[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"potentially-resectable-hepatocellular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:potentially-resectable-hepatocellular-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,74],{"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},"100649542","study-on-the-combined-treatment-of-hepatocellular-carcinoma-with-envafolimab-suvemcitug-and-haic-conversion-100649542",false,"NCT07738055","Study on the Combined Treatment of Hepatocellular Carcinoma With Envafolimab, Suvemcitug and HAIC Conversion","An Exploratory Study on the Use of Envafolimab Combined With Suvemcitug and HAIC for the Conversion Therapy of Potentially Resectable Hepatocellular Carcinoma","HCC","Inclusion Criteria:\n\n1. Sign a written informed consent form before enrollment;\n2. Age 18-75 years old;\n3. Diagnosed with hepatocellular carcinoma (HCC) by clinical assessment;\n4. Patients with stage IV or III unresectable liver cancer;\n5. Have measurable lesions (according to the RECIST 1.1 standard, non-lymph node lesions with CT scan diameter ≥ 10 mm, lymph node lesions with CT scan diameter ≥ 15 mm);\n6. Have not received any systemic anti-tumor treatment before, including but not limited to immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine treatment;\n7. Child-Pugh score ≤ 7 points;\n8. Have sufficient organ function; 1) Blood routine: White blood cell (WBC) ≥ 3.5 × 10\\^9\u002FL, absolute neutrophil count (ANC) 1.5 × 10\\^9\u002FL, platelet (PLT) ≥ 100 × 10\\^9\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL; 2) Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; 3) Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 mL\u002Fmin (using the standard Cockcroft-Gault formula); 4) Coagulation function: International normalized ratio (INR) ≤ 1.5 \u002F PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation treatment, as long as PT and INR are within the range prescribed by the anticoagulant drug, it is acceptable.\n\n10\\. Estimated survival period ≥ 3 months; 11. Pregnant women should agree to use contraceptive measures (such as intrauterine device, contraceptive pills, or condoms) during the study period and within 6 months after the study; the serum HCG test should be negative within 7 days before enrollment, and must be non-lactating patients; men should agree to use contraceptive measures during the study period and within 6 months after the study.\n\nExclusion Criteria:\n\n1. Those who refuse to sign the informed consent form or refuse to undergo follow-up;\n2. Subjects who have previously or concurrently suffered from other malignant tumors;\n3. Patients who have received systemic anti-tumor treatment in the past;\n4. Those who are currently candidates for liver transplantation or have undergone liver transplantation;\n5. Those with a risk of bleeding, or coagulation dysfunction, or are undergoing thrombolytic therapy; or have experienced esophageal or gastric variceal bleeding within the past 6 months;\n6. Subjects who are known to have previously been allergic to large molecule protein preparations or the components of the applied drugs;\n7. Subjects with any active autoimmune diseases or a history of autoimmune diseases (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaryitis, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism\u002Fhypothyroidism), and the use of drugs that cannot maintain thyroid function within the normal range, or previous thyroid surgery, and long-term thyroid hormone replacement therapy is required after the surgery; subjects with vitiligo or who had completely resolved asthma in childhood and do not require any intervention in adulthood can be included; subjects with asthma who require bronchodilators for medical intervention cannot be included);\n8. Subjects who are currently using immunosuppressants, or systemic, or absorbable local hormone treatments to achieve immunosuppression purposes (dose \\> 10mg\u002Fday prednisone or other drugs with equivalent efficacy), and are still using them within 2 weeks before enrollment;\n9. Subjects who are using traditional Chinese medicine or other immunomodulatory agents within 2 weeks before enrollment;\n10. Have poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure (2) unstable angina pectoris (3) having had a myocardial infarction within 1 year (4) having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;\n11. Subjects with congenital or acquired immune deficiencies, such as HIV-infected individuals, or active hepatitis (transaminase does not meet the inclusion criteria, for hepatitis B: HBV DNA ≥ 2000 IU\u002Fml or ≥ 104 copies\u002Fml; for hepatitis C: HCV RNA ≥ 2000 IU\u002Fml or ≥ 104 copies\u002Fml; after nucleotide antiviral treatment, below the above standards can be included); chronic hepatitis B virus carriers, HBV DNA \\\u003C 104 IU\u002Fml, can be enrolled during the trial period if they must receive antiviral treatment simultaneously;\n12. Less than 4 weeks before the study medication, or