[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peking University Cancer Hospital & Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":579},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,106,0,25,[9,44,70,98,126,148,167,195,215,235,253,276,304,324,345,362,385,410,430,447,467,489,513,540,558],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100641271","non-operative-management-and-following-immunotherapy-for-colorectal-cancer-and-other-gi-cancers-100641271",false,"NCT07656740","Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers","Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)","NOMIC","Inclusion Criteria:\n\n1. Retrospective Cohort Inclusion Criteria\n\n   * Pathologically confirmed gastrointestinal malignancy determined as MSI-H\u002FdMMR or POLE mutation, and initially resectable.\n   * Completed prior immunotherapy.\n   * No evidence of distant metastasis.\n   * Managed with W\\&W, LE, endoscopic surgery, or radical operation after treatment.\n2. Prospective Cohort Inclusion Criteria\n\n   * Pathologically confirmed gastrointestinal malignancy determined as MSI-H\u002FdMMR or POLE mutation, and initially resectable.\n   * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n   * Immunotherapy status: naive, currently receiving, or completed treatment, and evaluated by the PKUCH-NOMIC research group as cCR\u002Fnear-cCR or Non-cCR (≤ ymrT2N0).\n   * No evidence of distant metastasis.\n   * Absence of emergencies requiring immediate surgery (e.g., hemorrhage, perforation, obstruction).\n\nExclusion Criteria:\n\n* Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.\n* Serum creatinine \\> 1.5 times upper limit of normal (ULN).\n* History of pelvic radiation therapy.Inability to tolerate MRI examinations.\n* History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).\n* Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack \\[TIA\\], cerebral vascular accident \\[CVA\\]).\n* Prior receipt of other types of investigational anti-tumor therapies.\n* Pregnant or lactating women.\n* Concomitant diseases or mental health conditions that may interfere with study participation.","ALL",{"count":20,"type":21},50,"ESTIMATED","3 Years","OBSERVATIONAL","This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient\u002Fmicrosatellite instability-high (dMMR\u002FMSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a \"Watch \\& Wait\" (W\\&W) strategy, while those with near-cCR or non-cCR ($\\\\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD\u002FEMR). Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.",[26,27,28],"Gastrointestinal Cancer","Colorectal (Colon or Rectal) Cancer","Stomach (Gastric) Cancer",[30,31],"dMMR\u002FMSI-H","POLE-mutated","NOT_YET_RECRUITING","2026-06-15",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":33,"type":21},{"date":39,"type":21},"2030-10-15",{"name":41,"class":42},"Peking University Cancer Hospital & Institute","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100642171","phase-2-precision-medicine-for-immunotherapy-resistant-advanced-esophageal-cancer-100642171","NCT07653451","Precision Medicine for Immunotherapy-Resistant Advanced Esophageal Cancer","Precision Medicine Strategies for Advanced Esophageal Cancer Refractory to Immune Checkpoint Inhibitors","ESCC-PT","Inclusion Criteria:\n\n1. Signed written informed consent from previous studies and age ≥18 years.\n2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).\n3. Locally advanced, unresectable, or metastatic ESCC that progressed on or after standard second-line or later therapy containing immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 antibodies, or bispecific antibodies).\n4. At least one measurable lesion per RECIST 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Anticipated life expectancy ≥12 weeks.\n7. Adequate organ and bone marrow function within 14 days prior to the first dose (without blood transfusion, EPO, G-CSF, or other hematologic supports), as defined by:\n\n   * Absolute neutrophil count (ANC) ≥1.5×109\u002FL\n   * Platelet count ≥100×109\u002FL\n   * Hemoglobin ≥9 g\u002FdL (or ≥5.6 mmol\u002FL)\n   * Serum albumin \\>30 g\u002FL\n   * Serum creatinine ≤1.5×ULN (Upper Limit of Normal) or calculated creatinine clearance ≥60 mL\u002Fmin (using the Cockcroft-Gault formula)\n   * Total bilirubin ≤1.5×ULN\n   * AST and ALT ≤2.5×ULN (≤5.0×ULN for patients with documented liver metastases, provided total bilirubin is within normal limits)\n   * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN, and activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN\n8. Female patients of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to the first dose. WOCBP and male patients with WOCBP partners must agree to use highly effective contraception from signing the informed consent throughout the treatment period and for at least 6 months after the last dose. (Highly effective methods include oral\u002Fimplanted hormonal contraceptives, intrauterine devices \\[IUDs\\], or barrier methods combined with spermicide. Postmenopausal women aged \\>50 years must have been amenorrheic for ≥12 months to be considered postmenopausal).\n9. Required washout periods prior to the first dose of study treatment are as follows:\n\n   * Systemic anticancer therapies (chemotherapy, targeted therapy, immunotherapy, biological therapy, or hormonal therapy) or participation in clinical trials: \\>4 weeks.\n   * Systemic small-molecule targeted therapies: \\>2 weeks or 5 half-lives (whichever is longer).\n   * Prior Chinese herbal medicine with anti-tumor activity: \\>2 weeks.\n   * Prior major surgery or radiotherapy: \\>4 weeks (palliative radiotherapy for bone metastases: \\>2 weeks).\n\nExclusion Criteria:\n\nExclusion Criteria\n\n1. Currently receiving concurrent antitumor therapies (including chemotherapy, systemic therapy, immunotherapy, radiotherapy, or surgery) at the time of enrollment.\n2. History of other malignancies within the past 3 years (except for cured thyroid cancer, cervical carcinoma in situ, basal\u002Fsquamous cell skin cancer, or other cured localized tumors with disease-free survival \\>3 years).\n3. Adverse events (AEs) from prior antitumor therapies that have not resolved to baseline or Grade ≤1 (excluding alopecia, Grade 2 anemia, or irreversible, clinically insignificant, asymptomatic laboratory abnormalities).\n4. Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose, or not fully recovered from surgical procedures; or plans for surgery during the study period.\n5. Active peripheral neuropathy (PN) or neurotoxicity ≥ Grade 2, history of Grade 3 neurotoxicity\u002FPN, or prior permanent discontinuation of treatment due to neurotoxicity\u002FPN.\n6. Active pneumonitis\u002Finterstitial lung disease (ILD), history of pulmonary radiation within 12 months prior to the first dose, or clinically significant underlying pulmonary disease (e.g., chronic obstructive pulmonary disease).\n7. Symptomatic or active central nervous system (CNS) metastases requiring intervention (including steroid therapy with prednisone \\>10 mg\u002Fday or equivalents, or anticonvulsants) within 4 weeks prior to the first dose.\n8. Any other severe underlying medical condition, including but not limited to: uncontrolled diabetes, active infections, vaccination within 4 weeks, active peptic ulcer, uncontrolled epilepsy, cerebrovascular accident within 6 months, gastrointestinal bleeding within 3 months, or clinical signs of coagulopathy.\n9. Clinically significant cardiovascular disease, including:\n\n   * Left ventricular ejection fraction (LVEF) ≤50% or below the institutional lower limit of normal (LLN) determined by echocardiography (ECHO) or MUGA scan (if ECHO is unavailable).\n   * Heart failure classified as NYHA Class ≥III.\n   * Uncontrolled hypertension (systolic BP ≥150 mmHg and\u002For diastolic BP ≥95 mmHg despite optimal medical therapy).\n   * Prior or current cardiomyopathy.\n   * Unstable angina, or myocardial infarction within 6 months.\n   * Serious arrhythmia requiring medical intervention (excluding controlled atrial fibrillation or paroxysmal supraventricular tachycardia).\n10. QTc interval ≥450 ms for males, or ≥470 ms for females (using Fridericia's formula), or history of congenital long QT syndrome.\n11. Dyspnea due to advanced malignancy complications or other diseases, requiring continuous supplemental oxygen therapy at rest.\n12. Any other severe psychiatric, psychological, familial, or geographical conditions that, in the investigator's opinion, could interfere with study compliance, protocol execution, follow-up, or place the patient at high risk of treatment-related complications.\n13. History of HIV infection or positive HIV serology.\n14. Active viral hepatitis B or C (Note: Patients with HBV are eligible if HBV DNA is within the normal range\u002Fsuppressed on antivirals; patients with positive HCV antibody are eligible if HCV RNA is undetectable via PCR). Frequent viral load monitoring is mandatory.\n15. History of life-threatening allergies, known hypersensitivity to any study drug components, recombinant proteins, or excipients, or intolerance to EGFR antibodies or eribulin.\n16. Pregnant or lactating women.\n17. Any concurrent medical condition that, in the investigator's clinical judgment, could compromise protocol compliance.","18 Years",{"count":54,"type":21},90,"INTERVENTIONAL",[57,58],"PHASE2","PHASE3","This study is an open-label, biomarker-integrated umbrella trial designed to evaluate the clinical efficacy of molecular subtype- and genomic biomarker-guided precision therapies in patients with advanced esophageal cancer refractory to prior immunotherapy. Conducted in a two-step process, the study first enrolls patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed on prior immunotherapy, performing circulating tumor DNA (ctDNA) sequencing to stratify them into three distinct treatment cohorts, after which patients receive tailored combination regimens matched to their specific molecular profiling in the second step. Specifically, Cohort 1 includes patients with high EGFR expression or activation of EGFR-related signaling pathways, who will receive Afatinib (40 mg, p.o., Q.D.) combined with Toripalimab (240 mg, i.v., Q21D) in a 21-day treatment cycle, continuing until radiographic disease progression (PD), unacceptable toxicity, loss to follow-up, death, or other investigator-determined criteria for discontinuation, with a maximum toripalimab treatment duration of 24 months. Cohort 2 comprises patients harboring genomic alterations directly associated with cell cycle regulation or activation of cell cycle signaling pathways, who will be treated with Dalpiciclib (125 mg, p.o., Q.D. for 21 consecutive days followed by a 7-day off period in a 28-day cycle \\[Q4W\\]) combined with Pyrotinib maleate (320 mg, p.o., Q.D., administered within 30 minutes post-meal, Q4W) until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of consent, or investigator's decision for treatment discontinuation. Cohort 3 includes patients with other molecular profiles who do not fit Cohorts 1 or 2, who will receive Camrelizumab (200 mg, i.v., Q3W) and Apatinib (250 mg, p.o., Q.D.), with clinical efficacy evaluations performed every 6 weeks, continuing until radiographic PD, unacceptable toxicity, death, or treatment discontinuation, whichever occurs first. The study aims to recruit an estimated maximum of 90 subjects, enrolling up to 30 subjects per cohort, with the final sample size dependent on the observed toxicities and the prevalence of each molecular cohort within the screened population.",[61],"Esophageal Squamous Cell