[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-metastasis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,53,82,115,140,180,207,227,253,292,312,337,357],{"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":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100636840","phase-2-hepatic-arterial-infusion-of-liposomal-irinotecan-plus-oxaliplatin-and-capecitabine-as-adjuvant-therapy-for-colorectal-cancer-liver-metastases-100636840",false,"NCT07570914","Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases","An Exploratory Clinical Study of Hepatic Arterial Infusion of Liposomal Irinotecan Combined With Oxaliplatin and Capecitabine as Postoperative Adjuvant Therapy for Colorectal Cancer Liver Metastases","Inclusion Criteria:\n\n1. Age 18 to 75 years.\n2. Completion of radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment, with postoperative imaging showing no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease.\n3. Histologically confirmed colorectal cancer liver metastases.\n4. ECOG performance status of 0 or 1.\n5. Expected survival of at least 3 months.\n6. Clinical risk score of 3 or higher.\n7. Adequate bone marrow function, defined as absolute neutrophil count \\>2 × 10\\^9\u002FL, hemoglobin \\>9.0 g\u002FdL, and platelet count \\>100 × 10\\^9\u002FL.\n8. Adequate renal function, defined as serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥30 mL\u002Fmin according to the Cockcroft-Gault formula.\n9. Adequate hepatic function, defined as serum bilirubin ≤1.5 × the upper limit of normal, transaminases ≤2.5 × the upper limit of normal or ≤5 × the upper limit of normal if liver metastasis is present, and alkaline phosphatase ≤5 × the upper limit of normal.\n10. Female participants must not be pregnant or breastfeeding. Women of childbearing potential and male participants must use effective contraception during the study and for 6 months after completion of study treatment.\n11. Good compliance, ability to understand the study procedures, and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Contraindication to capecitabine, oxaliplatin, or irinotecan.\n2. Any history of hepatic interventional therapy, including transarterial infusion, hepatic arterial infusion, or transarterial chemoembolization.\n3. Receipt of adjuvant chemotherapy containing irinotecan after resection of the primary tumor, or receipt of adjuvant therapy without irinotecan with the last dose administered within 3 months before enrollment.\n4. Dihydropyrimidine dehydrogenase deficiency.\n5. History of severe cardiovascular disease resulting in inability to tolerate treatment.\n6. Peripheral neuropathy greater than Grade 1.\n7. History of another malignancy within the previous 5 years, except cured carcinoma in situ or basal cell carcinoma of the skin.\n8. History of allogeneic organ transplantation.\n9. Requirement for renal dialysis.\n10. Breastfeeding, pregnancy, or inadequate contraception in women of childbearing potential.\n11. Uncontrolled concomitant disease, including but not limited to severe active or uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, uncontrolled diabetes, or psychiatric illness that may affect study compliance.\n12. Participation in another clinical trial currently or within 4 weeks before enrollment.\n13. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.","ALL","18 Years","75 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine as postoperative adjuvant therapy in patients with colorectal cancer liver metastases after radical resection.\n\nEligible participants must have histologically confirmed colorectal cancer liver metastases and have completed radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment. Postoperative imaging must show no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease. Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine every 21 days for 2 to 4 cycles. After 2 cycles, treatment continuation will be determined by the investigator based on efficacy and tolerability.",[27,28,29],"Colorectal Cancer Liver Metastases (CRLM)","Colorectal Cancer","Liver Metastasis",[31,32,33,34,35,36,37,38,39,40],"Colorectal cancer","Colorectal cancer liver metastases","Postoperative adjuvant therapy","Hepatic arterial infusion chemotherapy","Liposomal irinotecan","Oxaliplatin","Capecitabine","Disease-free survival","Hepatic recurrence-free survival","No evidence of disease","NOT_YET_RECRUITING","2026-04-29",{"date":44,"type":45},"2026-05-06","ACTUAL",{"date":47,"type":21},"2026-05-30",{"date":49,"type":21},"2032-05-30",{"name":51,"class":52},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100543493","phase-2-fruquintinib-combined-with-sintilimab--radiotherapy-for-third-line-treatment-of-colorectal-cancer-with-liver-metastases-100543493","NCT06356584","Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases","Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases: A Randomized, Controlled, Multicenter Phase II Trial","Inclusion Criteria:\n\n* ECOG PS 0-2\n* Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)\n* MSS\u002FpMMR subtype\n* Previously received standard first- and second-line systemic anti-tumor therapy\n* At least one measurable lesion as defined by RECIST 1.1 criteria\n* Access to tumor samples for biomarker assessment\n* Expected survival of ≥3 months\n* Normal function of major organ systems (within 14 days before enrollment)\n* No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy.\n* Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial.\n\nExclusion Criteria:\n\n* Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.\n* Participating in an interventional clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.\n* Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.\n* Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for controlling pleural effusion).\n* Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered systemic therapy.\n* Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of investigational treatment. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved.\n* Received liver radiotherapy within the past 2 weeks before enrollment.\n* Known presence of central nervous system metastases and\u002For carcinomatous meningitis.\n* Received systemic corticosteroid therapy within 7 days before enrollment.",{"count":61,"type":21},62,[24],"Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.",[28,65,66,67,29],"Immunotherapy","Radiotherapy","Targeted Therapy",[31,65,66,69,70],"Targeted therapy","Liver metastasis","RECRUITING","2026-04-27",{"date":74,"type":45},"2026-04-28",{"date":76,"type":45},"2024-04-01",{"date":78,"type":21},"2026-10-01",{"name":80,"class":52},"Shandong Cancer Hospital and Institute",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":81},"100629590","scout-dose-of-resin-microspheres-100629590","NCT07476651","Scout Dose of Resin Microspheres","Lung Shunt Fraction Measurement With Scout Dose of Resin Yttrium-90 Microspheres for Radioembolization (LASER)","LASER","Inclusion Criteria:\n\n* Adults aged 19 years or older\n\n  * Hepatocellular carcinoma diagnosed radiologically according to the American Association for the Study of Liver Disease diagnostic criteria or diagnosed histologically, histologically diagnosed intrahepatic cholangiocarcinoma, or liver metastases\n\n    * Volume of liver not included in the treatment field is at least 30% of the total non-tumorous liver volume\n\n      * Child-Pugh class A\n\n        * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑥ Patients with lung shunt fraction ≤20% on MAA scan (planar image)\n\n          ⑦ Patients with no major organ abnormalities on blood tests performed within 2 months before treatment:\n\n          • A. Leukocytes ≥ 1,000\u002FµL and ≤ 20,000\u002FµL\n\n          • B. Hemoglobin ≥ 6.0 g\u002FdL (transfusion allowed to meet this criterion)\n\n          • C. Total bilirubin ≤ 2.0 mg\u002FdL\n\n          • D. Platelet ≥ 40,000\u002FµL\n\n          • E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants\n          * F. Aspartate transaminase (AST) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit)\n          * G. Alanine transaminase (ALT) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit)\n          * H. Creatinine ≤ 2.5 mg\u002FdL (no restriction for dialysis patients) ⑧ Patients with life expectancy of at least 3 months ⑨ For women of childbearing potential, those with negative serum pregnancy test ⑩ Patients who fully understand the content of the prospective observational study and provide written informed consent\n\nExclusion Criteria:\n\n1. Patients with biliary-enteric anastomosis or biliary stent\n2. Cases where the operator judges that even mild radiation pneumonitis could be fatal due to findings of emphysema or interstitial lung disease on chest CT\n3. Patients with a history of severe hypersensitivity reaction to iodinated contrast agents\n4. Patients with contraindications to angiography or catheter manipulation\n5. Patients with lung shunt fraction \\>20% on MAA scan (planar image)","19 Years",{"count":92,"type":21},30,[94],"NA","This study looks at a liver cancer treatment called radioembolization and tests a new, possibly more accurate way to check if the treatment is safe for a patient's lungs.\n\nRadioembolization is a procedure where tiny beads containing a radioactive substance (yttrium-90) are injected into the arteries that feed a liver tumor. These beads lodge mainly in the tumor and deliver radiation directly to it, while sparing most of the normal liver. However, some of these beads can bypass the liver circulation and travel to the lungs. If too many reach the lungs, they can cause serious radiation damage called radiation pneumonitis.\n\nTo avoid this, doctors currently perform a \"test run\" before the real treatment. They inject a different particle called MAA into the liver artery and then do nuclear medicine scans to see how much of it goes to the lungs versus the liver. This percentage is called the lung shunt fraction. If the lung shunt is 20% or higher, radioembolization is not done; if it is between 10% and 20%, the decision depends on tumor size. The actual treatment usually happens 1-2 weeks after this test.\n\nMAA particles are similar in size to the treatment beads but not identical; some are smaller. Because of this, MAA may slightly overestimate how much of the treatment dose would really go to the lungs. Also, MAA is fully imported and has had periods of supply problems worldwide. For these reasons, there is a need for another, more accurate and more reliable way to measure lung shunt.\n\nThe LASER study tests an approach called a \"scout dose.\" In this method, doctors take a small amount of the actual treatment beads (SIR-Spheres, a resin yttrium-90 microsphere product) and inject a low radioactive dose (0.56 GBq) into the liver artery on the day of treatment. They then perform a PET\u002FCT scan and calculate how much of this scout dose went to the lungs and how much stayed in the liver. Because the scout dose uses the same type of beads as the real treatment, it may give a more accurate picture of the true lung shunt.\n\nThe study will enroll 30 adult patients who have liver tumors (liver cancer, intrahepatic cholangiocarcinoma, or liver metastases) and are already scheduled to receive radioembolization. All participants must have good liver function (Child-Pugh A), good performance status (ECOG 0-1), and an MAA-based lung shunt fraction below 20%. They also need to meet standard blood test criteria and have a life expectancy of at least three months.\n\nEach patient first undergoes the usual work-up: liver artery angiography, MAA injection, and nuclear scans, which are used to plan the treatment dose. One to two weeks later, on the treatment day, the patient has another angiogram, receives the 0.56 GBq scout dose into the liver artery, and has a scout PET\u002FCT scan while the catheter is kept in place. After calculating the lung shunt from the scout dose, the patient is brought back to the angiography room and receives the planned treatment dose, reduced by the amount already given as the scout dose. The next morning, a treatment Y90 PET\u002FCT scan is performed.\n\nThe main measurement of interest is the lung shunt fraction calculated three different ways: from the initial MAA scan, from the scout Y90 PET\u002FCT, and from the treatment Y90 PET\u002FCT. The researchers will compare how closely these three values agree. They will also look at how much radiation the tumor and normal liver receive (tumor dose, normal liver dose) and the radiation dose to the lungs, again using all three imaging methods.\n\nPatients will be followed for one year with regular clinic visits, blood tests, and CT or MRI scans according to usual care. The study will carefully record side effects such as fatigue, pain, poor appetite, and more serious problems like liver failure or radiation pneumonitis, and grade them using a standard international system (CTCAE v5.0). The researchers expect that adding the scout dose and extra scan will lengthen the procedure by about two hours and cause some discomfort from lying down longer, but they do not expect a major increase in serious risks compared with standard treatment.\n\nBy the end of the study, the team aims to show whether the scout dose method can safely and accurately replace or complement the traditional MAA-based test. If successful, this could improve the precision of radioembolization planning and offer a reliable alternative when MAA is not available",[97,98,99,29],"Radioembolization","Hepatocellular Carcinoma (HCC)","Intrahepatic Cholangiocarcinoma (ICC)",[101,102,103,104,105,106],"lung shunt fraction","scout dose","resin microspheres","yttrium","radioembolization","selective internal radiation therapy","2026-04-13",{"date":109,"type":45},"2026-04-16",{"date":107,"type":45},{"date":112,"type":21},"2029-12-31",{"name":114,"class":52},"Seoul National University Hospital",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100581296","phase-1-ldrt-combined-with-immunochemotherapy-for-colorectal-cancer-with-liver-metastasis-100581296","NCT06848465","LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis","A Phase Ib Trial on the Safety and Feasibility of Low Dose Radiotherapy (LDRT) Combined With Immunochemotherapy for Colorectal Cancer With Liver-limited Metastasis","Inclusion Criteria:\n\n1. Age between18 and 75 years old.\n2. Histopathological confirmed MSS\u002FpMMR adenocarcinoma of the colon or rectum.\n3. The clinical baseline stage of rectal cancer assessed by MRI\u002FCT\u002FTransrectal ultrasound was T3-4Nx or TXN1-2.\n4. Simultaneous liver metastasis confirmed by imaging examination.\n5. No previous antitumor treatment.\n6. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n7. Adequate cardiac function (Left Ventricular Ejection Fractions \\> 50%), hepatic function (total serum bilirubin ≤ 1.5 × upper limit of normal, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 × upper limit of normal), renal function (serum creatinine ≤ 1.5 × ULN or glomerular filtration rate \\> 60 ml\u002Fmin, based on Cockcroft-Gault), and hematopoietic function (white blood cells ≥ 4.0 × 109 cells per L, neutrophils ≥ 1.5 × 109 cells per L, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 × 109 cells per L).\n8. Sign the informed consent and have good compliance.\n\nExclusion Criteria:\n\n1. Distant metastasis from other than the liver.\n2. BMI \\\u003C 18.5 kg\u002Fm² or weight loss ≥ 10% within the past 6 months (with consideration of the impact of large amounts of pleural and ascitic fluid on body weight).