[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"interventionName\":\"Chemotherapy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":651},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,179,0,25,[9,46,74,104,131,155,189,217,237,255,278,302,334,360,386,408,429,453,478,502,524,545,571,593,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652863","phase-2-study-of-adebrelimab-combined-with-thymalfasin-and-chemotherapy-for-neoadjuvant-treatment-of-esophageal-cancer-100652863",false,"NCT07780721","Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer","Exploratory, Single-Arm, Multicenter Clinical Study of Adebrelimab Combined With Thymalfasin and Chemotherapy as Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Has signed the written informed consent form and voluntarily participates in this study;\n* Aged 18-80 years, male or female;\n* Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;\n* Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;\n* Has at least one measurable lesion (per RECIST Version 1.1: the measurable lesion has a longest diameter ≥10 mm on spiral CT scan, or a malignant lymph node with short-axis diameter ≥15 mm);\n* Expected to achieve R0 resection;\n* ECOG Performance Status (PS) 0-1 (see Appendix 1);\n* Has not received any prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.;\n* Plans to receive surgical resection after completion of neoadjuvant therapy;\n* No contraindications to surgery.\n* Adequate organ function as specified below:\n\n  1. Hematology laboratory values (No blood products, hematopoietic growth factors, leukopoietic agents, thrombopoietic agents or anti-anemia medications are permitted within 14 days prior to the first study drug administration):\n\n     White blood cell count ≥ 3.0 × 10⁹\u002FL Absolute neutrophil count ≥ 1.0 × 10⁹\u002FL Platelet count ≥ 80 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL\n  2. Serum chemistry:\n\n     Total bilirubin ≤ 1.5 × ULN Alanine transaminase (ALT) ≤ 2.5 × ULN; Aspartate transaminase (AST) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula, see Appendix 2)\n  3. Coagulation function:\n\nInternational normalized ratio (INR) ≤ 1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n\n* Female subjects of reproductive potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of study drug, and must use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for at least 3 months after the last dose of study drug. Male subjects with female partners of reproductive potential must use effective contraception throughout the study and for 3 months after the last dose.\n* Subjects with good compliance and willingness to complete follow-up visits.\n\nExclusion Criteria:\n\n* Tumor invades adjacent organs of the esophageal lesion (major arteries or trachea);\n* Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;\n* Poor nutritional status with BMI \\\u003C 18.5 kg\u002Fm². Subjects whose nutritional status is corrected by symptomatic nutritional support prior to enrollment may be considered for inclusion upon assessment by the principal investigator;\n* History of allergy to any component of monoclonal antibodies, adebrelimab, thymalfasin, paclitaxel, carboplatin or other platinum agents;\n* Previously received or currently receiving any of the following treatments:\n\n  1. Any anti-tumor radiotherapy, chemotherapy, immunotherapy, targeted therapy or other anti-neoplastic agents;\n  2. Immunosuppressive agents or systemic corticosteroids administered for immunosuppressive purposes (prednisone \\>10 mg\u002Fday or equivalent dose) within 2 weeks prior to the first study drug administration. Inhaled or topical steroids, and corticosteroid replacement therapy (prednisone \\>10 mg\u002Fday or equivalent dose) are permitted in the absence of active autoimmune disease;\n  3. Live attenuated vaccines administered within 4 weeks prior to the first study drug administration;\n  4. Major surgery or severe trauma within 4 weeks prior to the first study drug administration.\n* Active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects receiving hormone replacement therapy may be enrolled). Subjects with psoriasis or childhood asthma\u002Fallergies completely resolved without any intervention in adulthood can be considered eligible; patients requiring medical intervention with bronchodilators are excluded.\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, history of solid organ transplantation or allogeneic bone marrow transplantation;\n* Poorly controlled cardiac signs or diseases, including but not limited to: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still poorly controlled after intervention.\n* Severe infection (CTCAE Grade \\>2) within 4 weeks before the first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Active pulmonary inflammation indicated by baseline chest imaging; subjects presenting with signs and symptoms of infection within 14 days before first dosing or requiring oral\u002Fintravenous antibiotics, except for prophylactic antibiotic use.\n* Active pulmonary tuberculosis confirmed by medical history or CT scan; history of active pulmonary tuberculosis within 1 year before enrollment; or history of active pulmonary tuberculosis more than 1 year previously without standardized treatment.\n* Hereditary bleeding diathesis or coagulation disorders. Clinically significant bleeding events or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++.\n* Diagnosis of another malignant tumor within 5 years prior to the first study drug administration, except malignancies with low risk of metastasis or death (5-year survival rate \\>90%). Fully treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of cervix, etc., may be considered for enrollment.\n* Pregnant or breastfeeding women.\n* Any other conditions judged by the investigator that may force premature study discontinuation, such as other severe diseases (including psychiatric disorders) requiring combined medication, alcohol abuse, drug abuse, family or social factors that may affect subject safety or compliance.","ALL","18 Years","80 Years",{"count":21,"type":22},31,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma. The study consists of a screening period (from the signing of informed consent by subjects to the first study drug administration, no more than 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (comprising safety follow-up and survival follow-up). During neoadjuvant therapy, patients will receive 2 to 3 cycles of adebrelimab combined with thymalfasin and chemotherapy, followed by surgical resection.",[28],"Esophageal Cancer",[30,31,32,28],"Chemotherapy","Adebrelimab","neoadjuvant treatment","NOT_YET_RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":22},"2026-08-30",{"date":41,"type":22},"2029-02-01",{"name":43,"class":44},"The Affiliated Hospital of Putian University","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100623064","testing-whether-hormone-therapy-with-ribociclib-is-as-effective-as-chemotherapy-followed-by-hormone-therapy-with-ribociclib-for-the-treatment-of-high-anatomic-stage-breast-cancer-with-low-recurrence-risk-the-rxfine-low-trial-100623064","NCT07391774","Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial","A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos\u002FHER2-neg Breast Cancer With RS Less Than or Equal to 25 (RxFINE-Low)","Inclusion Criteria:\n\n* STEP 0: Patient must be ≥ 18 years of age\n* STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration\n* STEP 0: Patient must be a postmenopausal woman or a man\n\n  * NOTE: Menopause can be determined by any of the following:\n\n    * Prior bilateral oophorectomy\n    * Age ≥ 60 years\n    * Age \\\u003C 60 years with amenorrhea for ≥ 12 months and estradiol and follicle stimulating hormone (FSH) levels in the postmenopausal range\n  * NOTE: FSH and estradiol levels should be repeated as clinically indicated to ensure menopausal status in patients with breast cancer with chemotherapy-induced amenorrhea\n* STEP 0: Patient must meet one of the following staging criteria postoperatively according to American Joint Committee on Cancer (AJCC) 8th edition criteria\n\n  * pT0-T3 with 3 positive ipsilateral lymph nodes (micro-or macrometastatic disease) and no planned axillary lymph node dissection after definitive surgery in the breast and axilla with curative intent.\n  * pT0-T3 with N2 or N3\n  * pT3 with N0-N3\n\n    * NOTES:\n\n      * Patients with T4 breast cancer are not eligible.\n      * Positive isolated tumor cells (ITCs) in axillary nodes without micro- or macrometastasis are considered N0 for eligibility purposes.\n      * ITC does not contribute to nodal count for staging purposes\n* STEP 0: Patient must have a primary breast tumor that is estrogen receptor (ER) positive with \\> 10% ER expression by immunohistochemistry (IHC) as per 2020 American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) Estrogen Receptor Testing Guideline.\n\n  * NOTE: ER 1-10% are reported as ER low positive. These tumors have less endocrine-sensitive disease and are not eligible)\n* STEP 0: Patient must have a primary breast tumor that is HER2-negative by current ASCO\u002FCAP guidelines utilizing immunohistochemistry and\u002For fluorescence in situ hybridization (FISH)\n* STEP 0: Patient may have multicentric or multifocal breast cancer if the highest stage tumor meets eligibility criteria outlined above, and the tumor sites are felt to represent a single disease process by local pathology or other sites of disease are also ER-positive (\\> 10%) and HER2 negative, if such testing is completed. If local pathology feels that multicentric or multifocal disease may represent distinct disease processes repeat disease receptor testing is required other sites of disease must also be also ER-positive (\\> 10%) and HER2-negative\n* STEP 0: For patients who have undergone a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection\n* STEP 0: For patients who have undergone mastectomy, the margins must be free of residual gross tumor. Patients with microscopic positive margins are eligible if post-mastectomy radiation treatment (RT) of the chest wall will be administered\n* STEP 0: Patient must have undergone axillary staging with sentinel lymph node biopsy (SLNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND)\n* STEP 0: Patient must have no evidence of locoregional or distant metastatic disease by clinical history and physical exam. Treating physician can consider additional imaging evaluation per National Comprehensive Cancer Network (NCCN) guidelines and\u002For institutional practice\n* STEP 0: Patient must be able to have Oncotype DX testing performed.