[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"digestive-system-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:digestive-system-neoplasms":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,55,83,115,142,166,188,218,238,257,273,313],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100610070","phase-3-symbiotic-gi-03-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-metastatic-colorectal-cancer-100610070",false,"NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis","ALL","18 Years",{"count":19,"type":20},800,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[26,27,28,29,30,31,32,33,34,35],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Colorectal Neoplasms",[37,38,39,40,41],"mCRC","metastatic disease","first-line","metastatic colorectal cancer","colon cancer","RECRUITING","2026-06-03",{"date":45,"type":46},"2026-06-04","ACTUAL",{"date":48,"type":46},"2025-12-11",{"date":50,"type":20},"2031-08-01",{"name":52,"class":53},"Pfizer","INDUSTRY",228,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100309067","phase-3-a-study-of-2nd-line-folfiri--bevacizumab-vs-irinotecan--bevacizumab-in-mcrc-100309067","NCT03303495","A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC","A Multinational, Randomized, Phase III Study of FOLFIRI With\u002FWithout Bevacizumab Versus Irinotecan With\u002FWithout Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.\n2. Age ≥18 years at the time of informed consent\n3. ECOG performance status (PS) of 0-2\n4. Written informed consent prior to study-specific screening procedures\n5. Life expectancy of at least 90 days\n6. Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy.\n7. Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neutrophil count: ≥1500\u002Fmm3 Platelet count: ≥10.0 x 104\u002Fmm3 Hemoglobin: ≥9.0 g\u002FdL Total bilirubin: ≤1.5 mg\u002FdL AST, ALT: ≤100 IU\u002FL (≤200 IU\u002FI if liver metastases present) Serum creatinine: ≤1.5 mg\u002FdL\n\nExclusion Criteria:\n\n1. History of other malignancy with a disease-free interval \\\u003C5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)\n2. With massive pleural effusion or ascites requiring intervention\n3. Radiological evidence of brain tumor or brain metastases\n4. Active infection including hepatitis\n5. Any of the following complication:\n\n   i) Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii) Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure) iii) Interstitial pneumonia or pulmonary fibrosis iv) Uncontrolled diabetes mellitus v) Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)\n6. Any of the following medical history:\n\n   Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes i) Serious hypersensitivity to any of the study drugs ii) History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency\n7. Previous treatment with irinotecan hydrochloride\n8. Current treatment with atazanavir sulfate\n9. Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment\n10. Pregnant or lactating females, and males and females unwilling to use contraception\n11. Requires continuous treatment with systemic steroids\n12. Psychiatric disability that would preclude study compliance\n13. Otherwise determined by the investigator to be unsuitable for participation in the study\n14. Concurrent gastrointestinal perforation or history of gastrointestinal perforation with 1 year before enrollment\n15. History of pulmonary hemorrhage\u002Fhemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within 1 month prior to enrollment.\n16. History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrollment\n17. Unhealed wound (except suture wounds from implantation of a central venous port), gastrointestinal ulcer, or traumatic fracture\n18. Current or recent (within 1 year) thromboembolism or cerebrovascular disease\n19. Currently receiving or requires anticoagulation therapy (\\> 325 mg\u002Fday of aspirin)\n20. Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)\n21. Uncontrolled hypertension\n22. Urine dipstick for proteinuria \\>+2",{"count":63,"type":20},280,[23],"The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.",[35,67,26,27,28],"Neoplasm Metastasis",[69,70,71,72],"FOLFIRI","CPT-11","Bevacizumab","2nd-line metastatic colorectal cancer",{"date":74,"type":46},"2026-06-05",{"date":76,"type":46},"2011-11-14",{"date":78,"type":20},"2026-12-31",{"name":80,"class":81},"Sun Yat-sen University","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":82},"100577113","efficacy-and-safety-of-multimodal-ablation-combined-with-pd-1-monoclonal-antibody-lenvatinib-and-tace-in-the-treatment-of-unresectable-primary-hepatocellular-carcinoma-a-single-arm-single-center-clinical-study-100577113","NCT06794073","Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study","Inclusion Criteria:\n\n1. Age 18-80 years, regardless of gender.\n2. Clinically or pathologically confirmed HCC.\n3. CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.\n4. Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \\>5 cm.\n5. Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..\n6. ECOG PS 0-1 and an expected survival \\>3 months.\n7. Child-Pugh score ≤7.\n\nExclusion Criteria:\n\n1. Child-Pugh class C liver dysfunction.\n2. Tumor thrombus in the main portal vein or hepatic vein.\n3. Extensive metastatic disease with an expected survival \\\u003C3 months.\n4. Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).\n5. History of esophageal\u002Fgastric variceal bleeding within the past month.\n6. History of other malignancies.\n7. Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \\\u003C1 month.\n8. Active infection; HBV co-infection (HBV DNA ≥2000 IU\u002FmL or ≥10⁴ copies\u002FmL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation.\n9. History of organ transplantation or hepatic encephalopathy.\n10. Uncorrectable coagulation disorders.\n11. Refractory massive ascites, pleural effusion, or cachexia.\n12. Pregnancy, impaired consciousness, or inability to comply with treatment.\n13. High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \\>12).