Fmm³\n4. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n5. AST (GOT) ≤ 2.5 × ULN; ≤ 5 × ULN if liver metastases are present\n6. ALT (GPT) ≤ 2.5 × ULN; ≤ 5 × ULN if liver metastases are present\n7. Creatinine ≤ 1.5 mg\u002FdL\n8. Proteinuria ≤ 1+ or \\\u003C 1.0 g\u002F24 h (urine protein-to-creatinine ratio \\\u003C 1 may be used; if 24-hour urine is collected, the measured value takes precedence) 8. No blood transfusion within 7 days prior to enrollment (a transfusion given on the same weekday 1 week earlier is considered ineligible).\n\n9\\. Women of childbearing potential must have a negative pregnancy test within 14 days prior to enrollment. Both male and female participants must agree to use appropriate contraception during the study and for 4 months after the last dose of study treatment. Female participants must also agree not to breastfeed during the study and for 4 months after the last dose. (Tests performed on the same weekday 2 weeks before the enrollment date are acceptable.) 10. Able to take oral medication. 11. Written informed consent obtained from the participant.\n\nExclusion Criteria:\n\n1. Prior treatment with fruquintinib for metastatic colorectal cancer.\n2. Prior treatment with any anti-CCR8 antibody, regardless of indication.\n3. Receipt of chemotherapy, radiotherapy, immunotherapy, or any antitumor therapy, or investigational agents within 14 days prior to enrollment, or persistence of CTCAE Grade ≥ 2 toxicities from prior therapies (excluding alopecia, hyperpigmentation, and peripheral sensory neuropathy).\n4. History of acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment.\n5. History or current findings of congestive heart failure of NYHA Class III or higher.\n6. Uncontrolled hypertension.\n7. Known central nervous system metastases. (If CNS metastasis is clinically suspected, brain CT or MRI must be performed during screening.)\n8. Active double primary malignancy (simultaneous or metachronous with disease-free interval \\\u003C 2 years), except for carcinoma in situ or intramucosal carcinoma lesions considered curable by local therapy.\n9. Serious comorbidities requiring inpatient treatment (e.g., paralytic ileus, bowel obstruction, pulmonary fibrosis, uncontrolled diabetes, heart failure, myocardial infarction, angina, renal failure, hepatic failure, psychiatric disorders, cerebrovascular disorders, or transfusion-requiring ulcers).\n10. Active infections, including:\n\n    \\- HBs antigen positive\n    * Patients may be eligible if receiving nucleoside analog antiviral therapy and HBV-DNA \\\u003C 20 IU\u002FmL (1.3 log IU\u002FmL).\n\n      \\- HBs antibody positive or HBc antibody positive AND HBV-DNA positive\n    * If HBV-DNA \\\u003C 20 IU\u002FmL, the patient may be eligible. - HCV antibody positive\n    * Patients may be eligible if HCV-RNA is below the detection limit. - HIV positive\n    * Patients may be eligible if HIV infection is ruled out by confirmatory testing.\n\n      * Other active infections requiring treatment.\n11. History of autoimmune disease or chronic\u002Frecurrent autoimmune disease (patients with type 1 diabetes, hypothyroidism manageable with hormone replacement, or localized skin diseases such as vitiligo, psoriasis, or alopecia not requiring systemic therapy are eligible).\n12. Requirement for systemic corticosteroids or immunosuppressive agents, or receipt of such therapy within 2 weeks prior to enrollment (treatment given on the same weekday 2 weeks earlier renders the patient ineligible), except for temporary administration for testing, allergic reactions, or edema associated with radiotherapy.\n13. Lack of willingness or inability to comply with study procedures.\n14. Considered unsuitable for the study by the principal investigator or sub-investigator.