[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ctla-4\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ctla-4":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,66],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100603052","phase-2-a-single-arm-multicenter-exploratory-clinical-study-of-tace-combined-with-iparomlimab-and-tuvonralimab-injection-ql1706-and-lenvatinib-for-perioperative-treatment-of-resectable-hepatocellular-carcinoma-100603052",false,"NCT07131501","A Single-Arm, Multicenter, Exploratory Clinical Study of TACE Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma","A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n1. Voluntarily participate, sign ICF, demonstrate good expected compliance, and be willing to cooperate with follow-up.\n2. Age 18-75 years, any gender.\n3. HCC diagnosis confirmed by histopathology, cytology, or imaging.\n4. Resectable HCC staged as CNLC IIb-IIIa (excluding Vp3 and Vp4) or CNLC Ib-IIa with high-risk recurrence factors, confirmed by multidisciplinary liver surgery expert panel.\n5. For CNLC Ib-IIa subjects, presence of at least ONE high-risk recurrence factor.\n6. No prior systemic therapy for HCC (chemotherapy, targeted therapy, immunotherapy, etc.). Subjects with prior curative surgery or ablation are eligible only if recurrence occurred \\>2 years post-resection. Subjects with prior other local therapies are excluded.\n7. Child-Pugh class A.\n8. ECOG PS score 0-1.\n9. Expected survival ≥12 months.\n10. Adequate organ function within 7 days prior to study intervention.\n11. For subjects with HBV infection.\n12. Women of childbearing potential: Must agree to abstinence or use highly effective contraception from ICF signing until ≥120 days after last study drug dose. Negative pregnancy test within 7 days prior to intervention. Not breastfeeding.\n13. Male subjects with WOCBP partners: Must agree to abstinence or use highly effective contraception from ICF signing until ≥120 days after last study drug dose. Must not donate sperm during this period. Males with pregnant partners must use condoms.\n\nExclusion Criteria:\n\n1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed carcinoma (\\>30% ICC component), or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years or concurrently. Cured localized cancers are eligible.\n2. Current or history of interstitial lung disease\u002Fpneumonitis requiring steroids, or other active lung disease potentially interfering with immune-related pulmonary toxicity evaluation\u002Fmanagement, or active pneumonia\u002Fsevere impaired pulmonary function on screening CT. Active tuberculosis.\n3. Active autoimmune disease or history of autoimmune disease with potential recurrence. Vitiligo, psoriasis, alopecia not requiring systemic therapy, controlled Type I diabetes on insulin, or childhood asthma resolved in adulthood without intervention are eligible. Asthma requiring bronchodilators is excluded.\n4. Systemic immunosuppressive therapy (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to intervention.\n5. Active infection, unexplained fever ≥38.5°C within 1 week prior, or baseline WBC \\>15 × 10⁹\u002FL. Therapeutic antibiotics (IV\u002Foral) within 2 weeks prior (prophylactic IV antibiotics ≤48h duration allowed).\n6. Primary or acquired immunodeficiency.\n7. Live attenuated vaccine within 4 weeks prior to intervention or anticipated need during study or within 60 days after last Iparomlimab and Tuvonralimab Injection dose.\n8. Significant bleeding symptoms or predisposition within 6 months prior. If baseline fecal occult blood positive, repeat test; if still positive, requires gastroscopy.\n9. Known hereditary\u002Facquired bleeding\u002Fthrombotic diathesis. Current therapeutic-dose anticoagulants\u002Fthrombolytics (prophylactic low-dose aspirin allowed).\n10. Arterial thromboembolic events within 6 months prior.\n11. Poorly controlled cardiac disease.\n12. Hypertension uncontrolled by medication (average SBP ≥140 mmHg or DBP ≥90 mmHg on ≥2 readings). History of hypertensive crisis or encephalopathy.\n13. Major vascular disease within 6 months prior.\n14. Serious unhealed wounds, active ulcers, or untreated fractures.\n15. Major surgery within 4 weeks prior or anticipated major surgery during study.