[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-cancer-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-cancer-recurrent":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,76,99,127,156,184],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100610325","splicing-based-predictive-learning-for-individual-chemotherapy-evaluation-in-colorectal-cancer-100610325",false,"NCT07226115","Splicing-based Predictive Learning for Individual Chemotherapy Evaluation in Colorectal Cancer","Splicing-Based Predictive Learning for Individual Chemotherapy Evaluation in Colorectal Cancer (SPLICE)","SPLICE","Inclusion Criteria:\n\n* Histologically confirmed stage II-III colorectal cancer (TNM classification, 8th edition)\n* Received standard adjuvant chemotherapy after curative resection\n* Availability of tumor tissue (FFPE or frozen) before chemotherapy\n* Sufficient clinical data for outcome analysis (recurrence, survival)\n* Age 18-80 years Stage\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Inadequate RNA quality or lack of consent","ALL","18 Years","80 Years",{"count":21,"type":22},200,"ESTIMATED","OBSERVATIONAL","Colorectal cancer (CRC) remains one of the leading causes of cancer-related mortality worldwide. Although adjuvant chemotherapy improves survival after curative resection, its efficacy varies widely among patients. The absence of reliable predictive biomarkers often leads to overtreatment or undertreatment.\n\nThis study aims to develop a machine learning-based predictive model for adjuvant chemotherapy response using tumor-derived alternative splicing signatures.\n\nBy integrating RNA-seq data, splicing isoform and clinical outcomes, this study seeks to identify molecular predictors of treatment response and recurrence risk after surgery.",[26,27,28,29],"Colorectal Cancer","Colorectal Cancer Recurrent","Colorectal Cancer Stage II","Colorectal Cancer Stage III",[31,32,33,34,35],"Chemotherapy","Adjuvant","Response","Splicing","Prediction","RECRUITING","2025-11-05",{"date":39,"type":40},"2025-11-10","ACTUAL",{"date":42,"type":40},"2024-06-21",{"date":44,"type":22},"2026-06-18",{"name":46,"class":47},"City of Hope Medical Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":74,"locationsCount":75},"100540293","stage-iiiii-colorectal-cancer-recurrence-100540293","NCT06314958","Stage II\u002FIII Colorectal Cancer Recurrence","Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment","CENSURE","Inclusion Criteria:\n\n* Stage II (high-risk) or III colorectal cancer (TNM classification, 8th edition).\n* Received standard diagnostic, staging, and therapeutic procedures as per local guidelines\n* Received stage-specific curative-intent resection followed by adjuvant chemotherapy.\n* Confirmed cancer-free survivorship confirmed at the time of study inclusion.\n\nExclusion Criteria:\n\n* Lack of written informed consent.\n* Development of recurrence in the first 6 months following adjuvant chemotherapy completion.\n* Hereditary colorectal cancer syndromes (identified through genetic testing)\n* Inflammatory bowel diseases",{"count":58,"type":22},400,"This study will develop an assay to predict disease recurrence in patients with stage II\u002FIII CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation.",[26,61,28,29,27],"Colorectal Adenocarcinoma",[63,64,65,66,67],"Recurrence-free Survival (RFS)","Overall Survival (OS)","Methylation","DNA methylation","carcinoembryonic antigen (CEA)","2025-07-02",{"date":70,"type":40},"2025-07-04",{"date":72,"type":40},"2023-03-15",{"date":44,"type":22},{"name":46,"class":47},4,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":48},"100589685","development-and-validation-of-microbiota-and-metabolite-based-prediction-model-for-recurrence-of-high-risk-colorectal-polyps-after-polypectomy-100589685","NCT06957626","Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy","Inclusion Criteria:\n\n* patients aged 40-75 years who undergo the colonoscopy with at least 1 advanced premalignant polyps or ≥ 3 adenoma\n\nExclusion Criteria:\n\n* patient with severe physical diseases that prevented them from adhering to the examination requirements,\n* patient with coagulopathy or other contraindications for biopsy or polypectomy,\n* patient with previous surgical procedures on the gastrointestinal tract,\n* presence of colorectal cancer or other malignant tumor at baseline\n* presence of inflammatory bowel disease or hereditary polyposis syndromes (such as family adenomatous polyposis or Lynch syndrome)\n* within 1 month before enrollment, oral antibiotics and