[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-cancers":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,41,70,101,133,172,201,226,257,297,316,339,363,390],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634409","phase-2-study-to-assess-the-efficacy-and-safety-of-rina-s-in-participants-with-advanced-gastrointestinal-gi-cancers-100634409",false,"NCT07539311","Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers","A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers","RAINFOL-09","Key Inclusion Criteria:\n\n• All study cohorts\n\n* Participant has histologically or cytologically confirmed GI cancer.\n* Participant has documented metastatic or unresectable disease, not amenable to treatment with curative intent.\n* Participant has measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at baseline.\n* Participant must have radiological disease progression while on or after receiving the most recent regimen.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has life expectancy ≥3 months.\n* Participant must be able to provide a newly obtained or archival tissue sample.\n* Participant must have adequate organ and bone marrow function, per laboratory test results prior to Rina-S administration.\n\nKey Exclusion Criteria (all study cohorts):\n\n* Participant has clinically significant non-malignant gastrointestinal disorders, including but not limited to, diarrhea \\> grade 1, ulcerative colitis, inflammatory bowel disease.\n* Participants with recent (up to 4 weeks) history of significant gastrointestinal bleeding, current cancer related ulcerations, fistula, abscess or recent perforation (within 4 to 6 weeks).\n* Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy.\n* Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease).\n* Prior treatment with topoisomerase-1 inhibitor containing antibody-drug conjugate (ADC).\n* Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase 2 study will be conducted in different countries around the world with up to about 160 participants.\n\nThe purpose of this study is to evaluate how well Rina-S works against GI cancers.\n\nThe medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo.\n\nParticipation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging\u002FX-rays) to monitor whether the study treatment is safe and effective.\n\nThe duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.",[27],"Gastrointestinal Cancers","RECRUITING","2026-06-19",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":32},"2026-05-11",{"date":36,"type":21},"2028-11",{"name":38,"class":39},"Genmab","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100514906","personalized-health-self-management-training-for-colorectal-cancer-survivors-100514906","NCT05984589","Personalized Health Self-Management Training for Colorectal Cancer Survivors","A Prospective, Randomized, Controlled, Double-Arm Study of RISE (Re-Invent, Integrate, Strengthen, Expand) Personalized Self-Management Training (PSMT) Compared to Standardized Self-Management Training (SSMT) in Gastrointestinal Cancer (GI) Patients","Inclusion Criteria:\n\n* Age ≥18 years at the time of consent.\n* History of Stage I-IV colorectal cancer (CRC) or other gastrointestinal cancer within the past 10 years prior to enrollment.\n* Ability to speak, write, and read English sufficiently to allow for program participation.\n* Identified by self-report as having willingness and interest to work on at least one lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical activity, body composition, alcohol use.\n* Scoring ≤3.5 on the World Cancer Research Fund\u002FAmerican Institute for Cancer Research (WCRF\u002FAICR) Health Behavior Adherence Scale or in the low-to-moderate range in any subcategory consistent with moderate to low adherence to healthy behavior recommendations (HBRs).\n* Ambulatory and independent in activities of daily living (ADL).\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.",{"count":49,"type":21},120,[51],"NA","This is a Phase 2 prospective, randomized, controlled, double-arm study to assess personalized self-management training (PSMT) intervention efficacy and patient experiences compared to standardized self-management training (SSMT). A total of 120 gastrointestinal (GI) cancer patients will be enrolled and randomized 1:1 to complete a 6-week self-management training program (either PSMT or SSMT) to be carried out by licensed occupational therapists with doctoral training.\n\nThis study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in GI cancer patients.",[54,55,56,57,27],"Colorectal Cancer","Healthy Lifestyle","Behavior, Health","Health Behavior",[59],"self-management training","2026-06-08",{"date":62,"type":32},"2026-06-10",{"date":64,"type":32},"2024-03-01",{"date":66,"type":21},"2028-11-30",{"name":68,"class":69},"University of Southern California","OTHER",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":80,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100643076","safety-and-efficacy-of-nom-and-opfs-versus-ro-for-dmmrmsi-h-or-pole-mutated-gastrointestinal-cancers-100643076","NCT07642323","Safety and Efficacy of NOM and OPFS Versus RO for dMMR\u002FMSI-H or POLE-Mutated Gastrointestinal Cancers","Safety and Efficacy of Nonoperative Management (NOM) and Organ Preservation First Strategy (OPFS) Versus Radical Operation (RO) for dMMR\u002FMSI-H or POLE-Mutated Gastrointestinal Cancers: A Single-Center, Bidirectional Registry Study","NOR-MP","Inclusion Criteria:\n\n* Histologically confirmed primary gastrointestinal adenocarcinoma or squamous cell carcinoma (e.g., colorectal cancer, gastric cancer, gastroesophageal junction cancer).