[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,587,0,25,[9,47,78,113,145,165,200,226,259,281,303,327,353,381,393,414,434,452,463,503,526,549,578,648,672],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054198","phase-3-a-study-to-access-intravenous-iv-telisotuzumab-adizutecan-in-combination-with-iv-bevacizumab-compared-to-standard-of-care-iv-bevacizumabin-combination-with-oral-trifluridine-and-tipiracil-in-adult-participants-with-refractory-metastatic-colorectal-cancer-100054198",false,"NCT07525206","A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer","An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)\u002F Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.\n* Life expectancy \\>= 12 weeks per investigator assessment\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent.\n* History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine\u002Ftipiracil.\n* History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.","ALL","18 Years",{"count":21,"type":22},700,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC).\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally.\n\nIn this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine\u002Ftipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[28],"Colorectal Cancer",[28,30,31,32,33],"Telisotuzumab Adizutecan","Bevacizumab","Trifluridine and Tipiracil","AndroMETa-CRC-560","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-05-22",{"date":42,"type":22},"2030-03",{"name":44,"class":45},"AbbVie","INDUSTRY",16,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100053279","a-study-of-mental-health-care-in-people-with-cancer-100053279","NCT06037954","A Study of Mental Health Care in People With Cancer","Mental Health Care Initiation Intervention for Older Adults With Cancer","Inclusion Criteria:\n\nPatients\n\n* Per medical record and\u002For self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older\n* Per medical record and\u002For self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment\n* Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9)\n* Per self-report, fluent in English\\*\\* \\*\\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study:\n\n  1. How well do you speak English? (must respond \"very well\" or \"well\" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)\n  2. What is your preferred language for healthcare? (must respond English)\n\nProviders\n\n* Per self-report, works in oncology, nursing, social work, psychology, or psychiatry\n* Per self-report, currently works in oncology at least 50% of the time\n* Per self-report, provided cancer care for at least three years at time of consent\n* Per self-report, fluent in English\n\nExclusion Criteria:\n\nPatients\n\n* Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11\n* Per research staff judgment and\u002For self-report, too ill or weak to complete study procedures\n* Per medical record and\u002For self-report, receiving hospice care at the time of enrollment\n* Per medical record and\u002For self-report, currently enrolled in mental health treatment\n\nProviders\n\n* N\u002FA","65 Years",{"count":56,"type":22},130,[58],"NA","The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.",[61,28,62,63],"Breast Cancer","Lung Cancer","Prostate Cancer",[65,66,67],"65 years and older","Mental health care","23-218","2026-07-09",{"date":37,"type":38},{"date":71,"type":38},"2023-09-07",{"date":73,"type":22},"2026-09",{"name":75,"class":76},"Memorial Sloan Kettering Cancer Center","OTHER",1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100053828","phase-1-evaluation-of-xya02-in-patients-with-advanced-solid-tumors-100053828","NCT07670312","Evaluation of XYA02 in Patients With Advanced Solid Tumors","A Phase 1b\u002F2, Multicenter, Non-randomized, Open-label, Multiple Dose First- In-Human Study of XYA02 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Signed informed consent form(s) (ICFs) obtained at Screening.\n2. Has an eligible relapsed\u002Frefractory tumor with measurable disease based on RECIST 1.1 at Screening.\n3. Age ≥18 years at Screening and confirmed at the discretion of the Investigator.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at Screening.\n5. Platelet (PLT) count ≥100,000\u002FmcL at Screening.\n6. Hemoglobin ≥9.5 g\u002FdL without packed red blood cells (RBCs) transfusion within 14 days prior to Screening.\n7. Absolute neutrophil count (ANC) ≥1,500\u002FmcL at Screening.\n8. Estimated creatinine clearance (CrCl) \\>60 mL\u002Fmin at Screening. Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN) at Screening.\n\n10\\. Total bilirubin ≤1.5 × ULN at Screening; in patients with a documented history of Gilbert syndrome ≤3 × ULN.\n\n11\\. At least 28 days from treatment with monoclonal antibody-based therapies at Screening.\n\n12\\. At least 5 half-lives from treatment with chemotherapy and small molecule inhibitors at Screening. 13. At least 28 days from experimental therapies not covered above at Screening.\n\n14\\. At least 28 days from radiation to more than 30% of the bone marrow or a wide field of radiation at Screening. Radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study drug is acceptable. (In case of patients treated with radiotherapy, previously irradiated lesions should not be considered a target lesion on computed tomography \\[CT\\] unless evidence of regrowth\u002Fdisease progression has been documented.) 