\n\n  * If Oncotype DX testing was previously performed, the results of Recurrence Score (RS) must be available and must meet Step 1 eligibility criteria.\n  * If Oncotype DX testing was not performed yet, tissue from the core, excisional biopsy or surgical specimen of the tumor lesion must be available and must be shipped to Exact Sciences for determination of the Oncotype DX Recurrence Score (RS) for eligibility and stratification.\n\n    * NOTE: Exact Sciences will notify the submitting institution of Recurrence Score results within two (2) weeks of receipt of the tumor specimen. Institutions will receive an email notification of eligibility status once Recurrence Score results are entered into Rave by the submitting institution\n* STEP 0: Patient must have had their final cancer surgery for breast cancer (including re-excision of margins) less than 16 weeks prior to Step 0 Pre-Registration.\n\n  * NOTE: This excludes additional surgery for reconstructive purposes\n* STEP 0: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 0: Patients with synchronous DCIS or LCIS are eligible\n* STEP 0: Patient with prior history of ER-negative DCIS diagnosed at least 5 years prior to Step 0 Pre-Registration without evidence of recurrence are eligible\n* STEP 0: Patient must not have a prior history of invasive ER-positive breast cancer. Patients with a history of ER-negative breast cancer are eligible if they were diagnosed at least 5 years prior to Step 0 Pre-Registration and have had no evidence of recurrence\n* STEP 0: Patients must not have received prior endocrine therapy such as tamoxifen, raloxifene, or aromatase inhibitors for chemoprevention within 5 years prior to Step 0 Pre-Registration with the exception of a short course of endocrine therapy of less than 6 weeks duration prior to Step 0 Pre-Registration.\n\n  * NOTE: The Oncotype DX for study eligibility must be performed on specimen obtained prior to initiation of any endocrine therapy\n* STEP 0: Patient must not be concurrently using systemic hormone replacement therapy (HRT). If receiving HRT at the time of breast cancer diagnosis, this must be discontinued prior to Step 0 Pre-Registration with appropriate washout\n* STEP 0: Absolute neutrophil count (ANC) ≥ 1,500\u002FµL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Platelets ≥ 100,000\u002FµL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Total bilirubin ≤ institutional upper limit of normal (ULN) or \\\u003C 1.5 x ULN for patients who have a bilirubin elevation in patients with well documented Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × institutional ULN (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fminute\u002F1.73 m\\^2 (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 Pre-Registration are eligible for this trial\n* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 0: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better\n* STEP 0: Patient must have a standard 12-lead electrocardiogram (ECG) within 28 days prior to Step 0 Pre-Registration, documenting:\n\n  * QT interval using Fridericia's correction (QTcF) \\\u003C 450 msec.\n  * Resting heart rate 50-90 beats per minute (determined from the ECG)\n* STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* STEP 0: Patient must not have comorbidities considered a safety risk for standard adjuvant chemotherapy, endocrine therapy or CDK4\u002F6 inhibitor as per Investigator's discretion\n* STEP 0: Patient must not have a contraindication to adjuvant chemotherapy based on treating physician's discretion\n* STEP 0: Patient must not have received prior chemotherapy for this malignancy\n* STEP 0: Patient must not have received prior CDK4\u002F6 inhibitor\n* STEP 0: Patient must not have a known contraindication to ribociclib per current Food and Drug Administration (FDA) indication\n* STEP 0: Patient must not have a known hypersensitivity to any of the excipients of ribociclib and\u002For endocrine therapy (ET) (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy)\n* STEP 0: Males must not expect to father children and males and their partners must be willing to use highly effective methods of contraception while on protocol treatment. Males must not donate sperm while on protocol treatment and for at least 12 weeks following the last dose of protocol treatment.\n\nHighly effective methods include the following:\n\n* Intrauterine device\n* Bilateral tubal occlusion\n* Vasectomized partner\n* Sexual abstinence If the highly effective contraceptive methods are contraindicated or strictly declined by the patient, or in the event of sexual activity of low frequency, a combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods) is also considered an acceptable birth control method. Local regulation\u002Fguidelines are to be followed with regard to highly effective birth control method, if more restrictive\n\n  * STEP 1: Patient must meet all Step 0 Pre-Registration eligibility criteria at the time of their Step 1 randomization\n  * STEP 1: Patient must not have had any major surgery or radiotherapy within 14 days prior to Step 1 randomization\n  * STEP 1: Patient must have a Recurrence Score (RS) of 0-25 from Oncotype DX testing from diagnostic biopsy or surgical specimen as reported by the Exact Sciences assay",{"count":54,"type":22},1978,[56],"PHASE3","This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.",[59,60,61,62,63],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Estrogen Receptor-Positive Breast Carcinoma","HER2-Negative Breast Carcinoma","RECRUITING",{"date":36,"type":37},{"date":67,"type":37},"2026-08-10",{"date":69,"type":22},"2029-07-31",{"name":71,"class":72},"National Cancer Institute (NCI)","NIH",140,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100629562","phase-2-symbiotic-lung-14-a-study-to-learn-about-the-study-medicine-called-pf08634404-in-combination-with-chemotherapy-in-adult-participants-with-transformed-small-cell-lung-cancer-100629562","NCT07476287","Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer","A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years at the time of informed consent.\n* Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).\n* Participants have not received systemic therapy for T-SCLC.\n* Have at least one measurable lesion as the target lesion based on RECIST v1.1.\n* Have sufficient tumor tissue from the diagnosis of transformed SCLC available.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a minimum life expectancy of \\>12 weeks.\n* Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \\\u003C1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula, including tumor necrosis\u002Fcavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula\n* History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)\n* Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)\n* History of allogeneic organ or hematopoietic stem cell transplantation\n* Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)\n* Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:\n\n  * Prior or current non-infectious pneumonitis requiring systemic therapy\n  * DLCO \\\u003C50% predicted\n  * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement\n* Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose\n* Baseline QTcF \\>480 msec\n* Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study\n* Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* History of significant bleeding disorders or recent major bleeding events\n* Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding\n* Active, uncontrolled, or symptomatic infection, including:\n\n  * Active TB\n  * Active hepatitis B or C\n  * Uncontrolled HIV infection\n* History of immunodeficiency\n* Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies\n* Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation\n* Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods\n* Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes\n* Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)\n* Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements",{"count":82,"type":22},40,[25],"This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.\n\nTo join the study, participants must meet the following conditions:\n\n* Are aged 18 years or older\n* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)\n* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)\n* Have healthy organs based on medical tests and are in good physical condition\n\nAfter joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[86,87,88,89,90,91],"Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Transformed Small Cell Lung Cancer","Lung Neoplasms","Carcinoma, Small Cell Lung","Small Cell Cancer Of The Lung",[88,86],"2026-08-14",{"date":95,"type":37},"2026-08-17",{"date":97,"type":37},"2026-07-02",{"date":99,"type":22},"2031-03-19",{"name":101,"class":102},"Pfizer","INDUSTRY",30,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100623150","phase-2-symbiotic-gi-16-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-gastroesophageal-cancer-100623150","NCT07392892","Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer","A PHASE 2\u002F3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA","Inclusion Criteria:\n\n* Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.\n* Evidence of locally advanced or metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* No prior systemic therapy for advanced or metastatic disease.\n* Adequate hepatic, liver, and renal function\n* HER-2 negative status based on local testing\n* PD-L1 positive status based on local testing\n\nExclusion Criteria:\n\n* Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":112,"type":22},840,[25,56],"This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\nBe 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.\n\nThe treatment will be given in repeated time periods called cycles.",[116,117,118,119],"Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma","Metastatic Gastric Cancer","Gastroesophageal Junction Cancer","Esophageal Adenocarcinoma",[121,122,123],"gastric cancer","gastroesophageal junction cancer","esophageal adenocarcinoma",{"date":95,"type":37},{"date":126,"type":37},"2026-05-14",{"date":128,"type":22},"2032-07-21",{"name":101,"class":102},74,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100610393","phase-2-symbiotic-lung-04-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-extensive-stage-small-cell-lung-cancer-100610393","NCT07226999","Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer","A GLOBAL PHASE 2\u002F3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n* Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.