Carcinoma","2026-06-12",{"date":64,"type":36},"2026-06-17",{"date":66,"type":21},"2026-07-01",{"date":68,"type":21},"2028-12-31",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":78,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"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,"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.",[82,83,84,85],"Gastrointestinal Cancers","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Anus",[87,88,89],"Gastrointestinal cancers","Colorectal cancer","Gastric cancer","2026-06-06",{"date":92,"type":36},"2026-06-11",{"date":94,"type":21},"2026-07-15",{"date":96,"type":21},"2030-01-15",{"name":41,"class":42},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":55,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100643410","68ga-fapi-psma-pet-imaging-for-the-diagnosis-of-solid-tumors-100643410","NCT07639801","68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors","Evaluation of Dual-Targeted 68Ga-FAPI-PSMA PET\u002FCT for the Diagnosis and Staging of Solid Tumors","Inclusion Criteria:\n\n* Age 18-75 years\n\n  * Patients with suspected or confirmed solid tumors (e.g., prostate cancer, hepatocellular carcinoma, ovarian cancer, or endometrial cancer)\n  * Patients scheduled to undergo tumor biopsy or surgical treatment within 2 months\n  * ECOG performance status of 0 or 1\n  * Expected survival of at least 12 weeks\n  * Adequate hematologic and organ function:\n  * White blood cell count ≥ 4.0 × 10\\^9\u002FL or neutrophils ≥ 1.5 × 10\\^9\u002FL\n  * Platelet count ≥ 100 × 10\\^9\u002FL\n  * Hemoglobin ≥ 90 g\u002FL\n  * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n  * ALT\u002FAST ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)\n  * Creatinine ≤ 1.5 × ULN\n  * At least one measurable lesion according to RECIST 1.1 criteria\n  * Ability to understand the study procedures and willingness to sign written informed consent\n\nExclusion Criteria:\n\n* Severe hepatic or renal dysfunction\n* Inability to remain in a supine position for approximately 30 minutes during PET\u002FCT scanning\n* Refusal or inability to participate in the clinical study\n* Claustrophobia or severe psychiatric disorders that would interfere with imaging procedures\n* Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study","75 Years",{"count":107,"type":21},20,[109],"NA","This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor microenvironment. Combining these two targets into a single imaging probe may improve the sensitivity and accuracy of tumor detection.\n\nIn this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET\u002FCT imaging using 68Ga-FAPI-PSMA. The imaging results will be compared with standard PET tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-FAPI-PSMA PET\u002FCT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.",[112,113,114,115,116,117,118],"Prostate Cancer","Hepatocellular Carcinoma","Ovarian Cancer","Solid Tumors","Endometrial Cancer","FAPI","PSMA",{"date":120,"type":36},"2026-06-10",{"date":122,"type":21},"2026-06",{"date":124,"type":21},"2026-12-31",{"name":41,"class":42},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":55,"phases":135,"briefSummary":131,"conditions":136,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100637294","phase-2-firmonertinib-in-perioperative-treatment-of-resectable-stage-ii-iiib-egfr-mutated-lung-adenocarcinoma-100637294","NCT07622706","Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma","An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma","Inclusion Criteria:\n\n* 1.Prior to the initiation of any study-related procedures, including examinations, sample collection, or analyses, written informed consent was obtained from all participating patients.\n\n  2.Male or female, aged \\>=18 years; 3.Histologically or cytologically confirmed primary lung adenocarcinoma within 60 days prior to study entry.\n\n  4.Stage II-IIIB disease (AJCC 9th edition) confirmed by systematic imaging (contrast-enhanced chest\u002Fabdominal CT, brain CT\u002FMRI, bone scan, or PET\u002FCT), with lesions eligible for radical resection.\n\n  5.EGFR mutation-positive (19Del and\u002For L858R, with or without T790M) as determined by NGS testing of tumor tissue or blood.\n\n  6.At least one measurable lesion with a longest diameter \\>=10 mm on baseline CT scan (except lymph nodes, which must have a short-axis diameter \\>=15 mm), and suitable for accurate and repeated measurement.\n\n  7.ECOG performance status 0-1. 8. Female patients should take adequate and effective contraception, must not breastfeed, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to demonstrate infertility:\n  1. Postmenopausal, defined as older than 50 years of age and having no menstruation for at least 12 months after stopping all exogenous hormone therapy.\n  2. For women under 50 years old, if there is no menstruation for 12 months or longer after stopping exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are in the postmenopausal range, they are considered postmenopausal.\n  3. Documented irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation.\n\n  9\\. Male patients should be willing to use barrier contraception, i.e., condoms.\n\nExclusion Criteria:\n\n* 1.Tumors with squamous cell carcinoma, large cell carcinoma, or neuroendocrine components such as small cell carcinoma.\n\n  2.Presence of EGFR exon 20 insertion mutation detected by genetic testing. 3.Prior exposure to other antitumor therapies before enrollment. 4.Major surgery within 4 weeks prior to the first dose of study drug (including surgery for the primary tumor, excluding procedures for vascular access).\n\n  5.Scheduled or planned medical procedures (e.g., endoscopy or biopsy) or surgical operations within the next 4 months.\n\n  6.The patient is pregnant or breastfeeding. 7.Use of strong CYP3A4 inhibitors within 7 days, or strong CYP3A4 inducers within 21 days prior to the first dose of study drug; use of traditional Chinese medicines or herbal preparations indicated for antitumor treatment, those with tumor adjuvant effects, or any other agents with known antitumor activity within 14 days prior to the first dose.\n\n  8.History of other malignancies or concurrent malignancies, except for those that have been definitively treated with curative intent and with no evidence of recurrence for at least 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, or papillary thyroid carcinoma).\n\n  9.Patients with severe or uncontrolled systemic diseases requiring treatment, deemed unsuitable for participation by the investigator. These include but are not limited to: uncontrolled hypertension, diabetes, chronic heart failure (NYHA class III-IV), unstable angina, myocardial infarction within the past year, active bleeding disorders; hepatitis B (including all HBsAg-positive patients), hepatitis C (HCV antibody positive), or human immunodeficiency virus (HIV) infection; as well as patients with active infections requiring intravenous treatment.\n\n  10.Patients with severe gastrointestinal dysfunction or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medication, uncontrolled nausea and vomiting, or a history of extensive gastrointestinal resection.\n\n  11\\. Meets any of the following cardiac assessment criteria: (1) Resting ECG corrected QT interval (QTc) \\>470 msec, with QTc corrected using the Fridericia formula (if the initial ECG shows QTc \\>470 ms, repeat the ECG twice and take the average of the three QTc results). (2) Any clinically significant abnormalities in heart rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or third-degree atrioventricular block, etc. (3) Any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death in first-degree relatives under 40 years old, or taking any concomitant medication known to prolong the QT interval that cannot be discontinued.\n\n  12\\. History of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid treatment, or patients with clinical manifestations suspected to be interstitial lung disease.\n\n  13\\. Any of the following laboratory test results indicating insufficient bone marrow or organ reserve function: (1) Absolute neutrophil count \\\u003C1.5×10\\^9\u002FL; (2) Platelet count \\\u003C100×10\\^9\u002FL; (3) Hemoglobin \\\u003C90 g\u002FL; (4) Alanine aminotransferase (ALT) \\>2.5× upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) \\>2.5×ULN; (6) Total bilirubin \\>1.5×ULN or, in the case of Gilbert's syndrome (unconjugated hyperbilirubinemia), \\>3×ULN; (7) Creatinine clearance \\\u003C50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); (8) Prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT) \\>=1.5 times ULN; 14. Known or suspected allergy to pralsetinib or any other component of its formulation; 15. Other situations where the patient is unable to comply with study procedures, restrictions, or requirements, and the investigator considers that such patient should not or is unsuitable to participate in the study; 16. Patients currently or previously participating in any other anti-tumor clinical study.",{"count":134,"type":21},60,[57],[137,138,139],"NSCLC","EGFR Positive Non-small Cell Lung Cancer","Neoadjuvant Therapy","2026-05-28",{"date":142,"type":36},"2026-06-03",{"date":144,"type":21},"2026-05-30",{"date":146,"type":21},"2029-11-30",{"name":41,"class":42},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":154,"targetDuration":4,"studyType":55,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":43},"100571036","establishment-and-clinical-transformation-of-adc-drug-efficacy-evaluation-system-for-breast-cancer-based-on-molecular-imaging-100571036","NCT06715020","Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging","Inclusion Criteria:\n\n1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);\n2. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 \u002FL, PLT ≥ 100×109\u002FL, Hb≥ 90 g\u002FL; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;\n3. Patients with confirmed or suspected breast cancer;\n4. Expected survival ≥12 weeks;\n5. Good follow-up compliance;\n6. Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;\n7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.\n\nExclusion Criteria:\n\n1. Severe abnormal liver and kidney function;\n2. Pregnant, pregnant and lactating women;\n3. Can not lie flat for half an hour;\n4. Unable to obtain informed consent;\n5. Suffering from claustrophobia or other mental illness;\n6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;\n7. Other conditions deemed unsuitable for participation in the trial by the investigator.",{"count":134,"type":21},[109],"The objective of the study is to construct a noninvasive approach 68Ga-TTP PET\u002FCT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.",[158],"Breast Cancer","RECRUITING",{"date":161,"type":36},"2026-06-02",{"date":163,"type":36},"2024-12-10",{"date":165,"type":21},"2026-12",{"name":41,"class":42},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":175,"minAge":52,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":55,"phases":178,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100638535","phase-4-abemaciclib-dose-escalation-in-early-high-risk-breast-cancer-adjuvant-therapy-100638535","NCT07599137","Abemaciclib Dose Escalation in Early High-Risk Breast Cancer Adjuvant Therapy","Study on the Safety and Efficacy of Abemaciclib Dose Escalation Strategy in Adjuvant Therapy for Early High-Risk Breast Cancer","ADES","Inclusion Criteria:\n\n* Aged ≥18 years;\n* Pathologically confirmed breast cancer with ER and\u002For PR positive, HER2 negative;\n* Completed radical mastectomy\u002Fradiacal breast surgery;\n* Plan to receive abemaciclib combined endocrine therapy for at least 12 weeks, with abemaciclib administered via a step-up dosing regimen;\n* ECOG performance status 0-1;\n* Adequate organ function meeting medication requirements (routine blood test, liver and renal function, and other indicators consistent with clinical medication safety criteria);\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Previous exposure to any CDK4\u002F6 inhibitor;\n* Active infection or severe infection requiring systemic anti-infective treatment;\n* Significant gastrointestinal diseases such as chronic diarrhea, inflammatory bowel disease, short bowel syndrome, which may affect drug absorption or increase the risk of diarrhea;\n* Significant baseline hepatic or renal dysfunction, or uncontrolled severe comorbidities judged by the investigator to affect safety or treatment adherence;\n* Pregnancy or lactation;\n* Any other condition deemed ineligible for enrollment by the investigator.","FEMALE",{"count":177,"type":21},86,[179],"PHASE4","Abemaciclib combined with endocrine therapy has become one of the important adjuvant treatment regimens for patients with HR+\u002FHER2- high-risk early breast cancer. However, adverse events such as diarrhea, fatigue, neutropenia and elevated liver enzymes are concentrated in the early stage of adjuvant therapy, which often lead to dose reduction, temporary drug interruption or even permanent discontinuation. This further affects treatment adherence, relative dose intensity (RDI) and treatment completion rate.