\n3. Received any of the following treatments: any investigational drug; enrolled in another clinical trial concurrently, unless it is an observational (non-interventional) clinical study; received anti-tumor vaccines or live vaccines.\n4. Active autoimmune diseases, or a history of autoimmune diseases. A history of liver disease including, but not limited to HBV infection or HBV DNA positive(≥1×10\\^4\u002Fml), HCV infection or HCV DNA positive(≥1×10\\^3\u002Fml) and liver cirrhosis.\n5. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.\n6. A history of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe\u002Funstable angina, coronary artery bypass grafting, cardiac insufficiency ≥ NYHA grade 2 and LVEF\\\u003C50%).\n7. The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years excluding adequately treated non-melanoma skin cancer, carcinoma in situ of cervix and superficial bladder tumour (non-invasive tumour, or carcinoma in situ, or T1).\n8. Pregnant or lactating women.\n9. The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.","80 Years",{"count":124,"type":21},9,[126],"PHASE1","In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.",[28,29,129],"LDRT","2026-04-02",{"date":132,"type":45},"2026-04-03",{"date":134,"type":45},"2025-02-28",{"date":136,"type":21},"2027-11-30",{"name":138,"class":52},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",2,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":81},"100410278","advanced-therapies-for-liver-metastases-100410278","NCT04622423","Advanced Therapies for Liver Metastases","Advanced Immune Gene and Cell Therapies for Liver Metastases","LiMeT","Inclusion and exclusion criteria - CRC patients\n\nInclusion criteria:\n\n1. Patients with histologically or cytologically confirmed diagnosis of CRC metastatic to the liver (stage IV disease, AJCC)\n2. Patients with indication to surgical resection and\u002For chemotherapy treatment\n3. Age ≥18\n4. ECOG PS 0-1 at enrollment\n5. Written informed consent\n6. Patients will be treated in IRCCS San Raffaele\n\nExclusion criteria:\n\n1. Pregnancy or lactation\n2. Inability to provide a written informed consent\n3. Extraepatic disease with the exception of selected cases in which the coexistence of extrahepatic disease does not constitute an exclusion criterion for hepatic resective surgery (for example in patients with extraepatic lesions in remission or in any case stabilized by chemotherapy)\n4. Severe comorbidities (e.g. cardiac diseases, history of psychiatric disabilities, HIV, autoimmune disorders)\n5. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy\n6. Other conditions (medical or psychiatric) that in the judgment of Investigators would make the patient an inappropriate candidate for the study\n\nInclusion and exclusion criteria - PDAC patients\n\nInclusion criteria:\n\n1. Patients with clinical\u002Fradiological diagnosis\u002Fsuspicious of pancreatic adenocarcinoma metastatic to the liver, with subsequent cytological\u002Fhistological confirmation (stage IV disease, AJCC)\n2. Age ≥18\n3. Karnofsky performance status ≥50\n4. Metastatic pancreatic adenocarcinoma patients with histological specimens from whole liver metastasis biopsy or core liver biopsy collected at IRCCS San Raffaele and stored in the institutional biobank Centro Risorse Biologiche (CRB-OSR)\n5. Written Informed consent\n6. Patients with clinical\u002Fradiological diagnosis of not metastatic primary PDAC that will undergo pancreatic resection at IRCCS San Raffaele\n\nExclusion criteria:\n\n1. Severe comorbidities (e.g., cardiac diseases, history of psychiatric disabilities) representing an absolute contraindication for whole or core liver metastasis biopsy\n2. Pregnancy or lactation\n3. Inability to provide a written informed consent\n4. Metastatic pancreatic adenocarcinoma patients enrolled in other research trials entailing the analysis of the liver metastasis histological sample",true,{"count":150,"type":21},625,"OBSERVATIONAL","Liver metastases (MTS) are the main cause of death for patients affected by colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC), thus representing the major unmet clinical need for these malignancies.\n\nBased on preliminary and published data, the investigators hypothesize that innovative immune, gene, and cell therapy approaches might overcome the tolerogenic liver microenvironment and represent powerful therapeutic tools for liver MTS of PDAC and CRC.\n\nThe investigators have therefore planned an observational clinical study to enroll distinct cohorts of patients (i.e., metastatic CRC, preneoplastic, metastatic, and non-metastatic PDAC) and finely characterize, through integrated state-of-the-art -omics, the immune and non-immune microenvironment of their primary tumor and\u002For liver metastases as well as correlate changes in the activation status and phenotype of peripheral blood leukocytes. Healthy volunteers will be enrolled as negative controls.\n\nThe investigators aim at identifying: i) actionable tumor-associated antigens (TAAs) and local immune suppressive and regulatory pathways; ii) biological parameters for early diagnosis of relapse; iii) the effect of therapies on the shaping of anti-tumor immune responses.\n\nData collected will be instrumental for the generation of novel advanced therapy medicinal products (ATMPs). Indeed, this protocol is part of a multi-partner translational program, supported by the AIRC 5 per Mille 2019 grant, focused on the development, validation, and implementation of clinical testing for ATMPs to ameliorate the cure of CRC and PDAC, and possibly to help the study of other solid tumors.\n\nMoreover, the systematic and long-term follow-up of enrolled patients will possibly point to early predictors of differential prognosis and patients' categories eligible for tailored therapies, including those with the novel ATMPs.\n\nIn this regard, two additional substudies were incorporated into the main LiMeT protocol in July 2024 and January 2026, respectively, supported by supplementary funding: 1) the TREATLIVMETS (Treating Liver Metastasis) project, funded by the European Research Council (ERC) under the Horizon Europe research and innovation program; 2) the \"Deciphering and targeting the immunological niche in PDAC\" project, funded by the Fondazione Regionale per la Ricerca Biomedica (FRRB) under the \"From Bed to Bench 2024\" call. In the latter substudy, machine learning will be integrated with the spatial multi-omic profiling of the immune landscape in preneoplastic and neoplastic lesions in a subset of IPMN and PDAC patients, supporting the discovery of new therapeutic targets and enabling the early detection of preneoplastic lesion progression.",[154,155,29,156],"Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Cancer (CRC)","IPMN, Pancreatic",[158,31,159,160,161,162,163,164,165,166,167,168,169,170],"Pancreatic ductal adenocarcinoma","PDAC","CRC","Liver metastases","Tumor microenvironment","Immunosuppression","Immune therapy","Cell therapy","Gene therapy","Tumor infiltrating lymphocytes","ATMP","Intraductal Papillary Mucinous Neoplasms","IPMN","2026-03-31",{"date":173,"type":45},"2026-04-06",{"date":175,"type":45},"2019-11-06",{"date":177,"type":21},"2030-06-30",{"name":179,"class":52},"IRCCS San Raffaele",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":81},"100617112","phase-1-nh002-mediated-sonoporation-with-chemotherapy-in-advanced-pancreatic-cancer-100617112","NCT07314385","NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer","A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis","Inclusion Criteria:\n\n1. Dated and signed informed consent\n2. Either sex, aged 18 to 80 years old (inclusive) at the date of consent\n3. With histologically or cytologically confirmed PDAC\n4. With life expectancy at least 12 weeks\n5. Two or more liver metastatic lesions; of them, at least one lesion with the longest diameter (measured on computed tomography \\[CT\\] or Magnetic resonance imaging \\[MRI\\]) at least 1 cm and not more than 5 cm as well as a depth not more than 7 cm from the skin to the lesion center, and considered feasible for sonoporation by the investigator\n\n   \\- Note: The number of liver metastatic lesions with the longest diameter at least 1 cm should be no more than 10.