\n14. Any other condition deemed unsuitable by investigators that may affect study participation.","80 Years",{"count":91,"type":20},17,[93],"NA","This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.",[96,97,98,28,99],"Carcinoma, Hepatocellular","Neoplasms, Glandular and Epithelial","Adenocarcinoma","Liver Neoplasms",[101,102,103,104,105],"Multimodal","Tislelizumab","lenvatinib","TACE","unresectable primary liver cancer","2026-05-08",{"date":108,"type":46},"2026-05-11",{"date":110,"type":46},"2026-01-31",{"date":112,"type":20},"2027-08-31",{"name":114,"class":81},"Shanghai Zhongshan Hospital",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":82},"100302760","eus-guided-rfa-for-solid-abdominal-neoplasms-100302760","NCT03221335","EUS-guided RFA for Solid Abdominal Neoplasms","Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.","Inclusion Criteria:\n\n* Age 18 years-old or above\n* Suffering from solid neoplasms of the stomach, liver, kidney or adrenals (\\\u003C5cm in largest diameter) that is indicated for treatment.\n* Unsuitable for surgery, due to one (or more) of the following items:\n\n  * ASA score \\> II\\*\n  * An alternative advanced malignancy\n  * Unsuitable for surgery upon expert's opinion for any other reason\n* Healthy individuals who are not keen for surgical resection\n* Eligible for endoscopic intervention\n* Written informed consent\n\nExclusion Criteria:\n\n* Coagulopathy (international normalized ratio \\>1.3, partial thromboplastin time greater than twice that of control), platelet count \\\u003C50,000x103\u002FuL\n* Pregnancy\n* Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study\n* Patients unwilling to undergo follow-up assessments\n* Patients with liver cirrhosis, portal hypertension and\u002For gastric varices.",{"count":123,"type":20},30,[93],"Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of solid abdominal neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic cancers.\n\nThe aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid abdominal neoplasms.",[28],[128,129,130,131,132],"EUS-guided RFA","liver","stomach","adrenal","kidney tumour","2026-03-19",{"date":135,"type":46},"2026-03-20",{"date":137,"type":46},"2016-05",{"date":139,"type":20},"2027-04",{"name":141,"class":81},"Chinese University of Hong Kong",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":82},"100624045","bioelectrical-impedance-analysis-for-perioperative-fluid-evaluation-in-colorectal-cancer-surgery-100624045","NCT07404527","Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery","Usefulness of Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation and Complication Prediction in Oncological Patients Undergoing Colorectal Surgery","Inclusion Criteria:\n\nAdult patients (≥18 years of age).\n\nHistologically confirmed head and neck cancer.\n\nIndication for induction chemotherapy followed by chemoradiotherapy with cetuximab.\n\nAdequate organ function as required by the study protocol.\n\nAbility to provide informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy or radiotherapy for head and neck cancer.\n\nPresence of uncontrolled comorbidities that would preclude study treatment.\n\nKnown hypersensitivity to cetuximab or components of the treatment regimen.\n\nPregnancy or breastfeeding.",{"count":150,"type":20},60,[93],"Sarcopenia is a complex syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength. In patients with cancer, sarcopenia is associated with poorer prognosis, increased treatment-related toxicity, higher postoperative complication rates, reduced response to therapy, and decreased quality of life. Importantly, sarcopenia may be present even in patients with preserved nutritional status or overweight.\n\nPatients with gastrointestinal cancers are at particularly high risk of developing sarcopenia, both as a consequence of the malignant disease itself and as a result of systemic anticancer treatment. Early identification of patients at risk is therefore essential in order to enable timely nutritional and supportive interventions.\n\nThe aim of this study is to evaluate the proportion of patients with gastrointestinal cancer who screen positive for sarcopenia risk using the SARC-F questionnaire before the start of systemic treatment and during treatment. Patients with a positive screening result will be referred for further clinical nutritional assessment and managed according to a multidisciplinary approach.",[154,28],"Gastrointestinal Cancer",[156],"SARC-F","2026-02-11",{"date":159,"type":46},"2026-02-13",{"date":161,"type":46},"2023-10-24",{"date":163,"type":20},"2026-03-31",{"name":165,"class":81},"Institute of Oncology Ljubljana",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100608052","phase-2-ip-rmhtnf-nc--tislelizumab--palliat-rt-for-git-tumor-malignant-ascites-after-failed-std-tx-100608052","NCT07196540","IP rmhTNF-NC + Tislelizumab + Palliat RT for GIT Tumor Malignant Ascites After Failed Std Tx","A Prospective, Non-Randomized, Two-Cohort Clinical Study of Intraperitoneal Injection of Recombinant Modified Human Tumor Necrosis Factor Combined With Tislelizumab and Palliative Radiotherapy in the Treatment of Malignant Ascites From Digestive Tract Tumors After Failure of Previous Standard Treatments","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years, regardless of gender. 2. Histologically or cytologically confirmed malignant ascites originating from digestive system tumors (confirmed by ascites cytology as malignant or clinically diagnosed as peritoneal metastases based on imaging and symptoms).\n\n  3\\. Presence of large-volume peritoneal metastatic lesions with radiotherapy indications as assessed by a Multidisciplinary Team (MDT) (Cohort A), including an abdominal mass with the longest diameter ≥ 5 cm, or masses invading structures such as the abdominal wall or intra-abdominal muscles causing symptoms like pain.\n\n  4\\. Moderate or greater amount of ascites, either (first-time treatment) or refractory to previous intraperitoneal therapy with conventional chemotherapeutic agents and\u002For biological response modifiers. Moderate ascites is defined as: ① Ascites depth ≥ 3 cm on supine ultrasound; ② Accompanied by clinical symptoms (such as chest tightness, shortness of breath, abdominal distension, and discomfort judged by the investigator to be related to ascites).\n\n  5\\. ECOG performance status of 0-2. 6. Expected survival time \\> 3 months. 7. Essentially normal cardiac and pulmonary function. 8. Adequate organ function, as evidenced by the following laboratory parameters:\n  1. Peripheral blood count: WBC ≥ 4.0 × 10⁹\u002FL, PLT ≥ 80 × 10⁹\u002FL, Hb ≥ 90 g\u002FL.\n  2. Renal function: Serum creatinine ≤ 2 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 ml\u002Fmin.\n  3. Liver function: Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); or Total bilirubin \\> ULN but with direct bilirubin ≤ ULN; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (ALT or AST ≤ 5 × ULN allowed for patients with liver metastases).