[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-liver-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-liver-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100432078","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-absk-011-in-patients-with-advanced-solid-tumor-100432078",false,"NCT04906434","A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor","A Phase 1, Open-Label Study of ABSK-011 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female, age 18 \\~ 75 (include both ends, or other age range required by local regulations or IRB).\n2. Escalation Part: Patients must have histological or cytological confirmed advanced solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists; and patients with advanced HCC must satisfy:\n\n   1. BCLC stage B or C and Child-Pugh score 5\\~6\n   2. Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing\n\n   Expansion Part: patients must have histological or cytological confirmed, BCLC stage B or C HCC, and have progressed on or intolerant to or have refused to receive or have no access to receive first line systemic therapy (by local guideline\u002Fregulation) and is unsuitable for other standard therapy(ies) (by local guideline\u002Fregulation) against HCC, and must satisfy:\n   1. Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive\n   2. Patient must have at least 1 measurable lesion (RECIST V1.1)\n   3. Child-Pugh score 5\\~7 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention\n3. ECOG performance status 0\\~1\n4. Life expectancy ≥ 3 months\n5. Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug (without blood transfusion or medication with stimulation factors within 14 days before 1st dose):\n\n   1. Absolute neutrophil count (ANC) ≥1.5×109\u002FL\n   2. Platelet count (PLT) ≥75×109\u002FL\n   3. Hemoglobin (Hb) ≥80 g\u002FL\n   4. Total bilirubin (TBIL) ≤1.5×ULN\n   5. Aspartate transaminase (AST) and alanine transaminase (ALT), ≤3×ULN (for patient with liver metastasis in escalation part or patient in expansion part: AST and AST ≤5×ULN)\n   6. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50 mL\u002Fmin based on Cockcroft-Gault formula\n6. Patients with HBV infection should follow local clinical practice and anti-HBV therapy should be performed to ensure adequate viral suppression (HBV-DNA \\\u003C 10000 IU\u002FmL or equivalent copies\u002FmL prior to enrollment). Patients are examined every cycle to monitor HBV-DNA levels. If virus reactivation occurred for patients without anti-viral treatment when enrolled, anti-HBV therapy will be started following local practice.\n7. Non-surgically sterilized male or female patients of childbearing potential must agree to use effective methods of birth control during the study and for up to 6 months after the last dose of study drug. Non-surgically sterilized female patients of childbearing potential must in non-lactation period, and have a negative β-HCG test result within 7 days before first administration.\n8. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to any component of the investigational drug product.\n2. Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor).\n3. Has a known second primary malignancy required active treatment.\n4. Has a known active central nervous system (CNS) metastases (if stable disease after treatment, free from or daily dexamethasone \\\u003C10 mg or other equivalent glucocorticoids can be enrolled).\n5. Liver tumor volume accounts for ≥50% of the whole liver.\n6. Inability to take oral medication or other factors significant preclude adequate absorption of oral medication, such as previously received total gastrectomy, residual gastric dysfunction after subtotal gastrectomy, short bowel syndrome after small bowel resection, active diarrhea required drug treatment, etc.\n7. Severe irritable bowel syndrome requires drug therapy.\n8. Prior organ transplantation requires anti-rejection drug therapy.\n9. Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure \\>30%), routine chemotherapy \\\u003C4 weeks (chemotherapy with nitrosourea or mitomycin \\\u003C6 weeks); oral chemotherapy, endocrine therapy, molecular targeted therapy or immunotherapy within ≤ 5 half-life or ≤ 4 weeks (whichever is shorter).\n10. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE v5.0) with the exception of which inclusion criteria allowed, alopecia, vitiligo and neurotoxicity Grade ≤2 that investigator believe don't affect safety assessment.\n11. Concomitant use of strong inhibitors or inducers of CYP3A4 (include grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice or products) within at least 14 day prior to the first dose of the study drug.