15. At least 28 days from major surgery or significant trauma with recovery of AEs to NCI-CTCAE Grade 1 or baseline at Screening.\n\n16\\. Availability of archival tissue or, if unavailable, will be willing to undergo a tumor biopsy if a low-risk biopsy procedure is feasible at Screening. 17. Has a life expectancy of ≥ 3 months at Screening.\n\nAdditional Inclusion Criteria for Phase 1 (Dose Escalation and Backfill):\n\n18\\. Has pathologically documented advanced, relapsed, or refractory NSCLC (non-squamous), ovarian (high grade serous), gastric\u002Fesophageal\u002FGEJ adenocarcinoma, or CRC at Screening. 19. Patient must have progressed on, have relapsed after, be refractory to, or be intolerant of at least 1 prior systemic therapy, without available subsequent standard of care and have no satisfactory alternative treatment options. No more than 4 prior lines of systemic therapy for advanced, relapsed, or refractory disease in NSCLC and ovarian and no more than 3 prior lines of systemic therapy in gastric\u002Fesophageal\u002FGEJ adenocarcinoma or CRC (excluding adjuvant chemotherapy).\n\nAdditional Inclusion Criteria for Phase 2 (Dose Expansion):\n\n20\\. Cohorts for 5 different prioritized tumor types and 1 basket cohort that are advanced\u002Funresectable or metastatic at Screening according to the following criteria:\n\n1. Cohort 2A: NSCLC non-squamous. Histologically confirmed locally advanced or metastatic NSCLC (non-squamous) that have relapsed after or are refractory to platinum-doublet based chemotherapy and\u002For immune checkpoint inhibitor (in combination or sequential). Patients with EGFR or anaplastic lymphoma kinase (ALK) mutations should have been treated with appropriate targeted therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy and\u002For immunotherapy).\n2. Cohort 2B: Ovarian. Histologically confirmed advanced or metastatic high-grade serous ovarian cancer that have relapsed after or are refractory to at least 1 prior line of chemotherapy and have no other satisfactory treatment options. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy or maintenance regimen).\n3. Cohort 2C: Gastric\u002Fesophageal\u002FGEJ adenocarcinoma. Histologically confirmed advanced or metastatic gastric, esophageal or GEJ adenocarcinoma that have relapsed after or are refractory to at least 1 prior line of therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n4. Cohort 2D: CRC. Histologically confirmed advanced or metastatic CRC that have relapsed after or are refractory to at least 1 prior line of therapy. BRAF mutated patients are excluded. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n5. Cohort 2E: Pancreatic cancer. Histologically confirmed locally advanced or metastatic pancreatic cancer that have relapsed after or are refractory to at least 1 prior systemic treatment regimen. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n6. Cohort 2F: Tumor agnostic. Histologically confirmed advanced or metastatic solid tumors other than ones in Cohorts 2A to 2E that have relapsed after treatment without available subsequent standard of care. The tumor indications in this group will be selected based on data from phase 1 and preclinical data.\n\nExclusion Criteria:\n\n1. Has been refractory (did not have a tumor response) to previous treatment with a topoisomerase 1 (TOP1) inhibitor antibody-drug conjugate, at the discretion of the investigator.\n2. Has a medical history of symptomatic congestive heart failure (CHF; New York Heart Association \\[NYHA\\] classes II-IV), prior documented left ventricular ejection fraction (LVEF) \\\u003C 50%, or serious cardiac arrhythmia requiring treatment at Screening and at the discretion of the Investigator.\n3. Has a clinically significant medical history of myocardial infarction or unstable angina within 6 months before Screening at the discretion of the Investigator.\n4. Has a QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 millisecond (ms) in males and \\> 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate performed at Screening.\n5. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at Screening at the discretion of the Investigator.\n6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals at Screening at the discretion of the Investigator.\n7. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at Screening. If known history of hepatitis, active hepatitis B infection is defined as hepatitis B surface antigen (HbsAg) positive or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive; and active hepatitis C infection is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) positive.\n8. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days before Screening.\n9. Male and female patients who are unwilling to use contraceptive methods at Screening (eg, concomitant use of a spermicidal agent and barrier contraceptive, intrauterine contraceptive during the study and for at least 7 months after the last dose of XYA02).\n10. Has clinically active brain metastases, defined as untreated and symptomatic, or requires therapy with steroids or anticonvulsants to control associated symptoms at Screening and at the discretion of the Investigator. Note: Patients with untreated asymptomatic brain metastases may be included in the study if they do not require radiotherapy treatment or surgical treatment, do not require treatment with steroids, and there are no untreated brain lesions \\> 20 mm in size.