\n  4. Adequate coagulation function, defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN.\n\n     9\\. Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels and clinical manifestations should be evaluated; patients can be enrolled if comprehensively assessed and not in an acute active phase.\n\n     10\\. For non-surgically sterilized or premenopausal female patients, use of a medically approved contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) is required during the study treatment period and for 6 months after the end of study treatment; Non-surgically sterilized premenopausal female patients must have a negative serum or urine HCG test within 7 days prior to study enrollment; must be non-lactating; For male patients with partners of childbearing potential, effective contraception should be used during the trial and for 6 months after the last dose of the study drug.\n\n     11\\. Voluntary participation in this study with good compliance, provision of written informed consent, and ability to cooperate with follow-up observations.\n\n     Exclusion Criteria:\n* 1\\. History of allergy to original tumor necrosis factor (TNF), its derivatives, or tislelizumab.\n\n  2\\. Diagnosis of malignancies other than digestive tract tumor within 5 years prior to the first dose (excluding radically cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has undergone radical resection).\n\n  3\\. Previous use of tumor necrosis factor (TNF) or its derivative drugs. 4. Significant tumor burden in other organs, and the investigator believes that enrollment in this study would be detrimental to the patient's disease control.\n\n  5\\. Treatment with any other investigational drugs within 7 days prior to the first dose, or participation in another interventional clinical trial; or receipt of anti-tumor drug therapy (including Chinese herbal medicine with anti-tumor indications) within 7 days before the first dose of the study drug.\n\n  6\\. Pregnant or breastfeeding women; women of childbearing potential unwilling to use contraception during the study period; or men unwilling to use effective contraception during treatment and for 1 year thereafter.\n\n  7\\. Significant impairment of vital organ function. 8. Patients with obvious bleeding tendency. 9. Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to the first dose, New York Heart Association (NYHA) Class III\u002FIV congestive heart failure, and uncontrolled arrhythmias (subjects with a pacemaker or atrial fibrillation with well-controlled heart rate are allowed).\n\n  10\\. Presence of ECG changes or history considered clinically significant by the investigator; QTcF interval \\> 480 ms during screening. For subjects with intraventricular conduction block (QRS interval \\> 120 ms), JTc interval may be used instead of QTc interval (if JTc is used instead of QTc, JTc must be ≤ 340 ms).\n\n  11\\. Uncontrolled hypertension (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg after optimal medical therapy), history of hypertensive crisis or hypertensive encephalopathy.\n\n  12\\. Presence of severe acute infection that is uncontrolled; current fever (\\> 38°C), or presence of purulent and chronic infections, or non-healing wounds.\n\n  13\\. Patients with radiologically confirmed encapsulated ascites; diagnosed abdominal infection.\n\n  14\\. Acute or chronic active hepatitis B or C infection: Hepatitis B virus (HBV) DNA \\> 2000 IU\u002FmL or 10⁴ copies\u002FmL; Hepatitis C virus (HCV) RNA \\> 10³ copies\u002FmL; co-infection with Hepatitis B surface antigen (HBsAg) and anti-HCV antibody positivity. Subjects can be enrolled if levels are below these criteria after nucleotide antiviral therapy; known history of human immunodeficiency virus (HIV) infection or positive HIV test.\n\n  15\\. History or evidence of significant bleeding tendency within 3 months prior to enrollment (bleeding \\> 30 mL, hematemesis, melena, hematochezia within 3 months), hemoptysis (\\> 5 mL of fresh blood within 4 weeks); history of hereditary or acquired bleeding disorders or coagulation dysfunction; history of clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; history of arterial or venous thrombotic diseases within 6 weeks prior to enrollment.\n\n  16\\. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n  17\\. Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or anticipation of the need for major surgery during the study treatment period.\n\n  18\\. Inadequate recovery from toxicity and\u002For complications from previous interventions or major surgery prior to initiation of treatment.\n\n  19\\. Pregnant or lactating women, or subjects who plan to conceive or father children during the study period from screening until the completion of the safety follow-up visit (90 days after the last dose for male subjects).\n\n  20\\. Radiotherapy within 4 weeks prior to the first dose of the study drug. All radiation-related toxicities must have been resolved, must not require corticosteroids, and must exclude radiation pneumonitis, radiation enteritis, etc. A 2-week washout period is permitted for palliative radiotherapy for non-CNS diseases.\n\n  21\\. Uncontrolled neurological or psychiatric disorders, or mental disabilities that lead to poor compliance and inability to cooperate or describe treatment response; uncontrolled primary brain tumors or central nervous system metastases with significant symptoms of intracranial hypertension or neuropsychiatric symptoms.\n\n  22\\. Any other condition deemed by the investigator as inappropriate for participation in this study.",{"count":174,"type":20},78,[176],"PHASE2","This study is a prospective, non-randomized, dual-cohort Phase II clinical trial designed to explore the efficacy and safety of radiotherapy combined with intraperitoneal injection of Recombinant Mutant Human Tumor Necrosis Factor (rmhTNF-NC) and tislelizumab in the treatment of malignant ascites that has failed prior standard therapy.