\n* Confirmed as deficient mismatch repair (dMMR) by immunohistochemistry (IHC), high microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next-generation sequencing (NGS), or harboring POLE exonuclease domain mutations.\n* Received neoadjuvant\u002Fconversion immunotherapy (immune checkpoint inhibitors, either monotherapy or combination therapy) prior to treatment response evaluation.\n* For the Retrospective Cohort (Part 1): Patients treated between \\[Start Month\u002FYear\\] and \\[End Month\u002FYear\\] who completed evaluation and subsequent strategy (NOM\u002FOPFS or RO).\n* For the Prospective Cohort (Part 2): Newly diagnosed patients who consent to long-term follow-up and multi-disciplinary team (MDT) assessment for organ preservation or radical surgery.\n* Age ≥ 18 years at the time of diagnosis.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Concurrently diagnosed with other active malignant tumors within the past 5 years.\n* Patients with proficient mismatch repair (pMMR) \u002F microsatellite stable (MSS) tumors, or wild-type POLE status.\n* Evidence of untreatable distant metastasis or systemic disease that precludes local tumor management (NOM\u002FOPFS or radical operation).\n* Inability to undergo regular endoscopic, radiological (MRI\u002FCT), or clinical follow-up due to compliance or geographic reasons.\n* Refusal to sign the informed consent form (applicable to the prospective cohort).",{"count":79,"type":21},22,"3 Years","OBSERVATIONAL","Purpose:\n\nThe purpose of this study is to evaluate the safety and efficacy of Non-Operative Management (NOM) and Organ Preservation First Strategy (OPFS) compared with Radical Operation (RO) in patients with deficient mismatch repair\u002Fmicrosatellite instability-high (dMMR\u002FMSI-H) or POLE-mutated gastrointestinal cancers.\n\nBackground \\& Design:\n\nWith the remarkable efficacy of neoadjuvant immunotherapy in dMMR\u002FMSI-H or POLE-mutated gastrointestinal tumors, organ preservation has become a promising alternative to highly invasive surgeries. The NOR-MP trial is a single-center, bidirectional registry study consisting of two parts: a retrospective cohort study and a prospective observational registry.\n\nIntervention Group (NOM\u002FOPFS): Patients who achieve a clinical complete response (cCR) or near-cCR after neoadjuvant immunotherapy will undergo a \"Watch \\& Wait\" (W\\&W) strategy. Patients with near-cCR or non-cCR who are eligible for organ preservation will undergo local excision (LE) or endoscopic resection (including ESD or EMR).\n\nComparison Group (Radical Operation): Patients who undergo standard radical surgical resection after neoadjuvant immunotherapy.\n\nThe study aims to determine whether an organ-preserving approach can achieve comparable oncological outcomes and safety profiles while significantly improving patients' quality of life compared to radical surgery.",[27,84,85,86],"Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Anus",[88,89,90],"Gastrointestinal cancers","Colorectal cancer","Gastric cancer","NOT_YET_RECRUITING","2026-06-06",{"date":94,"type":32},"2026-06-11",{"date":96,"type":21},"2026-07-15",{"date":98,"type":21},"2030-01-15",{"name":100,"class":69},"Peking University Cancer Hospital & Institute",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100595982","phase-2-single-dose-investigator-initiated-pilot-study-to-investigate-cytalux-pafolacianine-for-intraoperative-detection-of-malignant-tissue-in-subjects-undergoing-surgical-resection-for-cancer-100595982","NCT07039526","Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.","Inclusion Criteria:\n\n1. Male and Female patients 18 years of age and older\n2. Have a primary diagnosis, or a high clinical suspicion, of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC\u002Fdebulking, warranting surgery.\n3. Are scheduled to undergo surgical intervention for tumor resection or diagnostic laparoscopy for assessment of disease burden.\n4. Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux\n5. Willingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n\nExclusion Criteria:\n\n1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject\n2. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.