\n16. Inability to swallow pills, malabsorption syndrome, or GI condition affecting absorption.\n17. Bowel obstruction or related symptoms\u002Fsigns within 6 months prior requiring parenteral support\u002Ffeeding. Subjects with prior resolved obstruction treated definitively (surgically) may be eligible after assessment.\n18. Strong CYP3A4 inducers within 2 weeks prior or strong CYP3A4 inhibitors within 1 week prior.\n19. Known hypersensitivity to any study drug or excipient.\n20. Participation in another investigational drug study within 4 weeks prior.\n21. Pregnancy or lactation.\n22. Any other condition deemed unsuitable by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single-arm, multicenter, exploratory clinical study evaluating the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection (QL1706) and lenvatinib for perioperative treatment of resectable HCC (CNLC IIb-IIIa excluding Vp3\u002FVp4 or CNLC Ib-IIa with high-risk recurrence factors). Eligible subjects providing written informed consent will receive study treatment. The primary endpoint is MPR rate.",[27,28,29,30,31],"Hepatocellular Carcinoma","Immunotherapy","Preoperative","PD-1","CTLA-4","NOT_YET_RECRUITING","2025-08-13",{"date":35,"type":36},"2025-08-20","ACTUAL",{"date":38,"type":21},"2025-08-11",{"date":40,"type":21},"2029-08-31",{"name":42,"class":43},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100602802","phase-2-a-single-arm-multicenter-exploratory-clinical-study-of-transarterial-chemoembolization-tace-combined-with-iparomlimab-and-tuvonralimab-injection-and-bevacizumab-injection-for-the-treatment-of-unresectable-non-metastatic-hepatocellular-carcinoma-hcc-100602802","NCT07128251","A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n1. Voluntarily participate in the study and provide written informed consent.\n2. Age 18-75 years, inclusive (male or female).\n3. Histologically or cytologically confirmed HCC, or clinically diagnosed HCC according to the \\*Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition)\\*.\n4. Barcelona Clinic Liver Cancer (BCLC) Stage A, B, or C, not amenable to curative treatment (e.g., surgical resection, liver transplantation, or ablation).\n5. At least one measurable lesion according to RECIST v1.1 criteria.\n6. Suitable candidate for Transarterial Chemoembolization (TACE) with no known allergy or contraindication to iodized oil or epirubicin.\n7. Child-Pugh Liver Function Class A.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n9. Life expectancy ≥ 3 months.\n10. Adequate organ and bone marrow function.\n11. If positive for Hepatitis B Virus (HBV) infection, HBV DNA must be \\\u003C 2000 IU\u002FmL (\\\u003C 10,000 copies\u002FmL if only copies\u002FmL units available at the site) and the subject must be willing to receive continuous antiviral therapy throughout the study period. Subjects positive for Hepatitis C Virus (HCV) RNA must receive antiviral therapy according to clinical guidelines.\n12. Subjects with esophageal\u002Fgastric varices must undergo evaluation and appropriate management prior to enrollment.\n13. Women of childbearing potential (WOCBP): Must have a negative serum human chorionic gonadotropin (hCG) test within 7 days prior to initiation of study treatment; must be non-lactating; must agree to use highly effective contraception methods from signing informed consent until 120 days after the last dose of study treatment. A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (hysterectomy, bilateral salpingectomy\u002Foophorectomy). Male subjects with female partners of childbearing potential: Must agree to use highly effective contraception methods from signing informed consent until 120 days after the last dose of study treatment; must agree to refrain from sperm donation. Male subjects with pregnant partners must use condoms; no additional contraception is required.\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, mixed hepatocellular cholangiocarcinoma, or cholangiocarcinoma; history of other active malignancies within 5 years or concurrently with HCC. Cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma \\*in situ\\* of the prostate, cervix, or breast) are permitted.