\n\nAfter completing the informed consent process, eligible patients who meet the inclusion criteria will be enrolled. Participants will receive palliative radiotherapy combined with intraperitoneal perfusion of rmhTNF-NC and tislelizumab according to the study protocol. Before and after one cycle of treatment, abdominal ultrasound will be used to evaluate the response rate of ascites. Safety assessments will be conducted using NCI-CTCAE v5.0.",[28],"NOT_YET_RECRUITING","2025-09-20",{"date":182,"type":46},"2025-09-29",{"date":184,"type":20},"2025-09-26",{"date":186,"type":20},"2029-12-31",{"name":80,"class":81},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":198,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":82},"100487209","phase-2-camrelizumab-combined-with-chemoradiotherapy-in-advanced-esophageal-cancer-100487209","NCT05624099","Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.","Prospective Single-arm, Exploratory, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemoradiotherapy in the Treatment of Advanced First-line Esophageal Phosphorous Carcinoma","Inclusion Criteria:\n\n1. Sign written informed consent and voluntarily participate in this study;\n2. Patients with esophageal squamous cell carcinoma confirmed by histopathology and\u002For immunohistochemistry (8th edition 2017) had UICC\u002FAJCC TNM stage IVA or oligometastatic stage IVB;\n3. Survival is expected to exceed 3 months\n4. Age 18-75;\n5. ECOG PS 0-2\n6. Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy;\n7. Have at least one measurable lesion\n8. Normal function of major organs, including:\n\n   1. Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs)\n\n      White blood cell count ≥ 3.0×10\\^9\u002FL\n\n      Neutrophil count ≥ 1.0×10\\^9\u002FL\n\n      Platelet count ≥ 80×109\u002FL\n\n      Hemoglobin ≥ 80 g\u002FL\n   2. Blood biochemical examination:\n\n   Total bilirubin ≤ 1.5×ULN\n\n   ALT ≤2.5×ULN, AST ≤2.5×ULN,\n\n   Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL\u002Fmin\n9. Subjects have good compliance and cooperate with follow-up\n\nExclusion Criteria:\n\n1. The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage;\n2. Poor nutritional status, BMI \\\u003C 18.5 Kg\u002Fm\\^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator;\n3. Gastrointestinal bleeding (bleeding volume \\> 200ml\u002F day);\n4. Patients with deep ulcers as determined by the investigator;\n5. Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs;\n6. Has received or is receiving any of the following medical treatment:\n\n   1. any radiation, chemotherapy or other antitumor drugs for the tumor;\n   2. Being treated with immunosuppressive agents or systemic hormones for immunosuppression purposes (dose \\>10mg\u002F day prednisone or equivalent) within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of \\>10mg\u002F day or its equivalent are permitted;\n   3. Received live attenuated vaccine within 4 weeks before the first administration of the study drug;\n   4. Major surgery or severe trauma within 4 weeks before the first use of the study drug;\n7. A history of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which may be considered for inclusion after hormone replacement therapy); Patients with complete remission of psoriasis or childhood asthma\u002Fallergies who did not require any intervention as adults were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included;\n8. A history of immunodeficiency, including being HIV positive, or suffering from another acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;\n9. The presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to:\n\n   Such as (1) NYHAII grade or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention;\n10. Severe infection (CTCAE \\> 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging examination indicated active pulmonary inflammation, signs and symptoms of infection within 14 days before the first use of study drugs, or the need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use;\n11. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment;\n12. The presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL) and hepatitis C (HCV antibody positive and HCV RNA above the assay limit);\n13. In the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as the presence of other serious medical conditions (including mental illness) requiring concomitant treatment, alcoholism, substance abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.","75 Years",{"count":197,"type":20},75,[176],"This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.",[201,202,28],"Esophageal Neoplasms","Esophageal Diseases",[204,205,206,207],"Immunotherapy","Platinum","radiotherapy","Paclitaxel","2023-10-17",{"date":210,"type":46},"2023-10-19",{"date":212,"type":46},"2023-08-01",{"date":214,"type":20},"2027-12-31",{"name":216,"class":217},"Fujian Cancer Hospital","OTHER_GOV",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":195,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":236,"locationsCount":82},"100518148","phase-1-clinical-study-of-personalized-mrna-vaccine-encoding-neoantigen-in-subjects-with-resected-digestive-system-neoplasms-100518148","NCT06026774","Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Subjects With Resected Digestive System Neoplasms","A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard Adjuvant Therapy in Subjects With Resected Digestive System Neoplasms","Inclusion Criteria:\n\n1. Male or female, \\>\u002F= 18 years old and \\\u003C\u002F= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.\n2. Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms listed below that can be radical resected. Subjects must be able to receive at least 4 cycles of standard adjuvant therapy according to CSCO clinical guidelines after surgery. The toxic effects of previous anti-tumor treatments have returned to \\\u003C\u002F= grade 1 defined by NCI-CTCAE v5.0 or to the level specified by the inclusion\u002Fexclusion criteria.\n\n   Subjects with any of the following digestive system neoplasms:\n\n   a. Cholangiocarcinoma b. Pancreatic cancer c. Hepatocellular carcinoma d. Gastric cancer e. Colorectal carcinoma\n3. Expected survival \\>\u002F= 6 months.\n4. ECOG performance status score of 0 \\~ 1.\n5. Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 0.5cm\\*0.5cm of tissue required for surgical samples.\n6. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) \\>\u002F= 50%.\n7. The organ function level must meet the following requirements: absolute neutrophil count (ANC) \\>\u002F= 1.5 × 10\\^9\u002FL, platelet count (PLT) \\>\u002F= 80 × 10\\^9\u002FL, hemoglobin (Hb) \\>\u002F= 90 g\u002FL; serum total bilirubin (TBIL) \\\u003C\u002F= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C\u002F= 2.5 × ULN (if there is liver metastasis, TBIL \\\u003C\u002F= 3 × ULN, AST, ALT \\\u003C\u002F= 5 ×ULN are allowed), serum albumin \\>\u002F= 28g\u002FL, serum creatinine \\\u003C\u002F= 1.5 × BUN, Glomerular filtration rate \\>\u002F= 50mL\u002Fmin, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) \\\u003C\u002F= 1.5 × ULN (without anticoagulant therapy) .