\n\nPregnancy and Contraception:\n\nA woman of childbearing potential includes any female who has experienced menarche, has not undergone permanent sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and is not postmenopausal. Postmenopause is defined as at least 12 consecutive months of amenorrhea without another medical cause. Women using oral contraceptives, intrauterine devices, or mechanical barrier methods are considered capable of becoming pregnant. If a female participant is determined to be not capable of becoming pregnant, this must be documented in source records.\n\nWomen must use effective contraception for at least 1 month prior to first study treatment, from the time of consent, and for at least 4 months after the last dose. Men must use effective contraception during study treatment and for at least 4 months after the last dose.\n\nAcceptable contraception includes vasectomy or condom use for male participants or male partners, and tubal ligation, contraceptive pessary, intrauterine devices, or oral contraceptives for female participants or female partners.","ALL","18 Years",{"count":19,"type":20},68,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study aims to evaluate the efficacy and safety of the concurrent combination therapy of S 531011 + fruquintinib or S 531011 + fruquintinib + pembrolizumab in patients with MSS\u002FpMMR colorectal cancer.",[27,28],"Metastatic Colorectal Neoplasms","Microsatellite Stable \u002F Proficient Mismatch Repair Colorectal Cancer",[30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Colorectal Neoplasms","Metastatic Colorectal Cancer","Microsatellite Stability","DNA Mismatch Repair","Receptors, CCR8","CCR8 Antagonists","Fruquintinib","Pembrolizumab","Antibodies, Monoclonal","Immune Checkpoint Inhibitors","VEGFR Inhibitors","Combination Drug Therapy","Phase Ib Clinical Trial","Phase II Clinical Trial","NOT_YET_RECRUITING","2026-05-11",{"date":47,"type":48},"2026-05-18","ACTUAL",{"date":50,"type":20},"2026-05",{"date":52,"type":20},"2029-05",{"name":54,"class":55},"National Cancer Center Hospital East","OTHER",{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100594371","phase-2-an-open-label-phase-2-study-of-total-neoadjuvant-therapy-tnt-consisting-of-flot-with-pembrolizumab-and-short-radiation-for-patients-with-locally-advanced-gastroesophageal-junction-adenocarcinoma-100594371","NCT07018570","An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma","\\\u003CInclusion Criteria\\>\n\n1. Patients with histologically confirmed esophagogastric junction adenocarcinoma.\n2. Patients who are naive to systemic therapy and have esophagogastric junction carcinoma of Siewert Type I to III classified as T: 2-4, N: any, and M: 0 according to the 8th edition of the UICC-TNM classification.\n3. Patients aged 18 years or older as of the day of informed consent.\n4. Patients with ECOG Performance Status (PS) 0 or 1.\n5. Patients whose most recent laboratory values within 14 days before registration meet all of the following criteria (testing on the same day of the week two weeks before the date of registration is acceptable).\n\n\\[1\\] Neutrophil count ≥1,500\u002Fmm3 \\[2\\] Hemoglobin ≥9.0 g\u002FdL \\[3\\] Platelet counts ≥100,000\u002Fmm3 \\[4\\] Total bilirubin ≤1.5 mg\u002FdL \\[5\\] AST (GOT) ≤100 IU\u002FL \\[6\\] ALT (GPT) ≤100 IU\u002FL \\[7\\] Serum creatinine ≤1.5 mg\u002FdL 6) Patients who did not receive blood transfusion within 7 days before registration (ineligible if transfusion was performed on the same day of the week one week before the date of registration).\n\n7)Female patients of childbearing potential who tested negative for pregnancy within 14 days before registration. Male and female patients who have agreed to practice appropriate highly effective contraception with low user dependency during the study and for up to 120 days after discontinuation of the investigational drug.\n\n8)Patients who have given consent to provide samples for biomarker analysis. 9)Patients who have given their own written consent to participate in the study\n\n\\\u003CExclusion Criteria\\>\n\n1. Patients with a history of using an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody.\n2. Patients with a history of acute coronary syndrome (including myocardial infarction and angina unstable), coronary angioplasty, or stent implantation within 6 months before registration.