[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hubei Cancer Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":335},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,49,80,108,131,157,179,203,221,246,269,293,310],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100613189","diep-flap-breast-reconstruction-perioperative-biomarkers-and-outcomes-100613189",false,"NCT07263347","DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes","Prospective Observational Study of Perioperative Biomarkers and Outcomes in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction","Inclusion Criteria:\n\n1. Female, 18-70 years old.\n2. Clinically diagnosed with breast cancer and scheduled for immediate DIEP free-flap breast reconstruction after mastectomy.\n3. Conscious and able to understand and voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n1. Severe cardiac, hepatic, or renal dysfunction or severe coagulopathy (e.g., NYHA class III-IV, Child-Pugh class C, eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n2. Preoperative active infection, autoimmune disease, or long-term use of immunosuppressants\u002Fanti-inflammatory drugs (e.g., corticosteroids).\n3. Pregnant or breastfeeding.\n4. Prior ipsilateral breast surgery or radiotherapy that may affect local blood circulation assessment.\n5. Any condition deemed unsuitable by the investigator (e.g., poor compliance).","FEMALE","18 Years","70 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","Brief Summary This observational study will follow patients who undergo DIEP flap breast reconstruction to better understand a common surgical challenge called ischemia-reperfusion (I\u002FR) injury. I\u002FR injury can happen when a flap has a period without blood flow (ischemia) and then blood flow returns (reperfusion). This process may trigger inflammation and oxidative stress and is associated with fat necrosis or partial flap loss.\n\n1\\. What is being studied\n\n1. The investigators will measure inflammation and oxidative stress markers in blood (for example, interleukin-6 \\[IL-6\\]) from before surgery through the first 72 hours after surgery.\n2. These data will help map the normal and abnormal patterns of recovery after surgery and may inform future approaches to monitoring and protecting flap tissue.\n3. No experimental drug or device is given to participants in this study. Separate animal studies are developing a near-infrared imaging and antioxidant nanomaterial (Mn\u002FQD-SAC); this is not used in participants here.\n\n2\\. Who can take part\n\n1. Women aged 18-70 scheduled for immediate DIEP flap breast reconstruction after breast cancer surgery.\n2. Key exclusions include severe heart, liver, or kidney disease; significant clotting problems; active infection or autoimmune disease; long-term use of immunosuppressants\u002Fanti-inflammatory drugs; pregnancy or breastfeeding; or other reasons judged by the research team.\n\n3\\. What will happen if you join\n\n1. After providing informed consent, participants will have blood drawn at five time points: pre-operative baseline (within 24 hours before surgery) and at 0, 6, 24, and 72 hours after surgery (about 10 mL each time; total \\~50 mL).\n2. Blood will be processed and stored under secure conditions and tested for inflammation and oxidative stress markers.\n3. The investigators will also record routine clinical information from the medical record (such as age, BMI, surgery duration, ischemia time, and clinical assessments of flap outcomes and complications).\n4. Participation does not change the participant's clinical care before, during, or after surgery.\n\n4\\. Risks and benefits\n\n1. Risks are those of standard blood draws: brief pain, bruising, bleeding, dizziness, and rare infection.\n2. There is no direct medical benefit to participants. Results may help improve understanding and future care for patients undergoing flap reconstruction.\n\n5\\. Privacy and data protection\n\n1. Samples and data will be coded without names. Identifying information is stored separately with restricted access.\n2. Research results are not routinely added to the medical record or returned to participants unless a finding has clear, actionable clinical significance and is approved by the ethics committee.\n\n6\\. Time commitment and costs\n\n1. All blood draws occur during the routine hospital stay. There is no additional follow-up required after discharge.\n2. There is no cost to participate.\n\n7\\. Voluntary participation Joining the study is voluntary. Participants may withdraw at any time without affecting their medical care.",[25,26,27,28,29,30],"Breast Neoplasms","Ischemia-Reperfusion Injury","Postoperative Complications","Wound Healing","Oxidative Stress","Inflammation",[32,33,34,35],"Deep inferior epigastric perforator (DIEP) flap","Autologous breast reconstruction","Free tissue transfer","Ischemia-reperfusion injury","RECRUITING","2026-04-01",{"date":39,"type":40},"2026-04-03","ACTUAL",{"date":42,"type":40},"2025-12-20",{"date":44,"type":21},"2026-10",{"name":46,"class":47},"Hubei Cancer Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":60,"conditions":61,"keywords":68,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":48},"100613316","observational-study-of-gut-microbiota-in-abemaciclib-treated-patients-with-and-without-diarrhea-100613316","NCT07264998","Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea","Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study","Inclusion Criteria:\n\n1. Aged 18 to 75 years.