[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yongyi Zeng\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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},"100542934","phase-2-neoadjuvant-imrt-combined-with-camrelizumab-and-apatinib-for-resectable-hcc-with-pvtt-100542934",false,"NCT06349317","Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT","Neoadjuvant Intensity-modulated Radiotherapy Combined With Perioperative Camrelizumab and Apatinib in the Treatment of Resectable Hepatocellular Carcinoma Associated With Portal Vein Tumor Thrombus: a Single-arm Prospective Clinical Study","Inclusion Criteria:\n\n1. Signed written informed consent and able to comply with scheduled visits and related procedures;\n2. Age ≥18 and ≤75 years, regardless of gender;\n3. Patients with HCC who meet the clinical diagnostic criteria of China's \"Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma\" (2022 Edition) or are diagnosed by biopsy, and have at least one measurable lesion according to the mRECIST criteria;\n4. Presence of portal vein tumor thrombus (PVTT) of Cheng's type I\u002FII\u002FIII, with the primary tumor being resectable;\n5. Child-Pugh score of Class A;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1;\n7. No prior antitumor treatment (such as surgery, radiotherapy, TACE, ablation, chemotherapy, targeted therapy, immunotherapy, or systemic therapy).\n8. For patients with hepatitis B virus (HBV) infection, testing for HBV-DNA is required; direct treatment initiation is allowed if HBV-DNA ≤2000 IU\u002FmL; if HBV-DNA \\>2000 IU\u002FmL, antiviral therapy should be administered for one week before starting the treatment; all HBV positive patients will receive continuous antiviral treatment throughout the study; patients with hepatitis C virus (HCV) RNA positive must undergo antiviral treatment as per the guidelines;\n9. Participants must provide a fresh tumor biopsy sample during the screening period (can be waived after discussion with the medical monitor) and blood samples for monitoring immune cells, cytokine levels, and other relevant immune status in the tumor microenvironment;\n10. Expected survival of ≥12 weeks;\n11. Adequate organ and marrow function, as defined by the following laboratory values:\n\n    1. Hematology: Absolute Neutrophil Count ≥1.5×109\u002FL; Platelets ≥80×109\u002FL; Hemoglobin ≥90g\u002FL;\n    2. Liver function: Total bilirubin ≤3× upper limit of normal (ULN); Alanine Aminotransferase and Aspartate Aminotransferase ≤5×ULN; Serum albumin ≥30g\u002FL;\n    3. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or for patients with Cr \\>1.5×ULN, creatinine clearance (CCr) ≥45 mL\u002Fmin (Cockcroft-Gault formula); Urinalysis showing proteinuria \\\u003C2+; For participants with baseline proteinuria ≥2+, a 24-hour urine collection and quantitative protein \\\u003C1g is required;\n    4. Coagulation: International Normalized Ratio or APTT ≤1.5×ULN;\n12. Females of childbearing potential must agree to abstain from heterosexual intercourse or use effective contraception from signing the informed consent until at least 120 days after the last dose of study medication. They must have a negative serum HCG test within 1 week before treatment and must not be breastfeeding. Females who have not reached menopause (≥12 months of amenorrhea without an alternative medical cause) and have not undergone sterilization (e.g., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) are considered to be of childbearing potential;\n13. Male participants with partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable and effective contraceptive methods from the time of signing the informed consent until at least 120 days after the last dose of study medication. During the same period, male participants must also agree not to donate sperm. Male subjects whose partners are pregnant must use condoms and do not need to use other contraceptive methods.\n\nExclusion Criteria:\n\n1. PVTT located in the portal vein branch opposite the tumor, or with inferior vena cava tumor thrombus, extrahepatic metastasis, or tumor invasion of adjacent organs;\n2. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, and fibrolamellar carcinoma; active malignant tumors other than HCC within the past 5 years or concurrently, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, which are allowed;\n3. Currently with interstitial pneumonia or interstitial lung disease, or history of interstitial lung disease requiring hormone treatment, or other conditions that may interfere with the judgement and management of immunotherapy-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or participants with active pneumonia or severe impairment of lung function shown on a chest CT during screening; active tuberculosis;\n4. Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controllable with hormone replacement therapy are allowed); Patients with skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, and alopecia, those with controlled Type I diabetes mellitus undergoing insulin therapy, or individuals whose childhood asthma has fully resolved with no need for intervention in adulthood, are allowed; patients requiring bronchodilators for medical intervention of asthma are not allowed;\n5. Use of immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (dose \\>10mg\u002Fday of prednisone or equivalent) within 2 weeks before the start of the study;\n6. Active infection, fever of unknown origin ≥38.5°C within 1 week before the study start, or baseline white blood cell count \\>15×10\\^9\u002FL; therapeutic antibiotics orally or intravenously within 2 weeks before the study start (excluding prophylactic antibiotics given IV for no more than 48 hours);\n7. Congenital or acquired immunodeficiency (e.g., HIV infection);\n8. Receipt of live attenuated vaccines within 4 weeks before the study start or expectation of needing such vaccines during the camrelizumab treatment period or within 60 