\n8. For women of childbearing potential: having a negative serum or urine pregnancy test within 7 days prior to study initiation, agreement to remain abstinent or use contraceptive measures during the treatment period.\n9. For men: agreement to remain abstinent or use contraceptive measures during the treatment period.\n\nExclusion Criteria:\n\n1. Subjects with cancer requiring anti-tumor treatment within the 5 years prior to enrollment in the study (except stage I prostate cancer, cervical cancer in situ, breast cancer in situ, papillary thyroid cancer and non-melanoma skin cancer that have been treated).\n2. Subjects who received major surgery, or had obvious traumatic injury or long-term untreated wounds or fractures within 2 weeks prior to the first dose of iNeo-Vac-R01.\n3. Subjects whose sequencing data was found that there are no new antigens available for individualized immunotherapy after analysis.\n4. Subjects who prepare to undergo or have previously received bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation. Subjects who receive other anti-tumor treatments within 2 weeks prior to the first dose of iNeo-Vac-R01, including surgical treatment, chemotherapy, radiation therapy, targeted therapy, endocrine therapy, immunotherapy, biological therapy, interventional therapy, or other clinical trial related treatments.\n5. Subjects who need to use immunosuppressants, or systemic or absorbable local glucocorticoids therapy to achieve immunosuppressive effects and continue to use them within 7 days before the first administration (excluding those with daily doses of glucocorticoids less than 10mg of prednisone or doses of other therapeutic glucocorticoids equal to 10mg of prednisone).\n6. Subjects who received other vaccines within 4 weeks before the first dose of iNeo-Vac-R01, and are expected to receive other vaccines during treatment period of the study or within 60 days after the last dose of iNeo-Vac-R01.\n7. Subjects who have an active infection or uncontrollable infection requiring systemic treatment, including fungi, bacteria, viruses, or other infections; subjects with active tuberculosis;\n8. Subjects with positive hepatitis B surface antigen (HBsAg) and\u002For positive hepatitis B core antibody (HBcAb) and positive hepatitis B virus DNA titer detection greater than normal range; positive hepatitis C virus (HCV) antibody and HCV RNA detection greater than normal range; positive human immunodeficiency virus antibody; positive treponema pallidum-specific antibody.\n9. Subjects with autoimmune diseases or immune deficiencies treated with immunosuppressive drugs, except vitiligo, type 1 diabetes, autoimmune hypothyroidism requiring hormone treatment and psoriasis not requiring systemic treatment; known history of primary immunodeficiency.\n10. Subjects with cardiocerebrovascular events: previously or currently heart valve disease \\>\u002F= grade 3, heart failure within 8 weeks before the first dose of iNeo-Vac-R01 (New York Heart Association \\[NYHA\\] cardiac function \\>\u002F= grade II, myocardial infarction, unstable angina, stroke, transient ischemic attack, cardiac surgery (including coronary artery bypass grafting or percutaneous coronary intervention) within 8 weeks before the first dose of iNeo-Vac-R01, concomitant severe electrocardiogram abnormalities (such as ventricular flutter, ventricular fibrillation, multiform ventricular tachycardia, sick sinus syndrome, third degree atrioventricular block without pacemaker treatment, QTc \\>\u002F= 480ms, and other conditions evaluated by the investigators as severe abnormalities), hypertension with poor drug control (systolic blood pressure \\>\u002F= 160mmHg and\u002For diastolic blood pressure \\>\u002F= 100mmHg), or other cardiocerebrovascular diseases that have been evaluated by the investigators as unsuitable for participation in this trial.\n11. Subjects with respiratory disease: previously or currently pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe asthma, pulmonary hypertension or severe impairment of lung function, etc.\n12. Subjects with moderate to severe ascites with clinical symptoms; uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.\n13. Subjects with drug abuse; clinical or psychological or social factors that affect informed consent or research implementation.\n14. Subjects with a history of allergies to immunotherapy or vaccines, or other potential immunotherapy allergies identified by the investigators.\n15. Subjects identified that it is not suitable for enrollment or may not be able to complete this experiment for other reasons by the investigators.\n16. Vulnerable groups, including individuals with mental illness, cognitive impairment, critical patients, minors, pregnant or lactating women, etc.",{"count":226,"type":20},20,[228],"PHASE1","The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.",[28],"2023-09-08",{"date":233,"type":46},"2023-09-11",{"date":231,"type":20},{"date":214,"type":20},{"name":237,"class":81},"Sir Run Run Shaw Hospital",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":195,"enrollmentInfo":245,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":255,"leadSponsor":256,"locationsCount":82},"100518150","phase-1-clinical-study-of-personalized-mrna-vaccine-encoding-neoantigen-in-combination-with-standard-first-line-treatment-in-subjects-with-advanced-digestive-system-neoplasms-100518150","NCT06026800","Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms","A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms","Inclusion Criteria:\n\n1. Male or female, \\>\u002F= 18 years old and \\\u003C\u002F= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.\n2. Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms, have measurable disease at study entry defined by RECIST v1.1. Subjects must receive at least 4 cycles of standard first-line treatment according to CSCO clinical guidelines. The toxic effects of previous anti-tumor treatments have returned to \\\u003C\u002F= grade 1 defined by NCI-CTCAE v5.0 or to the level specified by the inclusion\u002Fexclusion criteria.\n3. Expected survival \\>\u002F= 6 months.\n4. ECOG performance status score of 0 \\~ 1.\n5. Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 2 puncture tissues with a tumor purity of ≥ 50% required for puncture samples and at least 0.5cm of tissue required for surgical samples. Alternatively, the original gene sequencing data required for tumor neoantigen analysis can be provided, including full exon sequencing data of tumor tissue, transcriptome sequencing data, and full exon sequencing data of peripheral blood.\n6. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) \\>\u002F= 50%.\n7. The organ function level must meet the following requirements: absolute neutrophil count (ANC) \\>\u002F= 1.5 × 10\\^9\u002FL, platelet count (PLT) \\>\u002F= 80 × 10\\^9\u002FL, hemoglobin (Hb) \\>\u002F= 90 g\u002FL; serum total bilirubin (TBIL) \\\u003C\u002F= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C\u002F= 2.5 × ULN (if there is liver metastasis, TBIL \\\u003C\u002F= 3 × ULN, AST, ALT \\\u003C\u002F= 5 ×ULN are allowed), serum albumin \\>\u002F= 28g\u002FL, serum creatinine \\\u003C\u002F= 1.5 × BUN, Glomerular filtration rate \\>\u002F= 50mL\u002Fmin, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) \\\u003C\u002F= 1.5 × ULN (without anticoagulant therapy) .\n8. For women of childbearing potential: having a negative serum or urine pregnancy test within 7 days prior to study initiation, agreement to remain abstinent or use contraceptive measures during the treatment period.\n9. For men: agreement to remain abstinent or use contraceptive measures during the treatment period.\n\nExclusion Criteria:\n\n1. Subjects with cancer requiring anti-tumor treatment within the 5 years prior to enrollment in the study (except stage I prostate cancer, cervical cancer in situ, breast cancer in situ, papillary thyroid cancer and non-melanoma skin cancer that have been treated).\n2. Subjects who received major surgery, or had obvious traumatic injury or long-term untreated wounds or fractures within 2 weeks prior to the first dose of iNeo-Vac-R01.\n3. Subjects whose sequencing data was found that there are no new antigens available for individualized immunotherapy after analysis.\n4. Subjects who prepare to undergo or have previously received bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation. Subjects who receive other anti-tumor treatments within 2 weeks prior to the first dose of iNeo-Vac-R01, including surgical treatment, chemotherapy, radiation therapy, targeted therapy, endocrine therapy, immunotherapy, biological therapy, interventional therapy, or other clinical trial related treatments.\n5. Subjects who need to use immunosuppressants, or systemic or absorbable local glucocorticoids therapy to achieve immunosuppressive effects and continue to use them within 7 days before the first administration (excluding those with daily doses of glucocorticoids less than 10mg of prednisone or doses of other therapeutic glucocorticoids equal to 10mg of prednisone).\n6. Subjects with symptomatic or untreated central nervous system metastases, except those underwent complete resection and\u002For radiotherapy and proven to be stable or improved (confirmed to be stable or improved for at least 4 weeks before the first dose of iNeo-Vac-R01 by CT or MRI, with no evidence of brain edema and no need for glucocorticoids or anticonvulsants.\n7. Subjects who received other vaccines within 4 weeks before the first dose of iNeo-Vac-R01, and are expected to receive other vaccines during treatment period of the study or within 60 days after the last dose of iNeo-Vac-R01.\n8. Subjects who have an active infection or uncontrollable infection requiring systemic treatment, including fungi, bacteria, viruses, or other infections; subjects with active tuberculosis;\n9. Subjects with positive hepatitis B surface antigen (HBsAg) and\u002For positive hepatitis B core antibody (HBcAb) and positive hepatitis B virus DNA titer detection greater than normal range; positive hepatitis C virus (HCV) antibody and HCV RNA detection greater than normal range; positive human immunodeficiency virus antibody; positive treponema pallidum-specific antibody.\n10. Subjects with autoimmune diseases or immune deficiencies treated with immunosuppressive drugs, except vitiligo, type 1 diabetes, autoimmune hypothyroidism requiring hormone treatment and psoriasis not requiring systemic treatment; known history of primary immunodeficiency.\n11. Subjects with cardiocerebrovascular events: previously or currently heart valve disease \\>\u002F= grade 3, heart failure within 8 weeks before the first dose of iNeo-Vac-R01 (New York Heart Association \\[NYHA\\] cardiac function \\>\u002F= grade II, myocardial infarction, unstable angina, stroke, transient ischemic attack, cardiac surgery (including coronary artery bypass grafting or percutaneous coronary intervention) within 8 weeks before the first dose of iNeo-Vac-R01, concomitant severe electrocardiogram abnormalities (such as ventricular flutter, ventricular fibrillation, multiform ventricular tachycardia, sick sinus syndrome, third degree atrioventricular block without pacemaker treatment, QTc \\>\u002F= 480ms, and other conditions evaluated by the investigators as severe abnormalities), hypertension with poor drug control (systolic blood pressure \\>\u002F= 160mmHg and\u002For diastolic blood pressure \\>\u002F= 100mmHg), or other cardiocerebrovascular diseases that have been evaluated by the investigators as unsuitable for participation in this trial.\n12. Subjects with respiratory disease: previously or currently pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe asthma, pulmonary hypertension or severe impairment of lung function, etc.\n13. Subjects with moderate to severe ascites with clinical symptoms; uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.\n14. Subjects with drug abuse; clinical or psychological or social factors that affect informed consent or research implementation.\n15. Subjects with a history of allergies to immunotherapy or vaccines, or other potential immunotherapy allergies identified by the investigators.\n16. Subjects identified that it is not suitable for enrollment or may not be able to complete this experiment for other reasons by the investigators.