\n2. Diagnosed with hormone receptor-positive (HR⁺) breast cancer.\n3. Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks.\n4. Willing and able to provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. History of major gastrointestinal diseases, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction, or having undergone major gastrointestinal surgery.\n2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may alter gut function.\n3. Pregnant or lactating women.\n4. Unwilling to provide informed consent or considered by the investigator to be unsuitable for the study for any other reason.","ALL","75 Years",{"count":59,"type":21},60,"Why is this study being done? Many patients with a type of breast cancer (called HR-positive) take a medicine called Abemaciclib. While this medicine is effective, a very common side effect is diarrhea, which can be severe enough to disrupt treatment and reduce quality of life. The reason why some patients get diarrhea and others do not is not well understood. This study aims to investigate whether the natural bacteria living in the gut (known as the gut microbiome) play a role in this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not.\n\nWhat will happen in the study? This is an observational study, which means that patients will receive their normal cancer treatment and will not be given any new or experimental drugs as part of this initial phase.\n\n* Patients who are already being treated with Abemaciclib will be invited to join.\n* They will be placed into one of two groups: those who experience diarrhea and those who do not.\n* Participants will be asked to provide stool (feces) samples and may also provide optional blood samples at specific times during their treatment.\n* Researchers will analyze these samples in the lab to study the types and functions of the gut bacteria.\n\nWho can participate?\n\n* Adult women (aged 18-75) diagnosed with HR-positive breast cancer.\n* Currently receiving treatment with Abemaciclib for at least 2 weeks.\n* Must be willing to provide informed consent and follow the study procedures.\n\nWhat are the potential benefits? Participants will not receive any direct medical benefit from taking part in this study. However, the information learned may help researchers better understand why diarrhea occurs and, in the future, could lead to new ways to prevent or treat this side effect for other cancer patients.\n\nHow is privacy protected? All personal information and samples collected will be de-identified using a unique code. This means that the data used for analysis cannot be directly linked back to the participant's identity. All data is stored securely according to strict ethical guidelines.",[25,62,63,64,65,66,67],"Hormone Receptor-Positive Breast Cancer","Abemaciclib","Abemaciclib-related Diarrhea","Drug-induced Diarrhea","Gastrointestinal Microbiome (Focus)","Microbiome",[63,69,70,67,71,72,73],"Hormone receptor-positive breast cancer","Drug-induced diarrhea","Gastrointestinal microbiome","Microbiome biomarkers","Abemaciclib-related diarrhea",{"date":39,"type":40},{"date":76,"type":40},"2025-12-21",{"date":78,"type":21},"2026-07",{"name":46,"class":47},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":57,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":107,"locationsCount":48},"100613315","gut-microbiota-and-diarrhea-in-breast-cancer-patients-receiving-pyrotinib-100613315","NCT07264985","Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib","Gut Microbiota Changes in Breast Cancer Patients Treated With Pyrotinib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study","Inclusion Criteria:\n\n1. Patients aged 18-75 years, regardless of gender.\n2. Diagnosed with HER2-positive breast cancer and currently receiving pyrotinib treatment (either as monotherapy or in combination with endocrine therapy), with a treatment duration of ≥ 2 weeks.\n3. Voluntarily agree to participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n1. History of significant gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, intestinal obstruction) or previous major gastrointestinal surgery.\n2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine intended to alter intestinal function.\n3. Pregnant or lactating women.\n4. Patients who refuse to provide informed consent or explicitly express unwillingness to participate. Patients found not meeting the inclusion criteria after enrollment will be discontinued from the study.",{"count":59,"type":21},"Background:\n\nPyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life. The reason why some patients develop diarrhea while others do not is not well understood. Recent research suggests that the community of bacteria in the gut (gut microbiota) may play a key role in this side effect.