probiotics were taken;\n* inability to provide informed consent or refusal to participate in the study.","40 Years","75 Years",{"count":85,"type":22},150,"The characteristics of the intestinal microbiota in high-risk colorectal polyp recurrence and their relationship with disease pathogenesis have not yet been fully elucidated. This study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of patients after polypectomy with recurrence of colorectal polyps. Additionally, this research holds significant importance for understanding the etiology of adenoma recurrence and develop a microbiota and metabolite-based predicting tool.",[88,27,89],"Colorectal Polyp","Colorectal Adenoma","2025-06-29",{"date":92,"type":40},"2025-07-01",{"date":94,"type":40},"2023-04-25",{"date":96,"type":22},"2026-04-30",{"name":98,"class":47},"Peking Union Medical College Hospital",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":48},"100596816","early-phase-1-a-dose-expansion-trial-of-intravenous-hnf4-srrna-for-unresectable-or-metastatic-colorectal-cancer-100596816","NCT07050394","A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer","A Dose-expansion Trial Exploring the Safety and Efficacy of Intravenous HNF4α srRNA in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender.\n2. Patients with colorectal cancer confirmed by histology or cytology.\n3. Patients with unresectable locally advanced or metastatic colorectal cancer.\n4. Patients who are not suitable for or intolerant of standard systemic therapy; or patients who have progressed after receiving standard systemic therapy (including but not limited to the following regimens) as confirmed by RECIST v1.1: chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted drugs such as anti-VEGF\u002FEGFR monoclonal antibodies.\n5. According to RECIST v1.1, patients must have at least one measurable lesion. Lesions that have received local treatment (including surgery, radiotherapy, TACE, and ablation) cannot be selected as target lesions, unless the lesion is the only measurable lesion and has clearly progressed according to imaging, in which case it may be considered as a target lesion.\n6. Life expectancy ≥ 12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.\n8. Fertile male participants and women of childbearing age must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Women of childbearing age include premenopausal women and women within 2 years of menopause. Women of childbearing age must have a negative serum pregnancy test within ≤7 days before the first dose of the investigational drug.\n9. Willing to sign the written informed consent form and voluntarily comply with the protocol.\n\nExclusion Criteria:\n\n1. Patients who have completed standard adjuvant chemotherapy after tumor resection and relapsed or developed metastasis after a drug-free interval of 6 months, and have not received standard systemic therapy.\n2. Patients with tumor tissue testing confirming mismatch repair deficiency or high microsatellite instability (dMMR\u002FMSI-H) who have not received immune checkpoint inhibitor treatment (PD-1 monoclonal antibody or PD-L1 monoclonal antibody).\n3. Patients with clinical or radiological evidence of current intestinal obstruction, perforation, or bleeding; or patients assessed by the investigator to be at high risk of perforation or bleeding.\n4. Serum albumin \\\u003C 28 g\u002FL, or bilirubin \\> 3×ULN, or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \\> 5×ULN.\n5. Patients with significant renal impairment, serum creatinine \\> 1.5×ULN, or creatinine clearance \\\u003C 40 mL\u002Fmin; urine protein \\\u003C2+ (if urine protein ≥2+, a 24-hour urine protein quantification is required, and patients with 24-hour urine protein quantification \\\u003C1 g may be eligible).\n6. Absolute neutrophil count \\\u003C 1.5×10\\^9\u002FL, or platelets \\\u003C 50×10\\^9\u002FL, or hemoglobin \\\u003C 9 g\u002FdL.\n7. International Normalized Ratio (INR) \\> 2.\n8. Patients with known brain metastases from tumors.\n9. Patients with uncontrolled hypertension, diabetes, or other severe cardiac or pulmonary diseases, or severe organ dysfunction.\n10. Patients who have received local or systemic anti-tumor treatments (including immunotherapy, targeted therapy, or chemotherapy) within 4 weeks, or radiotherapy within 3 weeks, except for treatment regimens assessed as disease progression according to RECIST (version 1.1) criteria.\n11. Patients with adverse events related to previous local or systemic anti-tumor treatments still ≥ Grade 2 (excluding alopecia and other events deemed tolerable by the investigator).