[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Liu Huang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":157},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,71,94,115,137],{"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":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100596923","phase-2-fruquintinib-vs-bevacizumab-combined-with-irinotecan-liposome-and-capecitabine-as-second-line-therapy-for-advanced-metastatic-colorectal-cancer-100596923",false,"NCT07051785","Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer","Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer：A Multicenter Randomized Controlled Trial","ARK","Inclusion criteria:\n\n1. Patients voluntarily enrolled in the study and signed an informed consent form, were compliant and cooperated with follow-up visits;\n2. Patients with metastatic colorectal adenocarcinoma confirmed by pathology or histology;\n3. Age: 18-75 (inclusive of 18 and 75), male or female;\n4. Patients who have previously failed or were intolerant to first-line standard therapy (recurrence within 6 months of the end of adjuvant chemotherapy is considered first-line treatment failure).\n5. ECOG score: 0-1;\n6. At least one measurable lesion (based on RECIST 1.1 criteria);\n7. Major organs and bone marrow function were essentially normal (no blood components or cell growth factors had been used in the 14 days prior to enrollment):\n\n   * Neutrophil count ≥ 1.5 × 10⁹\u002FL;\n   * Platelet count ≥ 100 × 10⁹\u002FL;\n   * Hemoglobin ≥ 90 g\u002FL;\n   * Coagulation parameters: International Normalized Ratio (INR) ≤ 1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;\n   * Liver function: Total bilirubin ≤ 1.5 × ULN; Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (with an exception for patients with liver metastases, where ALT\u002FAST may be up to 5 × ULN);\n   * Renal function: Serum creatinine ≤ 1.5 × ULN; Creatinine clearance (CCr) ≥ 50 mL\u002Fmin.\n8. Female participants of reproductive age must undergo a serum or urinalysis that shows no pregnancy within 14 days before the first dose of study treatment. Male or female patients of childbearing potential will voluntarily use an effective method of contraception, e.g., double-barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and for at least 6 months after the last dose of study medication.\n\nExclusion criteria:\n\n1. History of major surgery or severe trauma within 4 weeks prior to the initiation of the study drug.\n2. Use of immunosuppressive agents, including systemic or locally absorbed corticosteroids, for immunosuppressive purposes, with a daily dose of prednisone \\>10 mg or equivalent, and continued us within 2 weeks prior to enrollment.\n3. Prior exposure to any irinotecan-containing chemotherapy regimen.\n4. Reception of live attenuated vaccines within 4 weeks prior to the initiation of the study drug.\n5. Prior treatment with anti-angiogenic small-molecule targeted therapy.\n6. Presence of any active autoimmune disease or a history of autoimmune disorders (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypopituitarism, vasculitis, nephritis and etc.; not include vitiligo or childhood asthma that has fully resolved and does not require intervention in adulthood; asthma requiring bronchodilator therapy for medical management is included).\n7. History of other malignancies within the past 5 years, except for curatively resected skin basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ.\n8. Congenital or acquired immunodeficiency (e.g., HIV) or active hepatitis (e.g., hepatitis B: HBsAg positive and HBV DNA ≥ 10⁴ copies\u002FmL or \\>2000 IU\u002FmL; hepatitis C: HCV antibody positive).\n9. Uncontrolled cardiac clinical symptoms or diseases, including: (1) NYHA classification \\>2 heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n10. Hypertension that is not well-controlled with antihypertensive medication (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg).\n11. Active or uncontrolled severe infections (≥ CTCAE grade 2 infection).\n12. Urine routine suggests urinary protein ≥2+ and the amount of urinary protein \\>1.0g in 24 hours.\n13. Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding \\>30 mL within 3 months, vomiting blood, black stool, blood in stool), hemoptysis (\\>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke events and\u002For transient ischemic attack) within 12 months;\n14. Active peptic ulcer disease, ulcerative colitis, or uncontrolled gastrointestinal bleeding, or any gastrointestinal condition judged by the investigator, which may cause gastrointestinal bleeding, perforation, or bowel obstruction.\n15. Female participants who are pregnant (positive pregnancy test prior to drug administration) or are breastfeeding;.\n16. Patients who are allergic to the study drug or excipients.