[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-tumors":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,53,84,108,131,150,179,203,223,243,263,285],{"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":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100624207","phase-2-kqb198-in-combination-with-imatinib-in-participants-with-advancedmetastatic-gist-in-1st-line-setting-100624207",false,"NCT07406633","KQB198 in Combination With Imatinib in Participants With Advanced\u002FMetastatic GIST in 1st Line Setting","A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination With Imatinib in Participants With Advanced\u002FMetastatic GI Stromal Tumor in 1st Line Setting","Inclusion Criteria\n\nAll Participants:\n\n* Unresectable or metastatic disease\n* Tissue confirmation of GIST\n* Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V).\n* Measurable disease per RECIST v1.1.\n* Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago.\n* Adequate organ function and performance status\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Unable to swallow or GI condition that prevents absorption.\n* Other active malignancies within the last 2 years.\n* History of hypersensitivity to any component of KQB198 or imatinib.","ALL","18 Years",{"count":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.",[26,27,28,29,30],"GIST - Gastrointestinal Stromal Tumor","GIST","GIST Metastatic Cancer","Gastro Intestinal Stromal Tumour","Gastrointestinal Tumors",[32,33,34,35,36,37,38,39],"KQB198","imatinib","gleevec","gist","gastrointestinal stromal tumor","gastro intestinal stromal tumor","gist first line","gist 1st line","RECRUITING","2026-05-18",{"date":43,"type":44},"2026-05-19","ACTUAL",{"date":46,"type":20},"2026-05",{"date":48,"type":20},"2028-10",{"name":50,"class":51},"Kumquat Biosciences Inc.","INDUSTRY",8,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100640937","phase-1-opioid-free-anesthesia-and-postoperative-delirium-100640937","NCT07603596","Opioid-free Anesthesia and Postoperative Delirium","Effect of Opioid-free Anesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery","Inclusion Criteria:\n\n1. Patients who plan to undergo elective gastrointestinal surgery under general anaesthesia\n2. Age ≥65 years\n3. American Society of Anaesthesiologists (ASA) grade I-III\n4. Body mass index (BMI) of 18.0-30.0 kg\u002Fm²\n5. Frailty: mFI ≥ 0.27\n6. Signed informed consent\n\nExclusion Criteria:\n\n1. Patients undergoing emergency surgery\n2. Patients with language disorders or severe hearing or vision impairment that prevent communication\n3. Patients with a history of neurological and psychiatric disorders, including Alzheimer's disease (AD), other types of dementia, stroke, and psychosis\n4. Patients with long-term use of psychotropic medications (such as clozapine, risperidone, olanzapine, haloperidol, and chlorpromazine)\n5. Patients who have undergone cardiac surgery or craniocerebral surgery within the past year\n6. Patients who have participated in other relevant clinical trials within the past 3 months\n7. Patients with preoperative cognitive impairment (Telephone Interview for Cognitive Status-modified (TICS-m) score ≤ 27), as determined via the TICS-M test\n8. Each patient can be included only once, regardless of whether the reason for the second surgery is related to the primary cause\n9. Let me know if you need this in a different bullet style (e.g., asterisks) or with indentation adjustments.","65 Years",{"count":62,"type":20},174,[64],"PHASE1","Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery. This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 654 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay. The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients.",[67,30],"Postoperative Delirium",[69,70,71,72],"elderly patients","opioid-free anaesthesia","postoperative delirium","gastrointestinal surgery","NOT_YET_RECRUITING","2026-05-16",{"date":76,"type":44},"2026-05-22",{"date":78,"type":20},"2026-05-01",{"date":80,"type":20},"2028-06-30",{"name":82,"class":83},"Qianfoshan Hospital","OTHER",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":107},"100636344","phase-2-a-study-of-skb571-in-participants-with-gastrointestinal-tumors-100636344","NCT07564466","A Study of SKB571 in Participants With Gastrointestinal Tumors","A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).\n2. Participants must have histologically or cytologically confirmed gastrointestinal tumors.\n3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy ≥ 12 weeks as assessed by the investigator.\n6. Adequate organ and bone marrow function.