\n2. Presence of Vp3 or Vp4 portal vein tumor thrombosis (PVTT), any grade of hepatic vein or inferior vena cava invasion; any grade of bile duct invasion. \\*Note: Vp1 or Vp2 PVTT is permitted.\\*\n3. Presence of extrahepatic spread (EHS).\n4. Intrahepatic lesion(s) with maximum diameter ≥ 10 cm, \\> 10 intrahepatic lesions, or intrahepatic tumor burden ≥ 70% of liver volume, per RECIST v1.1.\n5. Prior systemic anti-cancer therapy for HCC, including molecular targeted agents, cytotoxic chemotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune checkpoint agonists, cellular therapies), or biologic therapy (e.g., cancer vaccines, cytokines, growth factors).\n6. Prior locoregional therapy for HCC, including therapeutic TACE, transarterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE).\n\n1\\) Prior curative surgery or ablation is permitted; one session of prophylactic TACE following curative resection is permitted.\n\n2\\) Prior percutaneous ethanol injection (PEI) or radiotherapy with curative intent is permitted.\n\n7\\. Prior or planned organ transplantation or allogeneic bone marrow transplantation.\n\n8\\. Current interstitial lung disease (ILD)\u002Fpneumonitis, history of ILD\u002Fpneumonitis requiring steroid treatment, or other pulmonary conditions that may interfere with the detection or management of immune-mediated pneumonitis (e.g., pulmonary fibrosis, organizing pneumonia \\[e.g., bronchiolitis obliterans\\], pneumoconiosis, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonia evidenced by screening chest computed tomography \\[CT\\] scan). Prior radiation pneumonitis within the radiation field is permitted. Active tuberculosis.\n\n9\\. Active autoimmune disease or history of autoimmune disease with potential for recurrence (e.g., autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects with hypothyroidism stable on hormone replacement are eligible). Conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), controlled Type I diabetes on insulin, or childhood asthma in complete remission without adult intervention are permitted. Asthma requiring bronchodilator therapy is excluded.\n\n10\\. Clinically significant ascites requiring therapeutic paracentesis or drainage (Child-Pugh score \\>2 for ascites; asymptomatic ascites detected only radiographically is permitted); uncontrolled or moderate\u002Flarge pleural effusion or pericardial effusion.\n\n11\\. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg based on ≥2 measurements) despite antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy.\n\n12\\. Clinically significant cardiac disease. 13. History of spontaneous rupture of hepatic tumor(s). 14. History of hepatic encephalopathy. 15. History or presence of central nervous system metastases. 16. Congenital or acquired immunodeficiency (e.g., HIV infection). 17. Thromboembolic event within 3 months prior to treatment (e.g., cerebrovascular accident \\[including transient ischemic attack, cerebral hemorrhage, cerebral infarction\\], deep vein thrombosis, pulmonary embolism).\n\n18\\. History of gastrointestinal (GI) bleeding within 6 months prior to treatment or high risk of GI bleeding (e.g., high-risk or severe esophageal\u002Fgastric varices, active GI ulceration, persistent fecal occult blood positivity). \\*Note: If fecal occult blood positive at baseline, repeat test; if persistently positive, esophagogastroduodenoscopy \\[EGD\\] required; exclusion if EGD shows varices\u002Flesions with bleeding risk.\\* 19. Abdominal fistula, GI perforation, intra-abdominal abscess, or bowel obstruction within 6 months prior to treatment.\n\n20\\. Major surgical procedure within 4 weeks prior to treatment or anticipated during study; unhealed wound, ulcer, or fracture within 4 weeks prior to treatment.\n\n21\\. Coagulopathy or bleeding diathesis (e.g., hemophilia); use of antiplatelet agents (e.g., aspirin \\>325 mg\u002Fday, dipyridamole, ticlopidine, clopidogrel, cilostazol) or anticoagulants (e.g., warfarin, low molecular weight heparin) within 10 days prior to treatment.\n\n22\\. Significant vascular disease within 6 months prior to treatment (e.g., aortic aneurysm requiring surgical repair, recent peripheral arterial thrombosis).