\n17. Any other conditions judged by the investigator which can potentially affect the study outcomes or compromise the safety or adherence of the participants, such as drug abuse, serious diseases (including psychiatric conditions like epilepsy), or other medical, psychological, or social factors that may endanger participant safety or adherence.","ALL","18 Years","75 Years",{"count":21,"type":22},68,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is divided into two phases. The first phase aims to preliminarily evaluate the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine as second-line therapy for advanced metastatic colorectal cancer. The second phase is designed to further assess the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine compared to bevacizumab in combination with chemotherapy, also as second-line treatment for advanced metastatic colorectal cancer.\n\nThe first phase is a single-arm study, while the second phase is a randomized (1:1) controlled trial. Entry into the second phase is determined by the investigators based on the efficacy results from the first phase study: if the primary endpoint of progression-free survival (PFS) is met in the first phase, participants will proceed to the second phase study. In the second phase, randomization is stratified according to the RAS status and the presence of disease progression within six months of adjuvant or neoadjuvant therapy.\n\nIn the second phase, patients will be ramdomly assigned to receive fruquintinib(4mg\u002Fd, PO, D1-14, Q3W) in combination with irinotecan liposome(56mg\u002Fm2, ivgtt, D1, Q3W) and capecitabine(800mg\u002Fm2, PO, BID, D1-14, Q3W) or bevacizumab(7.5mg\u002Fkg, ivgtt, D1, Q3W) in combination with the same chemotherapy. Every three weeks is a cycle.",[28],"Colorectal Cancer (CRC)",[30,31,32],"Colorectal Cancer","Fruquintinib","Second-Line","NOT_YET_RECRUITING","2025-06-26",{"date":36,"type":37},"2025-07-04","ACTUAL",{"date":39,"type":22},"2025-07-07",{"date":41,"type":22},"2028-07-06",{"name":43,"class":44},"Liu Huang","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100547841","exploratory-study-of-precise-therapy-for-advanced-tumor-patients-with-malignant-hydrothorax-or-ascites-by-using-ptc-drug-sensitivity-testing-100547841","NCT06413212","Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing","Inclusion Criteria:\n\n1. 18 to 75 years old, regardless of gender.\n2. Score of nutrition risk screening 2002 (NRS2002) is less than 3, NRS20023.\n3. Advanced and unresectable malignancy confirmed by biopsy diagnosis.\n4. Able to tolerate anti-tumor treatment, and without serious cardiopulmonary and other underlying diseases.\n5. Score of eastern cooperative oncology group (ECOG) is not higher than 2, ECOG≤2.\n6. Anticipated survival exceed six months.\n7. At least one measurable lesions (according to RECIST 1.1)\n8. Resistance or intolerance to standard therapy regimens.\n9. Signed informed consent form voluntarily.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Have Participated other clinical trials in six months.\n3. Severe liver dysfunction.\n4. Severe renal dysfunction.\n5. Patients with cognitive disorder, mental diseases and terrible compliance.\n6. Allergic to known chemotherapeutic agents.\n7. Other circumstance not suitable to participate in this trial determined by investigators.",{"count":52,"type":22},55,"OBSERVATIONAL","To explore the consistency between result of PTC drug screening tests and actual clinical outcome for patients with advanced malignancy.",[56,57,58,30],"Lung Cancer","Breast Cancer","Gastric Cancer",[60],"PTC: Patient-derived tumor-like cell clusters","RECRUITING","2025-05-31",{"date":64,"type":37},"2025-06-04",{"date":66,"type":37},"2023-08-04",{"date":68,"type":22},"2025-12",{"name":43,"class":44},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":70},"100531445","phase-2-clinical-efficacy-and-safety-of-paclitaxel-polymeric-micelles-for-injection-in-the-treatment-of-patients-with-taxans-resistant-pancreatic-adenocarcinoma-cholangiocarcinoma-lung-cancer-gastric-cancer-esophageal-carcinoma-or-breast-cancer-100531445","NCT06199895","Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer","Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxanes-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer","Inclusion Criteria:\n\n* 1.Male or female 18 years and older; 2.Patients with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer diagnosed by histological or cytological pathology; must have an evaluable lesion; 3.Previous treatment regimen includes Taxanes and is resistant to Taxanes (including patients with initial failure to remit or progression after remission) or previous use of Taxanes for at least 2 cycles without tumour shrinkage and the patient is not satisfied with current stable efficacy and is willing to be enrolled in this study; 4.ECOG (Eastern Cooperative Oncology Group) score ≤ 2 points; 5.expected survival of at least 3 months; 6.Blood routine examination meets the following criteria:\n\n  1. WBC≥3.0×109 \u002FL，ANC≥1.5×109 \u002FL;\n  2. PLT≥100×109 \u002FL；\n  3. Hb≥80g\u002FL； 7.Blood biochemical examination must meet the following criteria:\n\n  \u003C!