\n7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.\n8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Participants with other malignant tumors within 3 years before the first dose of study treatment.\n2. History or current metastases to central nervous system.\n3. Current uncontrolled concomitant diseases\n4. Clinically severe lung damage due to complications of lung disorder\n5. Participants with a history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis\n6. A history of severe skin diseases\n7. Unresolved toxicity from prior anti-tumor therapy\n8. Serious infection within 4 weeks before the first dose of study treatment\n9. Known active pulmonary tuberculosis.\n10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.\n11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.\n12. Pregnant or breastfeeding women.\n13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.","75 Years",{"count":93,"type":20},120,[23],"This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.",[30],[98],"Gastrointestinal tumors","2026-05-06",{"date":101,"type":44},"2026-05-11",{"date":103,"type":20},"2026-06-30",{"date":80,"type":20},{"name":106,"class":51},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.",25,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100614425","phase-1-a-study-of-bl-m24d1-in-patients-with-locally-advanced-or-metastatic-gastrointestinal-tumors-and-other-solid-tumors-100614425","NCT07279428","A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M24D1 for Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic digestive tract tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years;\n7. Must have at least one measurable lesion meeting the RECIST v1.1 criteria;\n8. ECOG performance status score of 0 or 1;\n9. Toxicities from prior antitumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;\n13. Urine protein ≤2+ or ≤1000mg\u002F24h;\n14. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should adopt adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, or immunotherapy within 4 weeks prior to the first dose or within 5 half-lives;\n2. History of severe heart disease;\n3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune or inflammatory diseases;\n5. Diagnosis of other malignancies within 5 years prior to the first dose;\n6. Hypertension poorly controlled by two antihypertensive medications;\n7. Patients with poorly controlled blood glucose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Lung diseases graded ≥3 according to CTCAE v5.0;\n10. Symptoms of active central nervous system metastases;\n11. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M24D1;\n12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n13. Cumulative dose of anthracyclines \\>360 mg\u002Fm² in previous (neo)adjuvant anthracycline therapy;\n14. Human immunodeficiency virus antibody positivity, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n15. History of interstitial lung disease (ILD) requiring steroid treatment, or current ILD;\n16. Active infection requiring systemic treatment within 4 weeks prior to the first investigational drug dose;\n17. Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first investigational drug dose;\n18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first investigational drug dose;\n19. Participation in another clinical trial within 4 weeks prior to the first dose;\n20. Pregnant or lactating women;\n21. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":116,"type":20},33,[64],"This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M24D1 for Injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.",[30,120],"Solid Tumors","2026-02-24",{"date":123,"type":44},"2026-02-27",{"date":125,"type":44},"2026-01-12",{"date":127,"type":20},"2027-12",{"name":129,"class":51},"Sichuan Baili Pharmaceutical Co., Ltd.",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":149,"locationsCount":130},"100610809","phase-1-a-study-of-lutetium-177lu-bl-arc001-in-patients-with-locally-advanced-or-metastatic-gastrointestinal-tumors-and-other-solid-tumors-100610809","NCT07232407","A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Lutetium [177Lu] BL-ARC001 Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Gender: no restriction;\n3. Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years;\n7. Must have at least one measurable lesion meeting the RECIST v1.1 criteria;\n8. ECOG performance status score of 0 or 1;\n9. Toxicities from prior antitumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;\n13. Urine protein ≤2+ or ≤1000mg\u002F24h;\n14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and must not be breastfeeding; all enrolled patients (regardless of gender) should use adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose;\n2. History of severe heart disease;\n3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune or inflammatory diseases;\n5. Diagnosis of other malignancies within 5 years prior to the first dose;\n6. Hypertension poorly controlled by two antihypertensive medications;\n7. History of interstitial lung disease (ILD) requiring steroid treatment, current ILD, or ≥ Grade 2 radiation pneumonitis;\n8. Symptoms of active central nervous system metastases;\n9. History of allergy to recombinant humanized or chimeric antibodies, or allergy to any excipient of Lutetium \\[177Lu\\] BL-ARC001;\n10. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n11. Cumulative dose of anthracyclines \\> 360 mg\u002Fm² in previous (neo)adjuvant anthracycline therapy;\n12. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n13. Active infection requiring systemic treatment;\n14. Participation in another clinical trial within 4 weeks prior to the first dose;\n15. Pregnant or lactating women;\n16. Any other condition deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":139,"type":20},22,[64],"This study is an open-label, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of Lutetium \\[177Lu\\] BL-ARC001 in patients with locally advanced or metastatic solid tumors.",[30,120],"2026-01-04",{"date":145,"type":44},"2026-01-07",{"date":147,"type":44},"2025-11-14",{"date":127,"type":20},{"name":129,"class":51},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":130},"100598122","phase-1-personalized-mrna-cancer-vaccine-for-gastrointestinal-solid-tumor-treatment-100598122","NCT07067385","Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment","Exploratory Clinical Study of Neoantigen Tumor Vaccine Therapy for Gastrointestinal Solid Tumors","PCV-GSTT","Inclusion Criteria:\n\n1. Voluntarily signs the informed consent form, and has good compliance.\n2. Male or female, aged 18 years or older.\n3. Patients with advanced gastrointestinal tumors: histologically and\u002For cytologically confirmed recurrent or metastatic gastrointestinal solid tumors not amenable to surgical or local curative treatment, with at least one measurable lesion as defined by RECIST v1.1. Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatment.\n\n   Patients with resectable gastrointestinal solid tumors for adjuvant treatment: tumors must be confirmed as completely resected (R0 or R1) by postoperative histopathology, with no prior neoadjuvant therapy, and assessed as fully resectable by imaging.\n4. Neoantigen load requirement: at least 10 predicted neoantigen epitopes.\n5. The subject must have a tumor lesion suitable for repeated sampling for sequencing and immune testing. Fresh or archived tumor tissue is required, preferably from surgical or core needle biopsy (CNB) samples, including both tumor and 2-3 soybean-sized peritumoral tissues. Paraffin blocks or at least 10-20 unstained tumor tissue sections (4-6 μm thick) with tumor content \\>20% are acceptable. If the subject cannot provide suitable samples but meets other inclusion\u002Fexclusion criteria, the investigator may still consider enrollment.\n6. ECOG performance status of 0 or 1.\n7. Life expectancy of at least 6 months.\n8. Adequate organ and hematologic function, with no severe dysfunction of the heart, lungs, liver, kidneys, or immune system, based on the following laboratory values:\n\n1). Hematology: ANC ≥ 1.5 × 10⁹\u002FL, WBC ≥ 3 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, HGB ≥ 90 g\u002FL. Within one week before screening, the subject must not have received blood or platelet transfusions, G-CSF, or erythropoietin (EPO); 2). Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); 3). Liver function: AST and ALT ≤ 3 × ULN (≤ 5 × ULN for patients with liver cancer or liver metastases); TBIL ≤ 1.5 × ULN (patients with Gilbert's syndrome: TBIL \\\u003C 3 × ULN); 4). Coagulation: INR ≤ 2 × ULN or APTT ≤ 1.5 × ULN (except for patients on anticoagulants); 5). Endocrine function: TSH within normal limits. Note: If baseline TSH is outside the normal range but free T3 and free T4 are within normal limits, the subject is still eligible.\n\n9\\. Agrees to provide peripheral blood samples and, optionally, fresh peritumoral tissue for sequencing.\n\n10\\. Male subjects with reproductive potential and female subjects of childbearing potential agree to use effective contraception from the time of informed consent until 6 months after the last dose of investigational drug.