\n\nFindings from the TRADE study suggest that a step-up dosing strategy, initiating at a lower dose followed by gradual titration to the standard dose, combined with standardized patient education and symptomatic management, may improve early treatment tolerance, reduce the burden of partial toxicities, and increase the likelihood of patients achieving and maintaining abemaciclib 150 mg twice daily. Based on the above evidence and clinical experience, step-up dosing has been adopted by some clinicians for real-world clinical practice.\n\nNevertheless, existing evidence is mainly derived from non-Chinese populations. There is still a lack of systematic real-world data on step-up dosing among Chinese breast cancer patients under routine outpatient management, including the early toxicity profile, dose escalation achievement rate at each stage, dose adjustment pathways (prolonged escalation, treatment pause or dose de-escalation), RDI distribution, correlation with quality of life, and baseline factors affecting treatment tolerance and dose target attainment. Therefore, it is necessary to conduct a real-world study focused on Chinese patients to fill the gap in local clinical evidence, and provide a basis for clinical pathway formulation, patient education, and subsequent multicenter validation studies.",[182],"HR+\u002FHER2- Breast Cancer",[184,185,186,187],"breast cancer","Abemaciclib","Dose Escalation","side effect","2026-05-19",{"date":190,"type":36},"2026-05-20",{"date":144,"type":21},{"date":193,"type":21},"2028-02-01",{"name":41,"class":42},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":202,"targetDuration":4,"studyType":55,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100638014","phase-2-iparomlimab-tolvorlimab-as-neoadjuvant-immunotherapy-for-locally-advanced-gastric-adenocarcinoma-with-microsatellite-instabilitymismatch-repair-deficiency-100638014","NCT07595523","Iparomlimab Tolvorlimab as Neoadjuvant Immunotherapy for Locally Advanced Gastric Adenocarcinoma With Microsatellite Instability\u002FMismatch Repair Deficiency","Prospective, Single-Arm, Single-Center Phase II Clinical Study of Iparomlimab Tolvorlimab as Neoadjuvant Immunotherapy for Locally Advanced Gastric Adenocarcinoma With Microsatellite Instability\u002FMismatch Repair Deficiency","Inclusion Criteria:\n\n1. The subject voluntarily enrolls in this study, is able to provide signed informed consent, and has good compliance.\n2. Aged 18 to 75 years (at the time of signing informed consent), male or female.\n3. Histologically confirmed gastric adenocarcinoma, clinically staged as Stage II-III (locally advanced) per AJCC 8th edition based on endoscopic ultrasound or contrast-enhanced CT\u002FMRI scan. The subject agrees to undergo radical resection, and the lesion is assessed as resectable by the investigator. No prior systemic therapy for the current disease, including anti-tumor chemotherapy, radiotherapy, or immunotherapy.\n4. Tumor biopsy demonstrates dMMR status and concurrently meets the criteria for MSI-H.\n5. ECOG performance status score of 0 to 1.\n6. Expected survival ≥ 6 months.\n7. Adequate major organ function, meeting the following criteria: a) Routine blood test (without blood transfusion or hematopoietic stimulating agents within 14 days): Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelets (PLT) ≥ 100 × 10⁹\u002FL; b) Blood biochemistry: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN; Total Bilirubin (TBIL) ≤ 1.5 × ULN; Serum Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin; Coagulation function: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤ 1.5 × ULN; c) Doppler echocardiography: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n8. Subjects of reproductive potential must use an effective contraceptive method during the study and for 120 days after study completion. Female subjects must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. History of other malignant diseases other than gastric cancer diagnosed within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, radically resected carcinoma in situ, and papillary thyroid carcinoma curable by local treatment).\n2. Currently participating in an interventional clinical study, or having received other investigational medicinal products or investigational device therapy within 4 weeks prior to the first dose.\n3. Received systemic therapy with Chinese patent medicine with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.\n4. History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.\n5. Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose.Note: Physiological doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) are permitted.\n6. History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n7. Known hypersensitivity to any study drug used in this study.\n8. Peripheral neuropathy ≥ Grade 2.\n9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1\u002F2 antibody).\n10. Received live vaccine within 30 days prior to the first dose (Day 1 of Cycle 1). Note: Inactivated seasonal influenza vaccine by injection within 30 days prior to the first dose is permitted; however, live attenuated influenza vaccine administered intranasally is not permitted.\n11. Pregnant or lactating female subjects.\n12. Presence of any severe or uncontrolled systemic disease, such as: a) Significant and symptomatic uncontrolled abnormalities in cardiac rhythm, conduction, or morphology on resting ECG; b) Unstable angina pectoris, congestive heart failure, chronic heart failure with NYHA class ≥ 2; c) Any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; d) History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease; e) Active pulmonary tuberculosis; f) Active or uncontrolled infection requiring systemic therapy; g) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; h) Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; i) Urinalysis showing urine protein ≥ ++ and confirmed 24-hour urine protein \\> 1.0 g; j) Mental disorders that prevent cooperation with study treatment.\n13. Presence of medical history, abnormal findings, or laboratory abnormalities that may interfere with study results or prevent the subject from completing the study; or any other conditions deemed by the investigator to be inappropriate for enrollment or to pose other potential risks.",{"count":203,"type":21},30,[57],"Study Background\n\n1. Clinical Rationale and Unmet Medical Need Gastric cancer is the 5th most common malignancy and the 3rd leading cause of cancer death worldwide. China accounts for \\>40% of global new cases, with nearly 90% of patients diagnosed at locally advanced stages and a 5-year overall survival (OS) rate of only 10%-49%. East Asia alone represents 58% of the global gastric cancer burden, with China reporting approximately 400,000 new cases and high mortality annually.\n\n   Although D2 radical gastrectomy remains the standard surgical treatment, local recurrence rates after surgery alone range from 24% to 54%, with most recurrences occurring within 2 years. Neoadjuvant chemotherapy is recommended by NCCN, ESMO, JGCA, and CSCO guidelines for locally advanced gastric cancer. However, the microsatellite instability-high\u002Fmismatch repair-deficient (dMMR\u002FMSI-H) subtype demonstrates poor response to chemotherapy but exceptional sensitivity to immunotherapy. Currently, no consensus exists on the optimal perioperative treatment for this population, and CSCO guidelines only recommend clinical trial participation or active surveillance.\n2. Immunotherapy Advances in dMMR\u002FMSI-H Gastric Cancer Immune checkpoint inhibitors (ICIs) targeting PD-1\u002FPD-L1 have revolutionized the treatment of dMMR\u002FMSI-H tumors by restoring anti-tumor immune responses. The phase II KEYNOTE-585 study (NCT03221426), the largest trial of neoadjuvant PD-1 monotherapy in this population, demonstrated a pathological complete response (pCR) rate of 32.8%, objective response rate (ORR) of 65.3%, and 3-year progression-free survival (PFS) rate of 78.5%-significantly superior to traditional chemotherapy (pCR 12.3%, 3-year PFS 52.1%). A phase II study of sintilimab monotherapy reported a pCR rate of 34.2%, major pathological response (MPR) rate of 52.2%, and grade ≥3 treatment-related adverse event (TRAE) rate of only 8.7%.\n\n   Dual immune checkpoint blockade further improves efficacy. The INFNITY study showed that neoadjuvant tremelimumab plus durvalumab achieved a pCR rate of 60% and MPR rate of 80% in 18 patients with resectable dMMR\u002FMSI-H gastric adenocarcinoma. These data confirm that immunotherapy, particularly dual checkpoint inhibition, offers superior efficacy and acceptable safety compared to chemotherapy in this patient subset.\n3. Study Agent: Apalimab\u002FTovorilimab (QL1706) Apalimab\u002FTovorilimab (QL1706) is a first-in-class bifunctional combination antibody developed using the MabPair® technology platform. It comprises anti-PD-1 antibody (apalimab) and anti-CTLA-4 antibody (tovorilimab) in a 2:1 molar ratio, simultaneously blocking both immune checkpoint pathways for synergistic anti-tumor activity.\n\n   Compared to separate administration of PD-1 and CTLA-4 inhibitors, QL1706 offers improved pharmacokinetics, enhanced targeting specificity, reduced off-target effects, lower TRAE rates, and simplified dosing (single infusion) that improves patient adherence. Clinical trials have demonstrated promising efficacy and safety across multiple tumor types:\n\n   Cervical cancer (DUBHE-C-206): ORR 33.8%, disease control rate (DCR) 64.9%, median PFS 5.4 months in platinum-refractory recurrent\u002Fmetastatic disease Hepatocellular carcinoma (DUBHE-H-308): ORR 40%, median PFS 8.1 months, 12-month OS rate 73.3% in combination with bevacizumab Non-small cell lung cancer (DUBHE-L-201): Median PFS 8.51 months, median OS 26.51 months, grade ≥3 TRAE rate 35.5% in combination with chemotherapy and bevacizumab\n4. Study Objectives and Significance This is a prospective, single-arm, single-center phase II clinical trial designed to evaluate the efficacy and safety of QL1706 as neoadjuvant therapy in patients with dMMR\u002FMSI-H locally advanced gastric adenocarcinoma. The primary objective is to assess the pCR rate, with secondary objectives including ORR, MPR rate, R0 resection rate, PFS, OS, and safety profile.