[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Runshi Pharmaceutical Technology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":172},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,39,61,83,105,128,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100639075","phase-3-a-phase-iii-study-of-syha1813-for-recurrent-or-progressive-high-grade-meningiomas-100639075",false,"NCT07613450","A Phase III Study of SYHA1813 for Recurrent or Progressive High-Grade Meningiomas","SYHA1813 vs Investigators' Choice Treatment in Patients With Recurrent or Progressive High-Grade Meningiomas: A Randomized, Controlled, Multicenter, Phase III Study","Inclusion Criteria:\n\n* 1\\. Aged \\>= 18 years.\n* 2\\. Histologically confirmed WHO grade II\u002FIII meningioma (WHO CNS 5th) that is progressive or recurrent.\n* 3\\. Individuals must have received surgery and radiation therapy.\n* 4\\. There is at least one measurable intracranial tumor lesion in the baseline period (RANO-meningioma).\n* 5\\. KPS≥60.\n* 6\\. The expected survival time is \\>=3 months.\n* 7\\. The organ function level and related laboratory indicators must meet requirement.\n* 8\\. Agree to use reliable and effective methods of contraception during the study treatment period and for at least 3 months after the last study treatment.\n\nExclusion Criteria:\n\n* 1\\. Individuals who are known to have severe allergic reaction to the study drug or any other ingredients\u002Fexcipients in the formulation.\n* 2\\. Meets one of the following conditions: patients with brainstem involvement or extracranial metastasis; patients with severe brain herniation or at risk of brain herniation.\n* 3\\. History of other malignant tumors within 3 years or concurrent active malignant tumors.\n* 4\\. The toxic reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade 1.\n* 5\\. Have used potent inhibitors or inducers of CYP3A4, CYP2C19 or CYP1A2 within the 14 days prior to randomization or are still requiring continued use of such agents.\n* 6\\. Individuals currently receiving warfarin or other oral anticoagulants (excluding those who use low-dose anticoagulants to maintain patency of central venous access or prevent deep vein thrombosis).\n* 7\\. Individuals who are unable to undergo enhanced MRI (such as those with pacemakers, metal dentures, claustrophobia, contrast agent allergies, etc.).\n* 8\\. Individuals with evidence or medical history of bleeding tendency within 2 months prior to randomization.\n* 9\\. Individuals with urine protein ≥ 2+, and 24-hour quantitative urine protein ≥ 1.0 g\u002F24 h upon testing.\n* 10\\. History of acquired immunodeficiency syndrome or HIV antibody positivity in the past; Active hepatitis C; Active hepatitis B.\n* 11\\. Individuals with poorly healing wounds or ulcers, or fractures that require treatment or exhibit poor healing.\n* 12\\. Within 14 days prior to randomization, there were severe chronic or active infections (including tuberculosis infections) that required intravenous injection of antibacterial, antifungal or antiviral therapy.\n* 13\\. Individuals with cardiovascular and cerebrovascular diseases of significant clinical significance.\n* 14\\. Have undergone surgery of major vital organs within 28 days prior to randomization (excluding puncture biopsy).\n* 15\\. Individuals with swallowing difficulties or known medication absorption disorders.\n* 16\\. Pregnant or lactating women.\n* 17\\. Any other conditions that may interfere with the participant's adherence to study procedures, compromise the participant's best interests in participating in the study, or affect study results.","ALL","18 Years",{"count":19,"type":20},136,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, controlled, open-label, multicenter, Phase III clinical study designed to compare the efficacy and safety of SYHA1813 versus treatment of investigators' choice in patients with recurrent or progressive high-grade meningioma not amenable to local therapy.",[26],"High Grade Meningioma","NOT_YET_RECRUITING","2026-05-21",{"date":30,"type":31},"2026-05-29","ACTUAL",{"date":33,"type":20},"2026-05-20",{"date":35,"type":20},"2029-10-15",{"name":37,"class":38},"Shanghai Runshi Pharmaceutical Technology Co., Ltd","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100572895","phase-2-a-phase-ii-study-of-syha1813-for-recurrent-or-progressive-high-grade-meningioma-100572895","NCT06739213","A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma","SYHA1813 