\n\n* Women of childbearing potential include premenopausal women and those within 2 years post-menopause.\n* A negative serum pregnancy test is required within 7 days before the first dose of the investigational product.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to any investigational drug or its components used in this study.\n2. Use of high-dose corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days before the first dose of study drug.\n3. Receipt of the following therapies or interventions within 28 days before the first dose of study drug:\n\n   1. Participation in an interventional clinical study;\n   2. Major surgery or traumatic injury, or expected to undergo major surgery during the study (minor procedures such as core needle biopsy or placement of a vascular access device within 7 days before the first dose are permitted);\n   3. Vaccination with a live attenuated vaccine, or planned vaccination during the study or within 5 months after the last dose of study treatment;\n   4. Systemic antitumor therapy (including chemotherapy, small molecule targeted therapy, antibody therapy, cellular immunotherapy, hormonal therapy), or local antitumor therapy (e.g., radiotherapy). Palliative radiotherapy for bone metastases completed \\>2 weeks before baseline tumor assessment is allowed. Also includes prior treatment with systemic immune-stimulating agents (e.g., interferons or interleukin-2).\n4. Presence of severe chronic or active infection within 28 days before the first dose, including but not limited to hospitalization due to infection, sepsis, or severe pneumonia, or any active infection deemed to compromise patient safety by the investigator. Systemic antibiotic treatment within 2 weeks before study start.\n5. Clinically significant residual toxicity (≥ grade 2 per CTCAE v5.0) from previous treatment (including systemic therapy, radiotherapy, or surgery), except for alopecia, hyperpigmentation, or other AEs deemed by the investigator not to affect study safety and where recovery to grade ≤1 is not required.\n6. Presence of central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if neurologically stable for at least 3 months, show no evidence of progression by imaging within 4 weeks before study drug initiation, have recovered from all neurologic symptoms, show no evidence of new or enlarging lesions, and have discontinued corticosteroids, surgery, or radiotherapy for at least 28 days. Carcinomatous meningitis is exclusionary regardless of stability.\n7. Active hepatitis B virus (HBV) infection (defined as HBsAg positive and HBV-DNA \\> 500 IU\u002FmL), hepatitis C virus (HCV) infection (defined as HCV-Ab positive and HCV-RNA positive), human immunodeficiency virus (HIV) infection (HIV-Ab positive), active tuberculosis, or any other active infection requiring systemic treatment within 14 days before first study drug administration (prophylactic anti-infective treatment is allowed).\n8. History of clinically significant cardiovascular or cerebrovascular disease within 6 months before the first dose, including but not limited to:\n\n   1. Acute myocardial infarction;\n   2. Unstable angina;\n   3. Stroke (excluding asymptomatic lacunar infarction not requiring intervention);\n   4. History of significant ventricular arrhythmias (e.g., sustained VT, VF, torsades de pointes);\n   5. NYHA class III or IV congestive heart failure;\n   6. QTcF ≥ 470 ms or history\u002Ffamily history of congenital long QT syndrome;\n   7. Baseline left ventricular ejection fraction (LVEF) \\\u003C 50% or significant wall motion abnormalities on echocardiography;\n   8. Poorly controlled hypertension (systolic BP \\> 160 mmHg or diastolic BP \\> 100 mmHg);\n   9. Other arrhythmias deemed unsuitable by the investigator.\n9. Active autoimmune diseases requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within 2 years before the first study dose. Physiologic replacement therapy (e.g., levothyroxine, insulin, or corticosteroids for adrenal or pituitary insufficiency) is permitted.\n10. History of other malignancies within 3 years before study treatment, except for those with curative potential after radical treatment, such as basal or squamous cell skin cancers, localized low-risk prostate cancer, papillary thyroid carcinoma, or any in situ carcinoma (e.g., cervical carcinoma in situ or ductal carcinoma in situ).