may have received live vaccines during the study period;\n13. Subjects with known history of substance abuse of psychotropic drugs, alcoholism or drug abuse;\n14. The investigator considers it necessary to exclude from this study, for example, if the subject is judged by the investigator to have other factors that may cause the study to be prematurely terminated, such as, other serious diseases (including mental disorders) that require combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect the safety of the subject, or the collection of data and samples.","ALL","18 Years","75 Years",{"count":21,"type":22},35,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is a single-center, exploratory clinical trial. Eligible patients with liver cancer, after signing the informed consent form, will be screened and enrolled. They will receive a 3-cycle conversion treatment with Envafolimab combined with Suvemcitug and HAIC. During the treatment process, clinical tumor imaging assessment will be conducted using RECIST V1.1. Imaging evaluations will be performed before treatment and at the end of the 3rd cycle of treatment (±3 days). Subsequently, an MDT assessment will be conducted to determine if the surgical resection criteria are met. If the criteria are met, a radical surgery will be performed based on the subject's wishes and postoperative treatment will be provided. If the criteria are not met, the study will be decided to continue with the original treatment plan or another treatment plan. CTCAE 5.0 will be used for safety assessment. Adverse events will be recorded throughout the study period until 30 days after the end of treatment (for severe adverse events or adverse events related to Envovalimab, the recording period will be extended to 90 days after the end of treatment). To ensure study safety, 3 patients will be enrolled as a safety introduction cohort first, and a 3-cycle conversion treatment with Suvemcitug combined with Envafolimab and HAIC will be used. If a DLT occurs, 3 more patients will be enrolled. If the overall DLT does not exceed 1\u002F3, the original treatment plan will be maintained for the study. If the overall DLT is greater than 1\u002F3, the drug related to the DLT will be re-evaluated and the dose will be adjusted.",[28],"Potentially Resectable Hepatocellular Carcinoma",[30,31,32],"Potentially resectable hepatocellular carcinoma","Envafolimab","Suvemcitug","NOT_YET_RECRUITING","2026-07-27",{"date":36,"type":37},"2026-07-30","ACTUAL",{"date":39,"type":22},"2026-07-31",{"date":41,"type":22},"2029-07-31",{"name":43,"class":44},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100577323","phase-2-camrelizumab-combined-with-rivoceranib-and-hepatic-arterial-infusion-chemotherapy-haic-as-conversion-therapy-for-potentially-resectable-hepatocellular-carcinomahcc-100577323","NCT06796803","Camrelizumab Combined With Rivoceranib and Hepatic Arterial Infusion Chemotherapy (HAIC) as Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma(HCC)","Camrelizumab and Rivoceranib Plus HAIC as Conversion Therapy for Potentially Resectable Intermediate-advanced Hepatocellular Carcinoma: a Multicenter, Open-label, Randomized, Phase 2\u002F3 Study","Inclusion Criteria:\n\n1. Signed Informed Consent Form (ICF)\n2. Aged ≥18 years and ≤75 years at time of signing ICF\n3. Documented diagnosis of HCC confirmed by histology\u002Fcytology or clinically\n4. Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium\n5. Patients with recurrence following prior radical surgical resection must have undergone the initial surgery at least 5 years prior to study entry\n6. At least one measurable lesion (per RECIST v1.1) untreated lesion\n7. ECOG performance status of 0 or 1\n8. Child-Pugh ≤7 score\n9. Life expectancy ≥12 weeks\n10. Adequate organ function\n11. No prior anti-tumor systemic therapies for HCC\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC\n2. Other active malignant tumor except HCC within 5 years or simultaneously\n3. Prior locoregional therapy (such as TACE、TAE、HAIC、TARE)\n4. There is an absolute contraindication to HAIC\n5. History of hepatic encephalopathy\n6. Diffuse HCC, intrahepatic tumor burden \\> 50%\n7. PVTT reaching the superior mesenteric vein, and bilateral PVTT are present\n8. Clinically significant ascites\n9. Prior allogeneic stem cell or solid organ transplantation",{"count":53,"type":22},398,[55,56],"PHASE2","PHASE3","The purpose of this phase 2\u002F3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.",[28],[60,61,62],"conversion therapy","hepatocellular carcinoma","camrelizumab and rivoceranib","RECRUITING","2026-07-15",{"date":66,"type":37},"2026-07-17",{"date":68,"type":37},"2025-02-20",{"date":70,"type":22},"2030-02-28",{"name":72,"class":44},"Shanghai Zhongshan Hospital",2,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100527116","phase-2-a-study-of-haic-combined-with-lenvatinib-and-envolizumab-in-potentially-resectable-hepatocellular-carcinoma-100527116","NCT06143579","A Study of HAIC Combined With