\n\nThis study will provide critical clinical evidence for the use of QL1706 in the neoadjuvant setting. The results will: (1) establish a new treatment option for dMMR\u002FMSI-H gastric cancer patients; (2) lay the foundation for subsequent multicenter randomized phase III trials; (3) explore potential predictive biomarkers of response and resistance mechanisms; and (4) investigate the feasibility of surgery-sparing strategies for selected patients with exceptional response. Ultimately, this trial has the potential to transform the perioperative treatment paradigm for dMMR\u002FMSI-H gastric cancer and improve patient outcomes.",[207],"Gastric Cancer","2026-05-18",{"date":190,"type":36},{"date":211,"type":21},"2026-06-01",{"date":213,"type":21},"2029-07-01",{"name":41,"class":42},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":55,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":232,"leadSponsor":234,"locationsCount":43},"100637118","5t4-targeting-nanobody-probe-for-pet-imaging-in-solid-tumors-100637118","NCT07589101","5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors","Preparation of 5T4 Tumor Novel Target Nanobody PET Probe and Clinical Translation in Lung Cancer","Inclusion Criteria:\n\n1. Patients with solid tumors;\n2. Presence of measurable lesions on imaging examinations;\n3. Expected survival ≥12 weeks.\n\nExclusion Criteria:\n\n1. Severe hepatic or renal dysfunction;\n2. Women who are planning pregnancy, pregnant, or breastfeeding;\n3. Unable to remain in supine position for 30 minutes;\n4. Refusal to participate in this clinical study;\n5. Diagnosis of claustrophobia or other psychiatric disorders;\n6. Other conditions deemed by the investigator as inappropriate for participation in the trial.","70 Years",{"count":107,"type":21},[109],"This study aims to evaluate a novel 5T4 targeted nanobody PET imaging tracer, 68Ga-MY, for the detection and evaluation of solid tumors.\n\nThe 5T4 oncofoetal antigen is considered a valuable tumor-associated antigen, which is expressed in many different cancers, but is rarely expressed in normal adult tissues. And cell surface expression of 5T4 is an important property for antibody-targeted therapies. It has been shown that 5T4 is expressed on tumour-initiating cells (TICs) and associated with worse clinical outcome. Moreover, decreased adherence due to 5T4 expression may be associated with cancer spread.\n\nIn this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET\u002FCT imaging using 68Ga-MY. The imaging results will be compared with 18F-FDG. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-MY PET\u002FCT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.",[227,158],"Lung Cancer","2026-05-08",{"date":230,"type":36},"2026-05-15",{"date":211,"type":21},{"date":233,"type":21},"2027-12-30",{"name":41,"class":42},{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":241,"targetDuration":4,"studyType":55,"phases":243,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":43},"100637444","early-phase-1-clinical-application-of-caix-targeted-pet-imaging-in-tumors-100637444","NCT07590310","Clinical Application of CAIX-Targeted PET Imaging in Tumors","Inclusion Criteria:\n\n-Hematological, hepatic, and renal functions meeting the following criteria: Complete Blood Count: WBC ≥4.0×10⁹\u002FL or Neutrophils ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90 g\u002FL; Coagulation: PT or APTT ≤1.5 × ULN (Upper Limit of Normal); Hepatic Function: T-Bil ≤1.5 × ULN; ALT\u002FAST ≤2.5 × ULN (or ≤5 × ULN for subjects with liver metastases); ALP ≤2.5 × ULN (or ≤4.5 × ULN for subjects with bone or liver metastases); Renal Function: BUN ≤1.5 × ULN, SCr ≤1.5 × ULN.\n\nNormal cardiac function;\n\n* Expected survival ≥12 weeks;\n* Good compliance with follow-up;\n* At least one measurable target lesion according to RECIST 1.1 criteria;\n* Women of childbearing potential (aged 18-49) must have a negative pregnancy test within 7 days prior to the examination. Male and female patients of childbearing potential must agree to use effective contraception to prevent pregnancy during the study and for 3 months after the examination;\n* Patients for whom the clinician recommends a PET\u002FCT examination for tumor diagnosis and staging;\n* Patients are fully capable of understanding the study, voluntarily agree to participate, and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe abnormalities in hepatic, renal, or hematological function;\n* Patients planning for pregnancy;\n* Pregnant or lactating women;\n* Inability to lie flat for 30 minutes;\n* Refusal to participate in this clinical study;\n* Presence of claustrophobia or other psychiatric disorders;\n* Any other condition deemed unsuitable for participation by the investigator.",{"count":242,"type":21},3,[244],"EARLY_PHASE1","According to the 2020 global cancer statistics, renal carcinoma ranks as the fourteenth most common malignant tumor worldwide. In 2020, there were 431,288 new cases and 179,368 deaths from renal cancer, and both the incidence and mortality rates are projected to continue rising by 2025. Early non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC) is crucial for improving prognosis. Nuclear medicine molecular imaging offers the advantages of real-time, dynamic, and non-invasive detection of lesions throughout the body. However, there is currently a lack of highly efficient and targeted molecular probes for early and accurate diagnosis of this tumor in clinical practice.\n\nThe high expression of CAIX plays a central role in the pathogenesis of renal cancer by altering cellular metabolism, inducing angiogenesis, promoting epithelial-mesenchymal transition (EMT), invasion, and metastatic spread. CAIX is highly expressed in 95% of ccRCC cases. In fact, CAIX expression levels have been reported as an independent predictor of survival in advanced ccRCC. Moreover, CAIX expression in normal tissues is limited, primarily restricted to the stomach, the basolateral aspects of proliferating small intestinal crypt epithelial cells, and the gallbladder. Therefore, the differential expression of CAIX between ccRCC tumors and normal tissues highlights its potential as a robust target for nuclear medicine molecular probe research and development in ccRCC.\n\nThis study utilized high-throughput screening to identify small molecules with high affinity for CAIX. These molecules were subsequently cyclized and modified to enhance their in vivo stability. A bifunctional chelator, H3RESCA, was introduced at the C-terminus to construct the small-molecule compound RESCA-CAIX-LT. PET probes were prepared by radiolabeling with 68Ga or 18F, and their diagnostic efficacy for renal cancer was investigated. Small-animal PET imaging initially demonstrated that the probe exhibits high affinity and excellent imaging performance. The modifications also altered the in vivo metabolic profile of the original design, reducing non-specific uptake in organs such as the stomach, small intestine, and gallbladder. Furthermore, toxicological experiments confirmed the probe's high safety profile and in vivo stability.",[247],"Kidney Cancers",{"date":230,"type":36},{"date":250,"type":36},"2025-03-01",{"date":124,"type":21},{"name":41,"class":42},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":55,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":43},"100585994","al18f-her2-bch-pet-in-breast-patients-treated-with-adc-therapy-100585994","NCT06909604","Al18F-HER2-BCH PET in Breast Patients Treated With ADC Therapy","Al18F-HER2-BCH PET\u002FCT to Predict Response in Breast Patients Treated With ADC Therapy","FHERAD","Inclusion Criteria:\n\n1. Aged ≥18 years old; ECOG 0 or 1;\n2. Patients with HER2 positive or low tumors;\n3. Receives neoadjuvant therapy\n4. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;\n5. Life expectancy \\> 3 months -\n\nExclusion Criteria:\n\n1. Significant hepatic or renal dysfunction;\n2. Is pregnant or ready to pregnant;\n3. Cannot keep their states for half an hour;\n4. Refused to join the clinical research;\n5. Suffering from claustrophobia or other mental disorders;\n6. Any other situation that researchers considered it unsuitable to participate in the trial.",{"count":20,"type":21},[109],"To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value in breast patients treated with ADC therapy",[158],[184,266,267,268],"PET\u002FCT","HER2 expression","ADC therapy",{"date":270,"type":36},"2026-05-13",{"date":272,"type":36},"2025-01-01",{"date":274,"type":21},"2026-12-30",{"name":41,"class":42},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":284,"targetDuration":4,"studyType":55,"phases":285,"briefSummary":286,"conditions":287,"keywords":291,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":303,"locationsCount":4},"100635401","comparison-of-68gaga-ctr-fapi-and-18f-fdg-petmri-for-lymph-node-staging-in-rectal-cancer-100635401","NCT07552207","Comparison of [68Ga]Ga-CTR-FAPI and 18F-FDG PET\u002FMRI for Lymph Node Staging in Rectal Cancer","Comparison of the Diagnostic Efficacy of [68Ga]Ga-CTR-FAPI PET\u002FMRI and 18F-FDG PET\u002FMRI for Lymph Node Metastasis in Middle to High Rectal Cancer","PKUCH-R12","Inclusion Criteria:\n\n* Confirmed rectal adenocarcinoma by pathological biopsy.\n* Lower margin of the tumor is ≥ 5 cm and ≤15 cm from the anal verge.\n* Planned to undergo radical surgery.\n* ECOG performance status score ≤ 2.\n* Patient is willing to undergo PET\u002FMRI examination.\n\nExclusion Criteria:\n\n* History of pelvic radiotherapy or chemotherapy.\n* Concurrent with other malignant tumors or active infections.\n* Pregnant or unable to sign the informed consent form.\n* Claustrophobia or inability to tolerate MRI examinations due to other reasons.",{"count":203,"type":21},[109],"This is a prospective, single-center, diagnostic study designed to compare the accuracy of \\[68Ga\\]Ga-CTR-FAPI PET\u002FMRI and \\[18\\]F-FDG PET\u002FMRI for the detection of lymph node metastasis in patients with initially untreated, resectable middle to high rectal cancer. The study aims to evaluate whether \\[68Ga\\]Ga-CTR-FAPI PET\u002FMRI provides higher sensitivity and specificity than traditional 18F-FDG PET\u002FMRI at both the patient level and the lymph node level.",[288,289,290],"Rectal Cancer","Lymph Node Metastases","PET \u002F MR",[292,293,294,295,296],"PET\u002FMR","[68Ga]Ga-CTR-FAPI","18F-FDG","Lymph Node Staging","Radiomics","2026-04-28",{"date":299,"type":36},"2026-05-04",{"date":301,"type":21},"2026-04-01",{"date":68,"type":21},{"name":41,"class":42},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":311,"targetDuration":4,"studyType":55,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":4},"100636564","phase-2-adebrelimab-or-retlirafusp-alfa-plus-recaticimab-and-chemotherapy-for-resectable-nsclc-100636564","NCT07567326","Adebrelimab or Retlirafusp Alfa Plus Recaticimab and Chemotherapy for Resectable NSCLC","A Phase II Study of Neoadjuvant Adebrelimab or Retlirafusp Alfa (SHR-1701) in Combination With Recaticimab and Chemotherapy for Resectable Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* 18-75 years old\n* Histologically or cytologically confirmed resectable stage II, IIIA, or selected IIIB (T2-3N2bM0 only) non-small cell lung cancer (NSCLC) according to the International Union Against Cancer (UICC) and American Joint Committee on Cancer (AJCC) 9th edition TNM classification for lung cancer, with the tumor judged by the investigator as amenable to curative-intent R0 resection.\n* Ability to provide tumor tissue specimens, either archived or freshly obtained prior to the first dose of study drug.