\n\nWhat is the purpose of this study? This is an observational study (Phase 1) that aims to understand the relationship between pyrotinib treatment, changes in gut bacteria, and the occurrence of diarrhea. The main goal is to compare the gut bacteria of patients who develop diarrhea while taking pyrotinib with those who do not. Researchers hope to identify specific bacteria that might protect against diarrhea, which could lead to new ways to prevent or treat this side effect in the future.\n\nWhat will happen in the study? Patients with HER2-positive breast cancer who are being treated with pyrotinib will be invited to participate. They will be divided into two groups: those who experience diarrhea and those who do not. Participants will provide stool samples at specific time points (e.g., 2 and 4 weeks after starting pyrotinib). They will also allow researchers to collect information from their medical records about their clinical condition and diarrhea symptoms. No experimental intervention will be administered in this phase of the study; all patients will receive standard medical care.\n\nPotential Benefits:\n\nParticipants will not receive any direct benefit from this observational phase of the study. However, the information gathered may help scientists better understand pyrotinib-induced diarrhea and develop future strategies to help other breast cancer patients manage this side effect more effectively.",[90,91,92],"Breast Cancer","Drug-Related Side Effects","Diarrhea",[94,92,95,96,67,97,98,99],"Pyrotinib","Gut Microbiota","HER2-Positive Breast Cancer","Drug Side Effect","Metagenomics","Observational Study","NOT_YET_RECRUITING","2025-11-24",{"date":103,"type":40},"2025-12-04",{"date":105,"type":21},"2025-12",{"date":78,"type":21},{"name":46,"class":47},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":115,"studyType":22,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":128,"leadSponsor":130,"locationsCount":48},"100612178","a-study-on-combined-low-pass-whole-genome-and-methylome-testing-of-bloody-nipple-discharge-specimens-for-benign-malignant-differentiation-100612178","NCT07250204","A Study on Combined Low-pass Whole-genome and Methylome Testing of Bloody Nipple Discharge Specimens for Benign-Malignant Differentiation.","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Spontaneous, unilateral, single-duct pathologic nipple discharge, predominantly bloody or serosanguinous, raising clinical suspicion of intraductal disease.\n3. Planned diagnostic breast surgery\u002Fbiopsy after specialist assessment (e.g., duct excision\u002Fmicrodochectomy, lumpectomy); patients who had ductoscopy but are still scheduled for surgery remain eligible.\n4. Study sampling (nipple discharge and one peripheral blood tube) feasible before surgery\u002Finvasive diagnostics without delaying standard care.\n5. Able and willing to provide written informed consent and allow access to surgical pathology and relevant clinical data.\n\nExclusion Criteria:\n\n1. Physiologic or non-pathologic discharge (typically bilateral, multiduct, expressible only with manipulation; milky\u002Fclear\u002Fgreen) or galactorrhea due to endocrine\u002Fdrug causes.\n2. Active breast infection\u002Finflammatory disease (e.g., abscess) as the source of discharge.\n3. Prior diagnosis and treatment of breast cancer (surgery\u002Fradiation\u002Fsystemic therapy).\n4. Recent invasive ductal manipulation likely to confound analysis (e.g., ductoscopy, duct cannulation\u002Firrigation), per investigator judgment.\n5. Pregnant or lactating patients.\n6. Significant hematologic disease\u002Fcoagulopathy precluding safe sampling.\n7. Inability to complete preoperative study sampling, refusal\u002Fwithdrawal of consent, or poor compliance.\n8. Any condition judged by investigators to compromise sample quality, data interpretation, or participant safety.",{"count":59,"type":21},"1 Month","This is a prospective, single-center diagnostic study testing whether a new, minimally invasive analysis of nipple fluid can distinguish benign from malignant causes of pathologic nipple discharge. Many patients with bloody or blood-tinged nipple discharge undergo surgery to make a diagnosis, yet most are ultimately found to have benign disease. The investigators aim to develop a laboratory test that analyzes DNA in nipple fluid to help avoid unnecessary operations while still identifying cancers.\n\nApproximately 30 adults with spontaneous, single-duct, unilateral bloody or serosanguinous nipple discharge who are already scheduled for standard diagnostic surgery will be enrolled at Hubei Cancer Hospital. Before surgery, the investigators will collect a small sample of nipple fluid (or gently obtain nipple aspirate fluid using a soft suction cup if needed) and one tube of blood. The investigators will analyze the fluid's DNA using two approaches: low-pass whole-genome analysis to look for copy number changes and fragmentation patterns, and genome-wide DNA methylation profiling. Surgical pathology will serve as the reference standard. Using these data, the investigators will build and validate a model to classify lesions as benign or malignant.