\n11. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, lymphopenia) not yet resolved to NCI-CTCAE Grade ≤ 1 or baseline at Screening. Patients with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator (eg, peripheral neuropathy, endocrinopathies).\n12. Has a concomitant medical condition that would increase the risk of toxicity at Screening.\n13. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product at Screening.\n14. Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer at Screening.",{"count":86,"type":22},190,[88,89],"PHASE1","PHASE2","This study will evaluate the safety, tolerability, and efficacy of XYA02 in participants with advanced solid tumors.",[92,93,94,95,28,96],"MUC1-expressing Advanced, Relapsed and\u002For Refractory Solid Tumors","Non-Small Cell Lung Cancer","Ovarian Cancer","GEJ Adenocarcinoma","Pancreatic Adenocarcinoma",[98,99,93,100,101,102,103],"MUC-1","solid tumor","Ovarian","GEJ adenocarcinoma","Colorectal","Pancreatic","NOT_YET_RECRUITING",{"date":37,"type":38},{"date":107,"type":22},"2026-07-15",{"date":109,"type":22},"2030-07-15",{"name":111,"class":45},"XYone Therapeutics, Inc",5,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":129,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100605991","phase-1-a-study-to-investigate-alep03-as-monotherapy-in-adult-patients-with-selected-advanced-or-metastatic-cldn1-solid-tumors-100605991","NCT07169734","A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","A Phase I\u002FII, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","Inclusion Criteria:\n\n* Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.\n* Have documented radiological disease progression at study entry.\n* Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.\n\nPhase I Dose Escalation:\n\n\\- Received and being refractory\u002Fintolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.\n\nPhase I RDE and Phase II:\n\n* Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.\n* Patients with actionable oncogenic drivers: received feasible targeted therapy.\n\nApplicable for Phase I Dose Escalation, Phase I RDE and Phase II:\n\n* Measurable disease per RECIST 1.1, as determined by the site.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.\n* Demonstrate adequate bone marrow and organ function as per the protocol.\n\nExclusion Criteria:\n\n* SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has a history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and\u002For immunosuppressive therapies.\n* Has clinically significant gastrointestinal bleeding.\n* Has an active infection requiring systemic treatment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.",{"count":121,"type":22},180,[88,89],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.",[125,126,28,127,128],"Cervical Squamous Cell Carcinoma","Squamous Non-small-cell Lung Cancer","Intrahepatic Cholangiocarcinoma","Urothelial Carcinoma",[130,131,132,133,134],"Claudin-1 Targeted Antibody-Drug Conjugate","Monotherapy","First-in-Human","Recommended Phase 2 dose","Recommended dose for expansion","2026-07-01",{"date":137,"type":38},"2026-07-02",{"date":139,"type":38},"2025-08-26",{"date":141,"type":22},"2029-10-04",{"name":143,"class":45},"Alentis Therapeutics AG",41,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100474909","phase-1-anti-ceacam5-adc-m9140-in-advanced-solid-tumors-proceade-crc-01-100474909","NCT05464030","Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)","A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)","Inclusion Criteria:\n\n* Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant\u002Frefractory to or progressed after standard systemic therapies for the advanced\u002Fmetastatic stage, if locally indicated and available to the participant. Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1\n* Participants with adequate hematologic, hepatic and renal function as defined in protocol\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm\u002Fhypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)\n* Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)\n* Participants with diarrhea (liquid stool) or ileus Grade \\> 1\n* Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and\u002For bowel obstruction\n* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] \\>= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of \\> 470 milliseconds (ms)\n* Cerebrovascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment)\n* Other protocol defined exclusion criteria could apply",{"count":153,"type":22},200,[88],"The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2)\n\nStudy details include:\n\n* Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2\n* M9140 is not available through an expanded access program",[28],{"date":137,"type":38},{"date":159,"type":38},"2022-08-04",{"date":161,"type":22},"2026-10-23",{"name":163,"class":45},"EMD Serono Research & Development Institute, Inc.",35,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":183,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":77},"100427519","phase-1-individual-response-to-hyperthermic-intraperitoneal-chemotherapy-hipec-treatment-of-peritoneal-carcinomatosis-from-peritoneal-mesothelioma-or-atypical-mesothelial-proliferation-or-from-ovarian-colorectal-or-appendiceal-histologies-100427519","NCT04847063","Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies","Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Primaries","* INCLUSION CRITERIA:\n* Confirmation of peritoneal carcinomatosis from peritoneal mesothelioma or atypical mesothelial proliferation, or from appendiceal, colorectal, or ovarian, histologies by the Laboratory of Pathology, NCI.