\n\n23\\. Severe infection within 4 weeks prior to treatment (e.g., requiring hospitalization for infection, bacteremia, or severe pneumonia complications); therapeutic antibiotics administered orally or intravenously within 2 weeks prior to treatment (prophylactic antibiotics, e.g., for UTI or COPD prevention, are permitted).\n\n24\\. Known hypersensitivity to the active substances or excipients of \\*\\*Iparomlimab and Tuvonralimab Injection\\*\\*, \\*\\*Bevacizumab Injection\\*\\*, or epirubicin; history of severe hypersensitivity to any other monoclonal antibody or anti-angiogenic targeted therapy.\n\n25\\. Use of immunosuppressive agents or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) for immunosuppressive purposes within 2 weeks prior to treatment.\n\n26\\. Administration of live attenuated vaccines within 4 weeks prior to treatment or planned during Iparomlimab and Tuvonralimab Injection treatment or within 60 days after the last dose.\n\n27\\. Treatment with any investigational agent within 4 weeks or 5 half-lives (whichever is longer) prior to treatment initiation.Subjects with any other condition deemed by the investigator to potentially affect study results or lead to premature study termination (e.g., alcoholism, drug abuse, other severe medical\u002Fpsychiatric disorders requiring concomitant therapy, significant laboratory abnormalities, or familial\u002Fsocietal factors compromising subject safety).",{"count":52,"type":21},47,[24],"This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.",[56,28,30,31,57],"Hepatocellular Carcinoma (HCC)","TACE",{"date":59,"type":36},"2025-08-17",{"date":35,"type":21},{"date":62,"type":21},"2029-12-30",{"name":64,"class":65},"Anhui Provincial Hospital","OTHER_GOV",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":83,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":44},"100593276","phase-4-efficacy-and-safety-of-iparomlimab-and-tuvonralimab-injection-in-combination-with-bevacizumab-after-progression-on-anti-pd-l1-therapy-in-advanced-melanoma-a-prospective-single-arm-exploratory-clinical-study-100593276","NCT07004335","Efficacy and Safety of Iparomlimab and Tuvonralimab Injection in Combination With Bevacizumab After Progression on Anti-PD-(L)1 Therapy in Advanced Melanoma: A Prospective, Single-Arm, Exploratory Clinical Study","Inclusion Criteria:\n\nParticipants must meet all of the following criteria for enrollment:\n\n1. Age ≥18 years;\n2. Histologically-confirmed unresectable Stage III or IV melanoma, unsuitable for local therapy;\n3. Confirmed PD according to iRECIST within 12 weeks after receiving the last dose of anti-PD-(L)1 monotherapy or in combination with other treatments (including anti-CTLA-4) for at least two doses. (Up to 25% of participants may have received both anti-CTLA-4 and anti-PD-(L)1 treatment);\n4. Participants with BRAF\u002FCKIT\u002FNRAS gene mutations must have progressed after targeted therapy;\n5. Intolerant to chemotherapy or refused standard therapy;\n6. Toxicity from the most recent treatment recovered to grade 1 or below (except alopecia); if participants underwent major surgery or radiotherapy \\>30 Gy, they must have recovered from treatment-related toxicities\u002Fcomplications;\n7. Life expectancy of at least 3 months;\n8. Eastern Cooperative Oncology Group (ECOG) score: 0-1;\n9. At least one measurable lesion confirmed according to RECIST 1.1 criteria;\n10. Laboratory test results at screening must meet the following requirements:\n\n    a) Hematological tests must meet the following criteria (no blood\u002Fblood product transfusion, no correction with G-CSF or other hematopoietic stimulants within 14 days): i. Hemoglobin (Hb) ≥ 90 g\u002FL ii. Neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL iii. Platelet count (PLT) ≥ 100×10\\^9\u002FL b) Biochemical tests must meet the following criteria: i. Total bilirubin (TBIL) \\\u003C 1.5 × upper limit of normal (ULN) ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 ULN (\\\u003C5 ULN for participants with liver metastasis) iii. Serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance rate \\> 50ml\u002Fmin (Cockcroft-Gault formula) iv. Urine routine test results show urine protein (UPRO) \\\u003C 2+ or 24-hour urine protein quantification \\\u003C1g;\n11. Women of childbearing potential must have taken reliable contraceptive measures, had a