vs Investigators' Choice as Treatment for Recurrent or Progressive High-Grade Meningioma: A Randomized, Controlled, Multicenter, Phase II Study","Inclusion Criteria:\n\n1. Aged \\>= 18 years;\n2. Histologically confirmed WHO grade II\u002FIII meningioma (WHO CNS 5th)\n3. There is at least one measurable lesion in the baseline period (RANO-meningioma);\n4. KPS≥60;\n5. The expected survival time is \\>=3 months;\n6. The organ function level and related laboratory indicators must meet requirements (no blood transfusion within 2 weeks):\n7. Female participants of childbearing potential must have a negative the blood pregnancy test results of within 7 days prior to randomization and agree to use reliable and effective contraception during the study treatment period and for at least 3 months after the last study treatment (or as required by the drug's instructions). Male participants with partners of childbearing potential must agree to use reliable and effective contraception during the study treatment period and for at least 3 months after the last study treatment (or as required by the drug's instructions).\n\nExclusion Criteria:\n\n1. Patients who are known or suspected to be allergic to the test drug or its components;\n2. Meets one of the following conditions: patients with brainstem involvement; patients with severe brain herniation or at risk of brain herniation; patients with extracranial metastasis during the screening period.\n3. A history of any other malignant tumors within 3 years (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured carcinoma in situ);\n4. Use of glucocorticoids at an equivalent dose exceeding 5mg of dexamethasone within 7 days prior to randomization.\n5. The toxicity of previous anti-tumor treatments has not recovered to Grade1(including brain edema after radiotherapy), with the exception of hair loss, uncomplicated laboratory abnormalities that do not require medical intervention, and other adverse reactions deemed by the investigator not to affect the safety of the study medication.;\n6. Use of a strong CYP3A4 inhibitor within 14 days prior to randomization or ongoing use of such inhibitors.\n7. Current use of warfarin or other oral anticoagulants (except for low-dose anticoagulants used to maintain central venous access or prevent deep vein thrombosis).\n8. Inability to undergo contrast-enhanced MRI\n9. Patients with evidence of bleeding tendency or medical history within 2 moths\n10. Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g\u002F24h;\n11. Human immunodeficiency virus (HIV) antibody positive; active hepatitis C (anti-HCV antibody positive and HCV RNA test positive); active hepatitis B (HBV DNA test for HBsAg is positive and HBV DNA is equal to or higher than 2×10\\^3 IU\u002Fml));\n12. The subject has poorly healed wounds, ulcers or fractures;\n13. Presence of a severe chronic or active infection (including tuberculosis and other infections).requiring intravenous antibiotic, antifungal, or antiviral treatment within 14 days prior to randomization\n14. Other severe systemic diseases, including but not limited to uncontrolled diabetes, kidney disease requiring dialysis, severe liver disease (Child-Pugh class B or C), acute pancreatitis, etc.\n15. Subjects with clinically significant cardiovascular and cerebrovascular diseases.\n16. Underwent major organ surgery within 28 days prior to randomization (excluding biopsy procedures).\n17. Received chemotherapy (including temozolomide), targeted therapy, immunotherapy, hormone therapy, or other antitumor treatments within 28 days prior to randomization; or used any NMPA-approved traditional Chinese medicine or patent Chinese medicine with anticancer activity within 14 days prior to randomization (regardless of cancer type).\n18. Subjects with dysphagia or known drug absorption disorders.\n19. Pregnant or lactating women.