\n12. Impaired cardiac function or clinically significant cardiac disease, including any one of the following:\n\n    1. New York Heart Association class III or IV congestive heart failure, unstable angina, or myocardial infarction within 6 months before administration of the study drug;\n    2. Clinically significant cardiac arrhythmia requiring active therapy;\n    3. Uncontrolled hypertension;\n    4. Left ventricle ejection fraction\\\u003C50%\n    5. Prolongation of QTcF (average of three times of examine, male \\> 450 ms, female \\> 470 ms) (Note: QTc interval corrected by Frederica's formula) at screening, and other ECG abnormalities with clinical significant by the judge of the investigator.\n13. Active infection or unexplained fever \\> 38.5℃.\n14. Active or record of gastrointestinal bleeding within 6 months (e.g. esophageal varices or ulcer bleeding).\n15. Patients with active HCV infection (HCV-RNA\\>103 copies\u002FmL or following local clinical practice) and require concomitant anti-HCV therapy during the study; or HBV HCV co-infection.\n16. History of immunodeficiency, including HIV serum test positive, or other acquired\u002Fcongenital immunodeficiency disease, or active tuberculosis.\n17. Any other clinically significant comorbidities, such as respiratory, metabolic, congenital, endocrine or central nervous system disease, or any other medical conditions, mental disturbances or social determinants, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.\n18. Combined with portal vein tumor thrombus of type IV.","ALL","18 Years","75 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open-label phase 1 study with an escalation part and an expansion part.",[27],"Advanced Liver Cancer","RECRUITING","2026-04-01",{"date":31,"type":32},"2026-04-07","ACTUAL",{"date":34,"type":32},"2020-02-26",{"date":36,"type":21},"2028-12-31",{"name":38,"class":39},"Abbisko Therapeutics Co, Ltd","INDUSTRY",32,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100492923","phase-1-oh2-oncolytic-viral-therapy-via-transcatheter-intraarterial-infusion-in-patients-with-advanced-liver-cancer-100492923","NCT05698459","OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer","A Phase I, Open-label, Dose Escalation Study to Evaluate the Safety ,tolerance and Pharmacokinetics of OH2 Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer","Inclusion Criteria:\n\n1. Have fully understood the study and voluntarily signed the informed consent (the informed consent must be signed before performing any procedure specified in the test);\n2. Age 18-75 years old (inclusive);\n3. Patients with primary or metastatic liver cancer confirmed histologically or cytologically;\n4. Patients with liver cancer who have failed standard treatment, are not suitable for or are not willing to accept standard treatment;\n5. ECOG physical condition 0 or 1;\n6. Meet Child-Pugh liver function rating: Grade A or B;\n7. Adequate bone marrow, liver, kidney and organ functions, meeting the following requirements in laboratory examination within 7 days prior to the first medication (no blood transfusion, blood products, no correction of granulocyte colony stimulating factor or other hematopoietic stimulating factors within 14 days prior to the laboratory examination) :\n\n   * Neutrophil absolute count (ANC) ≥1.5×109\u002FL, platelet ≥100×109\u002FL, hemoglobin ≥90g\u002FL;\n   * Serum total bilirubin ≤3 times the upper limit of the normal reference range (3×ULN);\n   * Alanine transaminase (ALT) and\u002For aspartate transaminase (AST) ≤5×ULN;\n   * Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL\u002Fmin (as calculated by Cockcroft-Gault formula);\n   * International Normalized ratio (INR) ≤1.5 or partially activated prothrombin time (APTT) ≤1.5×ULN;\n8. Subjects with chronic HBV infection must receive HBV-DNA \\\u003C 500IU\u002Fml and HBsAg positive patients must receive antiviral therapy according to the Guidelines for Chronic Hepatitis B Prevention and Treatment 2015 Edition. HCV-RNA positive patients must receive antiviral therapy according to the Hepatitis C Prevention and Treatment Guidelines 2015 Edition and have liver function within the normal range;\n9. Recovery of AE associated with previous systemic chemotherapy, radical\u002Fextensive radiotherapy to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) ≤ Class 1 (except hair loss, non-clinically significant and asymptomatic laboratory abnormalities);\n10. For subjects with herpes, 3 months after completion of herpes treatment;\n11. Expected survival ≥12 weeks;\n12. Fertile women must have a negative serum or urine pregnancy test within 7 days before the first dose. Fertile male or female patients volunteered to use effective contraceptive methods, such as dual screen contraception, condoms, oral or injectable contraceptives, and intrauterine devices, during the study period and within 90 days of the last study medication. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause or sterilization (e.g. hysterectomy, bilateral adnexectomy or irradiation of radioactive ovaries).\n13. More than 4 weeks after the end of previous anti-tumor therapy (including endocrine, chemical\u002Fradiotherapy, targeted therapy) (more than 6 weeks after the treatment of nitrosourea and mitomycin chemotherapy);\n14. Four weeks after major surgery;\n15. At least one measurable or evaluable lesion was present according to RECIST1.1 criteria.\n\nExclusion Criteria:\n\n1. A history of pleural effusion related to moderate or severe ascites, hemorrhagic esophageal varices, hepatic encephalopathy, or liver insufficiency within 6 months prior to screening;\n2. Patients with large tumors - tumors \\>50% by liver volume and\u002For invading inferior vena cava;\n3. Non-recovery to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) level 1 toxicity (excluding hair loss, non-clinically significant and asymptomatic laboratory abnormalities) due to prior antitumor therapy prior to initial administration of the study drug;\n4. Other malignancies (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix that have been effectively controlled) in the past 5 years;\n5. For subjects with known central nervous system metastases, if they have received BMS in the past and their condition is stable (no evidence of imaging progression is seen at least 4 weeks before the first administration of the trial therapy, and any neurological symptoms have returned to baseline), repeated imaging examinations confirm no evidence of new BMS or the expansion of the original BMS. Participants who do not require steroid therapy at least 14 days before the initial administration of the trial therapy are eligible to participate in the trial. Subjects with cancerous meningitis should be excluded regardless of whether they are clinically stable;\n6. Received standard anti-tumor therapy for liver cancer within 4 weeks before the first drug use, including surgery, interventional therapy, systemic therapy, radiotherapy and traditional Chinese medicine therapy (the instructions for traditional Chinese medicine therapy with clear anti-tumor indications, and a one-week washout period is enough before the first drug use);\n7. Received radical radiotherapy (including more than 25% bone marrow radiotherapy) within 4 weeks prior to initial medication;\n8. Have previously received similar drugs for antitumor therapy;\n9. Received major surgical operations (the definitions of major surgical operations refer to Grade 3 and Grade 4 operations specified in the \"Measures for the Clinical Application of Medical Technology\" implemented on May 1, 2009) or unhealed wounds, ulcers and fractures within 4 weeks before the first drug use;\n10. The subjects currently have active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases, or active bleeding from unexcised tumors, or other conditions determined by the researchers that may cause digestive tract bleeding and perforation;\n11. Patients with significant evidence or history of bleeding tendency within 2 months prior to initial medication (bleeding \\>30mL within 2 months, hematemesis, black feces, and hematochezia), hemoptysis (\\>5mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and\u002For transient ischemic attacks) within 12 months;\n12. Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to initial medication; New York Heart Association (NYHA) Grade \\>2 for congestive heart failure; Left ventricular ejection fraction (LVEF) \\\u003C50%; Primary cardiomyopathy, a history of clinically significant prolonged QTc interval, or QTc interval \\>470ms in women and \\>450ms in men during the screening period;\n13. Severe and uncorrectable electrolyte abnormalities determined by the investigator to be clinically significant;\n14. The patient had an active infection or developed an unexplained fever (body temperature \\>38.5oC) during screening and prior to initial administration;\n15. Preparing for or having previously received allogeneic organ or bone marrow transplantation, including liver transplantation;\n16. Subjects with a past or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function that might interfere with the detection and management of suspected drug-related pulmonary toxicity;\n17. Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to initial medication; Known human immunodeficiency virus (HIV) infection; The copy number of hepatitis B and hepatitis C virus was active.