\n* Measurable or evaluable disease as defined by RECIST v1.1. criteria and\u002For by peritoneal carcinomatosis index (PCI) score.\n* Participants must be assessed to be able to undergo optimal cytoreduction (i.e., completeness of cytoreduction score of 1 or 0) with laparoscopically assessed PCI score threshold as indicated below:\n\n  * Primary Histology: Appendiceal\u002FColorectal\u002FOvarian \u002F PCI Cutoff for Eligibility: Total Score \\\u003C 20 (out of 39 possible points)\n  * Primary Histology: Mesothelioma or atypical mesothelial proliferation \u002F PCI Cutoff for Eligibility: Total Score \\\u003C= 30 (out of 39 possible points)\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 1 (Karnofsky \\>= 80%).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count \\>= 1,000\u002FmcL\n  * Platelets \\>= 75,000\u002FmcL\n  * Total bilirubin within \\\u003C=1.5x institutional upper limit of normal (ULN)\n  * AST (SGOT)\u002F ALT (SGPT) \\\u003C= 3x institutional upper limit of normal (ULN), or \\\u003C= 5.0x ULN in participants with liver metastases (only)\n  * Creatinine within normal institutional limits\n\nOR\n\n--Creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal calculated using eGFR.\n\n* Because therapeutic agents used in this trial are known to be teratogenic, individuals of child-bearing potential (IOCBP) and individuals who are able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 180 days after last study treatment.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of the participant to co-enroll on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors .\n\nEXCLUSION CRITERIA:\n\n* Participants with known extra-abdominal metastatic disease from the participant s appendiceal, colorectal, ovarian, or peritoneal mesothelioma primary.\n* Participants who have received intraperitoneal chemotherapy or other anti-cancer therapy within the last 4 weeks prior to the start of study treatment.\n* Participants who have undergone major surgery within the last 12 weeks prior to the start of study treatment.\n* History of allergic reactions attributed to platinum-containing compounds.\n* History of dihydropyrimidine dehydrogenase deficiency (only participants with appendiceal or colorectal cancer).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant individuals are excluded from this study because the protocol involves major abdominal surgery and chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Note: Due to an unknown but potential risk for adverse events in nursing infants secondary to treatment of the participant, nursing (including breastfeeding) should be discontinued if the participant is undergoing treatment (i.e., nursing participants must agree to discontinue nursing activities).\n* HIV-positive participants with detectable viral load despite antiretroviral therapy are ineligible because of participants increased risk of lethal infections when treated with marrow-suppressive therapy. HIV-positive participants who have undetectable viral load on antiretroviral therapy may be considered for this study only after consultation with a NIAID physician.","120 Years",{"count":174,"type":22},60,[88],"Background:\n\nCytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen. CRS with HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve the results of CRS with HIPEC treatment on these tumors by choosing the chemotherapy drugs used in HIPEC.\n\nObjective:\n\nTo see if HIPEC after CRS can be improved, using either a model called the SMART (Sustained Microenvironment for Analysis of Resected Tissue) System or using 3-D cell culture (organoid) models, in order to test different chemotherapy drugs on tumors that were surgically removed prior to HIPEC treatment (these models are not attached to the body) versus tumors that were treated with HIPEC while still inside the body before being immediately surgically removed.\n\nEligibility:\n\nAdults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nElectrocardiogram (EKG)\n\nComputed tomography (CT) scan\n\nOther imaging scans, as needed\n\nTumor biopsy, if needed\n\nLaparoscopy (small cuts are made in the abdomen, and a tube with a light and a camera is used to see the organs in the abdomen), if needed\n\nParticipants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research.\n\nSome screening tests may be repeated in the study.\n\nParticipants will have CRS. As many of their visible tumors will be removed as possible during surgery except for a few specific tumors left to receive the HIPEC treatment. Then they will receive HIPEC and the remaining tumors will be immediately removed. Participants will be in the hospital for 7-21 days after this surgery (CRS with HIPEC).