\n6. Has failed frontline gemcitabine-based chemotherapy and is prepared for an application of NHI-reimbursed nal-IRI, LV, and 5-FU treatment\n7. Has not received previous radiotherapy, local therapy (e.g., radiofrequency ablation, irreversible electroporation, etc.), or cell therapy (autologous or allogenic) for PDAC\n8. Has recovered from all treatment-related toxicities or resolved to no greater than grade 1, based on common terminology criteria for adverse events (CTCAE) v.5.0, before enrollment\n9. With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n10. With adequate hematology function at screening, defined as:\n\n    * White blood cell (WBC) at least 3,500\u002Fmm3\n    * Absolute neutrophil count (ANC) at least 1,500\u002Fmm3\n    * Hemoglobin at least 10.0 g\u002FdL\n    * Platelet at least 100,000\u002Fmm3\n    * Prothrombin time (PT) not more than 1.5 fold upper limit of normal (ULN)\n    * Activated partial thromboplastin time (aPTT) not more than 1.5 fold ULN\n    * International normalized ratio (INR) of PT not more than 1.5 fold ULN\n11. With adequate hepatic function at screening, defined as:\n\n    * Total bilirubin not more than 2 fold ULN and 2.0 mg\u002FdL\n    * Alanine transaminase (ALT) and aspartate transaminase (AST) not more than 5 fold ULN and 200 U\u002FL\n12. With adequate renal function at screening, defined as:\n\n    * Serum Creatinine not more than 1.2 mg\u002FdL\n    * Creatinine clearance at least 50 mL\u002Fmin (Cockroft-Gault formula)\n13. Women of childbearing potential, including those experiencing chemical menopause or absence of menstruation for medical reasons, must consent to use at least two contraceptive precautions, one of which must be a condom or other adequate barrier method, and refrain from breastfeeding from informed consent until at least 5 months after the final dose of investigational product.\n14. Men must consent to use at least one contraceptive precaution from the initiation of the study treatment until at least 3 months after the final dose of the investigational product\n\nExclusion Criteria:\n\n1. Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days before screening\n2. Presence of diarrhea at least grade 2 based on CTCAE v.5.0\n3. Concomitant systemic infection requiring treatment\n4. Clinically significant co-morbid medical conditions, including cardiovascular disease, such as:\n\n   * Myocardial infarction within 180 days before screening\n   * Uncontrollable angina pectoris within 180 days before screening\n   * New York Heart Association (NYHA) Class III or IV congestive heart failure\n   * Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure at least 150 mmHg or diastolic blood pressure at least 90 mmHg lasting 24 hours or more)\n   * Arrhythmia requiring treatment\n5. Prior organ allograft or allogeneic bone marrow transplantation\n6. Received immunosuppressants within 28 days before screening or have received systemic steroid of equivalent dosage higher than prednisolone 30 mg\u002Fday for more than 7 days within 14 days prior to Cycle 1 Day 1\n7. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome\n8. Moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment\n9. Central nervous system metastasis\n10. Prior or concurrent malignancy other than PDAC within the last 3 years, except for carcinoma in situ of the cervix or basal type skin cancer\n11. Any major surgery within 4 weeks before screening. Patients must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before Cycle 1 Day 1\n12. Pregnant women or nursing mothers, or positive pregnancy tests at screening\n13. Severe mental disorder which may affect the subject s compliance to the study protocol, as judged by the investigator\n14. Prior history of allergy to agents that is similar to IP such as any MB ultrasound contrast agents or IRI or LV or 5-FU\n15. Judged by the principal investigator (PI) or sub-investigators to be inappropriate for participation in this study\n16. Known or suspected hypersensitivity reactions to NH002-related phospholipids or polyethylene glycol (PEG), including prior reactions to common PEG-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)\n17. Known or suspected hypersensitivity reactions to one or more of the ingredients of NH002, Definity, or other perflutren-containing echocardiographic contrast agent.\n18. Clinically unstable cardiopulmonary conditions, including but not limited to obstructive lung disease, cardiac shunt abnormalities, or arteriovenous shunt abnormalities, considered not suitable for participation in the trial, in the judgment of the investigator\n\n    \\-",{"count":188,"type":21},24,[126],"This is a phase I study that will enroll patients with pancreatic cancer and liver metastasis who have failed prior gemcitabine-based chemotherapy. Patients will be treated with nanoliposomal irinotecan plus 5-FU and leucovorin and NH002-based sonoporation to the liver metastasis.",[192,29],"Pancreatic Adenocarcinoma Metastatic",[194,195,196,197],"pancreatic adenocarcinoma","liver metastasis","sonoporation","nanoliposomal irinotecan","2025-12-17",{"date":200,"type":45},"2026-01-02",{"date":202,"type":21},"2026-01-01",{"date":204,"type":21},"2027-12-31",{"name":206,"class":52},"National Taiwan University Hospital",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100612641","phase-2-a-clinical-trial-of-envafolimab-combined-with-lenvatinib-for-kidney-cancer-with-liver-spread-100612641","NCT07256223","A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread","A Single-Arm, Multicenter, Prospective Clinical Study of Envafolimab Combined With Lenvatinib as First-Line Therapy in Renal Cell Carcinoma Patients With Liver Metastases","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in the study:\n\nProvide written informed consent prior to any study-specific procedures.\n\nAged between 18 and 75 years, inclusive.\n\nHistologically confirmed clear cell renal cell carcinoma with radiologically documented liver metastases, and having received no prior systemic antitumor therapy.\n\nPresence of at least one measurable liver metastasis lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (with the longest diameter ≥ 10 mm on computed tomography scan for non-lymph node lesions).\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nLife expectancy of ≥ 3 months.\n\nVoluntarily agree to participate in the study with good compliance.\n\nAdequate organ and bone marrow function, defined as follows:\n\nHematological:Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count (PLT) ≥ 70 × 10⁹\u002FL; Hemoglobin (HGB) ≥ 90 g\u002FL.\n\nHepatic:Serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; Serum albumin ≥ 28 g\u002FL; Alkaline phosphatase (ALP) ≤ 5 × ULN. (Subjects who meet the above criteria after conventional liver-protecting therapy and remain stable for at least one week, as assessed by the investigator, may be enrolled.)\n\nRenal:Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 50 mL\u002Fmin (using the standard Cockcroft-Gault formula).\n\nCoagulation:International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. (For subjects receiving anticoagulant therapy, enrollment is permitted if the PT and INR are within the therapeutic range intended by the anticoagulant medication.)