\n* Presence of measurable target lesions by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST version 1.1. Tumor imaging assessment must be performed within 28 days before the first dose.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* No prior anti-cancer therapy, including radiotherapy, chemotherapy, surgery, or targeted therapy, before study enrollment.\n* Adequate hematologic and end-organ function.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer (SCLC), mixed SCLC and NSCLC, or other non-NSCLC pathological types.\n* Known EGFR mutations or ALK positivity, or other actionable driver gene mutations for which approved targeted therapies are available and accessible.\n* Presence of malignant pleural effusion. For subjects with drainable pleural effusion during the screening period, at least one thoracentesis is required to rule out the presence of malignant cells.\n* Prior systemic anti-cancer therapy for non-small cell lung cancer. If the subject has previously received anti-cancer treatment with traditional Chinese medicine (TCM), enrollment is permitted only if the interval between the completion of TCM therapy and the first dose of study drug is at least 2 weeks.\n* Receipt of systemic immunosuppressive therapy within 2 weeks prior to the first dose, or expected need for systemic immunosuppressive medication during the study treatment period.\n* Current participation in an interventional clinical study treatment, or receipt of another investigational drug or investigational device within 4 weeks prior to the first dose.\n* History of malignancies other than NSCLC within 5 years prior to enrollment.\n* Presence of autoimmune disease.\n* Subjects with known or suspected interstitial lung disease; other moderate to severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity or significantly impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fobstructive bronchiolitis, etc.\n* Subjects with severe cardiovascular or cerebrovascular diseases. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.\n* Arterial or venous thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) within 3 months prior to the first dose.\n* Congenital or acquired immunodeficiency, including but not limited to human immunodeficiency virus (HIV) infection, active hepatitis B, or hepatitis C.\n* Evidence of active tuberculosis infection within 1 year prior to the first dose.\n* Severe infection within 4 weeks prior to the first dose.\n* Receipt of live attenuated vaccine within 28 days prior to the first dose, or planned receipt of live attenuated vaccine during the study period.\n* Major surgery (other than diagnostic procedures or biopsy) within 28 days prior to the first dose.\n* History of or planned allogeneic bone marrow transplantation or solid organ transplantation.\n* History of severe hypersensitivity reactions to other monoclonal antibodies or fusion proteins, or known allergy to any component of the randomly assigned treatment regimen.\n* Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n* Known history of substance abuse, alcohol abuse, or drug addiction.",{"count":312,"type":21},78,[57],"Although phase III studies have confirmed the efficacy and safety of perioperative immunotherapy plus chemotherapy for resectable NSCLC, there remains room for improvement in both short-term efficacy and long-term survival. Preclinical evidence suggests that PCSK-9 inhibition may synergize with PD-1 inhibitors to suppress tumor growth in mouse models. To date, no data are available on neoadjuvant PCSK-9 inhibitor therapy combined with immunotherapy and chemotherapy in resectable NSCLC. Therefore, this phase II study aims to evaluate the efficacy and safety of neoadjuvant adebrelimab or retlirafusp alfa (SHR-1701) plus recaticimab and chemotherapy in patients with resectable NSCLC.",[316],"Non Small Cell Lung Cancer",{"date":318,"type":36},"2026-05-05",{"date":320,"type":21},"2026-07",{"date":322,"type":21},"2030-12",{"name":41,"class":42},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":55,"phases":333,"briefSummary":334,"conditions":335,"keywords":336,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":4},"100633524","phase-2-optimization-of-dynamic-neoadjuvant-therapy-strategies-for-her2-positive-breast-cancer-based-on-her2-petct-molecular-imaging-100633524","NCT07527806","Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET\u002FCT Molecular Imaging","A Prospective, Double-Arm Study on the Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET\u002FCT Molecular Imaging","Inclusion Criteria:\n\n* Voluntary participation with written informed consent obtained prior to any study-related procedures\n* Age ≥ 18 years, male or female.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Histologically confirmed HER2-positive (IHC 3+, or IHC 2+ with ISH amplification) stage I-III (cT1-3\u002FcN0-2) breast cancer\n* Tumor diameter ≥ 1.5 cm assessed by imaging, with at least one PET-evaluable lesion present\n* Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status. For Arm B, ER expression ≥ 10% and must be strongly positive.\n* Adequate bone marrow, liver, and renal function: WBC \\> 3.0 × 10⁹\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, Hb ≥ 10.0 g\u002FdL; total bilirubin ≤ ULN (excluding Gilbert's syndrome), ALP ≤ 2.5 × ULN, AST\u002FALT ≤ 1.5 × ULN; creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n* Patients who participate in the trial have good compliance and are willing to comply with the follow-up visit.\n\nExclusion Criteria:\n\n* Prior treatment with any chemotherapy, anti-HER2 therapy, radiotherapy, or endocrine therapy, etc\n* Locally advanced (cT4\u002FcN3) or bilateral breast cancer\n* Patients with known allergies to any active ingredients or excipients of investigational medicinal product\n* Other malignancy diagnosed within 5 years prior to enrollment, excluding cervical carcinoma in situ and cured melanoma skin cancer\n* Left ventricular ejection fraction (LVEF) \\\u003C 55%\n* Uncontrolled hypertension (systolic \\> 150 mm Hg and\u002For diastolic \\> 100 mm Hg)\n* Severely cardiovascular disease\n* Current known infection with HIV, hepatitis B virus, or hepatitis C virus\n* Patients with pulmonary disease requiring continuous oxygen therapy, previous history of bleeding diathesis or patient is currently receiving anti-coagulant therapy, or immunosuppressive agent\n* Major surgical procedure or significant traumatic injury\n* Patient has other concurrent severe and\u002For uncontrolled medical conditions.\n* Concurrent participation in other interventional clinical trial\n* History of receiving any investigational treatment within 28 days prior to randomization\n* Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol\n* Inability to lie flat or presence of psychiatric disorders such as claustrophobia",{"count":332,"type":21},156,[57],"This study evaluates HER2-PET\u002FCT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer. Based on metabolic response after two cycles, patients receive either intenstified treatment (Arm A) or de-escalation treatment (Arm B), alongside with a concurrent standard-treatment control group (Arm C). The study aims to establish a response-adaptive, imaging-guided treatment paradigm to optimize neoadjuvant therapy in HER2-positive breast cancer.",[158],[184],"2026-04-14",{"date":339,"type":36},"2026-04-17",{"date":341,"type":21},"2026-05-01",{"date":343,"type":21},"2029-12-31",{"name":41,"class":42},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":18,"minAge":351,"maxAge":222,"enrollmentInfo":352,"targetDuration":353,"studyType":23,"phases":4,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":359,"leadSponsor":361,"locationsCount":43},"100633616","clinical-application-of-89zr-s-c1-petct-imaging-in-solid-tumors-100633616","NCT07529002","Clinical Application of 89Zr-s-C1 PET\u002FCT Imaging in Solid Tumors","Case inclusion criteria\n\n1. Patients with pathologically confirmed newly diagnosed solid tumors (such as melanoma, gastric cancer, colorectal cancer, etc.), or those with recent recurrence or suspected recurrence of previous solid tumors. Both male and female patients are eligible.\n2. Hematology, liver, and kidney function meeting the following criteria:\n\n   Hematology: WBC ≥ 4.0×10⁹\u002FL or neutrophil count ≥ 1.5×10⁹\u002FL, PLT ≥ 100×10⁹\u002FL, Hb ≥ 90 g\u002FL; PT or APTT ≤ 1.5 × ULN.\n\n   Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for subjects with liver metastases), ALP ≤ 2.5 × ULN (if bone or liver metastases are present, ALP ≤ 4.5 × ULN); BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN.\n3. Expected survival ≥ 12 weeks.\n4. Good compliance with follow-up.\n5. Presence of at least one measurable target lesion according to RECIST 1.1 criteria.\n6. Female subjects must use effective contraception (effective contraception refers to sterilization, intrauterine hormone devices, condoms, contraceptive pills\u002Fagents, abstinence, or vasectomized partner) during the study and for 6 months after the study ends; male subjects must agree to use contraception during the study and for 6 months after the study ends.\n7. Subjects must fully understand and voluntarily participate in this trial, and sign the Informed Consent Form.\n\nCase exclusion criteria\n\n1. Severe liver and kidney dysfunction.\n2. Women preparing for pregnancy, pregnant, or breastfeeding.\n3. Inability to lie flat for half an hour.\n4. Inability to provide informed consent.\n5. Suffering from claustrophobia or other psychiatric disorders.\n6. Known allergy to the investigational drug or its excipients.\n7. Other situations deemed unsuitable for trial participation by the researchers.","15 Years",{"count":107,"type":21},"1 Year","This project is driven by clinical needs and focuses on the mucin (MUC) family, key glycopeptide antigens involved in mediating immune evasion in solid tumors. We selected multiple members of this family as research subjects. Based on the MUC18 target, we developed the probe ⁸⁹Zr-SS-CNB001 (HuAA98-14, hereafter referred to as ⁸⁹Zr-s-C1). Studies have demonstrated that ⁸⁹Zr-s-C1 PET\u002FCT enables noninvasive in vivo identification of tumor lesions in patients with solid tumors, and its imaging efficacy positively correlates with MUC18 expression levels in the patient's tumor tissue.",[115],"2026-04-12",{"date":337,"type":36},{"date":337,"type":21},{"date":360,"type":21},"2028-03-01",{"name":41,"class":42},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":4},"100629096","pyrotinib-combined-with-trastuzumab-and-pertuzumab-for-maintenance-therapy-in-her2-positive-advanced-breast-cancer-100629096","NCT07470203","Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer","Efficacy and Safety of Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer：A Prospective, Single-Arm, Observational, Real-World Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification), with known HR status.\n3. Have unresectable locally advanced or metastatic disease. If recurrent (after \\[neo\\]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.\n4. Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.\n5. CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following: No evidence of brain metastases. Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n7. Have planned to receive maintenance anti-tumor therapy with pyrotinib in combination with HP\n8. Negative serum pregnancy test; women of childbearing potential must use a highly effective contraceptive method from study initiation until at least 6 months after the last dose of study medication.\n9. Voluntary participation with written informed consent obtained prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Other malignancy diagnosed within 5 years prior to enrollment.