negative pregnancy test (serum or urine) within 7 days before enrollment, and agree to use appropriate contraception during the trial and for 6 months after the last administration of the investigational drug. Nursing mothers should discontinue breastfeeding during the whole trial period and for 6 months after the last administration of the investigational drug to avoid the drug affecting the infant through milk. For men, they must agree to use appropriate contraception during the trial and for 120 days after the last administration of the investigational drug or have undergone surgical sterilization;\n12. Provide written informed consent, and are expected to have good compliance with the study protocol.\n\nExclusion Criteria:\n\nParticipants meeting any of the following will be excluded:\n\n1. Any active autoimmune disease or a history of autoimmune disease requiring treatment (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, pituitary炎, vasculitis, nephritis, hyperthyroidism; participants with vitiligo; childhood asthma that has completely resolved without any intervention in adulthood can be included; participants with asthma requiring bronchodilators for medical intervention cannot be included);\n2. Received more than 10 mg of prednisolone or other immunosuppressive therapy within seven days prior to study treatment;\n3. Severe allergic reaction to other monoclonal antibodies;\n4. Uncontrolled cardiac clinical symptoms or disease, such as: heart failure of NYHA class 2 or above; unstable angina; myocardial infarction within the past year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; QTc \\>450 ms (males); QTc \\>470 ms (females);\n5. Underwent any major surgery requiring general anesthesia within 28 days prior to the first dose;\n6. Active infection, unexplained fever ≥38.5°C within seven days prior to medication, or baseline white blood cell count \\>15×10⁹\u002FL; or suppurative and chronic infections, non-healing wounds;\n7. With bone metastasis who received palliative radiotherapy to \\>5% of the bone marrow area within four weeks prior to study entry;\n8. Known allergy to recombinant humanized anti-PD-(L)1 monoclonal antibody drugs, recombinant humanized anti-CTLA-4 monoclonal antibody, and\u002For their components;\n9. Concurrent other malignancies;\n10. Concurrent participation in other interventional clinical trials;\n11. HIV positive; HCV positive; HBsAg or HBcAb positive with detectable HBV DNA copies (quantitative detection limit of 500 IU\u002Fml);\n12. Received live vaccine vaccination within four weeks prior to treatment initiation;\n13. Ocular melanoma;\n14. With active brain metastasis (previously untreated asymptomatic brain metastasis patients with ≤3 brain lesions and longest diameter \\\u003C1 cm can be included. Previously treated brain metastasis patients who are clinically stable with no new or enlarged brain metastasis and have not used steroids for ≥14 days prior to study intervention can be included); other severe, acute, or chronic medical or mental disorders or laboratory abnormalities that may increase the risk associated with study participation or may interfere with the interpretation of study results, as judged by the investigator.",{"count":73,"type":21},40,[75],"PHASE4","Several studies have shown that the combination of Iparomlimab, Tuvonralimab, and Bevacizumab exhibits potent anti-tumor activity and favorable safety in various solid tumors, including liver cancer. However, the efficacy and safety of this regimen in melanoma patients with acquired resistance to immunotherapy remain unexplored and require further validation.\n\nThis study aims to evaluate the efficacy and safety of the Iparomlimab, Tuvonralimab, and Bevacizumab combination in patients with immune-resistant melanoma. Furthermore, it will analyze and compare treatment responses among different melanoma subtypes to identify optimal treatment strategies for clinical practice.",[78,31,79,80,81,82],"PD-(L)1","Advanced Melanoma","Iparomlimab","Tuvonralimab","Bevacizumab",[28,84],"Immune Checkpoint Inhibitors","2025-05-27",{"date":87,"type":36},"2025-06-04",{"date":89,"type":21},"2025-07-01",{"date":91,"type":21},"2029-01-31",{"name":93,"class":43},"Hebei Medical University Fourth Hospital"]