\n20. Presence of other conditions that may interfere with the participant's ability to comply with the study procedures or that may not allow the participant to derive the maximum benefit from the study, or that may affect the study outcomes, such as a history of psychiatric disorders, drug or substance abuse, or any other clinically significant disease or condition.",{"count":47,"type":20},56,[49],"PHASE2","This is a randomized, controlled, open-label, multicenter, Phase II clinical study designed to evaluate the efficacy and safety of SYHA1813 compared to investigators' choice in participants with recurrent or progressive high-grade meningioma.",[52],"Recurrent or Progressive High Grade Meningioma","2024-12-12",{"date":55,"type":31},"2024-12-18",{"date":57,"type":20},"2025-01-31",{"date":59,"type":20},"2028-01-13",{"name":37,"class":38},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100568544","phase-1-safety-and-efficacy-of-syha1813-single-agent-or-in-combination-with-different-regimens-in-unresectable-locally-advanced-or-metastatic-solid-tumors-100568544","NCT06682611","Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.","An, Phase Ib\u002FII Clinical Trial to Evaluate the Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.","Inclusion Criteria:\n\n1. Aged \\>= 18 years;\n2. Unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology:\n3. There is at least one measurable lesion in the baseline period (RECIST1.1);\n4. ECOG PS of 0-1;\n5. The expected survival time is \\>=3 months;\n6. The organ function level and related laboratory indicators must meet the following requirements (No blood transfusion or hematopoietic stimulating factor therapy received within 14 days prior to the first medication (queue 1 to 6)\u002Fprior to randomization (queue 7 and queue 8):\n\n   ANC≥1.5×10\\^9\u002FL； PLT≥100×10\\^9\u002FL（Liver cancer patients PLT≥75×10\\^9\u002FL）； Hb≥90 g\u002FL； TBIL≤1.5×ULN，and for Gilbert's syndrome, liver cancer or liver metastasis patients TBIL≤3×ULN； ALT和AST≤2.5×ULN，for liver cancer or liver metastasis patients ≤5×ULN； Child-Pugh Grade A (only applicable to queue 8)； ALB≥30 g\u002FL； Cr≤1.5×ULN，IF Cr\\>1.5×ULN，Ccr≥60 mL\u002Fmin（Cockcroft-Gault）is required； APTT and INR≤1.5×ULN\n7. The subjects must agree to take medically approved contraceptive measures for at least 6 months from the beginning of the study to the last dose of drug.\n\nExclusion Criteria:\n\n1. Patients who are known or suspected to be allergic to the test drug or its components;\n2. Excluding the disease studied in this trial, there are other primary malignant tumors that have progressed or require treatment within the past 3 years prior to screening (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured breast carcinoma in situ);\n3. The toxicity of previous anti-tumor treatments has not recovered (≤grode 1), except for hair loss and other adverse reactions judged by the investigator that do not affect the safety of the study medication;\n4. Active leptomeningeal disease or CNS metastases that are not well controlled;\n5. Uncontrollable active infections occurred within 14 days prior to the first medication (queue 1 to 6)\u002Fprior to randomization (queue 7 and queue 8), requiring systemic treatment with intravenous antibiotic infusion\n6. Patients with evidence of bleeding tendency or medical history within 28 days;\n7. Patients have risk factors for intestinal obstruction or intestinal perforation;\n8. The subject has poorly healed wounds, ulcers or fractures;\n9. Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g\u002F24h;\n10. Patients have large pleural effusions, pericardial effusions, or abdominopelvic effusions;\n11. Human immunodeficiency virus (HIV) antibody positive; active hepatitis C, with antibody positive and HCV RNA test positive; active hepatitis B, with HBsAg positive, and HBV-DNA value\\>500 IU\u002Fml or 2500 copies\u002FmL;\n12. Has a history of active tuberculosis;\n13. History of interstitial lung disease (except for radiotherapy-induced focal interstitial pneumonia), noninfectious pneumonitis requiring glucocorticoid therapy;\n14. Received immunosuppressants such as PD-1 or PD-L1 inhibitors in the recurrent or metastatic phase (only for Cohort 1);\n15. Prior treatment with a VEGFR-TKI inhibitor or other anti-angiogenic agent (except for Cohort 5,7,8);\n16. Pregnant or lactating women;\n17. Participants who may have poor compliance as judged by the investigator, such as a clear history of neurological or psychiatric disorders (including epilepsy or dementia), current psychiatric disorders, psychotropic drug abuse, etc.;",{"count":69,"type":20},380,[71,49],"PHASE1","This is an open-label, multi-center, multi-cohort, phase Ib\u002FII clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.",[74],"Unresectable Locally Advanced or Metastatic Solid