\n\nThe primary outcome is diagnostic accuracy (area under the ROC curve, sensitivity, and specificity). Secondary outcomes include positive and negative predictive values, model calibration, subgroup performance (e.g., ductal carcinoma in situ vs invasive cancer), and an estimate of potential clinical impact (for example, how many benign cases might safely avoid surgery at a high-sensitivity threshold). Study test results will not affect current clinical care; all participants will receive usual evaluation and surgery. Risks are minimal and may include brief nipple discomfort or skin irritation from gentle suction and routine blood-draw risks (bruising, lightheadedness). There is no direct benefit to participants, but the findings may support a future noninvasive test to guide care and reduce unnecessary surgery. Data will be de-identified and stored securely. Expected enrollment is from September 2025 to May 2026.",[90,118],"Nipple Discharge",[118,120,121,122,123],"Bloody nipple discharge","Nipple aspirate fluid (NAF)","Pathologic nipple discharge (PND)","Breast cancer","2025-11-23",{"date":126,"type":40},"2025-11-26",{"date":105,"type":21},{"date":129,"type":21},"2026-08",{"name":46,"class":47},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100607461","study-on-the-relationship-between-opioid-drugs-and-the-therapeutic-efficacy-of-immunotherapy-100607461","NCT07188857","Study on the Relationship Between Opioid Drugs and the Therapeutic Efficacy of Immunotherapy","Inclusion Criteria:\n\n* Aged ≥ 18 years; Histologically confirmed advanced NSCLC (Stage IIIb-IV); Need to receive ICIs treatment; Accompanied by moderate or severe pain (NRS score ≥ 4); Need to use opioid drugs for pain management; Able to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Suffering from severe dysfunction of important organs such as heart, liver, and kidney; Suffering from mental illness or receiving treatment with psychotropic drugs; Pregnant or lactating women; Participating in other clinical trials; Allergic to opioid drugs.","80 Years",{"count":139,"type":21},100,"Relationship between pain and the efficacy of immunotherapy: Does the degree of pain control affect the therapeutic efficacy of ICIs? Does the use of opioid drugs independently affect the efficacy of immunotherapy?",[142,143,144],"Pain Management","Immune Checkpoint Inhibitor","Opioid",[146,147,148],"pain management","opioids","immune checkpoint inhibitor","2025-09-16",{"date":151,"type":40},"2025-09-23",{"date":153,"type":21},"2025-09-17",{"date":155,"type":21},"2027-10-01",{"name":46,"class":47},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":48},"100547012","phase-2-sbrt-chemotherapy-and-ak112-neoadjuvant-therapy-for-luminal-type-breast-cancer-100547012","NCT06402435","SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Luminal-type Breast Cancer","A Single-arm, Open, Phase II Clinical Study of SBRT, Chemotherapy, and Ivonescimab Neoadjuvant Therapy for Luminal-type Breast Cancer","Inclusion Criteria:\n\nThis trial aims to enroll patients who treatment-naïve and voluntarily participate and provide written informed consent; Eligible participants must have histologically confirmed and HR+\u002FHER2-negative breast cancer (HER2 immunohistochemistry 0, 1+, or 2+\u002FFISH-); Patients must meet at least one of the following criteria: (1) tumor size \\>2 cm, (2) axillary lymph node metastasis, or (3) intent for breast-conserving surgery, but tumor-to-breast volume ratio makes preservation challenging; Additional eligibility requirements include age ≥18 years, an ECOG performance status of 0-1, and baseline laboratory values within acceptable ranges: white blood cell count (WBC) ≥2.0×10⁹\u002FL, absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count (PLT) ≥100×10⁹\u002FL, hemoglobin (Hb) ≥90 g\u002FL. Liver function parameters must be within ≤1.5×upper limit of normal (ULN) for total bilirubin (TBIL) and ≤3×ULN for alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Renal function must be preserved, with serum creatinine (Cr) ≤1.5× ULN, or if Cr exceeds this limit, the creatinine clearance rate should be ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula). Coagulation parameters should meet the following thresholds: activated partial thromboplastin time (APTT)≤1.5×ULN and prothrombin time (PT) or international normalized ratio (INR) ≤1.5×ULN.\n\nExclusion Criteria:\n\nReceived chemotherapy, targeted therapy, or radiotherapy within 12 months before the first dose of the investigational drug, or have undergone solid organ or hematologic transplantation; A history of myocardial infarction or uncontrolled arrhythmias (QTc ≥470 ms by Fridericia's formula) within 6 months before the first dose; NYHA class III-IV heart failure, left ventricular ejection fraction (LVEF) \\\u003C50%, or uncontrolled hypertension (systolic BP ≥150 mmHg and\u002For diastolic BP ≥100 mmHg); Patients with active HIV, tuberculosis, interstitial lung disease, severe pulmonary impairment, or autoimmune diseases requiring systemic immunosuppression will also be excluded; Participants must not have received a live vaccine within 28 days prior to the first dose, though inactivated influenza vaccines are permitted. Patients requiring systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or immunosuppressants within 14 days