\n2. Prior treatment with any tyrosine kinase inhibitor targeting HER2 and\u002For epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib.\n3. Patients who are difficult or unable to be followed-up.\n4. Other reasons that, in the investigator's judgment, make the patient unsuitable for participation in this study.",{"count":370,"type":21},42,"This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.",[373],"HER2-positive Breast Cancer",[375,376],"pyrotinib","HER2-positive breast cancer","2026-03-09",{"date":379,"type":36},"2026-03-13",{"date":381,"type":21},"2026-03-31",{"date":383,"type":21},"2029-09-30",{"name":41,"class":42},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":4},"100626950","pd-l1-targeting-peptide-probe-for-pet-imaging-of-solid-tumor-100626950","NCT07442292","PD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor","PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor","Inclusion Criteria:\n\n1. Aged 18-75, male and female, with ECOG score of 0 or 1;\n2. Subjects with lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;\n3. underwent PD-L1 IHC examination before therapy;\n4. The expected survival was more than 26 weeks;\n5. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \\>= 4.0 x 10\\^9\u002FL or neutrophil \\>= 1.5 x 10\\^9\u002F:, PLT \\>= 100 x 10\\^9 \u002F L, Hb \\>= 90g \u002F L; Pt or APTT \\\u003C= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \\\u003C= 1.5 x ULT (upper limit of normal value), ALT \u002F AST \\\u003C= 2.5 upper limit of normal value or \\\u003C= 5 x ULT (subject with liver metastasis), ALP \\\u003C= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \\\u003C= 4.5 upper limit of normal value); BUN \\\u003C= 1.5 x ULT, SCR \\\u003C= 1.5 x ULT;\n6. According to RECIST1.1, there was at least one measurable target lesion;\n7. Understand and sign informed consent voluntarily with good compliance.\n\nExclusion Criteria:\n\n1. The function of liver and kidney was seriously abnormal;\n2. Preparation for pregnant, pregnant and lactating women;\n3. Inability to lie flat for half an hour;\n4. Suffering from claustrophobia or other mental disorders;\n5. Other researchers considered it unsuitable to participate in the trial.",{"count":393,"type":21},40,"The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET\u002FCT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.",[396,397,398,399,400,401],"Lung Cancer (NSCLC)","Lung Cancer (SCLC)","Melanoma (Skin Cancer)","Melanoma Metastatic","PD-L1","PET \u002F CT","2026-03-03",{"date":404,"type":36},"2026-03-05",{"date":406,"type":21},"2026-02",{"date":408,"type":21},"2027-06",{"name":41,"class":42},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":416,"targetDuration":4,"studyType":55,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":43},"100472762","cldn182-targeting-nanobody-probe-for-pet-imaging-in-solid-tumors-100472762","NCT05436093","CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors","Inclusion Criteria:\n\n* 1\\. Aged \\>18 years old; ECOG 0 or 1;\n* 2\\. Patients with solid tumors;\n* 3\\. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);\n* 4\\. life expectancy \\>=12 weeks.\n\nExclusion Criteria:\n\n* 1\\. Significant hepatic or renal dysfunction;\n* 2\\. Is pregnant or ready to pregnant;\n* 3\\. Cannot keep their states for half an hour;\n* 4\\. Refusal to join the clinical study;\n* 5\\. Suffering from claustrophobia or other mental diseases;\n* 6\\. Any other situation that researchers think it is not suitable to participate in the experiment.",{"count":417,"type":21},15,[109],"The objective of the study is to construct a noninvasive approach 68Ga-ACN376 PET\u002FCT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.",[421],"Solid Tumor","2026-03-02",{"date":424,"type":36},"2026-03-04",{"date":426,"type":36},"2022-06-23",{"date":428,"type":21},"2027-12",{"name":41,"class":42},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":436,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":437,"targetDuration":4,"studyType":55,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":446,"locationsCount":43},"100463947","nectin-4-specific-lmw-pet-probe-imaging-in-urothelial-carcinoma-100463947","NCT05321316","Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma","Inclusion Criteria:\n\n1. 18-75 years old, male or female;\n2. Heart function is normal;\n3. Normal heart function;\n4. Estimated survival ≥12 weeks;\n5. Good follow-up compliance;\n6. presence of at least one measurable target lesion according to RECIST1.1 criteria;\n7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;\n8. Patients recommended by clinicians to undergo PET\u002FCT examination for tumor diagnostic staging;\n9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.\n\nExclusion Criteria:\n\n1. Serious abnormality of liver, kidney and blood;\n2. Pregnant patients;\n3. Pregnant and lactation women;\n\n3\\) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.",true,{"count":107,"type":21},[109],"To evaluate the ability of \\[68Ga\\]N188 to detect nectin-4 overexpression in patients with urothelial carcinoma, especially in patients with recurrent or advanced bladder cancer.",[441],"Urothelial Carcinoma",{"date":424,"type":36},{"date":444,"type":21},"2026-05-31",{"date":165,"type":21},{"name":41,"class":42},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":55,"phases":456,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":466,"locationsCount":4},"100625023","phase-2-shr-a1811-vs-pyrotinibcapecitabine-in-trastuzumab-resistant-her2-advanced-breast-cancer-a-randomized-study-100625023","NCT07417241","SHR-A1811 vs Pyrotinib\u002FCapecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study","Efficacy and Safety of SHR-A1811 Versus Pyrotinib Plus Capecitabine in Patients With Trastuzumab Primary-Resistant HER2-Positive Advanced Breast Cancer：A Prospective, Multicenter, Open-Label, Randomized, Controlled Study","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification).\n3. ECOG performance status 0-2.\n4. Estimated life expectancy \\>12 weeks.\n5. At least one measurable lesion per RECIST v1.1 criteria;\n6. Patients with trastuzumab primary resistance is defined as follows:\n\n   1. Progression during or within 12 months after treatment in neoadjuvant or adjuvant setting (at least 9 weeks of trastuzumab treatment);\n   2. For patients with de novo stage IV disease, progression during or within 3 months after treatment for locally advanced or metastatic disease in the first-line setting (at least 6 weeks of trastuzumab treatment).\n7. Adequate organ function as defined by the following laboratory criteria:\n\n   1. Hematologic: absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, platelet count (PLT) ≥100 × 10⁹\u002FL, hemoglobin (HGB) ≥90 g\u002FL.\n   2. Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) (≤5 × ULN in patients with liver metastases); total serum bilirubin (TBIL) ≤1.5 × ULN; serum albumin ≥30 g\u002FL.\n   3. Renal: serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance ≥50 mL\u002Fmin using the Cockcroft-Gault formula.\n   4. Coagulation: prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n   5. Cardiac: left ventricular ejection fraction (LVEF) ≥50%.\n8. Women of childbearing potential must have a negative pregnancy test at screening, and subjects of reproductive potential must agree to use effective contraception from study start until 6 months after the last dose of study treatment..\n9. Voluntary participation with written informed consent obtained prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Prior or current exposure to antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor, including but not limited to fam-trastuzumab deruxtecan (DS-8201a).\n2. Active brain metastases or leptomeningeal metastases (patients with asymptomatic\u002Finactive brain metastases are allowed to be enrolled);\n3. Other malignancy diagnosed within 5 years prior to enrollment, excluding cured non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ, or stage I grade 1 endometrial cancer;\n4. Radiotherapy, any anti-HER2 targeted therapy, or chemotherapy within 4 weeks prior to enrollment; endocrine therapy within 2 weeks prior to enrollment;\n5. Positive for human immunodeficiency virus (HIV);\n6. Known hypersensitivity to any study drug or its excipients, or to humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab, etc.);\n7. Clinically significant cardiovascular disease, such as severe\u002Funstable angina, symptomatic congestive heart failure (NYHA Class ≥II), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months prior to first dose, or cerebrovascular accident (including transient ischemic attack).\n8. Participants known or suspected to interstitial lung disease.\n9. Concurrent participation in any other interventional drug clinical trial.\n10. Refusal to comply with protocol-mandated follow-up. Presence of any additional severe physical or psychiatric disorder, or any laboratory abnormality that, in the investigator's judgment, could increase the subject's risk, confound study results, or render the patient unsuitable for enrollment.",{"count":455,"type":21},100,[57],"This is a prospective, multicenter, open-label, randomized, controlled Study. The purpose of this study is to evaluate the efficacy and safety of SHR-A1811 versus pyrotinib plus capecitabine in the treatment of trastuzumab primary-resistant HER2-positive advanced breast cancer.",[158,373],[376,460],"SHR-A1811","2026-02-11",{"date":463,"type":36},"2026-02-18",{"date":381,"type":21},{"date":343,"type":21},{"name":41,"class":42},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":473,"enrollmentInfo":474,"targetDuration":4,"studyType":55,"phases":476,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":43},"100624700","phase-1-a-phase-i-study-to-evaluate-the-safety-and-preliminary-efficacy-of-225acac-dotatate-injection-combined-with-tislelizumab-in-the-maintenance-treatment-period-for-patients-of-extensive-stage-small-cell-lung-cancer-es-sclc-with-somatostatin-receptors-sstr-as-first-line-treatment-100624700","NCT07413042","A Phase I Study to Evaluate the Safety and Preliminary Efficacy of [225Ac]Ac-DOTATATE Injection Combined With Tislelizumab in the Maintenance Treatment Period for Patients of Extensive-stage Small Cell Lung Cancer (ES-SCLC) With Somatostatin Receptors (SSTR)+ as First-line Treatment","Inclusion Criteria:\n\n1. Patients must have the ability to understand and sign an approved informed consent form (ICF).\n2. Patients must be \\>= 18 and \\\u003C＝80 years of age.\n3. Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation.\n4. Presence of at least 1 measurable site of disease (based on RECIST 1.1).\n5. ECOG score of 0 or 1.\n6. SSTR-PET positive.\n7. Sufficient bone marrow capacity and organ function:\n\n   Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml\u002Fmin (Cockcroft Gault formula).\n\n   Hemoglobin≥90g\u002FL, neutrophil count ≥1.5×10\\^9\u002FL, platelets≥100×10\\^9\u002FL. Serum total bilirubin ≤1.5×ULN. Serum albumin ≥30g\u002FL. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN，or ALT\u002FAST≤5×ULN with liver metastases.\n\n   Partially activated prothrombin time (APTT) ≤1.5 x ULN.\n8. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 6 months of the last use of the trial drug.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females.\n2. Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.\n3. Uncontrolled congestive heart failure.\n4. uncontrolled diabetes mellitus, including baseline fasting glucose \\> 2 x ULN.\n5. Known hypersensitivity to Lutetium\\[177Lu\\] Oxodotreotide Injection or \\[225Ac\\]Ac-DOTATATE Injection and their excipients.\n6. Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics.\n7. Unsuitable for the study for any reason, in the opinion of the investigator.","80 Years",{"count":475,"type":21},24,[477],"PHASE1","This is a phase I study to evaluate the safety and preliminary efficacy of \\[225Ac\\]Ac-DOTATATE injection combined with tislelizumab in the maintenance treatment period for patients of extensive-stage small cell lung cancer (ES-SCLC) with somatostatin receptors (SSTR)+ as first-line treatment.Patients with ES-SCLC who have completed the induction therapy of first-line standard treatment and are yet to enter the maintenance treatment period are planned to be enrolled.",[480],"SCLC, Extensive Stage","2026-02-09",{"date":483,"type":36},"2026-02-17",{"date":485,"type":36},"2026-01-20",{"date":487,"type":21},"2028-06-30",{"name":41,"class":42},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":496,"targetDuration":4,"studyType":55,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":43},"100622278","phase-2-adebrelimab-maintenance-therapy-for-ls-sclc-post-induction-chemo-adebrelimab-plus-crt-or-crt-alone-100622278","NCT07381543","Adebrelimab Maintenance Therapy for LS-SCLC Post Induction Chemo-Adebrelimab Plus CRT or CRT Alone","A Prospective, Exploratory, Two-Arm Study of Adebrelimab Maintenance Therapy in Limited-Stage Small Cell Lung Cancer Following Either Induction Chemo-Adebrelimab Plus Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Alone","Inclusion Criteria:\n\n1. Age: 18-75 years old, male or female;\n2. Patients with pathologically confirmed localized small cell lung cancer (as defined by the Veterans Administration Lung Study Group, VALG staging);\n3. No anticipated need for tumor resection during the study period (including patients unsuitable for surgery or unwilling to undergo surgery);\n4. No prior treatment for localized small cell lung cancer;\n5. Presence of measurable tumor target lesions (meeting RECIST 1.1 criteria);\n6. Expected survival \\> 3 months;\n7. ECOG PS: 0-1;\n8. Normal major organ function;\n\n   1. Complete blood count (CBC) (without transfusion or hematopoietic growth factor correction within 14 days):\n\n      Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count (PLT) ≥ 100 × 10⁹\u002FL; White blood cell count (WBC) ≥ 3.0 × 10⁹\u002FL;\n   2. Biochemical tests:\n\n      Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for subjects with Gilbert syndrome); Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ 50 mL\u002Fmin;\n   3. Coagulation function:\n\n      Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin time (PT) ≤ 1.5×ULN;\n   4. Doppler ultrasound assessment:\n\n   Left ventricular ejection fraction (LVEF) ≥50%;\n9. Women of childbearing potential must have a negative pregnancy test (βHCG) prior to treatment initiation. Women of childbearing potential and males (who have sexual intercourse with women of childbearing potential) must agree to use effective contraception continuously during treatment and for 6 months after the last dose.\n10. Patients voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Mixed SCLC and extensive-stage SCLC;\n2. History of other malignancies within the past 5 years or concurrent malignancies, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial or non-invasive bladder cancer;\n3. History of uncontrollable psychiatric disorders or severe intellectual or cognitive impairment;\n4. Active, known, or suspected autoimmune disease; however, subjects with hypothyroidism requiring only hormone replacement therapy or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are eligible;\n5. Subjects with any severe and\u002For uncontrolled medical conditions, including:\n\n   1. Subjects with uncontrolled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);\n   2. Subjects with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including male QTc ≥ 450 ms or female QTc ≥ 470 ms), and ≥ Grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] classification);\n6. Severe unhealed wounds, ulcers, or fractures;\n7. History of psychiatric drug abuse, alcoholism, or illicit drug use;\n8. Active hepatitis (HBV reference: HBsAg positive with HBV DNA levels exceeding upper normal limit; HCV reference: HCV antibody positive with HCV viral load exceeding upper normal limit);\n9. Human Immunodeficiency Virus (HIV, HIV 1\u002F2 antibody) positive;\n10. Patients unable to comply with the study protocol or participate in follow-up visits;\n11. Patients deemed unsuitable for this trial by the investigator.",{"count":497,"type":21},76,[57],"Observation and Evaluation of the Efficacy and Safety of Adalimumab Combined with Chemotherapy Followed by Radiotherapy or Radiotherapy Alone as First-Line Treatment for Limited-Stage Small Cell Lung Cancer",[501],"Localized Small Cell Lung Cancer",[503,504],"Localized small cell lung cancer","Without prior systemic anticancer therapy","2026-02-01",{"date":507,"type":36},"2026-02-04",{"date":509,"type":21},"2026-03",{"date":511,"type":21},"2028-08",{"name":41,"class":42},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":521,"targetDuration":4,"studyType":55,"phases":523,"briefSummary":524,"conditions":525,"keywords":528,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":537,"leadSponsor":539,"locationsCount":4},"100623250","phase-2-short-course-radiotherapy-with-tumor-draining-lymph-node-preservation-followed-by-pd-1-inhibitors-in-pmmrmss-stage-ii-iii-rectal-cancer-100623250","NCT07394192","Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR\u002FMSS Stage II-III Rectal Cancer","Exploratory Study on the Efficacy and Safety of Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR\u002FMSS Stage II-III Rectal Cancer","PKUCH- R11","Inclusion Criteria:\n\n* Age 18-75 years old, regardless of sex.\n\n  * Fibrocolonoscopy or digital rectal examination indicates that the distal border of the lesion is located 5-10 cm from the anal verge.\n\n    * Pathologically confirmed rectal adenocarcinoma.\n\n      * Imaging examinations (including pelvic MRI and chest-abdominal CT) confirm a clinical stage of II\u002FIII (cT3-T4aN0 or cT2-4aN+, MRF (-), with no distant metastasis) according to the AJCC Cancer Staging Manual, 8th Edition (2018) (for detailed TNM staging of rectal cancer).\n\n        * If N+, metastatic lymph nodes are confined to the mesorectal and superior rectal artery drainage regions, with no lateral pelvic lymph node metastasis.\n\n          ⑥ Confirmed by immunohistochemistry or molecular testing to be mismatch repair proficient (pMMR) or microsatellite stable (MSS).\n\n          ⑦ Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1 (see Appendix 2 for details).\n\n          ⑧ Meeting the following laboratory criteria: Hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.5 × 10⁹\u002FL; Neutrophil count ≥ 1.5 × 10⁹\u002FL, platelet count ≥ 100 × 10⁹\u002FL; Creatinine ≤ 1.0 × upper limit of normal (ULN), blood urea nitrogen (BUN) ≤ 1.0 × ULN; Alanine aminotransferase (ALT) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) ≤ 1.5 × ULN; Alkaline phosphatase (ALP) ≤ 1.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Urine protein negative; normal coagulation time; normal thyroid function.\n\n          ⑨ Patients with primary rectal cancer must have undergone no surgical interventions (excluding palliative stoma formation), chemotherapy, or other antitumor treatments from the time of diagnosis to enrollment.\n\n          ⑩ The planned radiation field must have no history of prior radiotherapy.\n          * The patient voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and is willing to cooperate with follow-up visits and data provision.\n\nExclusion Criteria:\n\n* Previous treatment with anti-PD-1\u002FL1, anti-CTLA-4 immunotherapies, or other investigational immunotherapeutic agents is excluded.\n\n  * Patients with severe autoimmune diseases are excluded, including active inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.\n\n    * Patients with symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonitis are excluded.\n\n      * Patients with clinical or imaging evidence of intestinal obstruction or perforation, or those deemed by the investigator to be at high risk of perforation or hemorrhage, are excluded.\n\n        * History of other malignancies, excluding curatively treated non-melanoma skin cancer and carcinoma in situ of the cervix, are excluded.\n\n          * Patients with severe cardiovascular or cerebrovascular diseases are excluded, including cerebrovascular accidents, transient ischemic attacks, myocardial infarction within 6 months prior to enrollment, or significant vascular diseases (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis). Also excluded are those with poorly controlled cardiac symptoms or conditions, such as unstable angina, heart failure of New York Heart Association (NYHA) Class II or higher, left ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography, or severe arrhythmias uncontrolled by medication.\n\n            * Physical examination findings, clinical laboratory abnormalities, or other uncontrolled conditions that, in the investigator's judgment, may interfere with the study results or increase the patient's risk of treatment complications are excluded.\n\n              * Lactating or pregnant women are excluded. ⑨ Patients with congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV) infection, or a history of organ transplantation or allogeneic stem cell transplantation, are excluded.\n\n                ⑩ Known active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or active tuberculosis are excluded.\n\n                ⑪ Patients with concurrent use of other immunomodulators, chemotherapeutic agents, other investigational drugs, or requiring long-term corticosteroid therapy are excluded.\n\n                ⑫ Patients with psychiatric disorders, substance abuse, or social issues that may affect compliance, as determined upon physician review, are excluded.