\n3. Patients with a history or findings of congestive heart failure of Class II or higher according to the New York Heart Association (NYHA) classification of cardiac function.\n4. Patient with active double cancers \\[simultaneous double cancers and metachronous double cancers with a disease-free interval of ≤2 years. However, carcinoma in situ or lesions equivalent to intramucosal carcinoma judged to have been cured by local treatment shall not be included in active double cancers\\].\n5. Patients with serious (requiring hospitalization) complications (e.g., intestinal paralysis, intestinal obstruction, pulmonary fibrosis, difficult-to-control diabetes mellitus, cardiac failure, myocardial infarction, angina unstable, renal failure, hepatic failure, psychiatric disorder, cerebrovascular disorder).\n6. Patients with active hepatitis B (HBs antigen positive) or hepatitis C.\n7. Patients with a history of HIV.\n8. Patients with complicated interstitial lung disease\u002Fpneumonitis or with a history of (non-infectious) interstitial lung disease\u002Fpneumonitis requiring steroid administration.\n9. Patients who received a live vaccine within 30 days before the start of investigational drug administration.\n10. Patients with concomitant autoimmune disease or a history of chronic or recurrent autoimmune disease.\n11. Patients who require systemic corticosteroids (except for prophylactic administration for testing or allergic reactions, or temporary use to reduce edema associated with radiotherapy) or immunosuppressive medication, or those who have received any of these treatments within 14 days before registration in this study.\n12. Patients with unhealed wounds (requiring sutures, antimicrobial administration, and cleaning procedures), ulcers, or fractures.\n13. Pregnant or lactating patients.\n14. Patients who are unwilling or unable to comply with the study protocol.\n15. Patients deemed by the investigator to be ineligible for this study.",{"count":63,"type":20},26,[24],"This study is to evaluate the effectiveness of treatment for esophagogastric junction carcinoma, total neoadjuvant therapy (TNT) including pembrolizumab and FLOT is conducted, aiming to choose between surgery or organ preservation treatment strategies.",[67],"Gastroesophageal Junction (GEJ) Adenocarcinoma",[69,70,71,72,73,37,74,75,76,77,78],"Esophagogastric junction carcinoma","Total neoadjuvant therapy","TNT","Radiation","Surgery","FLOT","Chemotherapy","Non-operative management","QOL","Phase II","RECRUITING","2025-08-25",{"date":82,"type":48},"2025-08-26",{"date":84,"type":48},"2025-07-24",{"date":86,"type":20},"2031-06",{"name":54,"class":55},1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100600685","phase-2-recurrentmetastatic-olfactory-neuroblastoma-evaluating-the-efficacy-and-safety-of-nivolumab-100600685","NCT07100704","Recurrent\u002FMetastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab","A Phase II Clinical Trial Evaluating the Efficacy and Safety of Nivolumab Monotherapy for Incurable Recurrent or Metastatic Olfactory Neuroblastoma.","Orion","Inclusion Criteria:\n\n1. Written informed consent obtained.\n2. Age ≥ 18 years.\n3. Histologically confirmed olfactory neuroblastoma.\n4. Not eligible for curative local therapy (surgery\u002Fradiation).\n5. Histological confirmation from recurrent\u002Fmetastatic lesion or PET-CT evidence.\n6. Disease progression after prior chemotherapy.\n7. ECOG Performance Status 0-1.\n8. Expected survival ≥ 3 months.\n9. At least one measurable lesion per RECIST v1.1.\n10. Adequate organ function; (1) Absolute Neutrophil Count ≥ 1,000\u002Fmm³ (2) Hemoglobin ≥ 8.0 g\u002FdL (3) Platelets ≥ 75,000\u002Fmm³ (4) Total bilirubin ≤ 1.5×ULN (≤3.0×ULN for constitutional hyperbilirubinemia) (5) AST\u002FALT ≤ 3×ULN (≤5×ULN with liver metastasis) (6) Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 40 mL\u002Fmin\n11. If the participant is female, she agrees to use contraception and refrain from breastfeeding during the treatment and for 5 months after the treatment. If the participant is male, he agrees to use contraception during the treatment and for 7 months after the treatment.