before the first dose will be excluded, except for short-term or low-dose corticosteroids, localized applications, and adrenal replacement therapy; Patients with active infections requiring systemic therapy within 14 days prior to enrollment, hepatitis B or C with detectable viral DNA\u002FRNA, history of prior treatment with immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies), participation in another clinical trial within 14 days, major surgery within 4 weeks before the first dose (except for biopsy procedures), severe allergic reactions to monoclonal antibodies or study drug components, pregnancy or lactation, active psychiatric disorders or substance abuse history; Patients who have ceased alcohol consumption may be included. Lastly, investigators may exclude participants based on any other conditions deemed inappropriate for study participation.",{"count":165,"type":21},50,"INTERVENTIONAL",[168],"PHASE2","Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with luminal breast cancer patients' overall survival (OS). Patients with luminal breast cancer have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of luminal-type breast cancer patients, increasing it from 13-15% to approximately 24%. Therefore, how to further improve the pCR rate of luminal-type breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1\u002FVEGF-A bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant treatment modality, in the treatment of luminal breast cancer.",[90],"2025-06-27",{"date":173,"type":40},"2025-07-02",{"date":175,"type":40},"2024-11-28",{"date":177,"type":21},"2027-09-01",{"name":46,"class":47},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":185,"targetDuration":4,"studyType":166,"phases":187,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":48},"100515543","neoadjuvant-radiotherapy-and-immediate-implant-based-breast-reconstruction-100515543","NCT05992870","Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction","Inclusion Criteria:\n\nWomen \\>18 years with histopathologically-confirmed breast cancer, who:\n\n* require mastectomy for any reason\n* a known indication for (adjuvant) radiotherapy\n* require implant-based breast reconstruction\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings\n* Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla\n* Pregnant or lactating\n* inflammatory breast cancer",{"count":186,"type":21},40,[188],"NA","Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.",[90,191,192],"Implant Breast Reconstruction","Neoadjuvant Radiotherapy",[194],"neoadjuvant radiotherapy, implant, breast reconstruction","2025-03-14",{"date":197,"type":40},"2025-03-17",{"date":199,"type":40},"2023-07-08",{"date":201,"type":21},"2025-10-31",{"name":46,"class":47},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":166,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":220,"locationsCount":48},"100546902","phase-2-sbrt-chemotherapy-and-ak104-neoadjuvant-therapy-for-triple-negative-breast-cancer-tnbc-100546902","NCT06401005","SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)","A Single-arm, Open, Phase II Clinical Study of SBRT, Chemotherapy, and Cadonilimab (AK104) Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n1. Histologically confirmed ER-\u002FPR-\u002FHER2- invasive breast cancer patients (ER\u002FPR immunohistochemistry negative or\\\u003C1%; Her2 immunohistochemistry of 0, 1+, or 2+\u002FFISH-) patients; patients meeting one of the following conditions: (1) tumor mass larger than 2cm, (2) the presence of axillary lymph node metastasis, and (3) the desire to conserve breasts, but the ratio of tumor size to breast volume is large and difficult to conserve breasts;\n2. Patients aged ≥18 years old;\n3. ECOG score of 0-1;\n4. Biochemical test indexes before enrollment must meet the following criteria, hematologic: white blood cell count (WBC) ≥ 2.0x10\\^9\u002FL; neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL; platelet count (PLT) ≥ 100×10\\^9\u002FL; hemoglobin (Hb) ≥ 90g\u002FL; function: total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); glutamate aminotransferase (ALT) ≤3 × ULN; aspartate aminotransferase (AST) ≤3 × ULN; renal function: creatinine (Cr) ≤1.5 × ULN; if \\>1.5 × ULN, creatinine clearance needs to be ≥50mL\u002Fmin (calculated according to Cockcroft-Gault formula); coagulation: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN.\n\nExclusion Criteria:\n\n1. Received chemotherapy, targeted therapy, or radiation therapy within 12 months prior to first use of study drug;\n2. Solid organ or blood system transplantation;\n3. Myocardial infarction, poorly controlled arrhythmia (including QTc intervals ≥ 470 ms) within 6 months prior to first use of study drug (QTc intervals are calculated using the Fridericia formula, which is: QTc=QT\u002FRR \\^0.33);\n4. Class III-IV cardiac insufficiency according to NYHA criteria or cardiac ultrasound: LVEF \\\u003C 50%;\n5. poorly controlled hypertension (defined as systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg), previous hypertensive crisis or hypertensive encephalopathy;\n6. Human immunodeficiency virus (HIV) infection, HIV-positive; active tuberculosis; previous and current subjects with interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis, and severely impaired lung function that may interfere with the detection and management of suspected drug-associated pulmonary toxicity;\n7. Known active or suspected autoimmune disease;\n8. Subjects who are allowed to enroll in a stable state and do not require systemic immunosuppressive therapy;\n9. Who have received a live vaccine within 28 days prior to the first use of study drug; however, inactivated viral vaccines for seasonal influenza are allowed;\n10. Who require systemic treatment with corticosteroids (\\> 10 mg\u002Fday prednisone equivalent dose) or other immunosuppressive medications within 14 days prior to the first use of study drug or for the duration of the study. Subjects. However, enrollment will be permitted in the absence of active autoimmune disease if the subject is treated with topical or inhaled steroids (low potency), systemic short-term use in small doses, single paracortical\u002Fintra-articular injections, or adrenocorticotropic hormone replacement therapy at a dose of ≤ 10 mg\u002Fday prednisone equivalent; and if any active infections that require systemic administration of Active infection requiring systemic administration of anti-infective therapy; subjects receiving prophylactic antibiotic therapy (e.g., for prevention of urinary tract infections or chronic obstructive pulmonary disease) are eligible for enrollment;\n11. Hepatitis B (those with a positive Hepatitis B Surface Antigen \\[HBsAg\\] or Hepatitis B Core Antibody \\[HBcAb\\] test and positive Hepatitis B Virus Deoxyribonucleic Acid \\[HBV-DNA\\] test), Hepatitis C (those with a positive Hepatitis C Virus \\[HCV\\] antibody test and positive Hepatitis C Virus \\[HBV\\] antibody test), and Hepatitis C (those with a positive Hepatitis B virus \\[HCV\\] antibody test and positive Hepatitis C Virus \\[HCV\\] antibody test) antibody test positive and hepatitis C virus ribonucleic acid \\[HCV-RNA\\] test positive); subjects with hepatitis B and hepatitis C co-infection (positive HBsAg or HBcAb test and positive HCV antibody test);\n12. Who have received other antibodies\u002Fdrugs targeting immune checkpoints in the past, such as anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte associated antigen- 4 (CTLA-4), and anti-cytotoxic T-lymphocyte associated antigen- 4 (CTLA-4). 4 (CTLA-4), etc.; are participating in another clinical study or are planning to start this study treatment less than 14 days from the end of treatment in the previous clinical study;\n13. Have undergone major surgery within 4 weeks prior to the first dose of study drug. Definition of major surgery for this study: surgery that requires at least 3 weeks of postoperative recovery time before receiving treatment on this study. Tumor puncture or lymph node excision biopsy allowed for enrollment;\n14. Pregnant or lactating females with a known history of severe allergy to any monoclonal antibody or the study drug and its excipients;\n15. Known history of psychotropic substance abuse or drug use; discontinued use of alcohol allowed for enrollment;\n16. Subjects with other factors that, in the judgment of the investigator, make them unsuitable for participation in this study.",{"count":211,"type":21},51,[168],"Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with triple-negative breast cancer（TNBC）patients' overall survival (OS). Patients with TNBC have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of TNBC patients, increasing it from 45% to approximately 60%. Therefore, how to further improve the pCR rate of TNBC breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Cadonilimab (AK104) is an PD-1\u002FCTLA-4 bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK104+chemotherapy, a neoadjuvant treatment modality, in the treatment of TNBC.",[90],"2024-11-27",{"date":217,"type":40},"2024-12-02",{"date":175,"type":21},{"date":177,"type":21},{"name":46,"class":47},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":166,"phases":230,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":48},"100570844","effect-of-different-surgical-approaches-of-granulomatous-mastitis-100570844","NCT06712524","Effect of Different Surgical Approaches of Granulomatous Mastitis","A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome of Granulomatous Mastitis","Inclusion Criteria:\n\nOnly the subjects who meet all the following criteria may be included in this study:\n\n1. Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;\n2. 18≤Age≤75 years old, female;\n3. Histologically confirmed granulomatous mastitis;\n4. low and moderate risk for anesthesia.