\n12. Patients with uncontrollable active infections (e.g., pulmonary or abdominal infections).\n13. Patients with malignancies other than colorectal cancer within the past 5 years, with the exception of low-risk malignancies with a low risk of metastasis or death (estimated 5-year overall survival \\> 90%), such as early gastrointestinal cancer treated effectively, cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, etc.\n14. Patients with active autoimmune diseases requiring systemic therapy within the past 2 years, or autoimmune diseases judged by the investigator to have a potential for recurrence or planned treatment, including but not limited to inflammatory bowel disease, celiac disease, Wegener's granulomatosis, Hashimoto's thyroiditis, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis.\n15. Patients who require systemic treatment with corticosteroids (prednisone or equivalent \\> 10 mg\u002Fday) or other immunosuppressive drugs within 14 days before the first dose of the investigational drug.\n16. Patients who are preparing for or have previously undergone allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n17. Patients who are positive for HBV-DNA or HCV RNA.\n18. Patients with known active tuberculosis. Patients suspected of having active tuberculosis must be excluded based on chest imaging, sputum tests, and clinical symptoms and signs.\n19. Patients who are positive for human immunodeficiency virus (HIV).\n20. Pregnant or breastfeeding women, or women who cannot rule out the possibility of pregnancy.\n21. Patients who have participated in other drug trials within the past 4 weeks.\n22. Other situations deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":107,"type":22},20,"INTERVENTIONAL",[110],"EARLY_PHASE1","This study is a single-arm, open-label, exploratory clinical trial. Building on the previous dose-escalation trial, this dose-expansion trial aims to evaluate the safety and tolerability of intravenous monotherapy with CD-GA-102 or its combination with immunotherapy and other systemic treatments in patients with unresectable locally advanced or metastatic colorectal cancer, and to preliminarily explore its efficacy in treating colorectal cancer.",[113,27,114],"Colorectal Cancer Metastatic","Colorectal Cancer Stage IV",[26,116,117],"Hepatocyte nuclear factor 4α","Differentiation therapy","2025-06-25",{"date":120,"type":40},"2025-07-03",{"date":122,"type":40},"2025-06-10",{"date":124,"type":22},"2028-06",{"name":126,"class":47},"Shanghai Changzheng Hospital",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":108,"phases":137,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":48},"100592378","phase-3-trifluridinetipiracil-plus-regorafenib-vs-trifluridinetipiracil-plus-bevacizumab-for-refractory-metastatic-colorectal-cancer-100592378","NCT06992648","Trifluridine\u002FTipiracil Plus Regorafenib vs Trifluridine\u002FTipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer","Trifluridine\u002FTipiracil Plus Regorafenib vs Trifluridine\u002FTipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial","REGTAS-2","Inclusion Criteria:\n\n1. Sign Informed Consent Form (ICF) must be obtained during the screening visit, prior to the performance of any study procedure；\n2. Male or female patient aged ≥18 years old;\n3. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded);\n4. RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy;\n5. Prior treatment regimens for the treatment of advanced colorectal cancer must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and\u002For an anti-EGFR monoclonal antibody for RAS wildtype patients;\n6. Has measurable or non-measurable disease as defined by RECIST version 1.1;\n7. Is able to swallow oral tablets;\n8. Estimated life expectancy ≥12 weeks;\n9. ECOG PS 0-1；\n10. Has adequate organ function as defined by the following laboratory values obtained within 7 days prior to randomization:\n\nAbsolute neutrophil count ≥1.5×109\u002FL; Platelet count ≥75×109\u002FL; Hemoglobin≥90g\u002FL (7 days without transfusion); Creatinine clearance ≥60 mL\u002Fmin, assessed using the Cockcroft \\& Gault formula; Total serum bilirubin \\\u003C1.5×upper limit of normal (ULN) (unless Gilbert disease confirmed); Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) ≤ 2.5×ULN (unless if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤ 5×ULN); Urine protein \\\u003C1+ on urinalysis or 24-hour urine protein \\\u003C1g; International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN (For patients receiving anti-coagulant therapy the adequate therapeutic levels of PT should be confirmed).