\n\nExclusion Criteria:\n\nHistory of or concurrent other malignancies, except for appropriately treated carcinoma in situ or non-melanoma skin cancer with evidence of cure.\n\nPrior systemic antitumor therapy for advanced disease (including antiangiogenic agents and immunotherapy), with the exception of palliative radiotherapy or preoperative PD-1 neoadjuvant therapy.\n\nPresence of metastatic lesions meeting any of the following: unifocal organ metastasis numbering more than 3, or total systemic metastatic foci exceeding 5.\n\nKnown history of hypersensitivity to any component of the investigational drug products.\n\nPoorly controlled cardiac symptoms or diseases, including: (1) heart failure of New York Heart Association (NYHA) Class II or higher; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n\nActive infection, or unexplained fever \\> 38.5°C occurring during the screening period or before the first dose (subjects with fever determined by the investigator to be tumor-related may be enrolled).\n\nAdministration of live vaccines within 4 weeks prior to the first dose of study treatment or anticipated during the study period.\n\nHistory of substance abuse, drug addiction, or chronic alcohol abuse.\n\nAny condition that, in the judgment of the investigator, would preclude participation in the study. This includes severe concomitant conditions (including psychiatric disorders) requiring treatment, significant laboratory abnormalities, or social\u002Ffamilial factors that could compromise subject safety or adherence to protocol requirements, including data and sample collection\n\n.\n\nActive hepatitis B infection.\n\nActive systemic autoimmune diseases.",{"count":92,"type":21},[24],"This is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.",[218,29],"Clear Cell Renal Cell Cancer (ccRCC)","2025-11-20",{"date":221,"type":45},"2025-12-01",{"date":221,"type":21},{"date":224,"type":21},"2028-05-30",{"name":226,"class":52},"Fudan University",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100602058","phase-2-hyperthermia-combined-with-immune-checkpoint-inhibitors-in-the-treatment-of-advanced-gastrointestinal-malignancies-with-liver-metastases-100602058","NCT07118566","Hyperthermia Combined With Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies With Liver Metastases","Hyperthermia Combined With Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies With Liver Metastases: A Multicenter, Open-label, Dual-cohort Phase II Exploratory Clinical Study","Inclusion Criteria:\n\n* Age between 18 and 75 years, male or female.\n* Histologically or cytologically confirmed diagnosis of gastrointestinal malignancy with liver metastases.\n* Prior treatment requirements:\n\nGastric cancer patients must have received at least one prior line of systemic therapy.\n\nColorectal cancer patients must have received at least two prior lines of systemic therapy.\n\n* Clinically assessed as suitable for hyperthermia combined with immune checkpoint inhibitor therapy.\n* At least one measurable lesion meeting RECIST 1.1 criteria.\n* Expected survival ≥6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Adequate organ and bone marrow function.\n* Willingness to provide sufficient baseline and post-treatment samples, ability to comply with long-term follow-up and evaluation, and signed informed consent.\n* No prior history of other malignancies.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Any comorbidities or underlying medical conditions that, in the investigator's judgment, render the patient unsuitable for study participation.\n* Presence of other severe physical or psychiatric disorders, or clinically significant laboratory abnormalities that may increase the risk associated with study participation, interfere with study results interpretation, or otherwise make the patient inappropriate for inclusion as determined by the investigator.",{"count":235,"type":21},40,[24],"This study aims to explore the synergistic antitumor effects and safety of hyperthermia combined with immune checkpoint inhibitors (ICIs) in patients with advanced gastrointestinal malignancies with liver metastases. Liver metastasis represents a common cause of treatment failure in gastrointestinal cancers, and the response rate to ICIs remains suboptimal in certain patients with liver metastases, potentially attributable to the immunosuppressive hepatic microenvironment. The combination of hyperthermia with ICIs, chemotherapy, or other therapeutic modalities may further enhance treatment efficacy. Hyperthermia could potentially reverse immunosuppression and improve ICI effectiveness through mechanisms including enhanced tumor blood perfusion, promoted antigen presentation, and increased immune cell infiltration. This multicenter, open-label, dual-cohort phase II trial will evaluate patients stratified by tumor type (colorectal cancer versus gastric cancer) to assess the objective response rate (ORR), progression-free survival (PFS), and safety profile of hyperthermia-ICI combination therapy. Concurrently, dynamic monitoring of peripheral immune markers (such as neutrophil-to-lymphocyte ratio and interleukins) and tumor microenvironment alterations will be conducted to identify potential predictive biomarkers, thereby providing preliminary evidence for subsequent phase III investigations. The ultimate objective is to develop more effective combination treatment strategies for patients with advanced gastrointestinal malignancies accompanied by liver metastases.",[239,65,29],"Gastrointestinal Cancer",[241,242,195,243],"gastrointestinal cancer","immunotherapy","hyperthermia","2025-08-07",{"date":246,"type":45},"2025-08-12",{"date":248,"type":21},"2025-08-15",{"date":250,"type":21},"2029-09",{"name":252,"class":52},"China Medical University, China",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":278,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":81},"100593065","phase-1-intra-tumoral-it-injection-of-vvdd-hil2-2-rg-1-for-metastatic-gastrointestinal-and-peritoneal-tumors-100593065","NCT07001592","Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors","A Phase I Dose-Escalation Trial of vvDD-hIL2-2-RG-1 (Vaccina Virus Double Deleted) Administered by Intra-tumoral (IT) Injection for Metastatic Gastrointestinal and Peritoneal Tumors","RIOT3","Inclusion Criteria:\n\n1. Males or females age, 18 to \\\u003C 70 years at the time of consent\n2. Histologically confirmed metastases from gastrointestinal tumors with molecular determinants for MSI and KRAS.\n3. For microsatellite stable (MSS) tumors, subjects must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy. For microsatellite instability-high (MSI-H) tumors, subjects must also have failed (or be ineligible for) systemic immunotherapy.\n4. Karnofsky Performance Status (KPS) of \\> 70\n5. Anticipated survival of at least 12 weeks.\n6. Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures (subject or subject's legally authorized representative (LAR) must have the ability to understand and willingness to sign a written informed consent).\n7. Adequate bone marrow function: WBC \\> 2,000 and \\\u003C50,000 cells\u002Fmm3, ANC \\> 1,000 cells\u002Fmm3, hemoglobin \\>8 g\u002FdL, and platelet count \\>100,000 cells\u002Fmm3.\n8. Adequate renal function: serum creatinine level ≤ 2xULN\n9. Adequate liver function: Serum bilirubin \\\u003C 1.5 x ULN\n10. Acceptable coagulation status: INR \\\u003C ULN +15%. All patients must be able to suspend anticoagulant therapy for study specific biopsies and intra-tumoral injection.\n11. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have negative serum or urine pregnancy test.\n12. If sexually active, to prevent pregnancy and to prevent the spread of virus, subject must use an acceptable method of contraception as well as barrier contraception from screening through 6 weeks following study treatment with vvDD-hIL-2-RG-1.