\n* Treatment-free for at least 6 months since last chemo\u002Fradiotherapy, among those treated (with curative intent) with prior chemo\u002Fradiotherapy for limited-stage SCLC\n* Have at least one measurable lesion as the targeted lesion based on RECIST V1.1.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula\n* history of another malignancy within 3 years\n* active autoimmune diseases requiring systemic treatment within the past 2 years",{"count":139,"type":22},550,[25,56],"This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have extensive-stage small cell lung cancer confirmed by lab tests.\n* Have not received chemotherapy or radiation for this type of lung cancer.\n* Be in good physical condition and have healthy organs based on medical tests.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better.\n\nParticipants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.",[143],"Small Cell Lung Cancer (SCLC)",[145,146,147],"small cell lung cancer","extensive stage small cell lung cancer","first-line",{"date":95,"type":37},{"date":150,"type":37},"2025-12-09",{"date":152,"type":22},"2034-03-11",{"name":101,"class":102},83,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":177,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100610070","phase-3-symbiotic-gi-03-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-metastatic-colorectal-cancer-100610070","NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":163,"type":22},800,[56],"The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[167,168,169,170,171,172,173,174,175,176],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Colorectal Neoplasms",[178,179,147,180,181],"mCRC","metastatic disease","metastatic colorectal cancer","colon cancer",{"date":95,"type":37},{"date":184,"type":37},"2025-12-11",{"date":186,"type":22},"2031-08-01",{"name":101,"class":102},308,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100625624","phase-2-cthpvdna-response-adapted-chemoradiation---retifanlimab-treatment-in-locally-advanced-anal-cancer-100625624","NCT07425054","ctHPVDNA Response-Adapted Chemoradiation +\u002F- Retifanlimab Treatment in Locally-Advanced Anal Cancer","ctHPVDNA Adapted ChemoRadiation +\u002F- Retifanlimab Treatment in Locally-Advanced Anal Cancer (CHART-AC)","CHART-AC","Inclusion Criteria:\n\n* Participants must have histologically proven stage T1-4N+M0 or T3-T4N0M0 anal canal or anal margin squamous cell carcinoma. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology. Special considerations include the following:\n\n  * Participants with excision of the primary tumor but with node positive disease or residual disease at the primary if T3-T4N0 will be eligible.\n* Age ≥18 years\n* ECOG performance status 0-2\n* Creatinine clearance \\>30 ml\u002Fmin by Cockcroft-Gault Equation.\n* HIV-infected participants are eligible if they meet the following eligibility criteria:\n\n  * A CD4 T-cell count \\>= 200\u002Fmm3 and a viral load \\\u003C 200 copies\u002Fmm3\n  * No history of AIDS-related complications within past year other than history of low CD4+ T-cell count (\\>200\u002Fmm3) prior to initiation of combination antiretroviral therapy.\n  * Participant must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer.\n  * Participant MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Participants will be eligible regardless of antiretroviral medication provided the regimen has been stable for at least 4 weeks.\n  * Participants must be PPD negative. Alternatively, the QuantiFERON-TB assay can be used. An individual is considered positive for M. tuberculosis infection if the IFN-γ response to TB antigens is above the test cut-off (after subtracting the background IFN-γ response in the negative control). The result must be obtained within 20 weeks prior to enrollment. PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment.\n* Tumor size must be documented based on physical examination including digital rectal exam and\u002For anoscopy\u002Fproctoscopy within 4 weeks prior to enrollment.\n* Staging imaging studies must include a PET scan AND either a CT with contrast of the abdomen\u002Fpelvis or an MRI with contrast of the pelvis. It is preferred that participants receive contrast. For participants with an allergy who cannot receive pre-medication, or any other reason they can't receive IV contrast, it is recommended that they undergo an MRI of the pelvis.\n* Participant must have no history of prior chemotherapy for anal cancer.\n* Participant must not have had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus. However, participants who undergo local excision or excisional biopsy are eligible provided there was tumor involvement of the anal canal and\u002For anal verge prior to the resection, if the margins were positive, and\u002For if the stage is T2N0 based on tumor size before the procedure. This means that participants with T1N0M0 anal margin squamous cell carcinoma who underwent surgical excision with negative margins and no involvement of the anal verge and\u002For anal canal are not eligible.\n* Participant must not be receiving any other standard anti-cancer therapy or experimental agent.\n* Participant must not have intercurrent illness including, but not limited to, ongoing or active infection or psychiatric\u002Fsocial situations that, in the judgement of the investigator, would limit compliance with study requirements.\n* Participant must not have had significant cardiovascular disease within 6 months prior to enrollment that has not been treated\u002Fcontrolled in the opinion of the treating investigators including myocardial infarction, unstable angina, stroke, transient ischemic attack, symptomatic coronary artery disease, symptomatic congestive heart failure, or uncontrolled cardiac arrhythmia.\n* Participant must not have a history of a different malignancy unless they are deemed by the investigator to be at low risk of recurrence.\n* Participants who are on anti-coagulation with warfarin within 2 weeks prior to enrollment must use an alternative anti-coagulant if planned to receive Capecitabine, otherwise, they must receive infusional 5-FU.\n\n  * NOTE: Low molecular weight heparin is permitted provided the participant's PT\u002FINR is \\\u003C 1.5. Participants who will received capecitabine and are on Dilantin for a seizure disorder must have Dilantin levels checked weekly.\n* Participants must have normal organ and marrow function as defined below:\n\n  * Hemoglobin ≥ 10.0 g\u002Fdl\n  * Platelet count ≥ 100,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Total bilirubin must be \\\u003C1.5 X institutional ULN OR conjugated bilirubin \\\u003C= institutional ULN if total bilirubin \\> 1.5 X ULN. Note that conjugated bilirubin only needs to be tested if total bilirubin \\>1.5 X ULN. Participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician.\n  * AST\u002FALT must be \\\u003C\u002F= 2.5 X institutional ULN (participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician).\n  * Albumin \\>\u002F= 3.0 g\u002FdL\n* Women must not be pregnant or breast-feeding because the study treatment may cause harm to an unborn fetus or breastfeeding child. A female of childbearing potential is defined as any woman, regardless of sexual orientation, or whether they have undergone a tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Women of childbearing potential and sexually active males must agree to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for at least six months after the completion of treatment.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Participants must have testing DPYD deficiency per institutional standards and must not be homozygous for DPYD deficiency.\n\nExclusion Criteria:\n\n* Any prior pelvic radiation or previous radiation that would result in overlapping radiation fields.\n* History of allergic reactions to compounds similar to capecitabine,\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator.\n* Participants with inflammatory bowel disease, scleroderma, or known homozygosity for DPYD deficiency.\n* Participants with a fistula between the tumor and invaded organ\n* Participant must not have active autoimmune disease or inflammatory bowel disease that has required systemic treatment in past 2 years\n* No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)\n* No participants with immunodeficiency or receiving systemic steroid therapy equivalent to \\> 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. Topical corticosteroid or occasional inhaled corticosteroids are allowed.\n* No live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.\n* Participants must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n* Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to retifanlimab.\n* Participants are excluded if known to be homozygous for Dihydropyrimidine Dehydronase",{"count":198,"type":22},33,[25],"This study is for people who have anal cancer and have not yet had treatment. The regular treatment for people who have anal cancer is chemoradiation therapy (CRT). CRT is when chemotherapy and radiation therapy are given at the same time. Studies show that CRT works well to treat anal cancer and prevents many people from needing surgery which may require a colostomy bag. Doctors know that CRT is an effective way to treat anal cancer. But, they are doing studies to find out how much dose of radiation and chemotherapy should be given during the CRT. Higher doses of chemotherapy and radiation could increase the risk of side effects, but lowering the dose of chemoradiation has the risk of not being as effective to treat the cancer. One way to predict whether participants need higher or lower doses of radiation therapy is to do a blood test called ctDNA (circulating tumor DNA) to test for the presence of human papillomavirus (HPV). This test is done at certain times while participants are getting CRT. This has been shown to be a marker for the presence of anal cancer.\n\nIn this study, doctors will tailor lower versus higher doses of CRT based on the tumor response that is measured by ctDNA. The purpose of this study is to see if customizing the dose of chemoradiation based on the amount of ctDNA will increase survival in participants with anal cancer and\u002For decrease the risk of side effects. Some participants in this study whose cancer does not respond as well to the CRT may have the opportunity to receive a drug called Retifanlimab that stimulates the body's immune system. Retifanlimab is approved by the Federal Drug Administration (FDA) for treating anal cancer that is recurrent or metastatic since there is proven benefit in these situations.",[202,203,204],"Anal Cancer","HPV-Related Carcinoma","Squamous Cell Carcinoma of the Anus",[206,207],"Chemoradiation","Retifanlimab","2026-08-13",{"date":93,"type":37},{"date":211,"type":37},"2026-06-19",{"date":213,"type":22},"2029-01",{"name":215,"class":44},"Jennifer Dorth",2,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":45},"100613129","phase-3-phase-iii-study-to-compare-gfh375-and-chemotherapy-in-patients-with-kras-g12d-mutant-metastatic-pancreatic-cancer-100613129","NCT07262567","Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer","A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety\u002FTolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form.