\n\nExclusion Criteria:\n\n1. Active progressive multiple primary cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less. However, lesions equivalent to carcinoma in situ or mucosal cancer that are considered curable by local treatment are not included as multiple primary cancers. Additionally, this may not apply if the attending physician determines that early-stage cancer will not be a prognostic factor.).\n2. Has a systemic infection that requires treatment.\n3. It has been determined that one is infected with HIV or AIDS-related diseases.\n4. Having an active autoimmune disease that required systemic therapy.\n5. Having interstitial lung disease.\n6. Pregnant or breastfeeding.\n7. Any other cases where the attending physician determines that the treatment in this protocol is inappropriate.",{"count":98,"type":20},14,[24],"This trial evaluates the efficacy and safety of nivolumab monotherapy in patients with recurrent or metastatic olfactory neuroblastoma that is difficult to treat with curative intent. Specifically, nivolumab 240 mg will be administered on Day 1 and Day 15 of each cycle, or nivolumab 480 mg will be administered on Day 1 of each cycle, and this will be continued until disease progression. One cycle is 28 days. The decision on which treatment to administer will be made through consultation between the participant in this trial and their attending physician.",[102],"Recurrent\u002F Metastatic Olfactory Neuroblastoma",[102,104],"Nivolumab","2025-07-27",{"date":107,"type":48},"2025-08-03",{"date":109,"type":48},"2025-04-15",{"date":111,"type":20},"2028-10-14",{"name":54,"class":55},2,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100488930","phase-3-tnt-of-scrtcapox-vs-scrtcapoxiri-for-locally-advanced-rectal-cancer-100488930","NCT05646511","TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer","A Multicenter Randomized Phase III Study of Short-term Radiotherapy Plus CAPOX and Short-term Radiotherapy Plus CAPOXIRI as Preoperative Treatment for Locally Advanced Rectal Cancer","ENSEMBLE","Inclusion Criteria:\n\n1. The content of this research was fully explained, and written informed consent was obtained from the subject.\n2. Histologically confirmed rectal adenocarcinoma.\n3. Radical resection is clinically possible without any distant metastases on imaging studies.\n4. Age of 18 years or older on the date of consent acquisition.\n5. Eastern Cooperative Oncology Group (ECOG) PS 0-1 (PS 0 if aged 70 years or older on consent acquisition date).\n6. Inferior margin of the tumor is within 12 cm of the AV.\n7. No prior tumor treatment.\n8. No history of radiation therapy to the pelvis, including treatment for other cancer types.\n9. Cases with cT3-4N0M0\\*or T1-4N1-2M0 based on Union Internationale Contre le Cancer (UICC) 8th edition.\n\n   (\\*5 cm\\\u003C AV ≤ 10 cm, T3a\u002FbN0M0, extramural venous invasion (EMVI) -, mesorectal fascia (MRF) clear and 10 cm \\\u003C AV ≤ 12 cm, T3a\u002FbN0-1M0, EMVI-, MRF clear are eligible only for those who refused surgery)\n10. UGT1A1 is wild-type or single heterozygous.\n11. Criteria for major organ function within 28 days prior to enrollment. If there are multiple test results within this period, the most recent one will be used, and blood transfusions and hematopoietic factor preparations will not be administered within 14 days before the test date for measurements before registration.\n\n    1. Neutrophil count: ≥1,500\u002Fmm3\n    2. Platelet count: ≥10.0×10 4\u002Fmm3\n    3. Hemoglobin concentration: ≥9.0 g\u002FdL\n    4. Total bilirubin: ≤2.0 mg\u002FdL\n    5. Aspartate transaminase (AST): ≤100 IU\u002FL or less\n    6. Alanine transaminase (ALT): ≤100 IU\u002FL or less\n    7. Serum creatinine: Creatinine clearance ≥30 mL\u002Fmin (by Cockcroft \\& Gault formula)\n\nExclusion Criteria:\n\n1. Extensive surgery (excluding colostomy and central venous port construction) within 4 weeks before starting protocol treatment.