-- -->\n\n  1. Total bilirubin ≤1.5 times the upper limit of normal (ULN)；\n  2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) ≤2.5 times ULN (ALT, AST, or ALP≤ 5×ULN for subjects with liver metastases, and ALP≤10×ULN for subjects with bone metastases);\n  3. Creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 ml\u002Fmin； 8.Functions of major organs such as heart, lung, liver and kidney are basically normal； 9.Subjects have good compliance and voluntarily comply with the clinical trial protocol during the study, followed up by the investigators； 10.All women of childbearing age, men of childbearing potential, or their spouses who have no plans to have children or donate sperm during the entire trial period and up to 6 months after the last dose of medication, or who voluntarily used effective contraception; Women of childbearing age who have a negative blood\u002Furine pregnancy test within 7 days prior to enrollment； 11.Subjects had fully understood the study and voluntarily signed the informed consent form .\n\nExclusion Criteria:\n\n* 1.Subjects with an allergic history to experimental drugs or any excipients； 2.Subjects with acute or chronic infections that have not been eliminated, or subjects with other serious diseases at the same time; 3.Subjects with active hepatitis and uncontrolled by antiviral therapy, or liver metastasis is more than 3\u002F4 of the whole liver； 4.Subjects with third-space effusions (e.g., moderate-to-massive pleural effusion, moderate-to-massive pericardial effusion, ascites) that cannot be controlled by drainage or other means; 5.Subjects with mental illness or disorder, poor compliance, or inability to cooperate, or describe treatment responses； 6.Subjects who cannot tolerate chemotherapy due to severe organic disease or major organ failure, such as decompensated heart and lung failure； 7.Subjects with bleeding disorders； 8.Subjects with organ transplant; 9.Subjects with bad drug addicts, long-term alcoholics, infectious diseases such as AIDS； 10.Subjects who still have grade ≥2 toxicity from previous antineoplastic therapy (except alopecia and grade ≤2 neurotoxicity caused by platinum) at enrollment; 11.Subjects are considered not able to complete the trial or otherwise unfit to participate in the study by the investigators.",{"count":79,"type":22},25,[25],"This study is a single-center, single-arm, open-label, phase II clinical trial designed to evaluate the efficacy and safety of Paclitaxel Polymeric Micelles for Injection for the treatment of patients with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer that are resistant to Taxanes.\n\nSubjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.\n\nIf subject does not develop disease progression , the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up.\n\nThis is a single-arm, small-sample clinical study with the primary efficacy goal of objective remission rate (ORR). The parameters of the trial were set: assuming a class I error of 0.025 unilaterally, power=90%, and a 15% improvement in ORR for objective remission rate, a total of 20 subjects would be required, and a total of 25 would be required for enrolment, taking into account a 20% shedding.",[83,84,56,85,86,57],"Pancreatic Adenocarcinoma","Cholangiocarcinoma","Stomach Cancer","Esophageal Carcinoma",{"date":88,"type":37},"2025-06-03",{"date":90,"type":37},"2023-11-28",{"date":92,"type":22},"2025-11",{"name":43,"class":44},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100591814","an-exploratory-clinical-study-evaluating-the-efficacy-and-safety-of-tunlametinib-combined-with-fruquintinib-in-the-third-line-treatment-of-advanced-colorectal-cancer-patients-with-ras-mutations-100591814","NCT06985316","An Exploratory Clinical Study Evaluating the Efficacy and Safety of Tunlametinib Combined With Fruquintinib in the Third-line Treatment of Advanced Colorectal Cancer Patients With RAS Mutations.","Inclusion Criteria:\n\n1)18 years old or older, both males and females are allowed; 2)ECOG performance status of 0 or 1; 3)Histologically or cytologically proven advanced colorectal cancer; 4)Previous gene testing results indicate positive RAS mutation; 5)According to RECIST v1.1 assessment, there is at least one measurable lesion; 6)Patients who have previously failed second-line systemic antitumor therapy, and have imaging evidence of disease progression, or who are intolerant to the treatment regimen; patients who have failed front line immunotherapy are allowed to receive cross-line treatment; 7)Expected survival period \\> 3 months; 8)The main organ functions and bone marrow function are normal, meeting