\n* Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.\n* Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.\n* Have received at least one prior standard systemic therapy.\n* Participants must have at least one measurable lesion (per RECIST 1.1 criteria).\n* Expected survival time ≥ 12 weeks as judged by the investigator.\n* Have adequate organ function\n\nExclusion Criteria:\n\n* Other malignant tumors that progressed or required treatment within 3 years prior to randomization.\n* With active central nervous system (CNS) metastasis.\n* Previous receipt of therapy targeted for KRAS G12D or pan-RAS\u002FKRAS.\n* Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.\n* Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.\n* With clinically significant severe cardiovascular diseases.\n* Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.\n* Complicated with major acute or chronic infectious diseases.\n* Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.\n* Pregnant or lactating females.\n* Other conditions deemed inappropriate for participation in the study by the investigator.",{"count":225,"type":22},320,[56],"This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.",[229],"Metastatic Pancreatic Cancer",{"date":93,"type":37},{"date":232,"type":37},"2025-12-04",{"date":234,"type":22},"2028-06",{"name":236,"class":102},"Genfleet Therapeutics (Shanghai) Inc.",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":45},"100532883","phase-2-pilot-trial-of-fecal-microbiota-transplantation-for-lymphoma-patients-receiving-axicabtagene-ciloleucel-therapy-100532883","NCT06218602","Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.","Inclusion Criteria:\n\n1. At least 18 years of age on the day of signing informed consent.\n2. Histologically\u002Fcytologically confirmed diagnosis of B-cell lymphomas.\n3. Is being planned to received FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel.\n4. Participants must have received or is receiving high-risk broad-spectrum antibiotics for minimum of two days within 180 days of scheduled Axicabtagene ciloleucel infusion. High-risk broad-spectrum antibiotics include carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam.\n5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the date of signing study consent.\n6. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n7. Absolute neutrophil counts should be greater than 1000\u002Ful at the time of administration of fecal enema.\n8. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 ≤ x the upper limit of normal (ULN)\\[except if Gilberts syndrome and then total bilirubin ≤ 3x is allowed\\], an AST, level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN. If liver metastases are present, then AST and ALT levels must be ≤ 4 x ULN\n9. Adequate renal function defined by an estimated creatinine clearance \\>30 mL\u002Fmin according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection.\n10. Highly effective contraception for both male and female subjects if the risk of conception exists. Highly effective contraception must be used 30 days prior to first study-drug administration, for the duration of trial treatment, and for at least for 12 months after treatment for females and 4 months after treatment for males. Should a female patient (or male participant's sexual partner) become pregnant or should either the female patient (or male participant's partner) suspect she is pregnant while the participant's study-participation is ongoing, the treating physician should be informed immediately.\n\nExclusion Criteria:\n\n1. If participant received major surgery within last 4 weeks, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n2. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n3. Has a diagnosis of primary immunodeficiency (excluding IgA deficiency).\n4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the study subject's best interest to participate, in the opinion of the treating investigator.\n5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n6. Pregnant or nursing women\n7. For women of childbearing age, a serum pregnancy test will be required within 72 hours prior to enrollment. If the serum test is positive, patient will not be allowed to enroll in the trial.\n8. Participants with history of irritable bowel disease and inflammatory bowel disease will be excluded from clinical trial.\n9. Participants with difficulties in oral administration or at risk of aspiration (e.g., neurological issues)",{"count":82,"type":22},[25],"To find out if adding treatment with fecal microbiota transplantation (FMT) is effective at treating gut-related side effects of antibiotic treatment in participants who are receiving standard therapy with anti-CD19 chimeric antigen receptor T-cell (CAR-T cell) therapy.",[247],"Lymphoma",{"date":95,"type":37},{"date":250,"type":37},"2024-02-19",{"date":252,"type":22},"2028-08-01",{"name":254,"class":44},"M.D. Anderson Cancer Center",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100385693","phase-2-a-study-of-multiple-therapies-in-biomarker-selected-participants-with-resectable-stages-ib-iii-non-small-cell-lung-cancer-nsclc-100385693","NCT04302025","A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)","NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer","NAUTIKA1","Inclusion Criteria for Neoadjuvant Therapy:\n\n* Pathologically documented NSCLC:\n* Newly diagnosed early-stage NSCLC stages IB, IIA, IIB, IIIA, or selected IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the American Joint Committee on Cancer (AJCC)\u002FUnion Internationale Contre le Cancer (UICC) NSCLC staging system\n* T4 primary NSCLC will be allowed only on the basis of size. Invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, and separate tumor nodules in a different ipsilateral lobe is not permitted\n* All participants will undergo clinical staging using computed tomography (CT) and positron emission tomography (PET) scanning, as well as brain imaging using magnetic resonance imaging (MRI). Invasive mediastinal staging by either mediastinoscopy or endo-bronchial ultrasonography is highly encouraged for participants with radiographically suspected mediastinal nodal disease (i.e., N2) but not mandated if the CT or PET scans showed no evidence of N2 disease\n* Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1\u002F2\u002F3 fusion; BRAF V600 mutation, RET fusion, PD-L1 expression in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation\n* Measurable disease, as defined by RECIST v1.1\n* NSCLC must have a solid or subsolid appearance on CT scan and cannot have a purely ground glass opacity appearance. For subsolid lesions, the tumor size (i.e., clinical T stage) should be measured based on the solid component only, exclusive of the ground glass opacity component\n* Evaluated by the attending surgeon prior to study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and verify that the participant is medically operable\n* Adequate pulmonary function to be eligible for surgical resection with curative intent\n* Adequate cardiac function to be eligible for surgical resection with curative intent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hematologic and end-organ function\n* Negative hepatitis B surface antigen (HBsAg) test at screening for cohort\n* Negative total hepatitits B core antibody (HBcAb) test at screening for cohort, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test at screening\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening\n* Male participants must be willing to use acceptable methods of contraception\n* Female participants of childbearing potential must agree to use acceptable methods of contraception\n\nInclusion Criteria for Adjuvant Therapy (TKI Cohorts and KRAS G12C cohort \\[if continuing on Divarasib\\]):\n\n* Participants whose tumors lack radiographic progression\n* ECOG Performance Status of 0 or 1\n* Adequate hematologic and end-organ function\n\nExclusion Criteria\n\n* NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease\n* Any prior therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 2 years\n* Participants with prior lung cancer\n* Major surgical procedure within 28 days prior to Cycle 1, Day 1\n* Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of participants with a negligible risk of metastasis or death and with expected curative outcome\n* Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1\n* Participants known to be positive for human immunodeficiency virus (HIV) are excluded if they meet any of the following criteria: cluster of differentiation 4 (CD4)+ T-cell count of \\\u003C350 cells\u002Fmicroliters (cells\u002FµL); detectable HIV viral load; history of an opportunistic infection within the past 12 months; on stable antiretroviral therapy for \\\u003C4 weeks\n* Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact participant safety\n* Pregnant or lactating, or intending to become pregnant during the study",{"count":264,"type":22},99,[25],"This trial will evaluate the efficacy and safety of various therapies in participants with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors that meet protocol-specified biomarker criteria.",[268],"Non-small Cell Lung Cancer",{"date":270,"type":37},"2026-08-11",{"date":272,"type":37},"2020-11-06",{"date":274,"type":22},"2030-05-30",{"name":276,"class":102},"Genentech, Inc.",38,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":216},"100598689","a-digital-treatment-platform-for-the-delivery-of-home-based-sequential-therapy-in-patients-with-glioma-ghost-trial-100598689","NCT07074756","A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma, GHoST Trial","MC240703 Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of glioma and intention to treat with either new or ongoing systemic therapy for at least 6 months.\n\n  * NOTE: Patient may be enrolled following completion of surgery and\u002For radiation therapy for newly diagnosed or recurrent tumor.