\n2. Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, and severe emphysema).\n3. Colonic stent in place.\n4. Contraindications for MRI such as cardiac pacemakers.\n5. Serious comorbidities (such as heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and active inflammatory bowel disease).\n6. Patients with multiple active cancers (simultaneous multiple cancers or metachronous multiple cancers with a disease-free interval of 5 years or less). However, carcinoma in situ or lesions equivalent to intramucosal carcinoma, which can be cured by local treatment, are not treated as active multiple cancers.\n7. Pregnant women, lactating women, positive pregnancy test, or unwillingness to use contraception.\n8. Hepatitis B surface (HBs) antigen positive or hepatitis C virus (HCV) antibody-positive. However, HCV-RNA-negative can be registered.\n9. Have human immunodeficiency virus (HIV) infection.\n10. MSI-high (MSI-H) or defective mismatch repair (dMMR) is known.\n11. Unwilling to donate specimens for \"Research on gene profiling and clinical significance using clinical specimens from cancer patients\" for whole-genome analysis based on the \"Action Plan for Whole-Genome Analysis, etc.\" (CONDUCTOR study).\n12. Any other patients the principal investigator or co-investigator deems inappropriate for study participation.",{"count":123,"type":20},608,[125],"PHASE3","This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.",[128],"Locally Advanced Rectal Cancer",[72,130,131,132,70,133,30,134,135,136,137,138,139,140,75,76,73,141,142,77,143,71],"CAPOXIRI","CAPOX","Rectal cancer","Rectal Neoplasms","Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Capecitabine","Oxaliplatin","Irinotecan","Antineoplastic Agents","MRI","Restaging","Organ preservation","2025-03-31",{"date":146,"type":48},"2025-04-03",{"date":148,"type":48},"2022-11-21",{"date":150,"type":20},"2030-12-31",{"name":54,"class":55},34,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":171,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100398271","phase-3-efficacy-and-safety-of-crt-durvalumab-and-surgery-for-sst-100398271","NCT04465968","Efficacy and Safety of CRT, Durvalumab and Surgery for SST","Efficacy and Safety of Durvalumab Before and After Operation or Durvalumab as Maintenance Therapy After Chemoradiotherapy Against Superior Sulcus Non-small Cell Lung Cancer","DEEP_OCEAN","Inclusion Criteria:\n\n1. A definite diagnosis of non-small cell lung cancer has been obtained by biopsy from the primary lesion.\n2. Meet all of the following (UICC-TNM classification 8th edition). I. Regarding the primary lesion, meet one of the following on chest CT. i. Direct invasion of the chest wall at or above the height of the first rib (at least invasion of the parietal pleura) ii. Direct invasion of the subclavian artery or vein II. Regarding regional lymph nodes, meet either of the following by chest CT and FDG-PET\u002FCT. Metastasis is also considered if lymph node metastasis is determined by either chest CT or FDG-PET\u002FCT.\n\n   i. cN0 ii. cN1 and no metastases to #10, #11, and #12 lymph nodes iii. cN3 (ipsilateral supraclavicular lymph node metastasis) and no metastases in regional lymph nodes (N1 and N2) other than \"#13, #14 lymph nodes\" III. No distant metastases (including intrapulmonary metastases in the same ling lobe and in a different lung lobe on the same side) on imaging tests including FDG-PET\u002FCT\n3. It is judged that radical resection is possible by lobectomy (including bilobectomy for 2 lobes), which satisfies the following \\[1\\] and \\[2\\].\n\n   I. The board respiratory surgeon judges that none of the following is true based on the image findings.