the following requirements:\n\n* Blood routine: Hemoglobin ≥80 g\u002FL (no blood transfusion in the last 14 days); Absolute neutrophil count ≥1.5×10\\^9\u002FL; Platelet count ≥90×10\\^9\u002FL;\n* Liver function: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); if liver metastasis is present, ALT and AST ≤5×ULN, ALP ≤6×ULN; Total bilirubin ≤1.5×ULN; Albumin ≥30 g\u002FL;\n* Kidney function: Serum creatinine ≤1.5×ULN or creatinine clearance calculated by the Cockcroft-Gault formula \\>60 mL\u002Fmin;\n* Heart function: Echocardiography shows left ventricular ejection fraction (LVEF) ≥55%; ECG QTcF ≤480ms; Creatine kinase (CK) ≤1×ULN, troponin\u002Fsensitive troponin ≤1×ULN;\n* Coagulation function: International Normalized Ratio (INR) for prothrombin time ≤1.5×ULN; Activated partial thromboplastin time (APTT) ≤1.5×ULN;\n* Urinalysis: Urine protein \\\u003C2; when ≥2, a 24-hour urine protein quantification test should be performed; if the quantification test \\\u003C1g\u002F24h, they can be included in the group; if urine protein ≥1g\u002F24h, they cannot be included; if urine protein ≥2 without quantification testing, they cannot be included; 9)Able to take oral medication; 10)Women of childbearing age must undergo a pregnancy test (serum or urine) within 14 days prior to enrollment, with negative results, and voluntarily use appropriate contraception during the observation period and for 3 months after the last administration of the study drug; for men, they should be surgically sterilized or agree to use appropriate contraception during the observation period and for 3 months after the last administration of the study drug; 11)Voluntarily participate and sign the informed consent form, expected to have good compliance and be able to cooperate with the study according to the protocol requirements.\n\nExclusion Criteria:\n\n1. There are contraindications that influence investigators' choices in the use of therapeutic drugs (according to the latest drug instructions).\n2. Previously received MEK inhibitors;\n3. Within 4 weeks before the first use of the drug, underwent major surgery (excluding biopsies and minor outpatient surgeries, such as the placement of vascular access) or experienced serious trauma;\n4. There is the presence of clinically symptomatic third space effusion (such as large pleural effusion or ascites) that cannot be controlled through drainage or other methods;\n5. Subjects with symptomatic or untreated brain metastases, leptomeningeal metastases, or spinal cord compression, except for the following conditions: asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain lesions, no need for corticosteroids or antiepileptic drug treatment, and imaging confirms stability of lesions for ≥4 weeks; for patients who have undergone stereotactic brain radiotherapy or surgical treatment, if there has been no disease progression in the brain for 3 months or more, they can be included;\n6. Impaired cardiac function or clinically significant cardiovascular diseases, including any of the following:\n\n   * Acute coronary syndrome occurring within 6 months prior to treatment initiation, including acute myocardial infarction, unstable angina, coronary artery bypass graft surgery, coronary angioplasty, and stent implantation;\n   * Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ II); evidence of clinically significant arrhythmias and\u002For conduction abnormalities within 6 months prior to treatment initiation or currently;\n   * Poorly controlled hypertension (systolic blood pressure ≥ 150 and\u002For diastolic blood pressure ≥ 100 mmHg under medication control);\n   * Abnormalities in heart valve morphology recorded by echocardiography (≥ grade 2), Note: Patients with grade 1 heart valve morphology abnormalities (such as mild regurgitation\u002Fstenosis) are allowed to enroll, but patients with moderate valve thickening are prohibited from enrolling;\n   * History of congenital long QT syndrome; or taking medications known to prolong the QT interval and unable to ensure discontinuation during the study.\n7. A history of retinal diseases during the past or screening, such as: retinal vein occlusion (RVO), retinal artery occlusion, retinal vasculitis, diabetic retinopathy, hypertensive retinopathy, retinal capillary dilatation (Costs disease), retinal pigment epithelial detachment (RPED), etc.; presence of risk factors for RVO during screening (for example, uncontrolled glaucoma or high intraocular pressure, history of hyperviscosity or hypercoagulable syndromes); retinal diseases such as RPED;\n8. Interstitial lung disease or interstitial pneumonia, including patients with clinically significant radiation pneumonia (i.e., those affecting daily activities or requiring intervention treatment);\n9. Positive for human immunodeficiency virus (HIV) antibodies, positive for syphilis antibodies (Anti