\n3. History of allergy to any of the components of CYTALUX™ (pafolacianine) injection\n4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule",{"count":108,"type":21},50,[24],"The goal of clinical trial is to test an FDA approved drug called Pafolacianine that attaches to cancer cells and lights up when seen through a special camera system in adults with a suspected primary diagnosis, or a high clinical suspicion of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC\u002Fdebulking, warranting surgery. The main question it aims to answer is:\n\n• Can CYTALUX™ (pafolacianine) injection used with near-infrared (NIR) fluorescent imaging improve the detection of malignant tissue in subjects undergoing surgical resection for cancer? Participants taking part in this study will receive the study medication. Then, during the surgery the investigator team will turn on the camera to evaluate if the tumor is visible with the help of the study medication. Taking part in this study will last about 2 months.",[112,27,113],"Esophageal Cancer","Gynecologic Cancers",[115,116,117,118,119,120,121,122],"Pafolacianine","CYTALUX","Folate receptor-alpha","Near-infrared fluorescence imaging","Intraoperative imaging","Fluorescence-guided surgery","esophageal cancer","gastrointestinal cancer","2026-06-03",{"date":125,"type":32},"2026-06-05",{"date":127,"type":32},"2025-08-19",{"date":129,"type":21},"2027-12",{"name":131,"class":69},"John Waters",1,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":159,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100633678","phase-1-phase-12-study-of-bhb810-in-advanced-gastric-and-gej-adenocarcinoma-100633678","NCT07529808","Phase 1\u002F2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma","Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.\n* Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.\n\n  * Participants in Phase 1 Backfill Cohorts \\& Phase 2 must be CDH17-positive by central testing.\n  * Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.\n* At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n* Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2.\n* Adequate organ and marrow function as defined in the protocol\n\nExclusion Criteria:\n\n* Prior cancer treatment as follows, relative to the first planned dose of trial intervention:\n\n  * Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)\n  * Monoclonal antibody-based therapy (including ADCs) within 4 weeks\n  * Immune checkpoint inhibitors within 4 weeks\n  * Wide-field radiation therapy (\\>30% marrow-bearing bones) within 4 weeks or \\\u003C 2 weeks of focal palliative radiation to nontarget lesions\n* Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF)\n* Known hypersensitivity or allergic reaction to BHB810 or it's excipients\n* Left ventricular ejection fraction \\\u003C50% or history of congestive heart failure Class III\u002FIV\n* QTc interval \\> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT\u002FQTc\n* Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant\n* Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled.\n* Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention\n* Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.",{"count":141,"type":21},164,[143,24],"PHASE1","This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.",[146,147,148,149,150,151,152,153,154,27,155,156,157,158],"Gastric Cancer","Gastric Adenocarcinoma","Gastric (Stomach) Cancer","Gastroesophageal Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastroesophageal Junction (GEJ) Adenocarcinoma","Gastroesophageal Junction (GEJ) Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Adenocarcinoma","Colorectal (Colon or Rectal) Cancer","Pancreatic Cancer","CDH17-positive Advanced Solid Tumors","Advanced Gastric Cancer",[160,161,162],"Antibody Drug Conjugate (ADC)","Monomethyl Auristatin E (MMAE)","CDH17 protein","2026-05-05",{"date":165,"type":32},"2026-05-08",{"date":167,"type":21},"2026-06",{"date":169,"type":21},"2028-12",{"name":171,"class":39},"BigHat Biosciences, Inc.",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100635601","phase-3-a-randomized-double-blind-placebo-controlled-prospective-multi-center-trial-evaluating-the-improvement-of-nutritional-status-and-sarcopenia-with-silkworm-pupa-tablets-in-patients-with-malignancies-100635601","NCT07554807","A Randomized, Double-blind, Placebo-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Sarcopenia With Silkworm Pupa Tablets in Patients With Malignancies","Inclusion Criteria:\n\n1. fully understand and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures\n2. Any gender, age at ICF signing: ≥ 18 years, ≤ 80 years\n3. Confirmed diagnosis of malignancy\n4. At screening\u002F enrollment, meet the definition of sarcopenia according to the 2019 Asian Working Group for Sarcopenia\n5. Generally good condition, ECOG performance status ≤ 2\n6. Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study\n\nExclusion Criteria:\n\n1. Presence of gastrointestinal obstruction preventing oral intake at screening\u002Fenrollment\n2. Use of immunosuppressants at screening\u002Fenrollment\n3. Life expectancy ≤ 3 months\n4. Presence of malabsorption syndrome or any condition affecting gastrointestinal absorption, e.g., chronic diarrhea (watery stools; daily stool frequency ≥ 5 times)\n5. Patients planning pregnancy, pregnant, or breastfeeding\n6. Known allergy to any component of the investigational products\n7. Presence of severe primary diseases of the heart, brain, lung, liver, kidney, endocrine, blood, nervous systems or other acute\u002Fchronic diseases that could significantly affect treatment and prognosis\n8. Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or patients deemed unsuitable for the study by the investigator","80 Years",{"count":180,"type":21},480,[182],"PHASE3","This is a randomized, double-blind, placebo-controlled, parallel-group, prospective, multi-center clinical trial, to evaluate the efficacy of silkworm pupa tablets in improving nutritional status and sarcopenia in patients with malignancies who have completed comprehensive treatment. All participants will be randomly assigned (1:1) to either experimental group (n=240): dietary advice + Wanshili Longbao Silkworm Pupa Tablets (main ingredients: freeze-dried active mulberry cocoon pupa powder, maltitol, milk mineral salt, mannitol, maltodextrin), 2 tablets three times daily before meals for 3 months, or control group (n=240): dietary advice + placebo (identical appearance), 2 tablets three times daily before meals for 3 months. The primary endpoint is sarcopenia prevalence at 3 months (based on AWGS 2019 criteria: muscle strength, muscle mass, and physical function).",[185,27,186],"Nutritional Deficiency","Sarcopenia",[188,189,190],"silkworm pupa tablets","gastrointestinal malignancies","nutritional risk","2026-04-21",{"date":193,"type":32},"2026-04-28",{"date":195,"type":21},"2026-04-01",{"date":197,"type":21},"2028-03-31",{"name":199,"class":69},"First Affiliated Hospital of Zhejiang University",4,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":200},"100568438","feasibility-study-of-cbct-for-igrt-in-cancer-patients-100568438","NCT06681233","Feasibility Study of CBCT for IGRT in Cancer Patients","A Feasibility Study of a Novel Cone-Beam CT Approach for Image Guided Radiotherapy in Cancer Patients","Inclusion Criteria:\n\n1. Patient age ≥ 18\n2. Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies\n3. A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered\n\nExclusion Criteria:\n\n1. Patient has ECOG Performance Status ≥3.\n2. Patient is wheelchair bound.\n3. Patient has a life expectancy \\\u003C3 months.\n4. Patient is unwilling or unable to provide informed consent to participate in the study.\n5. Patient is pregnant or has plans for pregnancy during the period of treatment.\n6. Patient is part of a vulnerable population (per ISO 14155:2020, \"individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response\"). This includes prisoners.",{"count":108,"type":21},[51],"Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems. The quality of conventional CBCT is good enough to align patients for their daily radiation therapy but CBCT images have poor contrast and are susceptible to imaging artefacts that limit their usability for other tasks in the radiation therapy workflow.\n\nVarian Medical Systems, the sponsor of this study, has developed new CBCT imaging technology called HyperSight that so far has demonstrated increased image quality compared with conventional CBCT images. This new HyperSight CBCT imager has previously been built into Varian Halcyon and Ethos treatment machines, where the imager is enclosed in a ring that rotates around the patient. Now, HyperSight has been built into a Varian treatment machine, called TrueBeam, where the imager is mounted on a C-shaped arm that rotates around you to acquire an image.\n\nThis study is being done to evaluate the image quality of HyperSight CBCT compared to conventional CBCT images, and to determine whether HyperSight CBCT can improve the process of delivering radiation treatments.\n\nThe goal of this study is to collect images from this new HyperSight-TrueBeam CBCT imager from a variety of patients and locations in the body. The images will be analyzed to determine whether their quality is high enough to use for tasks other than positioning patients for treatment. For example, the study will determine whether the HyperSight images could be used to calculate a radiation plan.",[212,213,214,215,216,27],"Head and Neck Cancers","Breast Cancer","Thoracic Cancers","Liver Cancer","Genito Urinary Cancer","2026-03-12",{"date":219,"type":32},"2026-03-13",{"date":221,"type":32},"2025-02-19",{"date":223,"type":21},"2026-09",{"name":225,"class":39},"Varian, a Siemens Healthineers Company",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":132},"100624179","clinical-evaluation-of-ai-decision-support-for-early-rehabilitation-after-surgery-100624179","NCT07406269","Clinical Evaluation of AI Decision Support for Early Rehabilitation After Surgery","Evaluation of Clinical Effectiveness and Implementation of an Artificial Intelligence Based Decision Support Tool That Guides Early Rehabilitation After Gastrointestinal and Oncology Surgery","DESIRE","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Undergoing gastrointestinal or oncological surgery\n* Postoperatively admitted to the surgical ward\n* Expected to remain admitted for at least 2 days after surgery\n\nExclusion Criteria:\n\n* Admitted to the intensive care unit (ICU) at the time of prediction on postoperative day 2\n* Inability to provide informed consent in Dutch or English",{"count":235,"type":21},103,[51],"After gastrointestinal or oncology surgery, it can be difficult to determine when a patient is ready to safely begin early rehabilitation or move toward discharge. Delays may prolong hospital stay, while premature decisions may increase risks.