\n\n   i. There is vertebral body infiltration that requires total spondylectomy ii. Presence of spinal cord infiltration iii. Invaded trachea or tracheal bifurcation iv. Invasion of aortic arch or ascending aorta v. Invading brachial plexus at C8 or higher vi. Esophageal infiltration that requires esophageal reconstruction for resection vii. Pneumonectomy is required for radical resection II. Meet all of the following. i. Predicted postoperative forced expiratory volume of 1 second (FEV1.0) ≥ 800 mL within 56 days before registration ii. SpO2 \\> 93% (room air) with the latest inspection value within 14 days before registration\n4. Consult with the radiotherapy doctor and it is judged that all of the following are met.\n\n   I. Radiation therapy is possible according to the protocol II. The irradiation field does not reach the hilum\n5. The age of the registration date is 20 years or older and 75 years or yonger.\n6. Performance status (PS) is 0 or 1 according to ECOG standards (PS must be described in medical records)\n7. The presence or absence of measurable lesions is not required.\n8. No history of following surgery irrespective of whether for a benign or malignant lesion.\n\n   I. Thoracoscopic surgery or thoracotomy with excision of the affected lung or esophagus or mediastinum (however, a history of thoracoscopic surgery without wedge resection or lung, esophagus, or mediastinal resection (eg, pleural biopsy)) is allowed) II. Median sternotomy surgery (with or without organ resection) III. Pulmonary resection other than wedge resection of the contralateral lung (whether open-heart surgery or thoracoscopic surgery)\n9. There is no history of chemotherapy, including treatment for other cancer types (including molecular targeted therapies and immune checkpoint inhibitors). However, the history of drug therapy as adjuvant therapy is allowed if it was completed more than 3 years ago. In addition, a history of hormone therapy for other cancer types is allowed.\n10. If there is a history of radiotherapy including other cancer types, the lung, hilum, mediastinum, and supraclavicular fossa are not included in the irradiation field.\n11. Chest CT does not show interstitial pneumonia or pulmonary fibrosis.\n12. No history of complication of autoimmune disease or chronic or recurrent autoimmune disease. However, patients with type 1 diabetes which is well controlled by appropriate treatment, hyperthyroidism\u002Fhypothyroidism that requires only antithyroid drug\u002Fhormone replacement therapy, autoimmune skin disease that does not require systemic treatment (Pemphigus, psoriasis vulgaris, pemphigus vulgaris, vitiligo), and celiac disease controlled only by dietary control are regarded as eligible if they have been inactive in the past 5 years, even with a history of autoimmune complications or history.\n13. No surgical treatment with general anesthesia within 14 days (2 weeks) before registration.\n14. No systemic administration of steroids, other immunosuppressive drugs, or immunoglobulins within 28 days (4 weeks) before registration. However, those that meet the following conditions are allowed.\n\n    I. Intranasal\u002Finhalation\u002Ftopical steroid injection or local steroid injection (for example, intra-articular injection) II. Systemic administration of steroid drugs at a dose of 10 mg\u002Fday or less in terms of prednisolone III. Steroids as premedication (eg CT premedication)\n15. Can be taken orally.\n16. No ischemic changes were observed on the latest 12-lead ECG within 28 days before registration. However, if a 12-lead electrocardiogram shows ischemic changes, echocardiography, exercise electrocardiography, etc. should be performed, and if it is judged that new treatment for ischemic heart disease is not necessary, it is qualified.\n17. The latest inspection value within 14 days before registration (possible on the same day two weeks before the registration date) satisfies all of the following.\n\n    I. White blood cell count ≧4,000\u002Fmm3 II. Hemoglobin ≥ 11.0 g\u002FdL (no blood transfusion within 14 days before the blood sampling date of the test used for registration) III. Platelet count ≧10×104 \u002Fmm3 IV. Total bilirubin ≤ 2.0 mg\u002FdL V. AST ≤ 75 U\u002FL VI. ALT ≤ 75 U\u002FL VII. Serum creatinine ≤ 1.2 mg\u002FdL\n18. Written informed consent from the patient to participate in the study.