\n\nFemale of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to randomization; All patients must agree to use a highly effective method of birth control as well as their partners during the study and lasting at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Prior trifluridine\u002Ftipiracil or TKI regimens for the treatment of advanced colorectal cancer;\n2. Pregnancy, lactating female or possibility of becoming pregnant during the study;\n3. Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization;\n4. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation);\n5. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease;\n6. Has severe or uncontrolled active acute or chronic infection;\n7. Has active or history of interstitial lung disease and\u002For pneumonitis, or pulmonary hypertension;\n8. Has any clinically significant active hepatitis, including but not limited to Hepatitis B or Hepatitis C Virus infection;\n9. Known carriers of HIV antibodies;\n10. Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and\u002For diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia;\n11. Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization;\n12. Major surgery within 4 weeks prior to randomization (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study;\n13. Prior radiotherapy if completed less than 2 weeks before randomization, except if provided as a short course for symptoms palliation only;\n14. Other clinically significant medical conditions; Other malignancies.",{"count":136,"type":22},302,[138],"PHASE3","The goal of this clinical trial is to demonstrate the non-inferiority of trifluridine\u002Ftipiracil + regorafenib vs trifluridine\u002Ftipiracil + bevacizumab in terms of progression free survival in patients with refractory metastatic colorectal cancer(mCRC) patients. It will also try to estimate the effect of trifluridine\u002Ftipiracil + regorafenib vs trifluridine\u002Ftipiracil + bevacizumab in terms of OS, ORR, and DCR in patients with refractory mCRC. Other secondary objectives are to compare the safety and tolerance, and the impact on QoL of trifluridine\u002Ftipiracil + regorafenib vs trifluridine\u002Ftipiracil + bevacizumab in patients with refractory mCRC.",[113,27],[142,143,144,145,146],"trifluridine\u002Ftipiracil","regorafenib","bevacizumab","non-inferiority","refractory metastatic colorectal cancer","2025-05-27",{"date":149,"type":40},"2025-05-28",{"date":151,"type":40},"2025-04-01",{"date":153,"type":22},"2027-12-31",{"name":155,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":108,"phases":168,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":48},"100575249","ga-68-fapi-46-pet-for-crc-recurrence-detection-in-elevated-cea-100575249","NCT06769828","Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA","Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance","Ga-68-FAPI-46","Inclusion Criteria:\n\n* Age ≥ 20 years old\n* The surgical intervention for colorectal cancer aims for curative resection, with the goal of achieving a disease-free status that persists for six months or more, as assessed clinically and through imaging studies.\n* Elevated serum CEA levels:\n\nExceeding the laboratory's normal range (5 ng\u002Fml) or, but not surpassing 13 ng\u002Fml; using the individual's post-surgery +\u002F- adjuvant chemotherapy or targeted therapy minimum value as a baseline, a consecutive increase of more than 10% for two times or as determined by the attending physician suggests suspicion of recurrence.\n\n* Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.\n* Signing the subject consent form.\n* ECOG grade 0-2.\n* The timing of F-18-FDG usage in this trial follows the \" 2023 - Colorectal Cancer Treatment Principles\" of our institution.\n\nExclusion Criteria:\n\n* pregnant woman and breastfeeding women\n* severe renal impairment (eGRF\\\u003C 30ml\u002Fmin)\n* Known or suspected allergy to radiopharmaceuticals\n* Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.