Lenvatinib and Envolizumab in Potentially Resectable Hepatocellular Carcinoma","FOLFOX-Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Lenvatinib and Envolizumab in Potentially Resectable Hepatocellular Carcinoma:A Single-arm, Open-label, Single Center, Phase II Trial","Inclusion Criteria:\n\n1. Patients who have signed ICF and are able to perform follow-up visits and relevant procedures required in the protocol;\n2. Age ≥ 18 years (at the time of signing the ICF);\n3. Clinically, histologically or pathologically confirmed hepatocellular carcinoma without extrahepatic metastases;\n4. No previous treatment containing PD- (L) 1 inhibitor and Lenvatinib;\n5. Potentially resectable HCC: (1)At least one measurable lesion (according to RECIST 1.1 criteria); (2)Patients with stage IIb\u002FIIIa (equivalent to BCLC B\u002FC) with portal vein tumor thrombus (according to Japanese PVTT grading criteria Vp3-Vp4) or more than three tumor nodules; (3)According to the assessment of the site multidisciplinary team (MDT), like surgical resection is not currently the treatment of choice;\n6. ECOG score: 0 \\~ 1;\n7. Child-Pugh score of ≤ 7\n8. Estimated survival of more than 6 months;\n9. Vital organ function meets the following requirements: (1) Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 100 × 109\u002FL; Hemoglobin (HGB) ≥ 90 g\u002FL; (2) Liver function: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or clearance of creatinine ≥ 50 mL\u002Fmin (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 × upper limit of normal (ULN); (3) Kidney function: Urine protein \\\u003C 2 +; if urine protein ≥ 2 +, 24-h urine protein quantitation test result should be ≤ 1 g;\n10. Normal coagulation function, no active bleeding and thrombosis (1) International normalized ratio (INR) ≤ 1.5 × ULN; (2) Active partial thromboplastin time (APTT) ≤ 1.5 × ULN; (3) Prothrombin time (PT) ≤ 1.5 × ULN;\n11. Female patients of childbearing age or male patients with female sexual partners of childbearing age should take effective contraceptive measures during study treatment and for 3 months after the end of study treatment; serum or urine HCG tests must be negative and must be non-lactating within 7 days before study enrollment;\n12. Patients should be compliant and cooperative with safety and survival follow-up.\n\nExclusion Criteria:\n\n1. Participate in other interventional clinical studies;\n2. Previous or concurrent other malignancies;\n3. History of liver transplantation or undergo liver transplantation;\n4. History of hypersensitivity to macromolecular protein preparations, the study drug or any of the excipients;\n5. Active autoimmune disease or history of autoimmune diseases (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery); Require bronchodilators for medical intervention of asthma; the patient has vitiligo or has complete remission of asthma in childhood, no intervention is required after adults can be included;\n6. Use immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose \\> 10 mg\u002Fday prednisone or other effective hormones), and continue to use within 2 weeks before enrollment;\n7. Uncontrolled cardiac clinical symptoms or diseases, for example: (1) NYHA class 2 or higher heart failure;(2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;\n8. Use traditional Chinese medicine immunomodulator within 2 weeks before enrollment;\n9. Severe active infection or unexplained fever \\> 38.5 degrees during screening and before the first dose (subjects can be enrolled due to tumor-induced fever at the investigator discretion);\n10. Congenital or acquired immunodeficiency: (1)HIV infection; (2)Active hepatitis (hepatitis B reference: HBV DNA ≥ 1000 IU\u002FmL; hepatitis C reference: HCV RNA ≥ 1000 IU\u002FmL); chronic hepatitis B virus carriers, HBV DNA \\\u003C 2000 IU\u002Fml, must receive concurrent antiviral therapy during the trial to be enrolled;\n11. Live vaccines less than 4 weeks prior to study medication or likely during the study;\n12. History of psychiatric drug abuse, alcoholism, or drug abuse;\n13. Chinese herbal medicine within 4 weeks prior to first treatment;\n14. Factors that may cause forced halfway termination of this study, such as other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, accompanied by family or social factors, which may affect the subject' s safety, the collection of data and samples, or other circumstances which are unsuitable for subject enrollment as judged by the investigator.",{"count":82,"type":22},48,[55],"This is a single term, open label, single Center, Phase II Trial. The study is to explore the efficacy and safety of FOLFOX-HAIC combined with Lenvatinib and Envolizumab in the treatment of patients with potentially resectable HCC.",[28],[87,88,89,90,91,92],"HAIC","Lenvatinib","Envolizumab","PD-L1","TKI","potentially resectable HCC","2023-11-16",{"date":95,"type":37},"2023-11-22",{"date":97,"type":22},"2023-12-15",{"date":99,"type":22},"2026-12-31",{"name":101,"class":44},"Sun Yat-sen University"]