\n19. The attending physician can judge that the enrolled patients understand the treatment and evaluation schedule of this study and can comply with them.\n\nExclusion Criteria:\n\n1. Having active double cancer (simultaneous double cancer\u002Fmultiple cancer and metachronous double cancer\u002Fmultiple cancer with a disease-free period of 3 years or less, even if the disease-free period is less than 3 years, clinical The 5-year relative survival rate is similar to that of stage I prostate cancer, clinical stage 0 completely responded to radiation therapy, stage I laryngeal cancer, and complete excision of the following pathological stage cancers. History of cancer equivalent to 95% or more is not included in active double cancer\u002Fmultiple cancer). Gastric cancer \"adenocarcinoma (general type)\": Stage 0-I, colon cancer (adenocarcinoma): Stage 0-I, rectal cancer (adenocarcinoma): Stage 0-I, esophageal cancer (squamous cell carcinoma, glandular) Squamous cell carcinoma, basal cell carcinoma): Stage 0, breast cancer (non-invasive ductal carcinoma, lobular carcinoma): Stage 0, breast cancer (invasive ductal carcinoma, lobular invasive carcinoma, Paget's disease): 0 Stage-IIA, endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I, prostate cancer (adenocarcinoma): Stage I-II, cervical cancer (squamous cell carcinoma): Stage 0, thyroid cancer (Papillary cancer, follicular cancer): stage I, stage II, stage III, renal cancer (clear cell carcinoma, chromophobe cell carcinoma): stage I, non-melanoma skin cancer, malignant melanoma without a definite diagnosis, etc. Lesions of intramucosal cancer\n2. Has an infectious disease that requires systemic treatment (including active pulmonary tuberculosis).\n3. When registering, a fever of 38.0°C or higher is generated.\n4. Women who are pregnant, possibly pregnant, within 28 days of delivery, or breastfeeding. A man who wants a partner to become pregnant. Or a reproductive male or female patient who is not willing to use an effective contraceptive by Week 13 (Day 91) after the last dose of durvalumab (see 6.4.7.).\n5. Participation in the study is considered to be difficult due to the combination of mental illnesses or symptoms that impair daily life.\n6. Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressive drugs in excess of 10 mg\u002Fday in terms of prednisolone.\n7. With uncontrolled diabetes.\n8. With uncontrolled hypertension.\n9. A gastrointestinal disorder accompanied by uncontrolled diarrhea.\n10. With unstable angina (angina with onset or exacerbation of attack within the last 3 weeks) or a history of myocardial infarction within 6 months.\n11. Poor valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congestive heart failure, and arrhythmia.\n12. Chest CT reveals severe emphysema.\n13. Either HBs antigen, HCV antibody, or HIV1\u002F2 antibody is positive.\n14. Continuous use of flucytosine (Ancotil®) is required.\n15. Participating in another clinical trial (excluding observational studies) during the 6 months prior to enrollment.\n16. A history of allogeneic organ transplant.\n17. A history of active primary immunodeficiency.\n18. Live vaccines (BCG, polio, measles-rubella mixture, measles, rubella, mumps, chickenpox, yellow fever, rotavirus, etc.) have been administered within 30 days before registration.\n19. Has hypersensitivity or allergy to the test drug or its additives used in this test.","20 Years","75 Years",{"count":164,"type":20},84,[125],"The safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST",[168,169,170],"Superior Sulcus Tumor","Non-small Cell Lung Cancer Stage IIB","Non Small Cell Lung Cancer Stage III",[168,172,173,174,175,176],"Pancoast Tumor","Non-Small Cell Lung Cancer","Durvalumab","Multi-modality therapy","Neoadjuvant therapy","2020-07-07",{"date":179,"type":48},"2020-07-10",{"date":181,"type":20},"2020-09-01",{"date":183,"type":20},"2030-08-31",{"name":54,"class":55},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":161,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":200,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},"100384691","phase-3-surgery-plus-chemo-versus-chemoradiotherapy-followed-by-surgery-plus-chemo-for-locally-recurrent-rectal-cancer-100384691","NCT04288999","Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer","JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study)","JCOG1801","Inclusion Criteria:\n\n1. Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer.\n2. The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal.\n3. Either of the following treatments was performed for the initial rectal cancer, and classified as R0\u002F1 or ER (Endoscopical R)0\u002F1 on pathological diagnosis.\n\n   i) Surgical resection (including local resection, with or without lymph node dissection).\n\n   ii) Endoscopic resection.\n4. Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy performed more than 168 days before registration is eligible.\n5. Recurrent rectal cancer diagnosed by any of the following modalities after treatment for the initial rectal cancer.\n\n   i) The recurrent lesion is pathologically diagnosed. ii) Diagnosed as local recurrence by more than two modalities among contrast-enhanced CT, contrast-enhanced MRI, or positron emission computed tomography (PET).\n\n   iii) Chronological progression of the lesion seen on more than one modality among contrast-enhanced CT, MRI, or PET.\n6. The main tumor location is within pelvis as seen on contrast-enhanced CT and MRI if recurrent lesion is multiple, or recurrent lesions spread outside of pelvis continuously.\n7. LRRC is diagnosed with no following condition. i) Judged as resectable endoscopically. ii) Depth of invasion within the muscularis propria as seen on contrast-enhanced CT, MRI, or PET in case of recurrence inside the intestine iii) Solitary ovarian metastasis. iv) Recurrence of the common iliac lymph node alone.\n8. LRRC is diagnosed as resectable, and all the following conditions must be fulfilled:\n\n   i) No distant metastasis on contrast-enhanced CT (cM0). ii) Estimated circumferential resection margin \\>0 mm. iii) Leg amputation not required. iv) Preservation of the first sacral nerve possible.\n9. No prior surgery for recurrent rectal cancer.\n10. No prior pelvic irradiation for any malignancies.\n11. A patient who has received systemic chemotherapy for any malignancies and the final dose was administered more than 14 days ago.\n12. Age at registration is 20 to 80 years old.\n13. Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.\n14. Measurable lesion is not mandatory.\n15. Adequate oral intake.\n16. Sufficient organ function. i) Neutrophil count \\>= 1,500\u002Fmm3 ii) Hemoglobin \\>= 9.0 g\u002FdL iii) Platelet count \\>= 100,000\u002Fmm3 iv) Total Bilirubin =\\\u003C 2.0 mg\u002FdL v) Aspartate aminotransferase (AST) =\\\u003C 100 U\u002FL vi) Alanine Aminotransferase (ALT) =\\\u003C 100 U\u002FL vii) Cr =\\\u003C 1.5 mg\u002FdL\n17. Open surgery or laparoscopic surgery is planned.\n18. Written informed consent is obtained.\n\nExclusion Criteria:\n\n1. Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.\n2. Infections requiring systemic treatment.\n3. Body temperature higher than 38 degrees Celsius at registration.\n4. Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future.\n5. Severe psychological disease.\n6. Continuous systemic corticosteroid or immunosuppressant treatment.\n7. Uncontrollable diabetes mellitus.\n8. Uncontrollable hypertension.\n9. Unstable angina pectoris, or history of myocardial infarction within 6 months.\n10. Uncontrollable valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.\n11. Positive serum Hepatitis B (HB)s antigen or serum Hepatitis C Virus (HCV) antibody.\n12. Positive serum HIV antibody.\n13. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.","80 Years",{"count":195,"type":20},110,[125],"JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.",[199],"Rectal Cancer Recurrent",[132,201,202,73,75],"Locally recurrent rectal cancer","Chemoradiotherapy","2020-06-02",{"date":205,"type":48},"2020-06-04",{"date":207,"type":48},"2019-10-01",{"date":209,"type":20},"2028-10",{"name":54,"class":55},45,""]