TP), positive for hepatitis C virus (HCV) antibodies and HCV RNA, positive for hepatitis B virus surface antigen (HBsAg) and HBV DNA (positive HBsAg requires further testing for HBV DNA, with HBV DNA ≥ 200 IU\u002Fml or ≥ 10\\^3 copies\u002Fml);\n10. A history of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulators or surgery) within 12 months prior to the start of treatment;\n11. It is known that there is a history of acute or chronic pancreatitis within 6 months before the start of treatment;\n12. Patients with active gastrointestinal bleeding who require treatment;\n13. History of allogeneic bone marrow transplantation or organ transplantation;\n14. Within 2 weeks prior to the initial administration of the drug, there are uncontrolled active infectious diseases (e.g., requiring intravenous administration of antibiotics, antifungals, or antiviral medications), or unexplained fever \\>38.5°C occurs during the screening period \u002F before the first dose of the drug;\n15. Incurable electrolyte abnormalities (hypokalemia, hypomagnesemia, hypocalcemia detected through blood biochemical tests);\n16. Past or currently existing neuromuscular diseases related to elevated CK (such as inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);\n17. Venous or arterial thrombotic events that occurred within the first 6 months prior to the initial use of the drug, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhages, cerebral infarctions), deep vein thrombosis, and pulmonary embolism, etc.;\n18. Symptoms of grade 3 bleeding as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) occurred within 4 weeks prior to the first use of the drug;\n19. Patients with a history of other malignant tumors in the past 5 years are excluded, except for those who have been completely cured of skin basal cell carcinoma or skin squamous cell carcinoma and cervical carcinoma in situ, and\u002For any malignant tumor patients who have been cured with no disease or who have been disease-free for at least 5 consecutive years;\n20. Those who are allergic to any component of this study drug are known;\n21. A clear history of neurological or psychiatric disorders, including epilepsy and dementia;\n22. Have received any of the following antitumor treatments prior to the initial study of drug administration (either on the market or in clinical trials): ① Antitumor immunotherapy within 3 weeks; ② Large molecular targeted antitumor therapy such as Bevacizumab within 3 weeks; ③ Chemotherapy or clearly antitumor traditional medicine within 2 weeks; ④ Small molecule targeted antitumor drug treatment within 2 weeks or within 5 half-lives (whichever is longer); ⑤ Subjects who have undergone palliative radiation therapy for bone metastasis within 2 weeks are excluded, but those who have received radiation treatment with an area of ≥30% of the bone marrow within 2 weeks are not allowed to be included;\n23. Before studying drug administration, all related toxic reactions from antitumor treatments (such as hair loss, skin pigmentation, grade 2 chemotherapy-related peripheral neurotoxicity, grade 2 toxicities caused by immune checkpoint inhibitors like elevated blood sugar or hypothyroidism, etc.) have not recovered to a level of ≤ grade 1 (as determined by NCI CTCAE v5.0);\n24. Patients may be used in conjunction with other anticancer drugs (bisphosphonates for the treatment of bone metastases are acceptable);\n25. Uncontrolled comorbidities, including but not limited to severe diabetes (fasting blood glucose \\> 250 mg\u002Fdl or 13.9 mmol\u002FL), or other severe diseases requiring systemic treatment;\n26. Vaccination with live vaccines or attenuated vaccines within 4 weeks prior to the first dose (Note: If enrolled, participants must not receive live vaccines during the study treatment period and within 30 days after the last dose of the investigational drug);\n27. For premenopausal female subjects (postmenopausal female patients must have been menopausal for at least 12 months to be considered infertile), a positive pregnancy test result; during the study and at least 30 days after the last administration of the study drug, females of childbearing potential who are hoping to become pregnant, breastfeeding, or unwilling to use effective contraceptive methods (including female partners of male subjects);\n28. Patients who are undergoing treatment and cannot discontinue intravenous or oral medications that have a prohibitive effect on CYP isoenzymes (strong inducers or strong inhibitors of CYP2C9 and CYP3A4) at least 1 week before starting the study treatment and during the study; patients who are taking medications with a narrow therapeutic window that are metabolized by CYP1A2;\n29. Inability to swallow capsules or refractory nausea and vomiting, malabsorption, external bile diversion, or any significant small bowel resection that may interfere with the complete