\n  * NOTE: Any number of prior recurrences is permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60\n* Expected survival ≥ 6 months in the opinion of treatment team\n* Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations\n* Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only\n\n  * Exception: Not required if patient is already on treatment. May be obtained prior to next treatment as needed per clinical care\n* Provide written informed consent\n* Ability to complete assessments and questionnaires by themselves or with assistance\n* SUBSTUDY 1: Enrolled in GHoST Master Protocol per eligibility criteria of the master study and clinically appropriate to proceed with bevacizumab treatment at the discretion of the treating physician\n* SUBSTUDY 1: Diagnosis of recurrent glioblastoma and intention to treat with bevacizumab\n\n  * NOTE: Any number of prior recurrences is permitted\n  * NOTE: Prior limited use of bevacizumab for radiation necrosis\u002Ftreatment related edema is permitted. Prior use should not exceed four infusions with the last dose administered ≥ 4 weeks prior to enrollment in this substudy\n* SUBSTUDY 1: Willing and able to adhere to the substudy for the duration of the substudy including undergoing treatment, and attending scheduled visits, and examinations\n* SUBSTUDY 1: Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only\n* SUBSTUDY 1: Provide written informed consent\n* SUBSTUDY 1: Ability to complete assessments and questionnaires by themselves or with assistance\n\nExclusion Criteria:\n\n* Pregnant or nursing, imprisoned, or lacking capacity for understanding\n* Uncontrolled and\u002For intercurrent illness or other condition which limits safety of or compliance with study proceedings\n* SUBSTUDY 1: Pregnant or nursing, imprisoned, or lacking capacity for understanding\n* SUBSTUDY 1: Uncontrolled and\u002For intercurrent illness or other condition which limits safety of or compliance with study proceedings",{"count":286,"type":22},202,[288],"NA","This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while addressing a great health disparity in patients with glioma.",[291,292,293],"Glioma","Recurrent Glioma","Recurrent Glioblastoma","2026-08-06",{"date":67,"type":37},{"date":297,"type":37},"2025-09-12",{"date":299,"type":22},"2028-08-31",{"name":301,"class":44},"Mayo Clinic",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100577852","a-study-of-bgb-b455-in-adults-with-advanced-or-metastatic-solid-tumors-100577852","NCT06803680","A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors","A Phase 1, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B455 in Patients With Selected Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer) will be enrolled in dose escalation cohorts, starting from Protocol Amendment 3.0.\n* Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.\n* Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.\n* ≥ 1 measurable lesion as assessed by RECIST v1.1.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese \\[or other country\\] patent medicines, ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).\n* Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).\n* Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\n* Any major surgical procedure ≤ 28 days before the first dose of study drug(s).\n* History of prior ≥ Grade 3 cytokine release syndrome (CRS).\n* Participants with toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":310,"type":22},90,[312],"PHASE1","The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.\n\nThe main questions it aims to answer are:\n\n* What is the recommended dosing for BGB-B455?\n* What medical problems do participants have when taking BGB-B455?\n\nThe study has two parts:\n\n* Phase 1a: dose escalation and safety expansion\n* Phase 1b: dose expansion",[315,316],"Advanced Solid Tumor","Metastatic Solid Tumor",[318,319,320,321,322,323,324,325],"Claudin-6","CLDN6+","advanced or metastatic solid tumor","CD3","BsAb","bispecific antibody","CD3-BsAb","CLDN",{"date":67,"type":37},{"date":328,"type":37},"2025-03-18",{"date":330,"type":22},"2028-04-29",{"name":332,"class":102},"BeOne Medicines",12,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":359},"100572300","study-of-tdxd-chemotherapy-pembrolizumab-and-trastuzumab-in-first-line-metastatic-her2-positive-gastric-or-gastroesophageal-junction-cancer-100572300","NCT06731478","Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)","Inclusion Criteria\n\n1. Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and\u002For adjuvant setting is permissible, provided there is \\>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.\n\n   Note: Prior use of IO (ie, anti-PD-1\u002FPD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \\>6 months between the end of IO therapy and the diagnosis of recurrent disease.\n4. Centrally determined HER2-positive (IHC 3+ or IHC 2+\u002FISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.\n\n   Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.\n5. Centrally determined tumor PD-L1 CPS using the PD-L1 assay:\n\n   * For the Main Cohort: PD-L1 CPS ≥1\n   * For the Exploratory Cohort: PD-L1 CPS \\\u003C1\n6. All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.\n7. At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n8. LVEF ≥50% within 28 days before randomization.\n\nExclusion Criteria\n\n1. Prior exposure to other HER2-targeting therapies (including ADCs).\n2. Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.\n3. Known total or partial DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions\u002Fcountries where DPD testing is SoC and with unknown DPD status. For regions\u002Fcountries where DPD testing is not SoC, local practice should be followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.\n4. Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.\n5. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n6. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on the average of the screening triplicate 12-lead ECG.\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n8. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).",{"count":342,"type":22},726,[56],"This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \\\u003C1 gastric or GEJ cancer.",[346,118],"Gastric Cancer",[348,349,30,350,351],"Enhertu","Trastuzumab Deruxtecan","DS-8201a","HER2 positive",{"date":67,"type":37},{"date":354,"type":37},"2025-02-27",{"date":356,"type":22},"2030-02-01",{"name":358,"class":102},"Daiichi Sankyo",250,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":216},"100554589","contact-radiotherapy-for-rectal-cancer-100554589","NCT06501053","Contact Radiotherapy for Rectal Cancer","Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial","CORRECT","Inclusion Criteria:\n\n* Adenocarcinoma of the rectum classified as:\n* cT1-cT3ab, \\\u003C 5 cm largest diameter and \\\u003C ½ circumference (MRI staging), N0-N1 (\\\u003C= 3 nodes \\\u003C 8mm diameter), M0\n* Performance status (ECOG) 0-1\n* Operable patient\n* Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm\n* 18 years or above\n* No comorbidity preventing treatment\n* Patient having read the information note and having signed the informed consent\n* Follow-up possible\n\nExclusion Criteria:\n\n* Inoperable patient\n* T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference\n* Distance from the lower tumor border to the anal verge \\>10 cm\n* N2-status at diagnosis or N1 with any node\\>= 8 mm diameter\n* Patient presenting with metastasis at diagnosis (M1)\n* Previous pelvic irradiation\n* Tumor with extramural vascular invasion\n* Poorly differentiated tumor\n* Simultaneous progressive cancer\n* Tumor invading external anal sphincter or growth within 1 mm of the levator\n* Tumor within 1 mm from MRF (mesorectal fascia)\n* Patient unable to receive CXB or CRT\n* Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy\n* Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol\n* Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment\n* Total DPD deficiency",{"count":369,"type":22},110,[288],"The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).",[373],"Rectal Cancer",[375,376,377,378],"organ sparing","brachytherapy","radiotherapy","nonoperative",{"date":67,"type":37},{"date":381,"type":37},"2025-03-03",{"date":383,"type":22},"2032-11",{"name":385,"class":44},"Alexander Valdman",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":130},"100615487","phase-2-a-study-of-targeted-post-surgery-radiation-therapy-for-non-small-cell-lung-cancer-with-remaining-lymph-node-cancer-after-treatment-100615487","NCT07293247","A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment","Involved-Station, Intensity-Modulated Post-Operative Radiation Therapy (I²-PORT) for Resected Non-Small Cell Lung Cancer With Residual Mediastinal Adenopathy After Neoadjuvant Therapy (ypN2)","* Histopathologic diagnosis of NSCLC, may have mixed or multiple histologies but no small cell component\n* No known EGFR mutation or ALK rearrangement\n* No metastatic disease (M0) per most recent PET\u002FCT and head CT\u002FMRI imaging\n* No disease progression per CT chest (including upper abdomen as per standard practice) with intravenous (IV) contrast (unless IV contrast is contraindicated) or FDG-PET performed post-neoadjuvant therapy ≤ 90 days prior to registration, either before or after surgery\n* No metastatic disease (M0) per head CT\u002FMRI imaging\n* Prior treatment with 2-4 cycles of neoadjuvant systemic therapy with any guideline (National Comprehensive Cancer Network \\[NCCN\\]) concordant regimen\n* Lobectomy or greater oncologic surgical resection within 8 weeks prior to registration\n* Complete (R0) resection showing ypN2 disease\n* No prior radiotherapy to the lungs or mediastinum\n* No treatment with a VEGF inhibitor ≤ 90 days prior to registration or plan to treat with adjuvant systemic therapy including a VEGF inhibitor\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n* Platelet count ≥ 50,000\u002Fmm\\^3\n* Calculated (Calc.) creatinine clearance ≥ 30 mL\u002Fmin\n* Total bilirubin ≤ 3 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 x upper limit of normal (ULN)\n* Not pregnant, because this study involves radiation therapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Cardiac function: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No idiopathic pulmonary fibrosis requiring anti-fibrotic medication: Patients with idiopathic pulmonary fibrosis or inflammatory\u002Finterstitial lung disease compromising pulmonary function or requiring ongoing treatment with nintedanib, pirfenidone, or other anti-fibrotic drug are excluded\n* HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial",{"count":394,"type":22},164,[25],"This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.",[398],"Lung Non-Small Cell Carcinoma","2026-08-04",{"date":401,"type":37},"2026-08-05",{"date":403,"type":22},"2026-07-14",{"date":405,"type":22},"2032-03-01",{"name":407,"class":44},"Alliance for Clinical Trials in Oncology",{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":428},"100490978","phase-3-testing-the-addition-of-total-ablative-therapy-to-usual-systemic-therapy-treatment-for-limited-metastatic-colorectal-cancer-the-erasur-study-100490978","NCT05673148","Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study","A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma\n* PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor\n* PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation\n* PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and\u002For omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants\n* PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible\n* PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy.\n\n  * Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.\n  * Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study.\n  * Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and\u002For stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility.\n  * Single sites include:\n\n    * Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field\n* PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1\n* PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration\n* REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration\n* REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined\n* REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1\n* REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months)\n* REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease\n* REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.\n\n  \\* Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 14 days prior to registration is required\n* REGISTRATION (STEP 1): Age \\>= 18 years\n* REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2\n* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* REGISTRATION (STEP 1): Platelet count \\>= 50,000\u002Fmm\\^3\n* REGISTRATION (STEP 1): Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \\>= 30 mL\u002Fmin\n\n  \\* Calculated using the Cockcroft-Gault equation\n* REGISTRATION (STEP 1): Total bilirubin =\\\u003C 1.5 x ULN\n* REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x ULN\n\n  \\* In the event of metastatic liver disease, =\\\u003C 5 x ULN\n* REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility\n* REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study\n\nExclusion Criteria:\n\n* N\u002FA",{"count":416,"type":22},364,[56],"This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and\u002For oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and\u002For microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.",[420,421],"Metastatic Colorectal Adenocarcinoma","Stage IV Colorectal Cancer AJCC v8",{"date":401,"type":37},{"date":424,"type":37},"2023-10-09",{"date":426,"type":22},"2032-08-12",{"name":407,"class":44},187,{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":23,"phases":438,"briefSummary":439,"conditions":440,"keywords":444,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":45},"100374167","petct-changes-during-chemoimmunotherapy-and-radiation-therapy-in-patients-with-stage-iv-non-small-cell-lung-cancer-100374167","NCT04151940","PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer","An Interventional Study of PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)","Inclusion Criteria:\n\n* Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer \\[AJCC\\]\u002FUnion for International Cancer Control \\[UICC\\] 8th edition for staging)\n* Evidence of stage IV disease on imaging by CT, PET\u002FCT, or magnetic resonance imaging (MRI)\n* Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor\n* Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion\n* Subjects must be ≥ 18 years of age\n* Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Creatinine =\\\u003C 2 mg\u002FdL or creatinine clearance \\> 50 mL\u002Fmin\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5x institutional upper limit of normal\n* Total bilirubin =\\\u003C 1.5 mg\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (\\>= 1500 per mm\\^3)\n* Platelet count \\>= 100 x 10\\^9\u002FL (\\>=100,000 per mm\\^3)\n* Capability to understand and comply with the protocol requirements and signed informed consent documents\n\nExclusion Criteria:\n\n* Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed \\>= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)\n* Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms\n* Has any serious or uncontrolled active infection that could create false positives on a PET\u002FCT scan, in the opinion of the treating investigator\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)\n\n  \\*\\*Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has known, active, and symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n\n  * Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day",{"count":437,"type":22},80,[288],"This study investigates the changes in positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET\u002FCT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.",[441,442,443],"Metastatic Lung Non-Small Cell Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8",[445],"Lung",{"date":294,"type":37},{"date":448,"type":37},"2019-09-26",{"date":450,"type":22},"2027-11-30",{"name":452,"class":44},"University of Washington",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":462,"phases":4,"briefSummary":463,"conditions":464,"keywords":466,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":45},"100639117","negativelow-hormone-receptor-and-apocrine-lobular-invasive-breast-carcinoma---a-real-world-international-cohort-study-100639117","NCT07613151","Negative\u002FLow Hormone Receptor and APOcrine Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study","NAPOLI: Negative\u002FLow Hormone Receptor and APOcrine Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study","NAPOLI","Inclusion Criteria:\n\n* Female or male patients aged ≥18 years;\n* Histologically confirmed ILC, confirmed by E-cadherin loss\u002Faberrant expression and\u002For p120 cytoplasmic relocalization and\u002For CDH1 alteration;\n* HR-negative (ER \\\u003C1% and PR \\\u003C1%) or HR-low (ER and\u002For PR 1-10%) disease, as defined by ASCO\u002FCAP guidelines, is eligible regardless of HER2 status (assessed according to 2025 ASCO\u002FCAP criteria, with HER2-low and HER2-ultralow status recorded where assessable);\n* HR-positive (ER\\>10% according to the ASCO\u002FCAP guidelines) ILC is eligible only if HER2 status is positive;\n* Mixed ductal-lobular carcinomas are eligible provided that a clearly identified invasive lobular component is present and predominant (\\>50% lobular) and HR-negative\u002Flow criteria are met;\n* Stage I-III disease at diagnosis; Patients with de novo stage IV disease who underwent surgery of the primary tumor will not be included in the main study cohort but may be captured in a separate exploratory cohort for dedicated analysis;\n* Patients who underwent surgery of the primary tumor at the participating institution, either upfront or after neoadjuvant systemic treatment;\n* Diagnosis occurred between 1 January 2000 and 31 December 2025;\n* Minimum follow-up of 12 months for patients without an event, unless recurrence or death occurred earlier;\n* Local review by a dedicated breast pathologist to confirm the diagnosis and the related molecular features, with particular attention to the confirmation of apocrine morphology.\n\nExclusion Criteria:\n\n* Pure IC NST without any lobular invasive component;\n* ER or PR expression \\>10% in the invasive component, in cases with negative HER2 status;\n* In situ lobular neoplasia (lobular carcinoma in situ) without an invasive component;\n* De novo stage IV disease (such patients, if they underwent surgery of the primary tumor, will be captured in a separate exploratory cohort for a dedicated analysis)\n* Synchronous invasive BC of another dominant histology requiring systemic treatment that precludes attribution of outcomes to HR-negative\u002Flow ILC;\n* Prior invasive BC under active systemic treatment at the time of diagnosis, unless clearly documented as unrelated and not expected to confound outcomes;\n* Insufficient data or follow up",{"count":359,"type":22},"OBSERVATIONAL","The NAPOLI Study is a retrospective multicenter observational study designed to characterize hormone receptor-negative\u002Flow invasive lobular carcinoma of the breast. The study will collect real-world clinicopathological, molecular, therapeutic and outcome data from patients diagnosed and treated at participating centers. The aim is to describe the clinical behavior, pathological features, receptor profile, treatments received and oncologic outcomes of this rare breast cancer subtype.",[465],"Lobular Breast Carcinoma",[467,468,469],"Breast","Cancer","Lobular Neoplasia","2026-08-03",{"date":294,"type":37},{"date":473,"type":37},"2026-05-01",{"date":475,"type":22},"2027-12-31",{"name":477,"class":44},"Istituto Oncologico Veneto IRCCS",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":492,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":45},"100523072","phase-1-atlcarcd30ccr4-for-cd30-hl-atlcarcd30ccr4-cells-100523072","NCT06090864","ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells","The Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed\u002FRefractory CD30+ Hodgkin s Lymphoma","During the period of cell procurement and lymphodepletion, subjects will be eligible to receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests. Eligibility must be maintained up until the subject is procured, receives lymphodepletion, or receives treatment for the subject to be considered eligible to proceed with the specific phase of the study.\n\nInclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study. As these criteria are unchanging they will be evaluated at the time of initial enrollment and not continuously throughout the study.\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria.\n\nExclusion Criteria:\n\n1. Subjects had major surgery within 28 days.\n2. Subject received investigational agents or tumor vaccines within 3 weeks.\n3. Subject received chemotherapy or radiation therapy within the previous 3 weeks.",{"count":21,"type":22},[312,25],"Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity.\n\nThe majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib\u002FII study was conducted based on these observations.\n\nThe purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further.\n\nThis is a single-center, open-label phase Ib\u002FII trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma.\n\nSubjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.",[489,490,491],"Hodgkin Lymphoma","Relapse","Refractory",[493,494],"cellular therapy","CD30+",{"date":294,"type":37},{"date":497,"type":37},"2024-04-25",{"date":499,"type":22},"2033-07-01",{"name":501,"class":44},"UNC Lineberger Comprehensive Cancer Center",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":523},"100580106","phase-1-evaluating-the-safety-tolerability-pharmacokinetics-pharmacokinetics-and-preliminary-efficacy-of-fs-8002-100580106","NCT06832982","Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002","A Single-arm, Open Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients with advanced solid tumors confirmed by histology or cytology who have failed or become intolerant to previous standard treatments, or who do not have a standard treatment regimen. Cohort 1 includes patients with advanced solid tumours confirmed by histology\u002Fcytology\u002Fimaging (limited exclusively to HCC), who have experienced treatment failure with standard therapy, are intolerant to it, or lack standardized therapeutic options; however enrollment allows unresectable\u002Fmetastatic HCC patients without prior systemic anti-cancer therapies; Cohort 2 comprises locally advanced\u002Funresectable\u002Fmetastatic gastric\u002Fgastroesophageal junction adenocarcinoma (G\u002FGEJA) patients confirmed via histological\u002Fcytological diagnosis whose initial line of immunotherapy combined with fluoropyrimidine + platinum-based chemotherapy has failed - excluding cases where the last administration occurred more than six months before recurrence during adjuvant\u002Fneoadjuvant settings;\n2. According to the evaluation criteria of RECIST V1.1 or RANO 2.0 (GBM only), at least one measurable lesion is required: the selected target lesion has not been treated previously locally, or the selected target lesion is located in the previous local treatment area, but is determined to be disease progression through imaging investigation;\n3. The subject has sufficient organ and bone marrow function;\n\nExclusion Criteria:\n\n1. Patients who have previously received TGF-β inhibitor therapy. previous treatment with bevacizumab or other VEGF or VEGFR-targeted drugs (only for patients with GBM);\n2. Have received any experimental drug treatment within 4 weeks prior to the first administration of the investigational drug;\n3. Have used any systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first administration of the study drug, including systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (small molecule targeted drugs are within 2 weeks before the first administration), systemic immunomodulators (including but not limited to IFN, IL-2 and tumor necrosis factor \\[TNF\\]). Received Chinese herbal or proprietary Chinese medicines with anti-tumor effects within 2 weeks before the first administration;For patients with GBM: less than 12 weeks from the end of previous radiotherapy (unless the progressing lesion is located outside the high-dose zone or 80% isodose line irradiation field, or there is pathological evidence), less than 24 days from the last TMZ treatment, or less than 6 weeks from the last carmustine treatment;\n4. Have used or are currently using aspirin (≥ 325 mg\u002Fday) or other anti-platelet aggregation drugs such as clopidogrel, dipyridamole, ticlopidine, and cilostazole, or full-dose anticoagulants or thrombolytics within 2 weeks prior to the first administration of the study drug;\n5. Those who have received major surgical treatment or significant traumatic injury within 4 weeks before the first administration of the study drug, or those who have a history of fistula, gastrointestinal perforation, or tumor invasion of large blood vessels within 6 months before the first administration; or those who have intestinal obstruction during the screening period;",{"count":510,"type":22},66,[312],"this is a single-arm, open phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacokinetics, and preliminary efficacy of FS-8002 and combination therapy in patients with advanced solid tumors",[514],"Advanced Solid Tumors","2026-08-02",{"date":399,"type":37},{"date":518,"type":37},"2025-02-24",{"date":520,"type":22},"2028-02-19",{"name":522,"class":102},"Shanghai Pushi Medical Science Co. Ltd",10,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":45},"100598985","phase-2-a-cancer-vaccine-stemvac-in-combination-with-chemotherapy-for-the-treatment-of-pd-l1-negative-metastatic-triple-negative-breast-cancer-100598985","NCT07078604","A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer","A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* Patients must be at least ≥ 18 years of age\n\n  * Note: Because no dosing or adverse event (AE) data are currently available on the use of STEMVAC in patients \\\u003C 18 years of age, children and adolescents are excluded from this study, but will be eligible for future pediatric trials, if applicable\n* Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status Score of ≤ 2\n* Histologically confirmed triple-negative breast cancer\n\n  * Tumors with estrogen receptor (ER)-low (≤ 5%) or negative and progesterone receptor (PR)-low (≤ 5%) or negative will be included\n  * HER2-negative or HER2-low will be defined by the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) 2023 \"Human Epidermal Growth Factor Receptor 2 (HER2) Breast Testing Guideline Update\" which reaffirms the 2018 \"HER2 Breast Testing Guideline Focused Update\"\n* Tumor is negative for PD-L1 marker testing per standard of care immunohistochemistry 22C3 pharmDx assay\n* Metastatic disease that is measurable based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Have at least 1 site of disease confirmed by the treating oncologist that could be biopsied during treatment. Lesions that will be biopsied should not be in a previously irradiated area unless progression has been demonstrated in such lesions\n* Patients can not have received any prior cancer immunotherapy in the metastatic setting\n* Prior Food and Drug Administration (FDA)-approved antibody drug conjugates are allowed\n* Patients are appropriate candidates to receive standard of care chemotherapy as per treating oncologist's clinical judgement\n* Patients who have received prior neoadjuvant or adjuvant chemotherapy are allowed\n* A minimum of 14 days washout since last systemic therapy or any palliative radiotherapy is required\n* Treatment with a bisphosphate or denosumab concurrently with protocol-specific therapy is allowed while on study (it is not exclusionary)\n* Patients must be at least 28 days post systemic steroids prior to enrollment, unless this is a steroid administered concurrently with chemotherapy or used as part of prophylaxis to prevent intravenous (IV) contrast reactions\n* Must have recovered from major infections and\u002For surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment\n* Willing to undergo up to two serial biopsies while on study\n* White blood cell (WBC) ≥ 2.5 THOU\u002FuL (Within 28 days of receiving first study vaccine)\n* Lymphocyte count ≥ 0.5 THOU\u002FuL (Within 28 days of receiving first study vaccine)\n* Absolute neutrophil count (ANC) ≥ 1.0 THOU\u002FuL (Within 28 days of receiving first study vaccine)\n* Hemoglobin (Hgb) ≥ 9 g\u002FdL (Within 28 days of receiving first study vaccine)\n* Platelets ≥ 75 THOU\u002FuL (Within 28 days of receiving first study vaccine)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be \\\u003C 3.0 mg\u002Fd (Within 28 days of receiving first study vaccine)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (Within 28 days of receiving first study vaccine)\n* Creatinine ≤ 1.5 x ULN mg\u002FdL or creatinine clearance \\> 60 mL\u002Fmin (Within 28 days of receiving first study vaccine)\n* Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a person of child-bearing potential. Acceptable methods of contraception are abstinence, condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study until the end of treatment on study\n\nExclusion Criteria:\n\n* Patient has received more than one line of prior therapy in metastatic setting\n* Patients with tumors that are PD-L1-positive per standard of care immunohistochemistry 22C3 pharmDx assay\n* Enrollment in a concurrent interventional clinical trial. Biomarker or tissue collection or any other non-interventional clinical trial enrollment is allowed. Participation in a trial for chimeric antigen receptor (CAR)-T cell therapy may be permitted if the CAR-T cell therapy is not planned to occur until after the currently proposed treatment (i.e. no longer participating in STEMVAC and chemotherapy trial)\n* Patients with any of the following cardiac conditions:\n\n  * Symptomatic restrictive cardiomyopathy\n  * Dilated cardiomyopathy\n  * Unstable angina within 4 months prior to enrollment\n  * New York Heart Association functional class III-IV heart failure on active treatment\n  * Symptomatic pericardial effusion\n* Patients with any autoimmune disease or comorbidities that require chronic systemic steroids or immunosuppressants. Patients with conditions requiring inhaled, intranasal or topical steroids are permitted\n* Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF\n* A non-breast malignancy requiring radiation or systemic therapy within last 5 years or any B-cell malignancy (e.g., chronic lymphocytic leukemia or follicular lymphoma) under active surveillance\n* Pregnant and breastfeeding individuals\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive), or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n* Major surgery within the 4 weeks prior to initiation of study vaccine\n* Must be 14 days between a non-study vaccine, including live attenuated and non-live vaccines and any STEMVAC vaccination\n\n  * Note: The minimum of 14 days does not apply to the tetanus and diphtheria (Td) vaccine\n* Any condition that may interfere with the patient's participation in the study per treating physician",{"count":532,"type":22},20,[25],"This phase II trial studies how well a cancer vaccine called STEMVAC works in combination with chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.",[536,537],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Triple-Negative Breast Carcinoma","2026-07-31",{"date":399,"type":37},{"date":541,"type":37},"2026-03-24",{"date":543,"type":22},"2028-06-30",{"name":452,"class":44},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":552,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":559,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":45},"100589029","phase-2-tumor-local-excision-postoperative-adjuvant-chemoradiotherapy-for-t1-2n0m0-lowultra-low-rectal-cancer-100589029","NCT06949098","Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low\u002FUltra-Low Rectal Cancer","An Exploratory Study of Local Resection Combined With Chemoradiotherapy in Patients With Low\u002FUltra-low Early-stage Rectal Cancer With a Strong Desire to Preserve the Anus","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender\n2. ECOG performance status 0-1\n3. Biopsy-proven rectal adenocarcinoma\n4. Distal margin of primary tumor ≤8 cm from anal verge\n5. Clinical stage I (cT1-2N0M0)\n6. Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation)\n7. The surgeon determined a local resection was feasible\n8. No contraindications to chemoradiotherapy\n\nExclusion Criteria:\n\n1. Failure to meet the above inclusion criteria\n2. Patients refusing to sign informed consent\n3. Impaired cognitive function or psychiatric disorders\n4. Patients deemed ineligible by investigators","75 Years",{"count":554,"type":22},60,[25],"This study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low\u002Fultra-low rectal cancer. The study plans to enroll 60 patients with T1-2N0M0 low\u002Fultra-low rectal cancer.",[558],"Rectal Cancer Stage I",[560,561,562,563],"Adjuvant Chemoradiotherapy","Local excision","Low\u002Fultra-low rectal cancer","Early rectal cancer",{"date":470,"type":37},{"date":566,"type":37},"2025-05-15",{"date":568,"type":22},"2032-05",{"name":570,"class":44},"Hebei Medical University Fourth Hospital",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":591,"locationsCount":592},"100561923","phase-1-a-study-of-bg-c477-in-participants-with-advanced-solid-tumors-100561923","NCT06596473","A Study of BG-C477 in Participants With Advanced Solid Tumors","A Multicenter, Open-Label, Phase 1a\u002Fb First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must sign the informed consent form (ICF) and be capable of giving written informed consent\n* Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy\n* Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator\n* Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy\n* Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease\n* ≥ 1 measurable lesion as assessed by RECIST v1.1\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477, for ≥ 6 months after the last dose of chemotherapy, and for ≥ 4 months after the last dose of tislelizumab,whichever comes later\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, for ≥ 3 months after chemotherapy, and for ≥ 4 months after the last dose of tislelizumab, whichever comes later.\n\nExclusion Criteria:\n\n* Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload\n* History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":579,"type":22},310,[312],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.",[514],[584,585,586],"BG-C477","advanced solid tumors","CEA ADC",{"date":470,"type":37},{"date":589,"type":37},"2024-10-03",{"date":475,"type":22},{"name":332,"class":102},58,{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":607,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":622},"100419847","phase-3-study-on-the-efficacy-of-treatment-by-radiotherapy-and-pembrolizumab-in-newly-diagnosed-metastatic-head--neck-cancers-100419847","NCT04747054","Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers","Randomized Trial of Loco-regional Radiotherapy Added to Pembrolizumab Alone or With Chemotherapy Versus Systemic Treatment Alone for Patients With Newly Diagnosed Head and Neck Squamous Cell Carcinoma With Synchronous Metastases","PembroMetaRT","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent form prior to any study specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n2. Histologically confirmed squamous cell carcinoma of head and neck (oral cavity, oropharynx, hypopharynx, and larynx) including unknown primary head and neck lymph nodes with distant metastases at presentation (T1-4 N0-3 M1). Histological confirmation is required in case of a single metastatic lesion.\n3. Eligible for treatment by pembrolizumab according to the European Marketing Authorization\n4. Patient ≥18 years old\n5. Performance status: 0-1 (WHO)\n6. Combined Positive Score (CPS) ≥1 for primary tumor (as determined per local practice)\n7. Subjects must have at least one measurable lesion as per RECIST v1.1 to assess efficacy\n8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization:\n\n   a. If randomization is done before treatment start: i. Absolute neutrophil count ≥1.5 × 10⁹\u002FL ii. Platelet ≥100 × 10⁹\u002FL iii. Hemoglobin ≥90 g\u002FL iv. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT), ≤3 × upper limit of normal (ULN), (unless documented liver metastases where ≤5 x ULN is permitted) v. Bilirubin ≤1.5 × ULN. vi. Serum albumin ≥25 g\u002FL vii. Creatinine clearance ≥30 mL\u002Fmin (calculated per institutional guidelines or by Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula) viii. Corrected serum calcium of ≤11.5 mg\u002FdL or ≤2.6 mmol\u002FL. b. If randomization if done after treatment start i. Absolute neutrophil count ≥1.0 × 10⁹\u002FL ii. Platelet ≥75 × 10⁹\u002FL iii. Hemoglobin ≥85 g\u002FL\n9. Patient must agree to use adequate contraception methods for the duration of the study treatment and up to 4 months after the last dose of pembrolizumab administration\n10. Patients must be affiliated to a Social Security System (or equivalent)\n11. No disease progression during systemic treatment if the randomization is done after the start of pembrolizumab for the current disease\n\nExclusion Criteria:\n\n1. Symptomatic central nervous system (CNS) metastases and \u002F or carcinomatous meningitis\n2. History of another malignancy within 2 years prior to study inclusion, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma\n3. Prior radiotherapy in the head and neck region\n4. Any prior or current non-surgical treatment for invasive head and neck cancer. (except for pembrolizumab +\u002F- chemotherapy for the current cancer for a maximum of 6 cycles). This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, chemotherapy, anti-PD-1\u002FPD-L1 and CTLA-4, prior radiotherapy (RT), or use of any investigational agent. Loco-regional recurrent or second primary head and neck cancer after prior surgical treatment alone in the head and neck region could be eligible.\n5. Known Acquired Immune Deficiency Syndrome (AIDS)\n6. Known currently active infection including hepatitis B or hepatitis C\n7. Patient having received live attenuated vaccine within 28 days prior to enrolment\n8. Pregnant or breast feeding woman\n9. Active autoimmune disease except vitiligo, type-1 diabetes, hypothyroid stabilized with hormonal substitution, or psoriasis which do not require systemic treatment\n10. Active immunodeficiency or ongoing immunosuppressive therapy\n11. Active symptomatic interstitial lung disease\n12. Significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial\n13. Any social, personal, medical, geographic and\u002For psychologic factor(s) that could interfere with the observance of the patient to the protocol and\u002For the follow-up and\u002For the signature of the informed consent\n14. Prior organ transplantation including allogenic stem-cell transplantation\n15. Other severe acute or chronic medical conditions including colitis, pneumonitis, pulmonary fibrosis or psychiatric conditions including active suicidal ideation; or laboratory abnormalities that may increase the risk associated with study participation and, in the judgment of the investigator, would make the patient inappropriate for entry into this study\n16. Person deprived of their liberty or under protective custody or guardianship\n17. Patient who have taken any investigational medicinal product or have used an investigational device within 30 days prior to study inclusion",{"count":602,"type":22},102,[56],"Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \\& neck cancers",[606],"Squamous Cell Carcinoma of Head and Neck",[608,609,610,611,612,613],"Metastatic","Radiotherapy","pembrolizumab","Squamous Cell Carcinoma","Head and Neck","Carcinoma","2026-07-30",{"date":538,"type":37},{"date":617,"type":37},"2021-12-01",{"date":619,"type":22},"2029-10-01",{"name":621,"class":44},"UNICANCER",26,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":630,"minAge":18,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":637,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":650},"100594671","phase-3-study-of-trastuzumab-deruxtecan-versus-standard-of-care-chemotherapy-for-her2-expressing-ihc-32-endometrial-cancer-100594671","NCT07022483","Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+\u002F2+) Endometrial Cancer","A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+\u002F2+) Endometrial Cancer (DESTINY-Endometrial02\u002F GOG-3122\u002F ENGOT-en30\u002FGINECO)","Key Inclusion Criteria\n\n* Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old)\n* Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed).\n* Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage IIC includes disease with aggressive histological types (aggressive histological types are composed of high-grade EECs (grade 3), serous, clear cell, undifferentiated, mixed, mesonephric-like, gastrointestinal mucinous type carcinomas, and carcinosarcomas) with any myometrial involvement. FIGO 2023 Stage III includes disease with local and\u002For regional spread of the tumor of any histological subtype.\n* Has HER2-expression (IHC 3+\u002F2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing.\n* Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory.\n\nKey Exclusion Criteria\n\n* Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.\n* Has recurrent or FIGO 2023 Stage IV\n* Has measurable residual tumor after surgery as determined by BICR assessment.\n* Is known to have a POLE mutation from an approved and\u002For validated local test, according to local regulations, if available\n* Has a medical history of MI within 6 months before randomization\u002Fenrollment, symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR Period to rule out MI.\n* Has a QTcF prolongation to \\> 480 msec based on average of the SCR triplicate12-lead ECG. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.\n* Has a history of (noninfectious) ILD\u002Fpneumonitis that required corticosteroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at SCR.","FEMALE",{"count":632,"type":22},710,[56],"This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.",[636],"Endometrial Cancer",[638,639,640,641],"endometrial cancer","cancer","T-DXd","HER2","2026-07-27",{"date":644,"type":37},"2026-07-28",{"date":646,"type":37},"2025-09-30",{"date":648,"type":22},"2032-03-23",{"name":358,"class":102},75,""]