days after the last dose of camrelizuma;\n9. Significant bleeding symptoms of clinical significance or a clear bleeding tendency within 6 months before the study start, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, or vasculitis; if baseline fecal occult blood is positive, retesting is allowed, and if still positive, gastroduodenoscopy is required;\n10. Known genetic or acquired bleeding (e.g., coagulopathy) and thrombotic tendencies, such as hemophilia, coagulation mechanism disorders, thrombocytopenia, etc.; currently receiving full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin, etc., is allowed);\n11. Arterial thromboembolic events within 6 months before the study start, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), CTCAE grade 3 or above deep vein thrombosis, pulmonary embolism, etc;\n12. Uncontrolled clinical symptoms or diseases of the heart, such as: (1) heart failure of NYHA class II or above or echocardiography showing LVEF \\\u003C50%; (2) unstable angina; (3) myocardial infarction within 1 year before treatment; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \\> 450ms for males and \\>470ms for females (QTc interval calculated using the Fridericia formula; if QTc is abnormal, continuous testing three times at 2-minute intervals is allowed, taking the average value);\n13. Hypertension not well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg based on the average of ≥2 blood pressure readings), allowing achievement of the above parameters through antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy;\n14. Major vascular diseases within 6 months before the study start (e.g., requiring surgical repair or recent peripheral arterial thrombosis of an aneurysm);\n15. Severe, unhealed, or open wounds and active ulcers or untreated fractures;\n16. Major surgery (excluding diagnostic) within 4 weeks before the study start;\n17. Inability to swallow pills, malabsorption syndrome, or any condition affecting gastrointestinal absorption;\n18. Intestinal obstruction and\u002For clinical signs or symptoms of gastrointestinal obstruction, including partial obstructions requiring parenteral hydration, parenteral nutrition, or tube feeding related to the underlying disease, within 6 months before the study start. Patients with incomplete obstruction\u002Fobstruction syndrome\u002Fintestinal obstruction signs\u002Fsymptoms at initial diagnosis who have undergone definitive (surgical) treatment to alleviate symptoms may be eligible for the study;\n19. Use of strong CYP3A4\u002FCYP2C19 inducers, including rifampin (and its analogs) and Hypericum perforatum, or strong CYP3A4\u002FCYP2C19 inhibitors within 2 weeks before the study start;\n20. Known allergy to any monoclonal antibody, antiangiogenic targeted drugs, or excipients;\n21. Participation in other drug clinical studies within 12 weeks before the study start.","ALL","18 Years","75 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus.",[27],"Hepatocellular Carcinoma","RECRUITING","2025-09-23",{"date":31,"type":32},"2025-09-29","ACTUAL",{"date":34,"type":32},"2024-04-22",{"date":36,"type":21},"2026-06",{"name":38,"class":39},"Yongyi Zeng","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100547349","early-phase-1-neoantigen-vaccine-plus-capecitabine-as-adjuvant-therapy-for-intrahepatic-cholangiocarcinoma-after-radical-resection-100547349","NCT06406816","Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection","Inclusion Criteria:\n\n1. Sign a written informed consent form and be able to comply with the scheduled visits and related procedures as per the protocol;\n2. Age ≥18 years and ≤75 years, any gender;\n3. Confirmed pathologically as a patient with intrahepatic cholangiocarcinoma;\n4. Not receiving neoadjuvant therapy, underwent surgical resection, and pathology confirmed high-risk factors for recurrence: positive margins, lymph node metastasis, vascular invasion, nerve invasion, diameter \\>5cm, classified as stage IB-IIIB according to AJCC TNM (8th edition, 2017), and have not yet received systemic adjuvant therapy;\n5. Child-Pugh score grade A;\n6. ECOG score of 0-1;\n7. If infected with hepatitis B virus (HBV), such as HBsAg positive, HBV-DNA must be tested and HBV-DNA should be \\\u003C2000 IU\u002FmL (if the research center uses copy\u002FmL as the detection unit, then it must be \\\u003C104 copy\u002FmL), and must have received at least 1 week of anti-HBV treatment before the start of the study and willing to undergo antiviral treatment throughout the study period; HCV RNA positive patients must receive antiviral treatment according to the treatment guidelines;\n8. The subjects are required to provide fresh or archived tumor tissue samples as requested in the post-operative protocol for use in gene sequencing and peptide gel vaccine preparation;\n9. Expected survival period ≥12 weeks;\n10. Has sufficient organ and bone marrow function, has not received blood transfusion or hematopoietic growth factor within 14 days before screening. Laboratory test values meet the following requirements, as follows: a. Hematology: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥50×10\\^9\u002FL; Hemoglobin (HGB) ≥90g\u002FL b. Liver function: Total bilirubin (TBIL) ≤3×upper limit of normal value (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤5×ULN; Serum albumin ≥30g\u002FL c. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or for subjects with creatinine \\>1.5×ULN, creatinine clearance rate (CCr) ≥45 mL\u002Fmin (Cockcroft-Gault formula); Urine routine results show urine protein \\\u003C2+; For subjects with urine protein ≥2+ on baseline urine routine testing, 24-hour urine collection should be performed and 24-hour urine protein quantification \\\u003C1 g d. Coagulation function: International normalized ratio (INR) or APTT ≤1.5×ULN;\n11. Fertile women: Must agree to abstain from sexual intercourse (avoid heterosexual intercourse) or use a reliable and effective method of contraception from the start of signing the informed consent form until at least 120 days after the last dose of study drug. Serum HCG test must be negative in the week before treatment; and must be non-lactating. If female patients have menstruated and have not reached postmenopausal status (consecutive absence of menstruation for ≥12 months, no other reason except for menopause), and have not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), they are considered fertile;\n12. For male subjects with fertile female partners, must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the start of signing the informed consent form until at least 120 days after the last dose of study drug. Male subjects must also agree not to donate sperm during the same period. Male subjects whose partners are pregnant must use condoms, and no other contraceptive method is necessary\n\nExclusion Criteria:\n\n1. Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, hilar cholangiocarcinoma, and gallbladder cancer;\n2. Patients with other active malignant tumors other than intrahepatic cholangiocarcinoma within 5 years or simultaneously. Patients with localized tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included;\n3. Currently with interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment in the past, or other possible interferences with the judgment and treatment of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with active pneumonia or severe lung function impairment shown by chest CT during screening; active tuberculosis;\n4. Presence of active autoimmune diseases or a history of autoimmune diseases that may relapse \\[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controlled only by hormone replacement therapy can be included)\\]; patients with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes mellitus treated with insulin, or patients with asthma who have completely resolved in childhood and require no intervention as adults can be included; patients with asthma requiring bronchodilators for medical intervention cannot be included;\n5. Within 2 weeks before the start of the study, use of immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \\>10mg\u002Fday prednisone or other equivalent glucocorticoids);\n6. Patients with active infections, with unexplained fever ≥38.5°C within 1 week before the start of the study, or with a baseline white blood cell count \\>15×10\\^9\u002FL;\n7. Patients with congenital or acquired immune deficiency (e.g., HIV infection);\n8. Within 4 weeks before the first dose, received or planned to receive live or attenuated live vaccines during the study;\n9. Within 6 months before the start of the study, significant clinical bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, etc. If positive for occult blood in stool at baseline, it can be retested; if still positive after retesting, endoscopy is required;\n10. Known existing hereditary or acquired bleeding disorders (e.g., hemophilia patients), coagulation disorders, thrombocytopenia, etc.); currently receiving full-dose oral or injected anticoagulants or thrombolytics for therapeutic purposes (prophylactic use of low-dose aspirin is allowed, etc.);\n11. Within 6 months before the start of the study, arterial thromboembolic events, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), CTCAE grade 3 or higher deep vein thrombosis, pulmonary embolism, etc;\n12. Uncontrolled heart clinical symptoms or diseases, such as: (1) New York Heart Association (NYHA) standard II or higher heart failure or echocardiography: LVEF (left ventricular ejection fraction) \\\u003C50%; (2) unstable angina pectoris; (3) myocardial infarction within 1 year before treatment; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \\>450ms (men); QTc \\>470ms (women) (QTc interval calculated using the Fridericia formula: if QTc is abnormal, it can be continuously measured for 3 times at intervals of 2 minutes and the average value is taken);\n13. Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (based on the average of blood pressure readings from ≥2 measurements); previous history of hypertensive emergencies or hypertensive encephalopathy is allowed;\n14. Within 6 months before the start of the study, the occurrence of major vascular diseases (e.g., aortic aneurysms requiring surgical repair or recent peripheral arterial thrombosis);\n15. Severe, unhealed, or open wounds, as well as active ulcerations or untreated fractures;\n16. Within 4 weeks before the start of the study, received major surgery treatment (excluding diagnostic procedures) or expect to undergo major surgery during the study period;\n17. Unable to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption;\n18. Within 6 months before the start of the study, experienced intestinal obstruction and\u002For had clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. If patients with incomplete obstruction\u002Fobstruction syndrome\u002Fintestinal obstruction signs\u002Fsymptoms at the time of initial diagnosis received definitive (surgical) treatment to resolve symptoms, they may be eligible for inclusion in the study;\n19. Within 2 weeks before the start of the study, the use of strong CYP3A4\u002FCYP2C1 inducers including rifampicin (and its analogues) and St. John's wort, or strong CYP3A4\u002FCYP2C19 inhibitors;\n20. Subjects who have received other neoantigen vaccines, or are allergic to any chemotherapy drugs, anti-angiogenic targeted drugs, or excipients",{"count":48,"type":21},10,[50],"EARLY_PHASE1","This study is a single-arm, open-label, exploratory clinical trial, with the primary objective to evaluate the efficacy and safety of the Neoantigen Vaccine plus capecitabine for the treatment of high-intermediate risk recurrent intrahepatic cholangiocarcinoma",[53],"Intrahepatic Cholangiocarcinoma","2025-05-12",{"date":56,"type":32},"2025-05-15",{"date":58,"type":32},"2024-05-06",{"date":60,"type":21},"2026-05",{"name":38,"class":39},""]