\n13. Subjects must be willing to comply with all study procedures, requirements, adhere to post-treatment care instructions and follow-up examinations.\n14. Have measurable disease based on RECIST 1.1 criteria.\n15. Have at least one tumor at least 1 cm in diameter amenable to safe intra-tumoral injection.\n\nExclusion Criteria:\n\n1. Pregnant or nursing an infant.\n2. Systemic corticosteroid or other immunosuppressive medication use within 2 weeks of the study treatment.\n3. Significant immunodeficiency (e.g. due to underlying illness and\u002For medication) in subject or household contacts (must be able to avoid household contact with immunodeficient person for 3 weeks).\n4. Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment, per investigator discretion.\n5. Active eczema or psoriasis or other inflammatory skin conditions\n6. Unstable cardiac disease which includes but is not limited to any of the following within 6 months prior to study entry: myocardial infarction (MI), unstable angina, congestive heart failure, myocarditis, ventricular arrhythmias diagnosed and requiring medication.\n\n   * New York Heart Association functional class III-IV heart failure on active treatment\n   * Pulse oximetry of \\\u003C 90% in room air at rest\n7. Subjects who have received radiation, chemotherapy or other potentially immunosuppressive therapy within 2 weeks prior to study screening and within 4 weeks prior to anticipated vvDD-hIL-2-RG-1 treatment.\n8. Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination.\n9. Subjects who, in the opinion of the Investigator, have a medical condition that would subject the subject to prohibitive risk by participation in this study, or who may be unable to safely complete the required tumor biopsies.\n10. Subjects with household contacts who are children \\\u003C 5 years old, have active eczema, psoriasis or other inflammatory skin conditions or have a significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus) and\u002For medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the subject's active dosing period and for three weeks following the study medication.\n11. Vaccination with a live virus in the previous 60 days prior to Day 0.\n12. Inability or unwillingness to give informed consent.\n13. Is unable or unwilling to comply with protocol follow-up requirements. -","69 Years",{"count":263,"type":21},18,[126],"This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each level.\n\nvvDD-hIL2 is a genetically modified vaccinia virus, derived from the virus previously used for smallpox vaccination. The modification is intended to target and destroy tumors while minimizing harm to healthy tissues by stimulating the body's immune response.\n\nParticipants will receive an injection of vvDD-hIL2 directly into their abdominal tumors at AHN West Penn. The study team will monitor for side effects and assess tumor response to the treatment.\n\nActive participation will last up to two months, involving seven clinic visits and approximately four lab visits at AHN West Penn Hospital. Visits will include standard of care procedures as well as study-specific tests and exams. Most visits will last one to two hours, with some extending to two to three hours. The drug administration day will require a twelve-hour visit.\n\nEffectiveness and side effects will be evaluated through blood draws, oral swabs, urinalysis and tissue biopsies. Tissue samples will be used for genomic analysis and stored for potential future research. Data collected may also be used for future research purposes.\n\nPrevious human trials of vvDD-hIL2 have reported side effects such as pain, rash or inflammation at the injection site, low-grade fevers, flu-like symptoms, and fatigue. There is a rare risk of rash transmission to close contacts with skin openings, and information on limiting contact and managing rash development will be provided.",[267,268,269,29,270,271,272,273,274,275,276,277],"Gastric Neoplasms","Esophageal Cancer","Liver Cancer","MSS-CRC","MSS","Gastric Adenocarcinoma","Peritoneal Cancer","Peritoneal Carcinoma","Peritoneal Metastases","MSI-H","Gastric Cancer",[279,280,242,281,282],"Oncolytic virus","vaccinia","intra-tumoral","intra-peritoneal","2025-06-02",{"date":285,"type":45},"2025-06-03",{"date":287,"type":45},"2025-05-06",{"date":289,"type":21},"2028-05",{"name":291,"class":52},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":81},"100446854","phase-2-cryoablation-combined-with-sintilimab-plus-lenvatinib-in-previously-treated-unresectable-liver-metastasis-from-solid-tumors-100446854","NCT05098847","Cryoablation Combined with Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis from Solid Tumors","A Phase II Study of Cryoablation Combined with Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis from Solid Tumors (CASTLE-04)","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at time of study entry.\n* Participants must have unresectable liver metastasis from solid tumors.\n* Participants must have progressed after, or were refractory to first- or later-line therapy in the liver metastatic setting.\n* Participants who had received previous antiangiogenic or anti-epidermal growth factor receptor (EGFR) therapy were eligible.\n* At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.\n* Performance status (PS) ≤ 2 (ECOG scale).\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥75 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula )\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* Prior treatment with cryoablation.\n* RFA and resection administered less than 4 weeks prior to study treatment start.\n* Radiotherapy administered less than 4 weeks prior to study treatment start.\n* Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:\n\n  1. history of interstitial lung disease\n  2. Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)\n  3. known acute or chronic pancreatitis\n  4. active tuberculosis\n  5. any other active infection (viral, fungal or bacterial) requiring systemic therapy\n  6. history of allogeneic tissue\u002Fsolid organ transplant\n  7. diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of monotherapy treatment.\n  8. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.\n  9. Live vaccine within 30 days prior to the first dose of Sintilimab treatment or during study treatment.\n  10. History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of Sintilimab treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":300,"type":21},25,[24],"The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib for patients with unresectable liver metastasis, who had progressed after, or were refractory to first- or later-line therapy.",[29],"2025-02-25",{"date":306,"type":45},"2025-02-27",{"date":308,"type":45},"2021-10-29",{"date":310,"type":21},"2025-10-30",{"name":226,"class":52},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":4},"100562920","the-role-and-safety-of-radiofrequency-ablation-in-recurrent-liver-metastasis-of-colorectal-cancer-100562920","NCT06609434","The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer","The Role and Safety of Radiofrequency Ablation in the Multidisciplinary Treatment of Intrahepatic Recurrence After Colorectal Cancer Liver Metastasis Surgery","Inclusion Criteria:\n\n1. Patients with colorectal cancer whose primary lesions have been resected or can be controlled;\n2. Multiple confined lesions in the liver, the number of which can be defined;\n3. The liver contains at least 2 lesions suitable for radiofrequency ablation;\n4. The maximum diameter of the intrahepatic tumor is \\\u003C5 cm;\n5. The location of the hepatic lesion does not show obvious invasion with neighboring organs or large blood vessels;\n6. No extrahepatic metastases or stable extrahepatic metastases;\n7. Re-operative hepatic surgical resection is not indicated or refused;\n8. Ultrasound or ultrasonography can show intrahepatic lesions;\n9. The patient and his\u002Fher family request active treatment;\n10. Voluntary informed consent;\n11. Male or female at least 18 years of age;\n12. Platelet count \\>50, 000\u002Fmm3 and prothrombin activity \\>50%;\n13. Subjects are willing to return to the study center for study follow-up;\n14. Life expectancy ≥ 6 months.