\n\nParticipants will give tumor, fluid samples (from the abdomen during surgery), blood, saliva, cheek swab, and stool for research. They will complete surveys about their health and quality of life.\n\nParticipants with peritoneal mesothelioma (mesothelioma primary only) will have genetic (DNA) testing to determine clinical (CLIA level) germline BAP1 status for research use.\n\nParticipants will have follow-up visits for up to 5 years from CRS with HIPEC.\n\nIf there is disease progression, participants may have CRS with HIPEC again. Participants will then have follow-up visits for up to 5 years from the date of last CRS with HIPEC.\n\n...",[178,179,94,180,181,182,28],"Peritoneal Mesothelioma","Peritoneal Carcinomatosis","Gastrointestinal Cancer","Appendiceal Cancer","Atypical Mesothelial Proliferation",[184,185,186,187,188,189,190,191],"cytoreduction","organoid model","cell culture model","SMART System","Peritoneal Metastasis","necrosis","Ki-67","cytoreductive surgery (CRS)",{"date":137,"type":38},{"date":194,"type":38},"2021-10-19",{"date":196,"type":22},"2034-12-30",{"name":198,"class":199},"National Cancer Institute (NCI)","NIH",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":222,"leadSponsor":224,"locationsCount":77},"100643558","early-phase-1-glp-1-ra-plus-soc-treatment-in-first-line-metastatic-pancreatic-colorectal-or-hepatocellular-cancer-100643558","NCT07627191","GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer","GLP-1 Receptor Agonist Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer","Inclusion Criteria:\n\n* Histological or cytological diagnosis of pancreatic adenocarcinoma or colorectal adenocarcinoma. Previous tumor tissue testing is acceptable. Please refer to the \"additional HCC cohort criteria\" below.\n* The subject has disease that is not amenable to curative-intent management (e.g., oligometastatic disease)\n* Measurable disease per RECIST v1.1 as determined by the investigator\n* Patients must be appropriate candidates for first-line, SOC treatment.\n\n  * SOC treatment as defined by NCCN® guidelines or institutional standard is allowable, however, options restricted to:\n\n    * Colorectal: FOLFOX or FOLIFIRI +\u002F- bevacizumab\n    * Pancreatic: mFOLFIRINOX\n    * HCC: Tremelimumab\u002FDurvalumab\n  * Patients are eligible who received prior perioperative chemotherapy for curative intent treatment and recurred ≥ 6 months since last dose of chemotherapy.\n* ≥ 18 years old on day of consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate archival frozen or fixed tissue available from primary or metastatic site for genotypic analysis (at least 15 unstained slides and\u002For tumor block)\n* Adequate hematologic and organ function laboratory values as follows:\n\n  * The ANC ≥ 1500\u002Fmm3 without colony stimulating factor support;\n  * Platelets ≥ 75,000\u002Fmm3;\n  * Hemoglobin ≥ 9 g\u002FdL;\n  * Bilirubin ≤ 1.5 ´ the ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL;\n  * Serum albumin ≥ 2.8 g\u002Fdl;\n  * ALT and AST ≤ 3.0 ´ ULN;\n  * Serum creatinine ≤ 1.5 ´ ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:\n\n    * Male: CrCl (mL\u002Fmin) = (140 - age) × wt (kg) \u002F (serum creatinine × 72);\n    * Female: Multiply above result by 0.85;\n* The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document\n* Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control or practice abstinence during the study and for 4 months after the last dose of study drug(s);\n\nAdditional Inclusion Criteria for HCC Cohort ONLY:\n\n* Histologically or radiologically confirmed hepatocellular carcinoma (per AASLD\u002FEASL criteria)\n* Unresectable or advanced HCC not amenable to curative surgery or locoregional therapy.\n* Barcelona Clinic Liver Cancer (BCLC) stage B or C.\n* Child-Pugh Score Class A; or Child-Pugh Class B7 or B8 at discretion of treating physician\n* Patients with HBV infection, characterized by positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibodies (anti-HBcAb) with detectable HBV deoxyribonucleic acid (DNA) (≥10 IU\u002FmL or above the limit of detection per local or central lab standard), must be treated with antiviral therapy, as per institutional practice to ensure adequate viral suppression (HBV DNA \\\u003C2000 IU\u002FmL) before enrolment. Patients must remain on antiviral therapy for the duration of their participation in the EAP and for 6 months after the last dose of EAP medication. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (\\\u003C10 IU\u002FmL or under the limit of detection per local or central lab standard) do not require anti-viral therapy before enrolment. These participants will be tested at every cycle to monitor HBV DNA levels and initiate anti-viral therapy if HBV DNA is detected (≥10 IU\u002FmL or above the limit of detection per local or central lab standard). HBV DNA detectable patients must initiate and remain on anti-viral therapy for time they are on the EAP and for 6 months after the last dose of EAP medication.\n\n  o Note: Testing required for subjects with a known history otherwise not required.\n* Patients with HCV infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon enrolment (management of this disease is per local institutional practice).\n\nExclusion Criteria\n\n* The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) for metastatic and\u002For unresectable disease.