\n\nThis study evaluates an artificial intelligence (AI)-based decision support tool that analyzes routinely collected hospital data to identify patients who are likely ready for early rehabilitation and discharge planning after surgery. The tool provides a simple yes\u002Fno output to support clinicians in their decision-making.\n\nThe AI tool does not replace clinical judgment. Treating physicians remain fully responsible for all care decisions.\n\nThe purpose of this study is to examine how well this tool performs in clinical practice and how it can be safely and effectively implemented to support postoperative care.",[239,27],"Oncologic Surgery",[241,242,243,244,245,246,247],"Artificial Intelligence","Clinical Decision Support System","Postoperative Care","Early Rehabilitation","Gastrointestinal Surgery","Oncological Surgery","Predictive Modeling","2026-02-06",{"date":250,"type":32},"2026-02-12",{"date":252,"type":21},"2026-06-01",{"date":254,"type":21},"2027-07-01",{"name":256,"class":69},"Erasmus Medical Center",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":278,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":132},"100572340","optimal-perioperative-pain-control-in-minimally-invasive-abdominal-cancer-surgery-100572340","NCT06731998","Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery","Evaluating Optimal Perioperative Pain Management: A Prospective Randomized Control Trial of Laparoscopic Transversus Abdominis Plane Block With Local Anesthetic, Laparoscopic Transversus Abdominis Plane Block Alone, and Local Anesthetic Alone in Minimally Invasive Oncologic Surgery","LapTAP","Inclusion Criteria:\n\n1. Male and female patients age ≥ 18 - 89\n2. Patients scheduled for elective (clinically indicated) hepatic, gastric, biliary, pancreatic, gynecologic, colorectal, other GI Minimally invasive oncologic surgery.\n3. Patients who have provided informed consent to participate in the study.\n4. Patients with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.\n5. Patients undergoing procedures anticipated to last more than 1 hour but less than 8 hours.\n6. Patients able to understand and self-report pain using the designated pain Visual Analog Scale\n\nExclusion Criteria:\n\n1. Patients age less than 18 or ≥ 90\n2. Pre-existing hepatic dysfunction, cirrhosis\n3. Patients with an ASA classification of IV or higher.\n4. Patients with chronic pain disorders or on long-term opioid or analgesic therapy.\n5. Patients with known contraindications to the study drugs or procedures (e.g., allergy to LA or contraindications to LapTAP).\n6. Patients with cognitive impairments or psychiatric conditions that could interfere with pain assessment or understanding of informed consent.\n7. Patients unable to understand the language in which consent and study-related information are provided (The study and the study-related information will be in the English Language)..\n8. Patients who have undergone major surgery within the last 6 months.\n9. Female patients who are pregnant.\n10. Patients currently enrolled in another clinical trial that might interfere with the outcome measures of this study.","89 Years",{"count":267,"type":21},48,[51],"This is a research study to evaluate the effectiveness of 3 different types of routine pain management regimens used during clinically indicated, minimally invasive oncologic (cancer) surgery. This project is considered \"Research\" and participation is voluntary. Upon enrollment in this study, the research team will collect data from the patient's medical records. The patient will undergo all of the normal testing and procedures required pre-operatively (standard of care). The study team will then randomly assign the patient (like a flip of a coin) to one of three different study arms for pain management during surgery:\n\n1. Laparoscopic Transversus Abdominis Plane Block (LapTAP) with Local Anesthetic (LA)\n2. Laparoscopic Transversus Abdominis Plane Block (LapTAP) only\n3. Local Anesthetic (LA) only The patient will receive standard pre- and post-operative care according to clinical guidelines (routine care). The study team will collect information from the patient's medical record for the first 24 hours after their surgery and upon discharge. This information will include pain scores, amount of medication required, any side effects the patient may have experienced, and satisfaction with pain control. Participation in the study will end upon discharge from the hospital.",[239,271,272,273,274,275,276,113,27,54,277],"Cancer","Cancer Surgery","Hepatic Cancer","Gastric (Cardia, Body) Cancer","Biliary Tract Cancer","Pancreatic Cancer Resectable","Minimally Invasive Surgical Procedures",[279,280,281,282,283,284,285,286,287],"Laparoscopic Transversus Abdominis Plane