absorption of the study drug;\n30. Researchers believe there are other situations that are not suitable for inclusion. For example, factors related to family or society may affect the safety of the subjects, or the collection of data and samples.",{"count":101,"type":22},34,[103],"NA","This study is a prospective, open-label, single-arm clinical study aimed at evaluating the efficacy and safety of Tunlametinib combined with Fruquintinib in the third-line treatment of advanced colorectal cancer patients with RAS mutations.",[106],"CRC, Colorectal Cancer","2025-05-14",{"date":109,"type":37},"2025-05-22",{"date":111,"type":22},"2025-05-19",{"date":113,"type":22},"2028-04-27",{"name":43,"class":44},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":70},"100591446","phase-1-glumetinib-combined-with-fruquintinib-in-the-treatment-of-met-amplification-or-protein-overexpression-in-third-line-unresectable-metastatic-colorectal-cancer-100591446","NCT06980532","Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer","Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer: A Prospective, Exploratory, Open-Label Clinical Study","Inclusion Criteria:\n\n1. The patients fully understood this study, voluntarily participated and signed the Informed Consent Form (ICF);\n2. Age ≥18 years old;\n3. Patients with unresectable metastatic colorectal cancer with microsatellite stable (MSS) confirmed by pathology or histology;\n4. Have MET amplification (FISH MET GCN≥4 or MET\u002FCEP7≥1.8; Or NGS, ≥20% of tumor cells, ≥200X sequencing depth, GCN≥4) or overexpression (IHC, 3+(≥50% of tumor cells are strongly positive) or 2+ (≥50% of tumor cells are moderately positive\u002Fstrongly positive and \\\u003C 50% of tumor cells are strongly positive); Immunohistochemistry (IHC) detection showed that the MET protein overexpression in the subjects was 3+(strongly positive in ≥50% of tumor cells) or 2+ (positive in ≥50% of tumor cells\u002Fweakly positive and strongly positive in \\\u003C 50% of tumor cells).\n5. Imaging confirmed progression after previous two-line standard anti-tumor regimens;\n6. According to RECIST1.1 criteria, the patient has at least one measurable target lesion; For lesions that have undergone radiotherapy in the past, they can only be included in measurable lesions when there is clear disease progression after radiotherapy.\n7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score: 0-1 point;\n8. The expected survival time is ≥3 months;\n9. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count ≥75×10\\^9\u002FL and hemoglobin 80 g\u002FL, white blood cell count (WBC) ≥3.0×10\\^9\u002FL (corrected by no blood transfusion, no blood products, no use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor within 14 days before laboratory tests);\n10. Liver and kidney functions: Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50mL\u002Fmin; AST and ALT ≤2.5 times the upper limit of normal values (for patients with liver invasion, ≤5 times the upper limit of normal values); Serum total bilirubin ≤2 times the upper limit of normal value (for patients with liver invasion ≤2.5 times the upper limit of normal value);\n11. The activated partial thromboplastin time (APTT), International normalized ratio (INR), and prothrombin time (PT) are ≤1.5 times the normal upper limit value.\n12. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods (such as intrauterine devices \\[IUD\\], contraceptives or condoms) during the test and 6 months after the last administration of the test drug; The serum pregnancy test must be negative within 7 days before enrollment in the study, and the subjects must be non-lactating. Male subjects who should agree that contraceptive measures must be adopted during the study period and within 6 months after the end of the study period;\n\nExclusion Criteria:\n\nHave received MET inhibitor treatment in the past; 2. Patients with unresectable metastatic colorectal cancer who have MSI-H\u002FdMMR (MSI detection shows instability at two or more sites, and MMR detection shows loss of expression at any one protein); 3. Patients with unresectable metastatic colorectal cancer whose BRAF gene test is mutant and who have not received BRAF inhibitors \u002FMEK inhibitors; 4. Patients with severe active bleeding, active peptic ulcers, unhealed gastrointestinal perforations, and peptic fistulas; 5. Have hypersensitivity reactions to any investigational drug or its components; 6. Concurrent severe and uncontrolled concurrent infections or other severe and uncontrolled concomitant diseases, moderate or severe renal injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.) 7. Infection during the active stage of hepatitis B and C (positive hepatitis B virus surface antigen and hepatitis B virus DNA exceeding 1 × 103 copies \u002FmL; Hepatitis C virus RNA exceeds 1 × 103 copies \u002FmL; 8. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 9. Have had or are currently suffering from other malignant tumors simultaneously (except for effectively controlled non-melanoma basal cell carcinoma of the skin, breast\u002Fcervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years); 10. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 11. Those with other malignant tumors requiring treatment; 12. The researchers judged that patients were not suitable to participate in this study.\n\n\\-",{"count":123,"type":22},42,[125,25],"PHASE1","Glumetinib combined withFruquintinib in the treatment of MET amplification or protein overexpression in third-line unresectable metastatic colorectal cancer: evaluation of efficacy and safety",[128],"Metastatic Colorectal Cancer","2025-05-13",{"date":131,"type":37},"2025-05-20",{"date":133,"type":37},"2025-04-25",{"date":135,"type":22},"2028-12-30",{"name":43,"class":44},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":70},"100558445","cadonilimab-combined-with-fruquintinib-and-sbrt-as-athird-line-and-posterior-line-treatment-in-patients-with-mss-crc-100558445","NCT06551207","Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC","Fuquinitinib Combined With Cardonilizumab and SBRT Versus Fuquinitinib in Third-line and Post-line Treatment of Metastatic Colorectal Cancer: a Randomized, Controlled, Open, Multicenter Clinical Study","Inclusion Criteria:• Provision of written Informed Consent Form (IC) prior to any study specific procedures\n\n* Age = 18 years, $75 years\n* Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer\n* MSI status: MSS\n* At least two or more standard systemic therapies prior treatment (based on Fu, oxaliplatin, irinotecan, bevacizumab and cetuximab) of cytotoxic chemotherapy, treatment failure or intolerable toxicities\n* ECOG 0-1\n* Patients must have measurable lesions\n* Expected overall survival ≥ 12 weeks\n* AST, ALT and alkaline phosphatase s 2.5 times the upper limit of normal (ULN), Serum bilirubin s 1.5 x ULN, creatinine\\\u003CULN\n* Prothrombin time (PT), international standard ratio (INR) ≤ 1.5 × ULN\n* Patients are allowed to have received radiotherapy, but the time from entering the group must be more than 4 weeks, and the currently selected radiotherapy lesions and evaluable lesions must be lesions that have not received radiotherapy\n* Fertile male or female patients voluntarily used an effective contraceptive method during the study period and within 6 months of the last study medication\n\nExclusion Criteria:\n\n* • Patients have received anti-PD-1 \u002F PD-L1 or anti-CTLA-4 immunotherapy or other immunexperimental drugs\n\n  * Patients with severe autoimmune diseases: active inflammatory bowel disease (including Cohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus ervthematosus, autoimmune vasculitis (such as Wegener's granuloma), etc\n  * Symptomatic interstitial lung disease or active infection\u002Fnon-infectious pneumonia\n  * Risk factors of intestinal perforation: active diverticulitis, abdominal abscess, gastrointestinal obstruction, abdominal cancer or other known risk factors of intestinal perforation\n  * If the patients underwent surgery, they should wait for the wound to heal completely before being considered for enrollment\n  * History of other malignant tumors ((except for the cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ)\n  * Patients who are preparinq for or have previously received an organ or allogenic bone marrow transplant\n  * Moderate or severe ascites with clinical symptoms required therapeutic puncture, drainage or Child-Pugh score \\> 2 (except those who only show a small amount of ascites on imaging without clinical symptoms); Uncontrolled or moderate or higher pleural effusion or pericardial effusion\n  * History of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 6 months before the start of treatment\n  * Abdominal fistula, gastrointestinal perforation, or abdominal abscess developed within 6 months before the start of study treatment\n  * Known hereditary or acquired bleeding (e.g. coagulation dysfunction) or thrombotic tendencies, e.g. in hemophiliacs; Currently or recently (within 10 days prior to the start of study therapy) used full dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (allowing prophylactic use of low-dose aspirin, low molecular weight heparin)\n  * Aspirin (\\> 325 mg \u002F day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel (≥ 75 mg) and clostazol are currently used or have been used recently (within 10 days before the start of study treatment)\n  * Thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) and pulmonary embolism occurred within 6 months before the start of the study\n  * Patient with an active infection, heart failure, heart attack, unstable angina pectoris, or unstable arrhythmia within the last 6 months\n  * Physical examination or clinical trial