\n11. Any other severe or uncontrolled disease or condition that, in the opinion of the investigator, could interfere with study participation or compliance, including but not limited to:\n\n    1. Severe respiratory disease, such as interstitial lung disease, severe asthma, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or evidence of active pneumonia on screening chest CT;\n    2. Severe venous or arterial thromboembolism, such as pulmonary embolism or deep vein thrombosis (excluding asymptomatic, untreated intermuscular venous thrombosis);\n    3. Symptomatic or large pleural effusion or ascites requiring symptomatic management;\n    4. Active or past history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis);\n    5. Symptomatic or significant pericardial, pleural, or abdominal effusion on screening;\n    6. Tumors encasing major blood vessels or with extensive necrosis or cavitation on imaging, which the investigator considers to pose a bleeding risk;\n    7. History of gastrointestinal perforation, surgical\u002Fwound healing complications, or significant bleeding events.\n12. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n13. History of substance abuse or psychiatric disorder that may interfere with compliance.\n14. Pregnant or breastfeeding women. Pregnancy is defined as the period from conception until the end of gestation. Pregnancy status must be confirmed by a serum hCG test within 7 days before study initiation.\n15. Prior treatment with cell therapies (e.g., TCR-T, CAR-T, TILs) or neoantigen-based cancer vaccines. Prior treatment with immune checkpoint inhibitors (e.g., PD-1, PD-L1). Receipt of immune-stimulating agents (e.g., thymosin, interferon, interleukin-2) within 6 weeks before study treatment.\n16. Genetic sequencing reveals functional defects in genes related to antigen presentation, antigen recognition, or cytotoxicity.\n17. Any other condition deemed inappropriate for study enrollment by the investigator.",{"count":159,"type":20},40,[64],"Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors",[163,30],"Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy",[165,166,167,168,169],"neoantigen","p-MHC-TCR","CRC","mRNA","machine learning","2025-07-14",{"date":172,"type":44},"2025-07-16",{"date":174,"type":44},"2025-07-01",{"date":176,"type":20},"2027-12-31",{"name":178,"class":83},"Ruijin Hospital",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":189,"studyType":190,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100552818","combined-screening-for-gastrointestinal-tumors-100552818","NCT06478030","Combined Screening for Gastrointestinal Tumors","Inclusion Criteria:\n\n* Subject residents from Zhejiang Province.\n* Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.\n* Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.\n\nExclusion Criteria:\n\n* Subject has heavy cardiovascular, liver or kidney disease.\n* Subject is already suffering from malignant tumors of the digestive tract.\n* Subject has severe intellectual disabilities or language communication barriers.\n* Subject has had gastrointestinal endoscopy in the past year.","40 Years","74 Years",{"count":188,"type":20},200000,"5 Years","OBSERVATIONAL","All participants are required to complete a questionnaire, a Helicobacter pylori (H. pylori) test, and a fecal immunochemical test (FIT). The questionnaire covers nine aspects: basic information of the participants, symptoms and previous examinations, medical history and surgical history, medication history, smoking history, alcohol consumption history, dietary habits, physical exercise, and family history. After quality control, the data is entered by staff into the Zhejiang Province Cancer Screening Information Platform. Risk assessments are performed based on the data collected and high-risk individuals are recommended for clinical screening. Additionally, tongue image, stool, urine, blood, tongue coating, saliva, gastric juice, and fresh tissue (gastric mucosa tissue and\u002For intestinal polyp tissue) samples are collected from all participants undergoing clinical screening.\n\nParticipants are required to complete at least one passive follow-up annually. Active follow-ups are conducted for those with positive screening results to ensure timely completion of endoscopic examinations. For those who have not undergone endoscopic examinations despite positive screening results, health education is provided, and they are mobilized at least four times within one month to complete endoscopic examinations. For participants diagnosed and treated for precancerous lesions and tumors, diagnostic and treatment data must be collected, and they are encouraged to follow up as per medical advice. Both active and passive follow-up results must be recorded in the screening follow-up information record form and reported to the Zhejiang Province Cancer Screening Information Platform.