Block","Local Anesthetic","Laparoscopic Surgical Procedure","pain management","cancer","cancer surgery","oncologic surgery","perioperative pain management","minimally invasive surgical procedures","2025-09-15",{"date":290,"type":32},"2025-09-18",{"date":292,"type":32},"2025-02-05",{"date":294,"type":21},"2026-12",{"name":296,"class":69},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":178,"enrollmentInfo":303,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":312,"leadSponsor":314,"locationsCount":4},"100606260","a-real-world-study-of-adebrelimab-based-combination-regimens-in-the-treatment-of-advanced-solid-tumors-100606260","NCT07173244","A Real-world Study of Adebrelimab-based Combination Regimens in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Signed informed consent and voluntarily enrolled in this study;\n2. Histologically or cytologically confirmed extensive-stage small cell lung cancer;\n3. Patients with other types of advanced solid tumors confirmed by histology or cytology; patients who, based on currently available data, the investigator believes may benefit from adebrelimab treatment may also be considered for enrollment;\n4. Patients in Cohort 1 who experience disease progression and whose second-line treatment options, as assessed by the investigator, include adebrelimab in combination therapy may be enrolled in Cohort 2;\n5. Age 18-80 years;\n6. Patients deemed by the investigator to be eligible for adebrelimab monotherapy or combination therapy;\n7. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Females and males of childbearing potential must agree to use appropriate contraceptive methods or undergo surgical sterilization during the trial and within 90 days after the last dose of the trial drug.\n8. Ability to comply with study and follow-up procedures.\n\nExclusion Criteria:\n\n1. Women who have been confirmed to be pregnant or breastfeeding;\n2. Patients with histologically or cytologically confirmed central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanomas and other skin tumors;\n3. Patients with a history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n4. Patients with known allergies to adebrelimab or any of its drugs and excipients;\n5. Patients who are deemed by the investigator to be unsuitable for participation in this study in any other circumstances, including but not limited to the following: (1) Patients with autoimmune diseases (AIDs), especially neurological AIDs, or AIDs that are moderate to severe or in active stage and cannot be controlled by immunosuppressants or require high-dose immunosuppressants to control symptoms; (2) Patients with tuberculosis infection, active tuberculosis, and suspected active TB should be examined by chest X-ray, sputum, and clinical symptoms and signs to exclude; (3) The patient has previously received or is about to receive solid organ transplantation or hematopoietic stem cell transplantation; (4) The patient needs to use large doses of antibiotics, glucocorticoids, proton pump inhibitors and other drugs for a long time.",{"count":304,"type":21},300,"This prospective, multicenter, non-interventional, observational, real-world study was designed to evaluate the safety and efficacy of an adebrelimab-based regimen in patients with advanced solid tumors.",[307,308,27],"Non-Small Cell Lung Cancer","Small Cell Lung Cancer","2025-09-08",{"date":288,"type":32},{"date":288,"type":21},{"date":313,"type":21},"2029-09",{"name":315,"class":69},"Tianjin First Central Hospital",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":132},"100585919","addressing-social-determinants-of-health-among-metro-detroit-cancer-survivors-100585919","NCT06908629","Addressing Social Determinants of Health Among Metro Detroit Cancer Survivors","Addressing Social Determinants of Health (SDOH) Among Metro Detroit Cancer Survivors: A Pilot Feasibility Study (The Resource Ready Study)","Inclusion Criteria:\n\n* 18 years or older\n* past or current cancer diagnosis\n* reside in metropolitan Detroit (Wayne, Oakland, Macomb counties)\n* English proficient\n* Actively receiving care through one of Karmano's Cancer Institute's outpatient clinics OR post treatment survivors in the Detroit Research on Cancer Survivors (ROCS) longitudinal cohort study who have reported past food insecurity and agreed to be contacted for further research\n\nExclusion Criteria:\n\n* none",{"count":49,"type":21},[51],"The goal of this screening study is to determine the feasibility of completing a social needs screening tool in participants who have a past or current cancer diagnosis and reside in Metro Detroit, Michigan. Main questions to answer are:\n\n* Can we have a completion rate of at least 80% of participants filling out the screening tool?