\n* Inability to undergo the necessary PET scan procedure\n* Refusal or unwillingness to sign the informed consent form\n* Severe medical conditions (severe disabilities, mental disorders)","20 Years","100 Years",{"count":167,"type":22},30,[169],"NA","This single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.",[27],[173,174],"Ga-68-FAPI-46 PET\u002FCT","Colorectal cancer (CRC)","2025-01-19",{"date":177,"type":40},"2025-01-22",{"date":179,"type":22},"2025-02-01",{"date":181,"type":22},"2026-04-14",{"name":183,"class":47},"Koo Foundation Sun Yat-Sen Cancer Center",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":192,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":108,"phases":195,"briefSummary":197,"conditions":198,"keywords":205,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":48},"100533709","phase-2-leflunomide-or-combination-of-mek-inhibitor-and-hydroxychloroquine-for-refractory-patients-with-ras-mutations-100533709","NCT06229340","Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations","New Therapeutic Approaches for Tumors With RAS Gene Mutations","NТО-RAS","Inclusion Criteria:\n\n1. Patient is able to provide informed consent and sign approved consent forms to participate in the study.\n2. Patient age is at least 18 years old.\n3. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.\n4. Histologically confirmed metastatic metastatic disease stage 4.\n5. Must have documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years by a local test on tumor tissue.\n6. More than 2 lines of standard drug antitumor therapy in the anamnesis.\n7. Must have disease progression as defined by RECIST version 1.1 criteria\n8. Appropriate hematologic and liver function:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FμL)\n   * Lymphocyte count ≥ 0.5 x 109\u002FL (500\u002FμL)\n   * Platelet count ≥ 100 x 109\u002FL (100,000\u002FμL) without transfusion\n   * Hemoglobin ≥ 90 g\u002FL without transfusion.\n   * Creatinine clearance ≥ 40 mL\u002Fmin\n   * Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n   * Serum bilirubin ≤ 1.5 x HGH, with the following exception:\n   * Patients with known Gilbert's disease or liver metastases: serum bilirubin level ≤ 3 x IUH\n   * AST, ALT, and alkaline phosphate ≤ 2.5 x HGN;\n\n10\\. For women of childbearing potential: consent to abstinence (abstain from heterosexual intercourse) or use at least two forms of effective contraception with an ineffectiveness rate \\\u003C 1% per year during treatment.\n\n11\\. Patients with asymptomatic new or advanced brain metastases (active brain metastases) are eligible to participate if the treating physician determines that localized treatment is not required.\n\nExclusion Criteria:\n\n1. Age over 85 years.\n2. Рresence of acute or active chronic infections.\n3. Impaired renal and hepatic function; - left ventricular ejection fraction (LVEF) \\\u003C 45%\n4. Known history of acute or chronic hepatitis B or C due to known potential hepatotoxicity of leflunomide.\n5. History of allergic reactions associated with compounds similar in chemical or biological composition to leflunomide or teriflunomide or other drugs in the combination.\n6. Uncontrolled intercurrent disease, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or mental illness\u002Fsocial situations that limit study compliance.\n7. Patients should not be pregnant or breastfeeding due to the potential for teratogenic effects and side effects of planned chemotherapeutic regimens.\n8. History of retinal disease (retinal tear, exudate, hemorrhage) or retinal vein occlusion, central serous retinopathy or retinal pigment epithelium detachment, or current risk factors for ROS (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).\n\nExit criteria:\n\n1. Refusal to continue participation in the study.\n2. Intolerable toxicity.\n3. Progression according to RECIST 1.1 and IRECIST criteria or clinically significant (in the opinion of the physician) progression requiring a change in anticancer treatment.\n4. Non-compliance with IND procedures.",true,"85 Years",{"count":107,"type":22},[196],"PHASE2","There is a huge variety of nucleotide substitutions that activate RAS. The search for new \"universal\" drugs for the RAS pathway that either interfere with RAS upregulation upstream in the signaling pathway or offset the consequences of RAS activation is important for improving therapeutic outcomes for patients with refractory malignancies.\n\nThe use of leflunomide or the combination of MEK inhibitor + hydroxychloroquine ± bevacizumab is promising for patients with mutations in RAS cascade genes who have failed all existing treatment standards.",[199,200,27,201,202,203,204],"RAS Mutation","Ras (Kras or Nras) Gene Mutation","Pancreas Cancer","Lung Cancer","Melanoma","Refractory Cancer",[199,200,26,201,203,202,204],"2024-01-19",{"date":208,"type":40},"2024-01-29",{"date":210,"type":40},"2023-10-03",{"date":212,"type":22},"2026-10-01",{"name":214,"class":47},"N.N. Petrov National Medical Research Center of Oncology"]