\n* BMI \\\u003C 25 kg\u002Fm2\n* For colorectal cancer only - Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) tumors.\n* For colorectal cancer only - BRAF V600E mutant tumors.\n* A personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).\n* A prior hypersensitivity reaction to semaglutide or any of the excipients in WEGOVY®. Serious hypersensitivity reaction, including anaphylaxis and angioedema, have been reported with WEGOVY®.\n* Cachexia\n* Subjects on insulin.\n* Subjects with a history of diabetic retinopathy\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  o Cardiovascular disorders including:\n  * For patients being considered for bevacizumab (or bevacizumab biosimilar) only:\n* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;\n* thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (eg, vena cava filter) within 6 months before the first dose of study treatment.\n\n  * Any of the following within 6 months before the first dose of study treatment:\n* unstable angina pectoris;\n* clinically-significant cardiac arrhythmias;\n* stroke (including transient ischemic attack (TIA), or other ischemic event);\n* myocardial infarction;\n\n  * GI disorders particularly those associated with a high risk of perforation or fistula formation including:\n\n    * Unresolved abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess.\n    * Uncontrolled nausea, vomiting, or abdominal pain.\n  * Other clinically significant disorders that would preclude safe study participation\n* Major surgery within 8 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n* Females who are known or suspected to be pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test result within screening.\n* Female patients planning on becoming pregnant while on study.\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment.\n* Male subjects unwilling to abstain from donating sperm during treatment.\n* Inability to comply with self-administration of GLP-1 RA subcutaneous injections.\n* Subject has known sensitivity to any of the products or components to be administered during dosing.\n* Concurrent use of other semaglutide containing products or any other GLP-1 receptor agonist.\n* Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.\n* Subject likely to not be available to complete all protocol-required study visits or procedures and\u002For to comply with all required study procedures to the best of the subject and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.\n\nAdditional Exclusion Criteria for HCC Cohort ONLY:\n\n* Child-Pugh Score Class B9; or Child-Pugh Class C\n* Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of EAP treatments.\n* History of allogenic organ transplantation (e.g., liver transplant).\n* History of hepatic encephalopathy within the past 12 months or requirement for medications to prevent or control encephalopathy (e.g., no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy.\n* Clinically meaningful ascites, defined as any ascites requiring non-pharmacologic intervention (e.g., paracentesis) to maintain symptomatic control, within 2 months before the first EAP treatment dose. Patients on stable doses of diuretics for ascites for ≥2 months are eligible.\n* Patients with main portal vein thrombosis (i.e., thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging.\n* Active or previously documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[except for diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). Patients without active disease in the last 5 years are excluded unless discussed with the Treating Physician and considered appropriate for EAP participation. The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients with celiac disease controlled by diet alone\n* Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV). HBV positive (presence of HbsAg and\u002For anti-HBcAb with detectable HBV DNA); HCV positive (presence of anti-HCV antibodies); HDV positive (presence of anti-HDV antibodies).\n\n  o Note: Testing required for subjects with a known history otherwise not required.\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* History of active primary immunodeficiency.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of EAP treatment. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as pre-medication for hypersensitivity reactions (e.g., CT scan pre-medication)\n* Receipt of live attenuated vaccine within 30 days before first dose of treatment. Note: patients, if enrolled, should not receive live vaccine while receiving study treatment, and up to 30 days after the last dose of study treatment.\n* Previous randomization or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n* Patients who have received anti-PD-1, anti-PD-L1, or anti-CTLA-4 before the first dose of EAP treatment.","99 Years",{"count":209,"type":22},30,[211],"EARLY_PHASE1","There is a growing number of patients diagnosed with gastrointestinal cancers who are also simultaneously being treated with GLP-1 Receptor Agonists (RA)s. To date, no clinical trial data exists to establish safety and\u002For feasibility with use of GLP-1 RAs during chemotherapy in the metastatic setting. The goal of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and correlative analyses of combining GLP-1 RAs with standard chemotherapy in patients with metastatic pancreatic, colorectal, or hepatocellular cancers in the first-line setting.",[214,28,215],"Pancreatic Cancer","Hepatocellular Carcinoma",[217,218],"GLP1 receptor agonists","gastrointestinal cancer","2026-06-30",{"date":137,"type":38},{"date":35,"type":22},{"date":223,"type":22},"2028-06-30",{"name":225,"class":76},"University of Arizona",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":77},"100614605","phase-2-capecitabineoxaliplatin-chemotherapy-and-cemiplimab-with-or-without-fianlimab-or-regn7075-in-locally-advanced-rectal-cancer-100614605","NCT07281768","Capecitabine\u002FOxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer","Combining Capecitabine\u002FOxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Age ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.