\n\nExclusion Criteria:\n\nThe subjects who meet any of the following criteria shall not be included in this study:\n\n1. Absolute and relative contraindication for surgery;\n2. Previous history of breast cancer or other malignancies;\n3. Pregnancy;\n4. Any serious complications which caused patients not suitable to participate this study.",{"count":229,"type":21},240,[188],"The objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. The patients were divided into traditional surgery group and plastic surgery group.",[233,234],"Breast-conserving Plastic Surgery","Granulomatous Mastitis",[236,237,238],"Granulomatous mastitis","breast conserving plastic surgery","Aesthetics scores","2024-11-26",{"date":217,"type":40},{"date":242,"type":40},"2024-11-01",{"date":244,"type":21},"2027-12-31",{"name":46,"class":47},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":56,"minAge":253,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":166,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":48},"100518554","phase-2-single-drug-chemotherapy-plus-immunotherapy-in-metastatic-non-small-cell-lung-cancer-elderly-patients-100518554","NCT06032052","Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients","Prospective, Single-arm Phase II Clinical Study of Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients","Inclusion Criteria:\n\n1. Regardless of sex, age ≥ 65, PS 0-2.\n2. metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by histology or cytology.\n3. No mutation or fusion of common driving genes, such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS proto-oncogene 1 (ROS-1).\n\n   (adenocarcinoma requires genetic testing).\n4. Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%).\n5. First-line treatment (stable brain or bone metastasis, or stable symptoms after local treatment).\n6. Before treatment, there were perfect enhanced CT images of chest and supraclavicular area, and measurable tumor lesions.\n7. The estimated survival time is not less than 6 months.\n8. The clinical laboratory criteria within 2 weeks before treatment are as follows: hemoglobin ≥ 110g \u002F L, leukocytes ≥ 4x109 \u002F L, platelet ≥ 100x109 \u002F L, liver and kidney function indexes (such as glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, urea nitrogen, creatinine) were all within 1.25 times of the upper limit of the normal value.\n9. Informed understanding and voluntary participation in this study, and informed consent has been signed.\n\nExclusion Criteria:\n\n1. Mutation or fusion of common driving genes (EGFR,ALK or ROS1).\n2. Have received systemic treatment before.\n3. Previous suffering from other malignant tumors (except stage I non-melanotic skin cancer or cervical carcinoma in situ) or other malignant tumors at the same time.\n4. Other drugs are being tested.\n5. Patients with positive HIV and are receiving antiviral therapy .\n6. Active pulmonary tuberculosis.","65 Years",{"count":255,"type":21},49,[168],"Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The proportion of elderly lung cancer patients in the global lung cancer population is steadily increasing, at the same time, it is also the age group with the highest lung cancer mortality, but there is little evidence for treatment of elderly lung cancer patients. In this study, the investigators set the definition of the elderly to 65 years and older.\n\nThe progression-free survival (PFS) and overall survival (OS) of immunotherapy plus chemotherapy were higher than those of chemotherapy alone, which established the dominant position of dual-drug chemotherapy combined with immunotherapy. Studies showed that elderly patients benefit from immunotherapy.\n\nIt is controversial whether elderly advanced non-small-cell-lung-cancer (NSCLC) patients should receive single-drug chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4 studies show that in the advanced NSCLC elderly patients, combined with cisplatin on the basis of single drug chemotherapy can not significantly prolong OS, and can not improve the overall health status of patients. Based on the results of this study, single drug chemotherapy is still the preferred first-line regimen. Another study showed that carboplatin combined with paclitaxel had longer OS than gemcitabine or vinorelbine alone in elderly patients with advanced NSCLC with a performance status (PS) score of less than 2. In the era of immunotherapy, it is not clear whether single-drug chemotherapy combined with immunotherapy can achieve the same therapeutic effect as dual-drug chemotherapy combined with immunotherapy. Therefore, the purpose of this study is to investigate the efficacy and safety of single-drug chemotherapy plus immunotherapy in elderly metastatic NSCLC patients.",[259,260],"Elderly Patients","Metastatic Lung Cancer","2024-03-13",{"date":263,"type":40},"2024-03-15",{"date":265,"type":40},"2024-02-01",{"date":267,"type":21},"2027-09",{"name":46,"class":47},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":57,"enrollmentInfo":276,"targetDuration":4,"studyType":166,"phases":278,"briefSummary":279,"conditions":280,"keywords":285,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":48},"100517660","omitting-ctv-for-locally-advanced-nsclc-responded-to-immunotherapy-and-chemotherapy-100517660","NCT06020430","Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy","Omitting CTV Radiotherapy for Locally Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Radiotherapy","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed non-small cell lung cancer;\n2. stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging system of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control（UICC);\n3. inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy;\n4. After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);\n5. performance status 0-1;\n6. measurable or evaluable lesions;\n7. Survival expectancy is not less than 6 months;\n8. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function\n\nExclusion Criteria:\n\n1. tumor progress after induction with immunothearoy and chemotherapy\n2. EGFR, ALK, or ROS1 mutation;\n3. Previous thoracic radiotherapy;\n4. grade 2 or more immune-related adverse events after induction immunotherapy\n5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);\n6. Pregnant or lactating women\n7. undergoing other clinical trials;\n8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;\n9. Patients with HIV positive and undergoing antiviral therapy;\n10. Active tuberculosis",{"count":277,"type":21},134,[188],"Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our previous sturdy indicated that patients who received induction immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting CTV radiation is feasible for patients undergoing concurrent radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to induction therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.",[281,282,283,284],"Non Small Cell Lung Cancer","Locally Advanced","Radiotherapy","Immunotherapy",[286],"omitting CTV",{"date":263,"type":40},{"date":289,"type":40},"2024-02-08",{"date":291,"type":21},"2027-10-08",{"name":46,"class":47},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":57,"enrollmentInfo":300,"targetDuration":4,"studyType":166,"phases":301,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":308,"leadSponsor":309,"locationsCount":48},"100518991","primary-tumor-radiotherapy-omitting-ctv-for-patients-with-advanced-nsclc-responded-to-immunotherapy-and-chemotherapy-100518991","NCT06037733","Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy","Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC);\n2. After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);\n3. Age 18 to 80 years old, performance status 0-1;\n4. measurable or evaluable lesions;\n5. Survival expectancy is not less than 6 months;\n6. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function\n\nExclusion Criteria:\n\n1. tumor progress after therapy with immunotherapy and chemotherapy\n2. EGFR, ALK, or ROS1 mutation;\n3. Previous thoracic radiotherapy;\n4. grade 2 or more immune-related adverse events after induction immunotherapy\n5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);\n6. Pregnant or lactating women\n7. undergoing other clinical trials;\n8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;\n9. Patients with HIV positive and undergoing antiviral therapy;\n10. Active tuberculosis",{"count":277,"type":21},[188],"The aim of this randomized study is to investigate pneumonitis, local tumor control, and survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC responded to immunotherapy and chemotherapy",[304,283,284],"Advanced Non-Small Cell Squamous Lung Cancer",[286],{"date":263,"type":40},{"date":261,"type":21},{"date":291,"type":21},{"name":46,"class":47},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":166,"phases":319,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":48},"100522304","ondanstron-weekly-vs-every-3-weeks-for-prevention-of-nausea-and-vomiting-induced-by-chemotherapy-combined-with-pd-1-blockade-100522304","NCT06080880","Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade","Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade：an Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years, no gender limit;\n2. Pathologically or cytologically confirmed malignant solid tumors;\n3. Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade；\n4. TPS \\> 1 %(PD-1);\n5. Adequate hematological function (leucocyte count ≥ 4000\u002FμL \\[to convert to ×109\u002FL,multiply by 0.001\\], hemoglobin ≥ 9.00 g\u002FdL \\[to convert to grams per liter, multiply by 10\\], and platelet count ≥ 100 × 103\u002FμL \\[to convert to ×109\u002FL, multiply by 1\\]);\n6. Hepatic function (alanine aminotransferase and aspartate aminotransferase ≤ 2.0 times the upper limit of the reference ranges), and renal function (creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 \\[to convert to millimeters per second per meter-squared, multiply by 0.0167\\])；\n7. Estimated survival time \\> 6 months；\n8. ECOG 0-1 points；\n9. Participants being informed and signed written consents.\n\nExclusion Criteria:\n\n1. Nausea or vomiting caused by reasons except for chemotherapy and PD-1 blockade;\n2. Participants with other malignant tumors history previously;\n3. Inability to read, comprehend, and finish questionnaires;\n4. Allergic to the drugs included in this study.\n5. Administered drugs with antiemetic activity within the 24 hours before receiving the first dose of study medication.",{"count":318,"type":21},98,[188],"The aim of this randomized study is to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade.",[322],"Nausea With Vomiting Chemotherapy-Induced",[324,325,326],"Chemotherapy-induced nausea and vomiting","PD-1 blockade","Ondanstron","2024-02-28",{"date":329,"type":40},"2024-02-29",{"date":331,"type":40},"2023-12-01",{"date":333,"type":21},"2027-11",{"name":46,"class":47},""]