findings that the investigator believes may interfere with the results or put the patient at increased risk for treatment complications, or other uncontrollable diseases\n  * The researchers believe that the patient has a lesion and needs emergency palliative radiotherapy \u002F emergency surgery (spinal cord compression, brain hernia, pathological fracture)\n  * Lactating or pregnant women\n  * History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation\n  * Patients with mental illness, substance abuse, or social problems that affect compliance will not be enrolled after researcher's review\n  * Known active infection and active tuberculosis infection were not included in the group; However, patients with hepatitis B virus (HBV) and hepatitis C virus (HCV) infection can be included in the group if their condition is stable after antiviral treatment\n  * Patients who received live vaccine within 30 days prior to enrollment\n  * Have clinical symptoms or diseases of the heart that are not well controlled\n  * Systolic blood pressure \\> 140mmg or diastolic blood pressure \\> 90mmg regardless of any antihypertensive drugs; or a history of hypertensive crisis or hypertensive encephalopathy\n  * Major vascular disease (such as aortic aneurysms requiring surgical repair or recent peripheral arterial thrombosis developed within 6 months\n  * Severe, unhealed or open wounds and active ulcers or untreated fractures\n  * Received major surgery within 4 weeks prior to the start of study treatment (except for diagnosis or expected to require major surgery during the study period\n  * Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption\n  * Had a history of intestinal obstruction and\u002For had clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to initiation of study therapy, including incomplete obstruction related to pre-existing disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding\n  * Patients with signs\u002Fsymptoms of incomplete obstruction\u002Fobstructive syndrome\u002Fileus at initial diagnosis may be admitted to the study if they have received definitive (surgical) treatment to resolve symptoms\n  * There is evidence of abdominal gas accumulation that cannot be explained by puncture or recent surgical procedures\n  * Metastatic disease involvina a maior airway or blood vessel or a large mediastinal tumor mass located in the center (\\\u003C30 mm from the crest)\n  * Patients with a history of hepatic encephalopathy For those who currentlv have interstitial oneumonia or interstitial luna disease, or who have a history of interstitial pneumonia or interstitial luna disease requiring hormone therapv. Or other\n  * Patients with a history of hepatic encephalopathy\n  * For those who currently have interstitial pneumonia or interstitial lung disease, or who have a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, Or other subjects with pulmonary fibrosis, institutionalized pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that may interfere with the judgment and management of immune-related pulmonary toxicity, or with evidence of active pneumonia or severe impairment of lung function visible on chest CT during the screening period, radiation pneumonia is allowed in the radiation field: Active tuberculosis\n  * Presence of active autoimmune disease or history of autoimmune disease with possible recurrence; Participants with non-systemic skin diseases such as vitiligo, psoriasis, and alopecia, controlled type 1 diabetes treated with insulin, or asthma in complete remission in childhood, were enrolled without any intervention as adults; Patients with asthma who require medical intervention with bronchodilators are not included\n  * Use of immunosuppressants or systemic hormone therapy for immunosuppression within 14 days prior to initiation of study therapy\n  * Known history of severe allergy to any monoclonal antibody, anti-angiogenesis targeting drug Severe infection, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, in the 4 weeks prior to initiation of study treatment; Therapeutic antibiotics were given orally or intravenously within 2 weeks prior to the start of study therapy\n  * According to the investigator's judgment, the patient has other factors that may affect the study results or lead to the forced termination of the study. There are serious abnormalities in laboratory examination, accompanied by family or social factors, which will affect the safety of the patient",{"count":145,"type":22},80,[103],"An assessment of 6-month progression-free survival in patients with mCRC with third-line and postline metastatic colorectal cancer in combination with cardonilizumab and fuquinitinib and SBRT compared with fuquinitinib monotherapy",[128],"2024-08-09",{"date":151,"type":37},"2024-08-13",{"date":153,"type":22},"2024-08-20",{"date":155,"type":22},"2027-12-30",{"name":43,"class":44},""]