\n* Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.\n* Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.\n* Must not have received any prior systemic treatment or radiation.\n* Candidate for sphincter-sparing surgical resection after neoadjuvant therapy according to the primary surgeon.\n* Patients have the following clinical staging:\n\n  * cT2 node-positive:\n  * T: Tumor is invading the muscularis propria but has not grown through it to the serosa\n  * N: At least 1 perirectal lymph node ≥5 mm and no more than 4 perirectal lymph nodes \\>10 mm in short axis\n  * M: No evidence of metastasis\n  * cT3 node-negative\n  * T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs\n  * N: No perirectal lymph nodes ≥ 5 mm in size that suggest tumor involvement\n  * M: No evidence of metastasis\n  * cT3 node-positive\n  * T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs\n  * N: At least 1 perirectal lymph node ≥ 5 mm and no more than 4 perirectal lymph nodes \\> 10 mm in size in short axis\n  * M: No evidence of metastasis\n* Absence of distant metastases on CT or MRI imaging\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.\n* LVEF assessment with documented LVEF ≥ 50% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.\n* Have expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).\n* History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason.\n* Currently using any chronic systemic steroids.\n* History of severe hypersensitivity reaction to any monoclonal antibody.\n* History of encephalitis, meningitis, dementia, Parkinson's or uncontrolled seizures within 1 year prior to the first dose of study drug.\n* Uncontrolled infection of HIV, HBV, HCV, or Tuberculosis.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active autoimmune disease.\n* Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.\n* Patient has a pulse oximetry of \\\u003C92% on room air.\n* Patient is on supplemental home oxygen.\n* Has clinically significant heart disease.\n* Troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline.\n* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.\n* Patient is pregnant or breastfeeding.\n* Unwilling or unable to follow the study schedule for any reason.\n* Patient received a live vaccine within 30 days of planned start of study medication.\n* Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.\n* Patients with T4 disease or N2 disease (as defined by \\>\u002F= 4 lymph nodes, each greater or equal to 10 mm in short axis).\n* Evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or endorectal ultrasound or pelvic CT scan.\n* Patients with symptomatic untreated bowel obstruction due to rectal cancer.",{"count":234,"type":22},66,[89],"The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab\u002Ffianlimab, or cemiplimab\u002FREGN7075 with capecitabine\u002Foxaliplatin (CAPOX) for the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer (T2 node-positive, T3 node-negative, T3 node-positive).",[28],[239,240,241,242,243,244,245,246,247,248,249,250,251],"Rectal Cancer","Cemiplimab","Fianlimab","REGEN7075","Oxaliplatin","Capecitabine","Immunotherapy","Anti-PD-1 (Programmed Death-Ligand 1)(protein immune checkpoint)","PD-L1 (Programmed Death-Ligand 1)(protein immune checkpoint)","Adenocarcinoma","Carcinoma","CAPOX","Chemotherapy",{"date":135,"type":38},{"date":254,"type":22},"2026-07",{"date":256,"type":22},"2030-07",{"name":258,"class":76},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100599051","phase-2-comparing-18f-fapi-pet-guided-abdominal-radiotherapy-combined-with-second-line-standard-therapy-and-cadonilimab-versus-second-line-standard-therapy-in-colorectal-cancer-with-peritoneal-metastasis-100599051","NCT07079462","Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis","A Prospective Randomized Controlled Study Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis","Inclusion Criteria:\n\n* 1\\. Age of 18 years or older. 2. Peritoneal metastasis of colorectal cancer confirmed by histological or cytological examination (International Union Against Cancer 8th edition of colorectal cancer staging).\n\n  3\\. Progression after receiving standard first-line treatment before enrollment; but excluding any type of immunotherapy.\n\n  4\\. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months.\n\n  5\\. ECOG score of 0-1. 6. Expected survival time of ≥ 24 weeks. 7. Laboratory tests for bone marrow, liver and kidney organ functions and coagulation function within 7 days before the first administration were in compliance with the study requirements (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factors for correction within 7 days before the laboratory tests).