\n17. Vulnerable groups, including individuals with mental illness, cognitive impairment, critical patients, minors, pregnant or lactating women, etc.",{"count":226,"type":20},[228],"The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 in combination with first-line treatment in subjects with advanced digestive system neoplasms.",[28],[250,251,252,28],"iNeo-Vac-R01","Personalized mRNA Vaccine","Neoantigen",{"date":233,"type":46},{"date":231,"type":46},{"date":214,"type":20},{"name":237,"class":81},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":195,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":265,"briefSummary":266,"conditions":267,"keywords":268,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":271,"leadSponsor":272,"locationsCount":82},"100517604","phase-1-clinical-study-of-personalized-mrna-vaccine-encoding-neoantigen-alone-in-subjects-with-advanced-digestive-system-neoplasms-100517604","NCT06019702","Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms","A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms","Inclusion Criteria:\n\n1. Male or female, \\>\u002F= 18 years old and \\\u003C\u002F= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.\n2. Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms, have measurable disease at study entry defined by RECIST v1.1. Subjects must have tumor progression after standard treatment or are intolerant or are unwilling to receive standard treatment. The toxic effects of previous anti-tumor treatments have returned to \\\u003C\u002F= grade 1 defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 or to the level specified by the inclusion\u002Fexclusion criteria.\n3. Expected survival \\>\u002F= 6 months.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 \\~ 2.\n5. Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 2 puncture tissues with a tumor purity of ≥ 50% required for puncture samples and at least 0.5cm of tissue required for surgical samples. Alternatively, the original gene sequencing data required for tumor neoantigen analysis can be provided, including full exon sequencing data of tumor tissue, transcriptome sequencing data, and full exon sequencing data of peripheral blood.\n6. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) \\>\u002F= 50%.\n7. The organ function level must meet the following requirements: absolute neutrophil count (ANC) \\>\u002F= 1.5 × 10\\^9\u002FL, platelet count (PLT) \\>\u002F= 80 × 10\\^9\u002FL, hemoglobin (Hb) \\>\u002F= 90 g\u002FL; serum total bilirubin (TBIL) \\\u003C\u002F= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C\u002F= 2.5 × ULN (if there is liver metastasis, TBIL \\\u003C\u002F= 3 × ULN, AST, ALT \\\u003C\u002F= 5 ×ULN are allowed), serum albumin \\>\u002F= 28g\u002FL, serum creatinine \\\u003C\u002F= 1.5 × BUN, Glomerular filtration rate \\>\u002F= 50mL\u002Fmin, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) \\\u003C\u002F= 1.5 × ULN (without anticoagulant therapy) .\n8. For women of childbearing potential: having a negative serum or urine pregnancy test within 7 days prior to study initiation, agreement to remain abstinent or use contraceptive measures during the treatment period.\n9. For men: agreement to remain abstinent or use contraceptive measures during the treatment period.\n\nExclusion Criteria:\n\n1. Subjects with cancer requiring anti-tumor treatment within the 5 years prior to enrollment in the study (except stage I prostate cancer, cervical cancer in situ, breast cancer in situ, papillary thyroid cancer and non-melanoma skin cancer that have been treated).\n2. Subjects who received major surgery, or had obvious traumatic injury or long-term untreated wounds or fractures within 2 weeks prior to the first dose of iNeo-Vac-R01.\n3. Subjects whose sequencing data was found that there are no new antigens available for individualized immunotherapy after analysis.\n4. Subjects who prepare to undergo or have previously received bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation. Subjects who receive other anti-tumor treatments within 2 weeks prior to the first dose of iNeo-Vac-R01, including surgical treatment, chemotherapy, radiation therapy, targeted therapy, endocrine therapy, immunotherapy, biological therapy, interventional therapy, or other clinical trial related treatments.\n5. Subjects who need to use immunosuppressants, or systemic or absorbable local glucocorticoids therapy to achieve immunosuppressive effects and continue to use them within 7 days before the first administration (excluding those with daily doses of glucocorticoids less than 10mg of prednisone or doses of other therapeutic glucocorticoids equal to 10mg of prednisone).\n6. Subjects with symptomatic or untreated central nervous system metastases, except those underwent complete resection and\u002For radiotherapy and proven to be stable or improved (confirmed to be stable or improved for at least 4 weeks before the first dose of iNeo-Vac-R01 by CT or MRI, with no evidence of brain edema and no need for glucocorticoids or anticonvulsants.\n7. Subjects who received other vaccines within 4 weeks before the first dose of iNeo-Vac-R01, and are expected to receive other vaccines during treatment period of the study or within 60 days after the last dose of iNeo-Vac-R01.\n8. Subjects who have an active infection or uncontrollable infection requiring systemic treatment, including fungi, bacteria, viruses, or other infections; subjects with active tuberculosis;\n9. Subjects with positive hepatitis B surface antigen (HBsAg) and\u002For positive hepatitis B core antibody (HBcAb) and positive hepatitis B virus DNA titer detection greater than normal range; positive hepatitis C virus (HCV) antibody and HCV RNA detection greater than normal range; positive human immunodeficiency virus antibody; positive treponema pallidum-specific antibody.\n10. Subjects with autoimmune diseases or immune deficiencies treated with immunosuppressive drugs, except vitiligo, type 1 diabetes, autoimmune hypothyroidism requiring hormone treatment and psoriasis not requiring systemic treatment; known history of primary immunodeficiency.\n11. Subjects with cardiocerebrovascular events: previously or currently heart valve disease \\>\u002F= grade 3, heart failure within 8 weeks before the first dose of iNeo-Vac-R01 (New York Heart Association \\[NYHA\\] cardiac function \\>\u002F= grade II, myocardial infarction, unstable angina, stroke, transient ischemic attack, cardiac surgery (including coronary artery bypass grafting or percutaneous coronary intervention) within 8 weeks before the first dose of iNeo-Vac-R01, concomitant severe electrocardiogram abnormalities (such as ventricular flutter, ventricular fibrillation, multiform ventricular tachycardia, sick sinus syndrome, third degree atrioventricular block without pacemaker treatment, QTc \\>\u002F= 480ms, and other conditions evaluated by the investigators as severe abnormalities), hypertension with poor drug control (systolic blood pressure \\>\u002F= 160mmHg and\u002For diastolic blood pressure \\>\u002F= 100mmHg), or other cardiocerebrovascular diseases that have been evaluated by the investigators as unsuitable for participation in this trial.