\n\nExclusion Criteria:\n\n1. Suffering from, but not limited to, the following serious illnesses: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening cardiac arrhythmia within the last 6 months;\n2. Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test prior to receiving study treatment;\n3. Known hypersensitivity to any of the intravenous imaging agents that will be used in the study;\n4. Have portal or hepatic vein tumor infiltration\u002Fcancer embolism;\n5. Prothrombinogen international normalized ratio \\>1.5 times the upper limit of normal (UNL) at the study center;\n6. Platelet count \\\u003C50, 000\u002Fmm3, absolute neutrophil count \\\u003C1500\u002Fmm3, or hemoglobin value \\\u003C10.0 g\u002FdL;\n7. Serum creatinine ≥ 2.5 mg\u002FdL or calculated creatinine clearance (CrCl) ≤ 25.0 ml\u002Fmin;\n8. Serum bilirubin \\>3.0 mg\u002FdL;\n9. Serum albumin \\\u003C2.8 g\u002FdL;\n10. Body temperature \\>101°F (38.3°C) immediately prior to study treatment;\n11. Being treated with other investigational drugs;\n12. Heart failure NYHA functional class III or IV.\n13. Any other circumstances that the investigator deems inappropriate for enrollment.",{"count":320,"type":21},111,[94],"The goal of this clinical trial is to learn if radiofrequency ablation works to treat recurrent colorectal cancer liver metastases after surgery in adults. It will also learn about the safety of radiofrequency ablation. The main questions it aims to answer are:\n\nIs radiofrequency ablation safe and effective in the treatment of recurrent colorectal cancer liver metastases? What medical problems do participants have when treating with radiofrequency ablation? Does radiofrequency ablation enable patients with recurrent colorectal cancer liver metastases to live longer? Researchers will compare systemic therapy combined with radiofrequency ablation to systemic therapy to see if radiofrequency ablation works to treat liver metastases better.\n\nParticipants will:\n\nReceive systemic treatment for colorectal cancer liver metastases. Undergo (or not) radiofrequency ablation for colorectal cancer liver metastases.\n\nVisit the hospital once every 3 months for checkups and tests.",[324,29],"Colo-rectal Cancer",[326,29,327],"Colo-rectal cancer","radiofrequency ablation","2024-09-25",{"date":330,"type":45},"2024-09-27",{"date":332,"type":21},"2024-10",{"date":334,"type":21},"2026-12",{"name":336,"class":52},"Peking University Cancer Hospital & Institute",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":81},"100169467","liver-transplantation-and-colorectal-cancer-100169467","NCT01479608","Liver Transplantation and Colorectal Cancer","A Randomized Controlled Clinical Trial to Evaluate the Benefit and Efficacy of Liver Transplantation as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma","Inclusion Criteria:\n\n* Histologically verified adenocarcinoma in colon or rectum.\n* No signs of extra hepatic metastatic disease or local recurrence according to PET\u002FCT scan.\n* No signs of extra hepatic metastatic disease or local recurrence according to CT or MR (thorax\u002Fabdomen\u002Fpelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit\n* No signs of local recurrence judged by colonoscopy \u002F CT colography within 12 months prior to the faculty meeting at the transplant unit\n* Good performance status, ECOG 0 or 1.\n* Satisfactory blood tests Hb \\>10g\u002Fdl, neutrophiles \\>1.0 (after any G-CSF), TRC \\>75, Bilirubin\\\u003C2 x upper normal level, ASAT,ALAT\\\u003C5 x upper normal level, ,Creatinine \\\u003C1.25 x upper normal level. Albumin above lower normal level.\n* Standard surgical procedure with adequate resection margins including circumferential resection margins (CRM) of at least ≥2mm for rectal cancer patients.\n* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national\u002Flocal regulations.\n* Received at least 3 cycles of chemotherapy (6 weeks of treatment), with no increase in size of the lesions according to RECIST-criteria\n\nAdditional inclusion criteria for patients included in part A:\n\n\\- Six or more liver metastases technically resectable\n\nAdditional inclusion criteria for patients included in part B:\n\n* Metachronous liver metastases (more than 12 months from diagnosis of CRC and\u002For end of adjuvant treatment)\n* Pathological classification of primary tumor as pN0 disease.\n* CEA\\\u003C100 ng\u002Fml at time of primary diagnosis as well as at time of diagnosis of metastatic disease.\n* Liver metastases not eligible for curative liver resection.\n* Before start of 1. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less.\n* At least 10% response (RECIST-criteria) on 1. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 1. line chemotherapy.\n\nAdditional inclusion criteria for patients included in part C:\n\n* Liver metastases not eligible for curative liver resection.\n* Received 1.line treatment.\n* Before start of 2. or 3. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less.\n* At least 10% response (RECIST-criteria) on 2. or 3. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 2. or 3. line chemotherapy.\n* Two years or more time span from the CRC diagnosis and date of being listed on the transplantation list.\n\nAdditional inclusion criteria for patients included in part Arm D:\n\nPatients with expected overall survival of 6-12 months without a liver transplant.\n\nThe patient might be included without further chemotherapy treatment. Patients may have resectable pulmonary lesions at time of inclusion in the present study.\n\nExclusion Criteria:\n\n* Weight loss \\>10% the last 6 months\n* Patient BMI \\> 30\n* Other malignancies\n* Prior extra hepatic metastatic disease or local relapse.\n* Patients who have not received standard pre-operative, per-operative or post-operative treatment for the primary CRC.\n* Palliative resection of primary CRC tumor.\n* Previous randomization in this trial.\n* Any reason why, in the opinion of the investigator, the patient should not participate.",{"count":300,"type":21},[94],"Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.\n\nThe investigators have previously included 21 patients in a pilot study. All patients had advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously reported outcome for this patient group and is comparable or better than survival following repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further improve the results.\n\nThe investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection.\n\nThe investigators will also explore if patient selection according to nomo-grams for outcome of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50% or even cure from the disease.",[28,29],"2024-02-05",{"date":350,"type":45},"2024-02-07",{"date":352,"type":45},"2012-04-11",{"date":354,"type":21},"2027-12",{"name":356,"class":52},"Oslo University Hospital",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":81},"100466872","phase-2-a-combination-therapy-including-anti-pd-1-immunotherapy-in-mss-rectal-cancer-with-resectable-distal-metastasis-100466872","NCT05359393","A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis","Radiotherapy Followed by Chemotherapy and Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Liver\u002F Pulmonary Metastasis(Miracle-1): A Prospective, Single Arm, Multi-Center, Phase II Clinical Trial","Miracle-1","Inclusion Criteria:\n\n* Age 18\\~75;\n* Patient signs informed consent;\n* ECOG score 0\\~1;\n* Initial colonoscopy and pathology: adenocarcinoma;\n* MRI: rectal cancer located less than 10cm from the anus;\n* Imaging confirms that there are measurable metastases in the liver or lung, which are evaluated as NED acceptable by MDT discussion;\n* no previous treatment;\n* Patients have adequate organ function;\n* No contraindications to surgery or chemoradiation;\n* The relevant test results within 7 days before the first dose must meet the following requirements:\n\n  1. Blood routine examination (no blood transfusion within 7 days before screening, no correction with hematopoietic stimulating factor drugs):\n\n     * Hb≥90g\u002FL\n     * ANC≥1.5×10\\^9\u002FL; LC≥0.5×10\\^9\u002FL;\n     * PLT≥100×10\\^9\u002FL;\n     * WBC≥3.0×10\\^9\u002FL, ≤15×10\\^9\u002FL;\n  2. Blood chemistry (no blood transfusion or albumin within 7 days prior to screening):\n\n     * ALT, AST≤1.5 ULN;\n     * ALP≤2.5 ULN;\n     * TBIL≤1.5 ULN;\n     * Cr≤1.5 ULN, CrCL≥50 mL\u002Fmin;\n     * PT, APTT≤1.5 ULN, INR≤1.5 ULN(not receiving anticoagulation);\n  3. TSH is within the normal range; if TSH is out of the normal range, FT3 and FT4 should be investigated. If the test results of FT3\u002FFT4 cannot be obtained, T3 and T4 can be accepted. If the level of T3\u002FT4 is normal, the patients can be selected.\n  4. Urine test: urine protein\\\u003C2+; if the urine protein≥2+, the 24-hour urine protein quantification must be≤1g;\n  5. Echocardiography: LVEF≥55%;\n  6. 12-lead ECG: Fridericia corrected QTcF\\\u003C470 msec.\n* Expected survival time \\>6 months;\n* The gene status of KRAS, NRAS, BRAF and HER2 is clear;\n* Patients with microsatellite stability or mismatch repair protein defects;\n* Patients are willing and able to follow the protocol during the study, including receiving treatment and scheduled follow-up and examination.\n\nExclusion Criteria:\n\nPatients will not be accepted into this study if they meet any of the following criteria:\n\n1\\. History of tumor-related disease and treatment:\n\n1. Age \\\u003C18 or \\>75 years;\n2. other malignancy within 5 years, except adequately treated carcinoma in situ of the cervix or squamous cell carcinoma of the skin, or largely controlled basal cell carcinoma of the skin;\n3. malignant pleural effusion or malignant ascites;\n4. patients with severe medical comorbidities that preclude radiotherapy and surgery;\n5. previously treated;\n6. clinical or radiological evidence of spinal cord compression or a tumor within 3mm of the spinal cord on MRI\n7. the presence of distant metastases besides the liver and lungs, including brain, bone, ovarian, peritoneal and retroperitoneal multiple lymph node metastases;\n8. Patients who are considered suitable for using intense systemic treatment to achieve conversion after MDT discussion;\n9. pathological diagnosis of indolent cell carcinoma;\n10. patients with microsatellite instability or dMMR;\n11. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. that require emergency surgical resection;\n\n2\\. Co-morbidities and treatment history:\n\n1. Presence of immunodeficiency disorders, including primary immunodeficiency disorders (e.g. caused by genetic factors) or secondary immunodeficiency disorders (e.g. caused by HIV infection or treatment related to immunological agents, etc.);\n2. Presence of any autoimmune disease that still requires treatment or a previous history of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, rheumatic heart valve disease, glomerulonephritis, etc. Excluding hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy and type I diabetes with manageable and stable blood glucose;\n3. known or suspected interstitial pneumonia; other moderate to severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function, including idiopathic pulmonary tissue fibrosis, mechanized pneumonia\u002Focclusive fine bronchitis, etc.;\n4. severe cardiovascular disease, including but not limited to conditions meeting NYHA criteria (Class III or higher), or myocardial infarction or cerebrovascular accident (cerebral ischaemia, symptomatic cerebral infarction, etc.) occurring within 3 months prior to the first dose, or unstable arrhythmia or unstable angina pectoris with coronary artery disease occurring within 1 month prior to the first dose, or congestive heart failure, or pre-existing symptomatic superior vena cava syndrome, etc.;\n5. an arteriovenous thrombotic event, such as deep vein thrombosis and pulmonary embolism, within the previous 3 months;\n6. history of live attenuated vaccination within 28 days prior to the first study dose or anticipated need for live attenuated vaccination during the study;\n7. active hepatitis B (defined as positive hepatitis B virus surface antigen \\[HBsAg\\] test result and HBV-DNA test value ≥ 500 IU\u002Fml);\n8. Hepatitis C (defined as a positive test result for hepatitis C virus antibody \\[HCV-Ab\\]) ;\n9. history of tuberculosis infection or treatment within 1 year prior to signing informed consent;\n10. presence of severe infection within 4 weeks prior to first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; or active infection requiring systemic antibiotic therapy according to NCI-CTCAE v5.0 grade ≥ 2 within 2 weeks prior to first dose, or unexplained fever \\>38.5°C during screening\u002Fprior to first dose (at the investigator's discretion, due to oncologic causes fever due to tumor causes may be enrolled);\n11. previous allogeneic bone marrow transplantation or solid organ transplantation received or intended to be received;\n12. Hemoptysis with a maximum daily hemoptysis of approximately ≥2.5 ml within 2 months prior to signing informed consent; clinically significant bleeding symptoms or a clear bleeding tendency within 1 month prior to signing informed consent, e.g. gastrointestinal bleeding, bleeding gastric ulcer, fecal occult blood ++ at baseline, vasculitis; known hereditary or acquired bleeding and thrombotic tendencies, e.g. hemophilia, impaired coagulation skills, thrombocytopenia, hypersplenism, etc.;\n13. abnormal coagulation (INR \\> 1.5 or APTT \\> 1.5 × ULN) with bleeding tendency or undergoing thrombolysis or requiring long-term anticoagulation with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday)\n14. peripheral neuropathy ≥ grade 2 according to NCI-CTCAE v5.0;\n15. Co-morbidities of other infectious diseases that are not suitable for participation in this study.",{"count":366,"type":21},52,[24],"Although patients with locally advanced rectal cancer and resectable liver\u002Fpulmonary metastasis could benefit from surgery resection, these patients still have a poorer prognosis compared to those without distal metastasis. Based on previous studies, there is no confirmation of whether these patients could benefit from preoperative immunotherapy combined with conventional chemoradiotherapy. This study proposes a combination therapy, preoperative short-course radiotherapy followed by neoadjuvant chemotherapy and anti-PD-1 immunotherapy, for microsatellite-stable patients with locally advanced rectal cancer and resectable liver\u002Fpulmonary metastasis, to assess its impact on tumor retreat, decline of postoperative metastasis and recurrence, and the disease-free survival and overall survival of patients. Besides, this study will provide high-level medical evidence for future clinical treatment of patients with advanced rectal cancer.",[370,29,371,372],"Advanced Rectal Cancer","Pulmonary Metastasis","Microsatellite Stable Colorectal Carcinoma","2022-11-09",{"date":375,"type":45},"2022-11-14",{"date":377,"type":21},"2022-12-01",{"date":379,"type":21},"2027-09-01",{"name":226,"class":52}]