\n\nThis is a government collaboration project. All subjects will also be followed by record linkage to Cancer Register and Population Register.",[30],"2025-01-23",{"date":195,"type":44},"2025-01-28",{"date":197,"type":44},"2023-03-01",{"date":199,"type":20},"2028-12-31",{"name":201,"class":83},"Zhejiang Cancer Hospital",2,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":130},"100575653","phase-2-the-use-of-propranolol-in-the-perioperative-period-of-resectable-gastrointestinal-tumors-100575653","NCT06775080","The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors","The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors and the Study of Its Immune Mechanism Research","Inclusion Criteria:\n\n1. Surgically resectable primary gastric cancer and colorectal cancer;\n2. Age greater than 18 years old and less than 65 years old;\n3. Negative pregnancy test for women of childbearing age;\n4. ECOG score ≤2;\n5. Signed informed consent.\n6. Resting blood pressure greater than 100\u002F60mmHg, heart rate greater than 60 beats per minute.\n\nExclusion Criteria：\n\n1\\) Pregnant or breastfeeding women, or women with pregnancy plans within six months; 2) Patients with absolute or relative contraindications to propranolol:\n\n1. Pathological sinus node syndrome;\n2. Sinus bradycardia (less than 60 beats\u002Fminute);\n3. First, second or third degree AV block;\n4. Resting blood pressure less than 100\u002F60 mmHg;\n5. untreated pheochromocytoma;\n6. untreated thyroid disease;\n7. Patients on dihydropyridine or non-dihydropyridine calcium channel blockers (e.g., diltiazem, verapamil, nifedipine, amlodipine);\n8. Severe peripheral vascular disease (intermittent claudication);\n9. Patients on antiarrhythmic drugs (e.g., amiodarone, sotalol, digoxin);\n10. Patients with renal insufficiency (defined as creatinine clearance greater than 0.15 mmol\u002FL);\n11. Patients with hepatic insufficiency: AST or ALT or ALP \\> 2.5 times the upper limit of normal (ULN), bilirubin \\> 1.5 times the ULN, ALP \\> 2.5\n12. Patients using colistin, digoxin, rizatriptan, cimetidine, hydralazine, guanethidine, or ergotamine.\n13. Patients with a history of major depressive episodes; 3) Patients who have undergone surgery for GI tumors within the previous six months; 4) Patients receiving neoadjuvant chemotherapy prior to planned gastrointestinal tumor resection; 5) patients using conventional anxiolytic drugs (e.g. benzodiazepines), alpha-adrenergic agonists (e.g. colistin); 6) Patients using selective or non-selective β-adrenergic inhibitors (e.g., propranolol, metoprolol, atenolol, sotalol) within the last three months; 7) Patients with a history of stroke; 8) Patients with moderate or severe asthma, defined as requiring hospitalization or oral steroid therapy; (9) Those who, in the opinion of the physician, have other reasons for not being included in the treatment.",{"count":159,"type":20},[23],"In this study, perioperative propranolol β-blockade was administered to patients with surgically resectable primary gastrointestinal tumors to explore the safety, efficacy, and alleviation of perioperative psychological stress. At the same time, a multi-omics study was conducted using clinical samples to explore the activation of anti-tumor immune response and its mechanism.",[30],"2025-01-09",{"date":216,"type":44},"2025-01-14",{"date":218,"type":44},"2024-12-01",{"date":220,"type":20},"2027-04-30",{"name":222,"class":83},"Huashan Hospital",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":242,"locationsCount":130},"100574127","phase-1-a-study-of-gnc-077-in-patients-with-locally-advanced-or-metastatic-gastrointestinal-tumors-and-other-solid-tumors-100574127","NCT06755242","A Study of GNC-077 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics or Preliminary Efficacy and Antitumor Activity of GNC-077 Multi-specific Antibody Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Able to understand the informed consent form, voluntarily participate in and sign the informed consent form;\n2. Gender is not limited;\n3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);\n4. Patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors confirmed by histopathology and\u002For cytology who failed standard treatment;\n5. Must have at least one measurable lesion that meets the RECIST v1.1 definition;\n6. Have archived primary or recurrent tumor tissue specimens that can be submitted for central review;\n7. ECOG ≤1;\n8. The expected survival time as judged by the investigators was ≥3 months;\n9. Bone marrow function, renal function and liver function need to meet the requirements;\n10. Coagulation function: fibrinogen ≥1.5 g\u002FL; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN;\n11. Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose;\n12. Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;\n2. Patients with active infection requiring intravenous antibiotics that had not been completed more than 1 week before enrollment, with the exception of prophylactic antibiotics for puncture or biopsy;\n3. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;\n4. Toxicity from prior antineoplastic therapy is not reduced to grade I as defined in CTCAE, version 5.0;\n5. Patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement;\n6. Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;\n7. Patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation;\n8. Had a history of severe cardiovascular and cerebrovascular diseases;\n9. Patients with or with unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening;\n10. Brain parenchymal metastases and\u002For meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases;\n11. Patients with massive or symptomatic effusions or poorly controlled effusions;\n12. Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries;\n13. Subjects with clinically significant bleeding or significant bleeding tendency within the previous 4 weeks were screened;\n14. Complicated with other malignant tumors within 3 years before the first administration;\n15. Poorly controlled hypertension (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg);\n16. Diabetic patients with poor glycemic control;\n17. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-077;\n18. Who had participated in a clinical trial of an unmarketed drug within 4 weeks before the trial dose;\n19. Had received a live vaccine within 4 weeks before the trial dose;\n20. Other circumstances that the investigator deemed inappropriate for participation in the trial.",{"count":231,"type":20},20,[64],"This study is an open-label, multicenter, dose-escalation and cohort expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.",[30,235],"Solid Tumor","2024-12-25",{"date":238,"type":44},"2025-01-01",{"date":240,"type":20},"2025-01",{"date":127,"type":20},{"name":129,"class":51},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":130},"100410808","pd-l1-targeting-molecular-imaging-of-solid-tumors-100410808","NCT04629326","PD-L1 Targeting Molecular Imaging of Solid Tumors","Inclusion Criteria:\n\n* 1\\. Aged \\>18 years old; ECOG 0 or 1;\n* 2\\. Patients with Gastrointestinal tumors;\n* 3\\. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);\n* 4\\. life expectancy \\>=12 weeks.\n\nExclusion Criteria:\n\n* 1\\. Significant hepatic or renal dysfunction;\n* 2\\. Is pregnant or ready to pregnant;\n* 3\\. Cannot keep their states for half an hour;\n* 4\\. Refusal to join the clinical study;\n* 5\\. Suffering from claustrophobia or other mental diseases;\n* 6\\. Any other situation that researchers think it is not suitable to participate in the experiment.",{"count":231,"type":20},[251],"NA","The objective of the study is to constrcut a noninvasive approach WL12 PET\u002FCT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1\u002FL1 treatment.",[30],"2024-08-16",{"date":256,"type":44},"2024-08-19",{"date":258,"type":44},"2021-07-20",{"date":260,"type":20},"2024-11",{"name":262,"class":83},"Peking University Cancer Hospital & Institute",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":130},"100527822","early-phase-1-bgt007h-cells-for-the-treatment-of-recurrentrefractory-gastrointestinal-tumors-100527822","NCT06152757","BGT007H Cells for the Treatment of Recurrent\u002FRefractory Gastrointestinal Tumors","Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent\u002FRefractory Gastrointestinal Tumors","Inclusion Criteria:\n\n* 1\\. Resources sign written informed consent;\n* 2, age ≥18, male and female can;\n* 3\\. Expected survival ≥3 months;\n* 4\\. The Eastern Cancer Collaboration (ECOG) physical status score was 0-1;\n* 5\\. Biopsy specimen or pathological wax section test (within 3 years before accepting the signed informed consent) : positive target test;\n* 6\\. According to RECISTv1.1 solid tumor evaluation criteria, there is at least one measurable lesion;\n* 7\\. Patients with advanced gastrointestinal tumors (esophageal cancer, gastric cancer, pancreatic cancer or colorectal cancer, etc.) who have been diagnosed by histology\u002Fcytology as having failed the standard of second-line or above treatment or are not suitable for\u002Frefuse to accept the standard treatment or cannot tolerate the standard treatment; The definition of intolerance: according to CTCAE V5.0, the occurrence of ≥Ⅳ hematological toxicity or ≥Ⅲ non-hematological toxicity or ≥Ⅱ damage to the heart, liver, kidney and other important organs during treatment; Treatment failure is defined as disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence);\n* 8, can establish monopexy or venous blood collection venous access, and there are no other contraindications for blood cell separation;\n* 9, with adequate organ and bone marrow function;\n* 10\\. During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose, and the result is negative.