\n* Can we determine procedures for patient referrals based on social needs\n* Can we implement brief interventions based on food access and digital inclusion (ensuring everyone has access to the digital technologies they need to participate in society)",[271,327,27,328,329],"Cancer Survivors","Neuroendocrine Tumors","Multiple Myeloma, Neoplasms","2025-08-25",{"date":332,"type":32},"2025-08-26",{"date":334,"type":32},"2024-09-03",{"date":336,"type":21},"2027-05",{"name":338,"class":69},"Barbara Ann Karmanos Cancer Institute",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":17,"minAge":345,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":346,"phases":4,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":357,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":361,"locationsCount":4},"100583143","expanded-access-protocol-for-the-use-of-sl-28-in-the-treatment-of-advanced-solid-tumors-100583143","NCT06872489","Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic solid tumor confirmed by histopathology;\n* Having at least one evaluable or measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n* For patients with relapsed\u002Frefractory neuroblastoma with original diagnosis based on tumor histopathology, Karnofsky or Lansky performance status of ≥ 50%;\n* ECOG Performance Status from 0 or 3;\n* The expected survival time is more than 12 weeks;\n* 2 to 65+ old, gender is not limited;\n* The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;\n* Be able to comply with trial and follow-up procedures;\n* Adequate bone marrow and organ function;\n* Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);\n* Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse)or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug.\n* The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;\n* For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.\n* Immunotherapy: At least 42 days after completing any type of immunotherapy, including immune checkpoint;\n* Radiation therapy: 60 days should have elapsed in the case of completing radiation.\n* Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 7 days prior to SL-28 therapy.\n\nExclusion Criteria:\n\n* Untreated or active primary central nervous system (CNS) tumor or metastasis;\n* Patients diagnosed of having primary and secondary immunodeficiencies;\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Arterial\u002Fvenous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n* Known allergy to any of the agents or their ingredients used in this study;\n* Patients who are on hemodialysis;\n* Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;\n* Patients with untreated positive blood cultures or progressive infections.","2 Years","EXPANDED_ACCESS","This is an Expanded Access Program (EAP) that will give the participants access to the drug SL-28 before it is approved by the FDA. Participants in this study will have Advanced Solid Tumors who failed to respond to standard therapy (chemotherapy, immunotherapy) or developed progressive disease at any phase of standard therapy.\n\nResearchers think the SL-28 will be effective because SL-28 has a direct activity against different types of tumors.\n\nSL-28 is a cell-based therapy, based on leukocytes isolated from healthy donors and are activated through the proprietary process. After quality assessment (sterility, viable cell count, purity, and absence of infectious diseases), they are stored at -80°C until use. Upon need, the SL-28 is thawed, followed by checking their viability, count, and sterility. Adult and older adult patients aged 18 to 65+ who meet the eligibility criteria will be included in the study. Patients receive SL-28 IV once daily on days 1-5 and 8-12. Based on the patient's response, the need for additional injections will be evaluated. If improvements in the patient's condition are confirmed by MRI, further injections can continue on a rate 5 days a week.",[349,350,351,352,353,354,355,27,356,156],"Neuroblastoma in Children","Neuroblastoma, Recurrent, Refractory","Advanced Cancer","Advanced Malignant Neoplasm","Prostate Cancer Patients With Bone Metastasis","Lung Cancer Non-Small Cell Cancer (NSCLC)","Lung Cancer - Non Small Cell","Head and Neck Cancer","AVAILABLE","2025-07-17",{"date":360,"type":32},"2025-07-23",{"name":362,"class":39},"Second Life Therapeutics",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":373,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":132},"100590347","phase-3-prophylactic-or-preemptive-entecavir-in-patients-with-gastrointestinal-cancer-who-are-inactive-hepatitis-b-carriers-100590347","NCT06966232","Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers","An Open, Multicentre, Phase 3, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers","Inclusion Criteria:\n\n1. Patients with age between 18 and 75\n2. Patient with histology-proven locally advanced unresectable or metastatic gastrointestinal cancers (colorectal cancer, gastric cancer, esophageal cancer, hepatocellular carcinoma, pancreatic cancer, and cholangiocarcinoma)\n3. Planned to receive first-, second-, or third-line anti-tumor therapy (chemotherapy or PD-1\u002FPD-L1 monoclonal antibody immunotherapy)\n4. Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-2\n5. Patients planned for at least 4 cycles of chemotherapy or immunotherapy\n6. Patients with at least 6 months' life expectancy from date of recruitment\n7. Patients with chronic or past HBV infection (HBsAg-positive or HBcAb-positive), and hepatitis B is inactive\n8. Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), and bilirubin\n9. Patients with negative HBV-DNA\n10. Adequate major organ function (laboratory tests 14 days before randomization meeting requirements for anti-tumor therapy)\n11. Patients who sign the informed consent\n12. Patients with good compliance during chemotherapy and follow-ups.\n\nExclusion Criteria:\n\n1. History of liver cirrhosis\n2. Prior HBV reactivation\n3. Received anti-HBV therapy for chronic hepatitis B within 6 months before enrollment\n4. Active co-infection with other hepatitis viruses\n5. HIV infection\n6. Autoimmune hepatitis\n7. History of hepatic radiotherapy\n8. Scheduled hepatic radiotherapy or radioisotope therapy\n9. Pregnant or lactating women\n10. Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder\n11. Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history\n12. According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.","75 Years",{"count":372,"type":21},136,[182],"There has been no report on whether the patients with gastrointestinal cancer who are also inactive hepatitis B carriers should receive prophylactic use or preemptive use of an anti-viral drug entecavir during anti-tumor therapy. This open, multicentre, phase 3, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug entecavir on the outcomes of patients with gastrointestinal cancer who are also inactive hepatitis B carriers during chemotherapy or immunotherapy and the subsequent follow-ups, including two cohorts of chemotherapy and immunotherapy.",[27],[27,377,378,379,380],"Entecavir","Hepatitis B Carrier","Chemotherapy","Immunotherapy","2025-05-02",{"date":383,"type":32},"2025-05-11",{"date":385,"type":21},"2025-05-15",{"date":387,"type":21},"2027-05-20",{"name":389,"class":69},"Sun Yat-sen University",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":397,"sex":17,"minAge":18,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":408,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":132},"100562361","electroacupuncture-combined-with-self-administered-acupressure-for-the-prevention-of-capecitabine-associated-hand-foot-syndrome-100562361","NCT06602167","Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome","Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Sign a written informed consent form;\n2. Male or female ≥ 18 years old;\n3. Patients with gastrointestinal cancer or breast cancer who are diagnosed with cancer by pathology will receive capecitabine treatment for the first time according to the label;\n4. The performance status of the Eastern Cancer Collaboration Group is 0-2;\n5. Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy, minimum daily total dose of capecitabine 2000 mg\u002Fm\\^2);\n6. Expected lifespan ≥ 3 months;\n7. Laboratory requirements: platelet count ≥ 100 × 10\\^9\u002FL, white blood cell count\\>3.0 × 10\\^9\u002FL, hemoglobin ≥ 10.0 g\u002FdL, normal liver and kidney function;\n8. Adequate contraception.\n\nExclusion Criteria:\n\n1. Previous use of capecitabine or liposome doxorubicin or any other tyrosine kinase inhibitor that may induce HFS (such as sorafenib, sunitinib, and apatinib) for chemotherapy;\n2. The initial dose of capecitabine is less than 800mg\u002Fm\\^2;\n3. Radiation therapy or surgery should be performed within 4 weeks before the start of treatment;\n4. Skin diseases that may interfere with clinical trial results;\n5. Known drug\u002Falcohol abuse;\n6. Pregnant women or lactating patients;\n7. Participate in another clinical trial and the patient has received the investigational drug within the last 30 days prior to the start of treatment (i.e. follow-up in the previous trial was not exclusive);\n8. Known patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles or any component of capecitabine;\n9. Receive any acupuncture and moxibustion treatment ,there is lymphedema in the area stimulated by acupuncture;\n10. Patients with any chemotherapy- or radiotherapy-related toxicities that have not subsided to grade 2 or lower will be excluded, except for stable sensory neuropathy.\n11. Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss, will also be grounds for exclusion.",true,"85 Years",{"count":400,"type":21},220,[51],"This study hypothesizes that electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment is effective in preventing Hand-Foot Syndrome (HFS) caused by capecitabine. It aims to explore the effectiveness of this combined approach in preventing HFS in patients with malignant tumors undergoing oral capecitabine treatment. Further exploration of prevention and treatment methods may enhance the quality of life for patients during the treatment process.",[404,405,406,407,213,27],"Capecitabine","Hand-foot Syndrome","Electroacupuncture","Self-administered Acupressure",[409,410,411,412,413,88],"electroacupuncture","capecitabine","self-administered acupressure","Hand-foot syndrome","Breast cancer","2024-12-09",{"date":416,"type":32},"2024-12-12",{"date":418,"type":32},"2024-10-08",{"date":420,"type":21},"2027-12-31",{"name":422,"class":69},"Affiliated Hospital of Qinghai University"]