\n\n                ⑬ Patients with allergies or contraindications to the investigational drug(s) are excluded.",{"count":522,"type":21},44,[57],"This study aims to evaluate the efficacy (pathological complete response rate) of short-course radiotherapy with preservation of tumor-draining lymph nodes followed by sequential PD-1 inhibitor neoadjuvant therapy in patients with stage II-III pMMR\u002FMSS locally advanced rectal cancer.",[288,526,527],"Radiotherapy","PD-1 Inhibitor",[529,530,531,532,533],"short-course radiotherapy","tumor-draining lymph nodes","PD-1 inhibitors","pMMR\u002FMSS","locally advanced rectal cancer",{"date":535,"type":36},"2026-02-06",{"date":505,"type":21},{"date":538,"type":21},"2031-12-31",{"name":41,"class":42},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":105,"enrollmentInfo":547,"targetDuration":4,"studyType":55,"phases":548,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":557,"locationsCount":4},"100622412","phase-2-capox-and-bevacizumab-with-or-without-primary-tumor-radiotherapy-and-iparomlimab-and-tuvonralimab-as-first-line-treatment-for-ras-mutantmss-metastatic-rectal-cancer-100622412","NCT07383285","CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant\u002FMSS Metastatic Rectal Cancer","CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant\u002FMSS Metastatic Rectal Cancer: An Open-label, Randomized, Multi-center Phase II Study","Inclusion Criteria:\n\n1. The subjects were able to understand the informed consent form, voluntarily participated and signed the informed consent form;\n2. On the day of signing the informed consent form, the subjects were aged between 18 and 75 years old, regardless of gender;\n3. Pathological tissue diagnosis confirmed rectal adenocarcinoma (including signet ring cell carcinoma and mucinous adenocarcinoma);\n4. The lower boundary of the lesion was within 15 cm from the anal verge;\n5. The clinical stage was stage IV;\n6. The genetic test results were KRAS or NRAS mutations, without BRAF V600 mutations, and the immunohistochemical results were pMMR;\n7. The subjects had not received palliative drug treatment, or had received 1 cycle of FOLFOX\u002FCAPOX and had not undergone tumor efficacy assessment;\n8. According to the RECIST 1.1 standard, there was at least 1 measurable lesion or assessable lesion at the baseline;\n9. The primary lesion existed and had not undergone radiotherapy previously;\n10. The ECOG score was 0 or 1 (Appendix 4);\n11. The expected survival period was ≥ 6 months;\n12. Female subjects with fertility or male subjects whose partner had fertility agreed to adopt effective contraceptive measures starting from 7 days before the first administration until 120 days after the last administration (refer to Appendix 3);\n13. The subjects were capable and willing to comply with the visit, treatment plan, laboratory tests and other research-related procedures stipulated in the research protocol;\n14. Within 7 days before the first administration, they had good organ function\n\nExclusion Criteria:\n\n(1) Subjects with untreated active brain metastases or meningeal metastases; if the brain metastases of the subject have been treated and the condition of the metastases is stable (brain imaging examination at least 4 weeks before the first administration shows stable lesions, and there are no new neurological symptoms or the neurological symptoms have recovered to baseline levels), and there is no evidence of new onset or enlargement of the metastases, they are allowed to be enrolled; (2) Have the following cardiovascular conditions:\n\n1. Active coronary heart disease with angina pectoris or patients who need to take medication to prevent angina attacks;\n2. NYHA II-IV grade chronic heart failure;\n3. Uncontrolled hypertension after drug treatment (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);\n4. Major vascular diseases (such as aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis);\n5. Has had thromboembolic or cerebrovascular embolic events within 6 months. (3) Have the following digestive system diseases:\n\n1\\) Within 6 months, there has been abdominal fistula, gastrointestinal perforation or abdominal abscess or active gastrointestinal bleeding. If the perforation or fistula has been treated by resection or repair, and the disease has been judged by the investigator to have recovered or alleviated, it is allowed to be enrolled; 2) Have gastric, duodenal ulcers or ulcer malignancy, intestinal obstruction\u002Fobstruction with incomplete obstruction; 3) Have chronic enteritis and\u002For inflammatory bowel disease; (4) Have abnormal coagulation conditions:\n\n1. Have bleeding (including hemoptysis) or coagulation disorders;\n2. Are taking warfarin, aspirin (except for small doses of less than 100 mg per day), low molecular weight heparin and other antiplatelet aggregation Chinese and Western drugs.\n\n(5) Within 28 days before the first administration or 5 half-lives (whichever is shorter, but at least 2 weeks) have received any other interventional clinical trials or received other anti-tumor treatment for the purpose of alleviating symptoms of bone metastases is allowed; (6) Within 28 days before the first administration have received major surgical treatment (such as major surgeries through the abdomen or thorax; excluding drainage, diagnostic punctures or peripheral vascular access replacement surgeries); (7) Within 14 days before the first administration need to receive continuous 7 days of systemic corticosteroid treatment (≥ 10 mg\u002Fday prednisone, or equivalent other corticosteroids) or immunosuppressant treatment; except for inhalation or local application of corticosteroids, or receiving physiological replacement doses of corticosteroids due to adrenal insufficiency; allowed for short-term (≤ 7 days) corticosteroids for prevention (for example, contrast agent allergy) or treatment of non-autoimmune diseases (for example, delayed-type hypersensitivity reaction caused by exposure to allergens); (8) Within 28 days before the first administration have received live vaccines (including attenuated live vaccines); (9) Have interstitial lung disease, or have a history of non-infectious pneumonia requiring oral or intravenous administration of glucocorticoids; (10) Within 2 years before the start of the study treatment need systemic treatment for active autoimmune diseases, or the investigator judges that there is a possibility of recurrence or planned treatment for autoimmune diseases. The following are excluded: a) Skin diseases that do not require systemic treatment (such as: vitiligo, alopecia, psoriasis or eczema); b) Hypothyroidism caused by autoimmune thyroiditis, only requiring stable doses of hormone replacement therapy; c) Type I diabetes that only requires stable doses of insulin replacement therapy; d) Childhood asthma has completely resolved, and no intervention is needed after adulthood; e) The investigator judges that the disease will not recur without external triggering factors. (11) Within 5 years prior to the first administration, having another malignant tumor, except for cured skin squamous cell carcinoma, basal cell carcinoma, non-invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL at the time of prostate cancer diagnosis (if measured), patients who have received radical treatment and have no biochemical recurrence of prostate-specific antigen (PSA)), and in situ cervical\u002Fbreast cancer; (12) Having uncontrolled comorbidities, including but not limited to the following conditions: a) Active HBV or HCV infection; b) Subjects with positive HBsAg and\u002For HCV antibody during the screening period, must undergo HBV DNA and\u002For HCV RNA testing. Subjects with HBV DNA ≤ 500 IU\u002FmL (or ≤ 2000 copies\u002FmL) and\u002For negative HCV RNA can be enrolled; during the trial, the study investigator decides to monitor HBV DNA based on the subject's condition; c) Known HIV infection or AIDS history; d) Active tuberculosis; e) Active infection or systemic use of anti-infective drugs for more than 1 week before the first administration of this study and within 28 days before the first administration; fever of unknown origin occurred within 2 weeks before administration; f) Uncontrolled hypertension (resting blood pressure ≥ 160\u002F100 mmHg), symptomatic heart dysfunction (NYHA II-IV), unstable angina pectoris or myocardial infarction within 6 months, or QTc prolongation or risk of arrhythmia (baseline QTc \\> 470 msec corrected by Fridericia method, refractory hypokalemia, long QT syndrome, resting heart rate \\> 100 bpm atrial fibrillation or severe valvular heart disease); g) Active bleeding that cannot be controlled by medical treatment; (13) Toxicity from previous anti-tumor therapy has not recovered to CTCAE ≤ 1 grade (NCI-CTCAE v5.0) or baseline level, except alopecia, skin pigmentation (allowing any grade), and immune-related adverse reactions that require physiological dose substitution (such as hypothyroidism, pituitary insufficiency, type I diabetes, etc.); (14) Previous history of allogeneic bone marrow or organ transplantation; (15) Previous history of allergic reactions to antibody drugs, hypersensitivity reactions, or intolerance (such as severe allergic reactions, immune-mediated liver toxicity, immune-mediated thrombocytopenia or anemia); (16) Pregnant and\u002For lactating women; (17) Other situations that the investigator considers to affect the safety or compliance of the treatment with the study drug, including but not limited to moderate to large pleural\u002Fabdominal effusion\u002Fpericardial effusion, refractory pleural\u002Fabdominal effusion\u002Fpericardial effusion, intestinal obstruction or subacute intestinal obstruction, mental disorders, etc.; (18) Previous treatment with immune checkpoint blockers or T-cell co-stimulation drugs, including but not limited to immune checkpoint blockers such as PD-1, PD-L1, CTLA4, LAG3, etc., therapeutic vaccines, etc.",{"count":5,"type":21},[57],"Research objective: To compare the efficacy and safety of Capox + Bev versus Capox + Bev combined with primary site radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for RAS Mutation\u002FpMMR metastatic rectal cancer patients.\n\nStudy endpoint:\n\nPrimary endpoint: 12-month progression-free survival rate (PFSR)\n\nSecondary endpoints:\n\n* The objective response rate (ORR) and disease control rate (DCR) as determined by the investigator according to the RECIST 1.1 standard, time to response (TTR), duration of response (DOR), progression-free survival (PFS), 6-month progression-free survival rate (PFSR), overall survival (OS);\n* The frequency and severity of adverse events (AEs) during treatment (NCI CTCAE 5.0).\n\nThis study will enroll 106 patients (stratification factors: presence or absence of liver metastasis; whether NED could be achieved). They were randomly assigned in a 1:1 ratio to:\n\nThe treatment group: Capox + Bev combined with primary site radiotherapy and (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w).\n\nThe control group: Capox + Bev, administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev, administered every 3 weeks (Q3w).",[551],"Rectal Neoplasms Malignant","2026-01-26",{"date":554,"type":36},"2026-02-03",{"date":505,"type":21},{"date":343,"type":21},{"name":41,"class":42},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":565,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":55,"phases":568,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":577,"locationsCount":578},"100567904","a-study-on-the-improvement-of-postoperative-symptoms-and-survival-benefits-of-modified-bufei-decoction-in-elderly-patients-with-lung-cancer-undergoing-radical-surgery-100567904","NCT06674252","A Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery","A Randomized Controlled Multicenter Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery","Inclusion Criteria:\n\n* Patients with postoperative lung cancer who have clear histological or cytological diagnosis.\n\n  * Age ≥ 65 years old, both male and female are eligible. According to the MDASI-TCM scale evaluation, any of the three symptoms of cough, fatigue, and shortness of breath should score ≥ 4 points, or the sum of the three should score ≥ 6 points.\n\n    * The heart function is basically normal; ALT\u002FAST is within 2 times the normal value; SCr is within the normal range.\n\nTraditional Chinese medicine syndrome differentiation is characterized by deficiency of both lungs and kidneys.\n\nExclusion Criteria:\n\n* Patients with severe pulmonary infections. ⑵. Patients with mental illness. ⑶. Patients with depression.","65 Years",{"count":567,"type":21},174,[109],"This is a randomized double-blind placebo-controlled phase II clinical study that included patients with symptoms such as cough, shortness of breath, and fatigue after lung cancer resection surgery. They were given orally modified Bufei Tang granules twice a day for 28 days, with one packet taken orally with water. Using the MDASI-TCM symptom scoring system, evaluate the scores of symptoms such as cough, shortness of breath, and fatigue before and after the experiment, and calculate the difference in scores between the control group and the experimental group before and after the experiment.",[571],"Lung Cancers",{"date":573,"type":36},"2026-01-27",{"date":575,"type":36},"2025-06-13",{"date":428,"type":21},{"name":41,"class":42},2,""]