\n\nExclusion Criteria:\n\n* 1\\. Active central nervous system metastasis (except stable after treatment);\n* 2, HIV positive, HBsAg positive simultaneously detected HBV DNA copy number positive (quantitative detection ≥1000cps\u002Fml), HCV antibody positive and HCV RNA positive;\n* 3, mental or mental illness can not cooperate with treatment and efficacy evaluation;\n* 4\\. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;\n* 5\\. Active or uncontrollable infection requiring systemic treatment within 14 days prior to enrollment;\n* 6\\. Any unstable systemic disease (including but not limited to: Active infections (except local infections); Unstable angina pectoris Cerebral ischemia or cerebrovascular accident (within 6 months prior to screening) Myocardial infarction (within 6 months prior to screening) Congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥Ⅲ; Severe arrhythmias requiring medical treatment; Have heart disease that requires treatment or uncontrolled hypertension after treatment (blood pressure \\> 160mmHg\u002F100mmHg);\n* 7, combined with lung, brain, kidney and other important organ dysfunction;\n* 8\\. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy, or is expected to undergo major surgery during the study period;\n* 9\\. Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis;\n* 10\\. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical cancer or basal cell carcinoma of the skin, and other malignant tumors with a disease-free survival of more than 5 years;\n* 11, received chimeric antigen receptor modified T cells (including CAR-T, CTT-T) treatment within half a year;\n* 12\\. Combined graft-versus-host disease (GVHD)\n* 13\\. Subjects who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 hours prior to cell transfusion (except for inhalation or topical use);\n* 14\\. Severe allergy or history of allergy;\n* 15\\. Subjects requiring anticoagulation therapy;\n* 16, pregnant or breastfeeding women, or six months within the pregnancy plan (unisex;\n* 17\\. Researchers believe that there are other reasons for not being included in the treatment.",{"count":271,"type":20},14,[273],"EARLY_PHASE1","This study is an exploratory single-arm, open, modified \"3+3\" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent\u002Frefractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection.\n\nFour dose levels were designed for this study: 1.0×10\\^8cells, 3.0×10\\^8cells, 1.0×10\\^9cells, and 3.0×10\\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent\u002Frefractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.",[30],"2023-11-22",{"date":278,"type":44},"2023-12-01",{"date":280,"type":44},"2023-10-09",{"date":282,"type":20},"2027-07-19",{"name":284,"class":51},"BioSyngen Pte Ltd",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":292,"targetDuration":4,"studyType":21,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":4},"100510124","phase-2-phase-ii-study-of-reuse-of-oxaliplatin-hypersensitivity-in-gastrointestinal-tumors-100510124","NCT05922358","Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors","Observation of Oxaliplatin Hypersensitivity and Neurotoxicity in GI Tract, and Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors: A Prospective, Open-Label, Multicenter, Phase II Study","Inclusion Criteria:\n\n1. Patients who plan to receive oxaliplatin treatment;\n2. Male or female aged 18-75 year;\n3. ECOG PS 0-2;\n4. The expected survival time is more than 3 months;\n5. Capable and willing to accept survey patients\n\nExclusion Criteria:\n\n1.Patients who were not suitable for the enrollment of this study judged by the investigator",{"count":293,"type":20},500,[23],"The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.",[30],"2023-06-19",{"date":299,"type":44},"2023-06-28",{"date":301,"type":20},"2023-09-01",{"date":303,"type":20},"2026-09-01",{"name":305,"class":306},"Fujian Cancer Hospital","OTHER_GOV"]