\n18. Pregnant women (positive pregnancy test before medication) or breastfeeding women;\n19. Known allergy to any herpes virus and OH2 inJ ingredients;\n20. Any other medical condition, clinically significant metabolic abnormality (e.g., uncontrolled diabetes, thyroid dysfunction), physical abnormality, or laboratory abnormality, in which, in the investigator's judgment, there is reason to suspect that the patient has a medical condition or condition unsuitable for the study drug (e.g., the presence of epileptic seizures and the need for treatment), Or it could affect the interpretation of the findings, or put patients at high risk.\n21. Received the corresponding experimental drugs in clinical trials of other unapproved or unmarketed drugs within 4 weeks before the first drug use;\n22. As determined by the investigator, the subjects had other factors that might have led to the forced termination of the study.",{"count":49,"type":21},12,[24],"An open-label dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of OH2 injection via transcatheter Intraarterial infusion in patients with advanced hepatocellular carcinoma",[27],[54],"Oncolytic Virus","2024-12-19",{"date":57,"type":32},"2024-12-20",{"date":59,"type":32},"2023-05-05",{"date":61,"type":21},"2026-01",{"name":63,"class":39},"Binhui Biopharmaceutical Co., Ltd.",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":64},"100322201","phase-1-plasmodium-immunotherapy-for-breast-and-liver-cancers-100322201","NCT03474822","Plasmodium Immunotherapy for Breast and Liver Cancers","Clinical Study of Plasmodium Immunotherapy for Advanced Breast Cancers and Advanced Liver Cancers","Inclusion Criteria:\n\n* 18-70 years of age, male or female.\n* Patients with advanced breast cancer and advanced liver cancer confirmed by histopathology and imaging; and imaging lesions of the tumor are clear and measurable.\n* Previously received at least one standard therapy.\n* The time interval of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 1 months for patients who had received chemotherapy or radiotherapy; at least 5 half-life for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions).\n* ECGO score of 0 or 1;\n* Expected survival ≥ 6 months;\n* PLT ≥100× 10\\^9\u002FL, NE ≥ 1.5 × 10\\^9\u002FL, and HGB ≥ 100 g\u002FL; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.).\n* The peripheral blood count of immune cells is close to normal or normal, the immune function test result is close to or at the level of normal population, and the function of heart, lung, liver and kidney are basically normal (the liver function classification of Child-push is A or B, Cr≤1.5×ULN);\n* Patient compliance meets the need for follow-up;\n* The subjects are able to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Patients with severe hemoglobin disease or severe G6PD deficiency;\n* Patients with splenectomy or splenomegaly;\n* Patients with drug addiction or alcohol dependence;\n* With the following diseases or conditions: serious or uncontrolled systemic disease or any unstable systemic diseases (including but not limited to active infection, grade three hypertension, unstable angina, congestive heart failure, class III or IV heart disease, severe arrhythmia, liver and kidney dysfunction or metabolic disease), a clear history of neurological or psychiatric disorders, etc.\n* Accept any other anti-tumor treatment at the same time.\n* Patients with significantly lower immune function than those in the normal population.\n* Lung function is seriously damaged, the MNW \\\u003C39% or can't get out of bed, still feel short of breath when resting.\n* Advanced liver cancer patients with severe varicose vein in the esophagus.\n* Rough cough, dyspnea, without normal diet or difficult to cooperate.\n* Poor body condition, the researchers assess that the patients can't tolerate the immune therapy.\n* Pregnant or lactating women.\n* Women of childbearing age with positive result for pregnancy tests.\n* Any case that researchers believe that the patient does not suit for this clinical study.","70 Years",{"count":74,"type":21},60,[24,76],"PHASE2","The purpose of this study is to evaluate the safety and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced breast cancers and advanced liver cancers.The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.",[79,27],"Advanced Breast Cancer",[81,82,83,84],"Advanced breast cancer","advanced liver cancer","Plasmodium immunotherapy","Plasmodiun vivax","2024-02-17",{"date":87,"type":32},"2024-02-20",{"date":89,"type":32},"2018-08-10",{"date":91,"type":21},"2026-06-30",{"name":93,"class":39},"CAS Lamvac Biotech Co., Ltd."]