Tumors","2024-11-08",{"date":77,"type":31},"2024-11-12",{"date":79,"type":20},"2024-11-13",{"date":81,"type":20},"2027-11-13",{"name":37,"class":38},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100566508","phase-3-a-study-of-simmitinib-versus-chemotherapy-for-participants-with-advanced-oesophageal-squamous-cell-carcinoma-100566508","NCT06656091","A Study of Simmitinib Versus Chemotherapy for Participants With Advanced Oesophageal Squamous Cell Carcinoma","Simmitinib Versus Investigator's Choice of Chemotherapy for Participants With Advanced or Metastatic Oesophageal Squamous Cell Carcinoma : a Randomised, Open-label, Multicentre, Phase 3 Study","Inclusion Criteria:\n\n* 1\\. Have fully understood and voluntarily sign the ICF for this study; 2. Age of 18-75 years (inclusive), male or female； 3. Histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable, local recurrence or with distant metastasis； 4. Second-line patients with disease progression after only first-line standard therapy（Standard treatment: Chemotherapy with platinum, paclitaxel, or fluorouracil combined with immunosuppressive regimen. Progression during maintenance therapy will be allowed.Concurrent chemoradiotherapy with recurrence or metastasis after surgery is considered as first-line treatment. Progression during Concurrent chemoradiotherapy\u002F adjuvant\u002Fneoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）; 5. At least one evaluable lesion according to RECIST 1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1; 7. Expected survival is more than 3 months； 8. Have recovered from any prior adverse effects of chemotherapy, surgery, radiation, or other antitumor therapy to CTCAE V5.0 criteria ≤ Grade 1 or baseline (except for toxicity such as hair loss that the investigator determines is not a safety risk)； 9. Adequate organ function, defined as:\n\n  1. Absolute Neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n  2. Platelet count (PLT) ≥ 100× 10\\^9\u002FL;\n  3. Hemoglobin (Hb) ≥ 90 g\u002FL;\n  4. Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL\u002Fmin(According to the Cockcroft-Gault formula);\n  5. Serum total bilirubin (TBIL) ≤ 1.5 × ULN;\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases);\n  7. Prothrombin time (PT)、activated partial thromboplastin time (APTT)、international normalized ratio(INR)≤1.5 × ULN(No previous anticoagulant therapy) 10. Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment. Female participants must have a negative serum or urine pregnancy test result within 7 days prior to randomization and must be non-lactating.\n\nExclusion Criteria:\n\n* 1\\. Patients who have previously received any anti-tumor therapy within 4 weeks prior to randomization; 2. Patients who have previously received major surgical treatment、open biopsy、other clinical trial drug treatment or any live attenuated vaccine within 4 weeks prior to randomization, or are expected to received any live attenuated vaccine during the study.\n\n  3\\. Patients who have previous treatment with anti-angiogenic drugs (such as anlotinib, apatinib, Fruquintinib, Surufatinib, Bevacizumab, etc.) 4. LVEF \\\u003C50%； 5. BMI≤18.5 kg\u002Fm\\^2； 6. Symptomatic central nervous system (CNS) metastases or meningeal metastases 7. Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ； 8. Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months； 9. Urine protein ≥ ++ and 24 h urine protein \\> 1.0 g at screening period； 10. Presence of any severe and\u002For uncontrolled disease before starting treatment； 11. Patients with Liver cirrhosis or active hepatitis； 12. Patients with abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before randomization； 13. Patient previously had or currently has a mental disorder or suffers from epilepsy and requires treatment； 14. Patients had prior retinal pigment epithelial detachment or have evidence of ongoing retinal pigment epithelial detachment； 15. Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to randomization; 16. Patients had prior interstitial lung disease,or have evidence of active non-infectious pneumonia treated with corticosteroids； 17. Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders.","75 Years",{"count":92,"type":20},450,[23],"To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.",[96],"Advanced Oesophageal Squamous Cell Carcinoma","2024-10-23",{"date":99,"type":31},"2024-10-24",{"date":101,"type":20},"2024-10-31",{"date":103,"type":20},"2027-01-30",{"name":37,"class":38},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100560456","phase-1-a-phase-study-of-simmitinib-or-irinotecan-liposomes-combined-with-dp303c-in-gastric-adenocarcinoma-or-gastroesophageal-junction-adenocarcinoma-100560456","NCT06577376","A PhaseⅠ\u002FⅡ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","A Multicenter, Open-label Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of Simmitinib or Irinotecan Liposomes Combined With DP303c Injection in the Treatment of HER2 Expressing Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* 1\\. Aged 18-75 (including) years old; 2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology; 3. Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum\u002Ffluorouracil combination chemotherapy with or without immune checkpoint inhibitors); 4. There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),; 5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2); 6. Adequate organ or bone marrow function\n\nExclusion Criteria:\n\n* \\*Eligibility Criteria:\n\nInclusion Criteria:\n\n1. Aged 18-75 (including) years old;\n2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;\n3. Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum\u002Ffluorouracil combination chemotherapy with or without immune checkpoint inhibitors);\n4. There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),;\n5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2);\n6. Adequate organ or bone marrow function\n\nExclusion Criteria:\n\n1. Patients who have experienced toxicity during previous treatment with trastuzumab or trastuzumab biosimilars, resulting in permanent discontinuation of trastuzumab or trastuzumab biosimilars;\n2. Patients with a history of allergies to any component of DP303c and deemed severe by the researchers\n3. There is uncontrolled serosal fluid accumulation that requires frequent drainage or medical intervention;\n4. Active leptomeningeal disease or uncontrolled CNS metastasis;\n5. Has a history of serious cardiovascular and cerebrovascular diseases;\n6. There was a peripheral neuropathy of grade ≥ 2 (refer to NCI CTCAE 5.0) prior to enrollment;\n7. History of gastrointestinal perforation and\u002For fistula within 6 months of first use of medication;\n8. Inability to swallow medication orally or presence of clinically significant gastrointestinal diseases;\n9. Urine protein ≥++ and 24-hour urine protein quantification\\>1.0 g during screening period;\n10. There are eye diseases that require intervention, such as corneal diseases, retinal diseases, or active eye infections;\n11. Used CYP3A4 strong inhibitors or CYP3A4 strong inducers 14 days before the first medication ;\n12. Used UGT1A1 strong inhibitor before first medication and wash-off period is less than 5 half-lives.",{"count":113,"type":20},252,[71,49],"This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation\u002Fdose extension of DP303c combined with irinotecan liposomes, as well as RCT stage of DP303c combined with irinotecan liposomes.",[117,118,119],"Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","Expressing Human Epidermal Growth Factor Receptor-2 (HER-2)","Disease Progression After Receiving at Least One and at Most Two Lines of Systemic Treatment in the Past","2024-09-02",{"date":122,"type":31},"2024-09-05",{"date":124,"type":20},"2024-08-26",{"date":126,"type":20},"2027-08-26",{"name":37,"class":38},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100555464","phase-2-a-study-of-simmitinib-plus-irinotecan-in-advanced-esophageal-squamous-cell-carcinoma-100555464","NCT06512428","A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma","An Open-label, Multicenter Phase II Clinical Trial to Explore the Safety and Efficacy of Simmitinib Plus Irinotecan Liposome in Patients With Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Have fully understood and voluntarily sign the ICF for this study;\n2. Age of 18-70 years (inclusive), male or female;\n3. Esophageal squamous cell carcinoma confirmed histologically or cytologically\n4. Second-line patients with disease progression after only first-line standard therapy（Standard treatment: chemotherapy with platinum plus fluorouracil or taxane combined with immunosuppressive regimen .Progression during adjuvant\u002Fneoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）\n5. At least one measurable lesion according to RECIST 1.1;\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;\n7. Expected survival is more than 3 months\n8. Adequate organ function, defined as:\n\n   Absolute Neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 75× 10\\^9\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL\u002Fmin; Prothrombin time (PT)、activated partial thromboplastin time (APTT)、international normalized ratio(INR)≤1.5 × ULN;\n9. Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.\n\nExclusion Criteria\n\n1. Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;\n2. Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;\n3. Prior systemic treatment with anti-VEGF drugs, irinotecan, or any other topoisomerase I inhibitor\n4. LVEF \\\u003C50%；\n5. BMI≤18.5 kg\u002Fm\\^2\n6. Symptomatic central nervous system (CNS) metastases or meningeal metastases;\n7. Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;\n8. Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;\n9. Urine protein ≥ ++ and 24 h urine protein \\> 1.0g at screening period;\n10. Presence of any severe and\u002For uncontrolled disease before starting treatment;\n11. Severe lung disease within 6 months before first dosing ；\n12. Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;\n13. Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders","70 Years",{"count":137,"type":20},138,[49],"To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.",[141],"Advanced Esophageal Squamous Cell Carcinoma","RECRUITING","2024-07-15",{"date":145,"type":31},"2024-07-22",{"date":147,"type":31},"2024-03-15",{"date":149,"type":20},"2026-01-30",{"name":37,"class":38},1,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":171,"locationsCount":151},"100526244","phase-1-a-study-of-simmitinib-plus-sg001-in-advanced-solid-tumors-100526244","NCT06132217","A Study of Simmitinib Plus SG001 in Advanced Solid Tumors","A Phase I\u002FII Study To Evaluate The Safety, Tolerability, Pharmacokinetic Profile And Preliminary Efficacy Of Simmitinib Plus SG001 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Have fully understood and voluntarily sign the ICF for this study;\n2. Age of 18-75 years (inclusive);\n3. Dose escalation phase: patients with histologically or cytologically confirmed inoperable or metastatic advanced solid tumors;\n4. Dose expansion phase: patients who have failed standard treatment (PD or intolerable toxicity after treatment), have no available standard treatment.According to the previous data, the specific tumor cohort was expanded.\n5. In the expansion phase, patients should agree to provide tissue specimens for detection of PD-L1 expression levels and\u002For MSI or dMMR status;\n6. At least one measurable lesion according to RECIST 1.1;\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;\n8. Adequate organ function, defined as:\n\nNeutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 100× 10\\^9\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN; Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio(INR)≤1.5 × ULN; Thyroid Stimulating Hormone (TSH)≤ULN; Left ventricular ejection fraction (LVEF)≥50%; Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.\n\nExclusion Criteria:\n\n1. Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;\n2. Urine protein ≥ ++ and 24 h urine protein \\> 1.0g at screening period;\n3. Symptomatic central nervous system (CNS) metastases or meningeal metastases;\n4. Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;\n5. History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma;\n6. Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;\n7. Patients with any active autoimmune disease requiring systemic therapy within 2 years prior to the first dose;\n8. Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;\n9. Presence of any severe and\u002For uncontrolled disease before starting treatment;\n10. Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;\n11. Dose expansion phase: Prior systemic therapy with immunosuppressants or immunoagonists targeting PD-1, PD-L1, CTLA-4, etc;\n12. Dose expansion phase: Prior systemic therapy with Antiangiogenic drugs including Anlotinib, Afatinib , Lenvatinib, Sorafenib and Fruquintinib, etc;",{"count":160,"type":20},168,[71,49],"This is an open-label Phase I\u002FII trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for simmitinib in combination with SG001 in patients with advanced solid tumors. Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 3 cohorts at the RP2D from Phase I.",[164],"Advanced Solid Tumor","2023-11-09",{"date":167,"type":31},"2023-11-15",{"date":169,"type":20},"2024-01-30",{"date":103,"type":20},{"name":37,"class":38},""]