\n12. Subjects with respiratory disease: previously or currently pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe asthma, pulmonary hypertension or severe impairment of lung function, etc.\n13. Subjects with moderate to severe ascites with clinical symptoms; uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.\n14. Subjects with drug abuse; clinical or psychological or social factors that affect informed consent or research implementation.\n15. Subjects with a history of allergies to immunotherapy or vaccines, or other potential immunotherapy allergies identified by the investigators.\n16. Subjects identified that it is not suitable for enrollment or may not be able to complete this experiment for other reasons by the investigators.\n17. Vulnerable groups, including individuals with mental illness, cognitive impairment, critical patients, minors, pregnant or lactating women, etc.",{"count":226,"type":20},[228],"The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 alone in subjects with advanced digestive system neoplasms.",[28],[250,251,252,28],{"date":233,"type":46},{"date":231,"type":20},{"date":214,"type":20},{"name":237,"class":81},{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":284,"phases":4,"briefSummary":285,"conditions":286,"keywords":299,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":226},"100435367","spanish-series-of-patients-treated-with-the-radionuclide-lutetium177-100435367","NCT04949282","Spanish Series of Patients Treated With the Radionuclide Lutetium177","SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177","SEPTRALU","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any data collection.\n* Patients must be diagnosed with unresectable or metastatic, progressive, somatostatin receptor positive tumour\n* Aged ≥18 years.\n\nExclusion Criteria:\n\n* None","100 Years",{"count":283,"type":20},5000,"OBSERVATIONAL","This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.",[287,26,288,289,290,291,292,293,294,27,28,29,295,30,296,33,297,298],"Neuroendocrine Tumors","Pancreatic Neoplasms","Stomach Neoplasms","Neuroectodermal Tumors","Neoplasms, Germ Cell and Embryonal","Neoplasms by Histologic Type","Neoplasms","Neoplasms, Nerve Tissue","Endocrine Gland Neoplasms","Gastrointestinal Disease","Pancreatic Disease","Endocrine System Diseases",[300,301,302,303],"GEP-NET","Gastro-Entero-Pancreatic Neuroendocrine Tumour","Luthatera","Somatostatin receptor positive tumour","2022-12-22",{"date":306,"type":46},"2022-12-23",{"date":308,"type":46},"2021-05-10",{"date":310,"type":20},"2035-12-31",{"name":312,"class":81},"Sociedad Española de Medicina Nuclear e Imagen Molecular",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":82},"100458627","phase-2-anlotinib-hydrochloride-capsules-combined-with-tqb2450-injection-in-esophageal-squamous-cell-carcinoma-patients-100458627","NCT05252078","Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients","An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy","ALTER-E005","Inclusion Criteria:\n\n* Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.\n* ≥ 18 years old.\n* ECOG performance status of 0-1\n* Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.\n* Patients received radical (R0) resection of squamous cell carcinoma with no recurrence in imaging examination within 6-12 weeks after surgery, and need adjuvant therapy assessed by the researchers.\n* Laboratory tests must be met:\n* Neutrophils count =\u002F\\> 1.5 x 109\u002FL, platelets count =\u002F\\> 75 x 109\u002FL, Hb =\u002F\\> 90 g\u002FL, WBC =\u002F\\> 3 x 109\u002FL.\n* total bilirubin =\u002F\\\u003C 1.5 x ULN, ALT and AST =\u002F\\\u003C 2.5 x ULN.\n* Creatinine =\u002F\\\u003C 1.5 x ULN.\n* APTT, INR, PT =\u002F\\\u003C 1.5 x ULN.\n* TSH =\u002F\\\u003C ULN.\n* Myocardial enzymes in the normal range.\n* LVEF =\u002F\\> 50%.\n\nExclusion Criteria:\n\n* Patients received other antitumor adjuvant therapy after surgical resection.\n* Concurrent malignancy (except cured basal cell carcinoma of the skin).\n* Patients was diagnosed cervical esophageal carcinoma.\n* Patients who have received prior targeted therapy (anti-VEGF\u002FVEGFR) or immunity therapy (anti-PD-1\u002FPD-L1\u002FCTLA-4).\n* Patients who are allergic to other monoclonal antibodies.\n* Patients with a history of immunodeficiency (or active autoimmue disease), or other acquired congenital immunodeficiency diseases.\n* Immunosuppressant, systemic, or absorbable local hormone therapy (\\> 10mg\u002F day of prednisone or other equivalent hormone) is required for immunosuppression and continued within 2 weeks of initial administration.\n* Patients with multiple factors affecting oral administration.\n* Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage.\n* With bleeding tendency. Patients with any bleeding or bleeding event CTC AE grade 3 in the 4 weeks prior to initial administration. The presence of digestive diseases or active bleeding of unresected tumors, or other conditions that the investigator determined which could lead to gastrointestinal bleeding or perforation.\n* Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.\n* Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg).\n* Patients with myocardial infarction, myocardial ischemia, arrhythmias with poor control (including QTC interval male \\> 450 ms, female\\> 470 ms) and cardiac insufficiency of grade II according to NYHA standard.\n* Active or uncontrolled severe infection (≥ CTC AE Grade 2 infection).\n* HIV test positive.\n* Proteinuria =\u002F\\>2+ and confirmed 24-hour urinary protein quantification \\> 1.0 g.\n* Vaccination with prophylactic or attenuated vaccine within 4 weeks prior to initial administration.\n* According to the investigators' judgment, there are factors that endanger patient or prevent patients from completing the study.",{"count":123,"type":20},[176],"This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).",[325,201,202,27,31,28,30,29,292,326,327],"Esophageal Squamous Cell Carcinoma","Neoplasms, Squamous Cell","Carcinoma, Squamous Cell","2022-12-14",{"date":330,"type":46},"2022-12-16",{"date":332,"type":46},"2022-06-02",{"date":334,"type":20},"2026-11",{"name":336,"class":81},"Jiangxi Provincial Cancer Hospital"]