\n\n  8\\. Women with reproductive capacity must have a negative blood pregnancy test result within 7 days before the first administration. Male or female patients with reproductive capacity voluntarily use effective contraceptive methods during the study period and within 6 months after the last study medication, such as double barrier contraceptive methods, condoms, oral or injectable contraceptive drugs, intrauterine devices, abstinence, etc. All female patients will be considered to have reproductive capacity, unless the female patient has naturally menopause, artificial menopause or sterilization (uterus removal, bilateral ovary removal).\n\n  9\\. Voluntary enrollment and signing of informed consent form, following the trial treatment plan and visit schedule.\n\nExclusion Criteria:\n\n* 1\\. Absolute neutrophil count (ANC) \\\u003C 1.5 × 109\u002FL, or platelet count \\\u003C 100 × 109\u002FL (for patients with liver metastasis, platelet count \\\u003C 80 × 109\u002FL), or hemoglobin \\\u003C 9 g\u002FdL; blood transfusion within 2 weeks prior to enrollment is not allowed to meet the inclusion criteria.\n\n  2\\. Serum total bilirubin \\> 1.5 times the upper limit of normal (ULN); for patients with liver metastasis, \\> 2.5 times ULN.\n\n  3\\. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 2.5 times ULN, or for patients with liver metastasis, ALT and\u002For AST \\> 5 times ULN.\n\n  4\\. Serum creatinine \\> 1.5 times ULN, or creatinine clearance rate \\\u003C 50 ml\u002Fmin (calculated according to the Cockcroft-Gault formula).\n\n  5\\. Partial thromboplastin time (APTT) or prothrombin time (PT) \\> 1.5 times ULN (based on the normal values of the clinical trial center).\n\n  6\\. The researcher determines clinically significant severe electrolyte abnormalities.\n\n  7\\. Urine protein test of 2+ or above, or 24-hour urine protein quantification ≥ 1.0 g\u002F24h.\n\n  8\\. Hypertension that is not well controlled by medication, defined as: systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg.\n\n  9\\. The patient currently has active peptic ulcer, ulcerative colitis, or other digestive tract diseases or active bleeding from an unresected tumor, or the researcher determines that it may cause gastrointestinal bleeding or perforation; or if there was a previous gastrointestinal perforation or gastrointestinal fistula, and the patient has not recovered after surgical treatment.\n\n  10\\. Within 6 months before enrollment, there is a history of arterial thrombosis or deep vein thrombosis, or within 2 months before enrollment, there is evidence or history of bleeding tendency or history of bleeding, regardless of severity.\n\n  11\\. Within 12 months before enrollment, a stroke event or transient ischemic attack occurred.\n\n  12\\. Within 6 months before enrollment, heart disease including congestive heart failure, acute myocardial infarction, severe\u002Funstable angina pectoris or coronary artery bypass surgery; or NYHA class 2 or above heart dysfunction patients; left ventricular ejection fraction (LVEF) \\\u003C 50%.\n\n  13\\. Uncontrolled malignant pleural effusion, ascites or pericardial effusion (defined as not being effectively controlled by diuretics or puncture as determined by the researcher).\n\n  14\\. Any patient who has received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody (or any other antibody acting on the T cell co-stimulation or checkpoint pathways) before enrollment.\n\n  15\\. Within 4 weeks before enrollment, received any form of radiotherapy. 16. At the screening stage, there is a clinically detectable second primary malignant tumor, or other malignant tumors occurred in the past 5 years, excluding fully treated non-melanoma skin cancer, cervical carcinoma in situ and superficial bladder tumor \\[non-invasive tumors, carcinoma in situ and T1 (tumor invasion of the lamina propria)\\], if present.\n\n  17\\. Known clinical significance of liver disease history, including but not limited to known hepatitis B virus (HBV) infection and positive HBV DNA (≥ 1 × 104\u002Fml); known hepatitis C virus (HCV) infection and positive HCV RNA (≥ 1 × 103\u002Fml), or liver cirrhosis, etc.\n\n  18\\. Pregnant or lactating women or women with a possibility of pregnancy who have a positive pregnancy test before the first medication; or female participants who are unwilling to implement strict contraception during the study.\n\nThe researcher considers that the subject has any clinical or laboratory abnormalities or non-compliance issues that make them unsuitable to participate in this clinical study.",{"count":267,"type":22},40,[89],"Main objective:\n\n1\\. To compare the objective response rate (ORR) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer.\n\nSecondary objectives:\n\n1. To compare the disease control rate (DCR), duration of continuous remission (DoR), progression-free survival (PFS) and overall survival (OS) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer.\n2. To evaluate the safety and tolerability of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib.",[28,271,272],"Peritoneal (Metastatic) Cancer","FAPI PET",{"date":137,"type":38},{"date":275,"type":38},"2024-08-07",{"date":277,"type":22},"2028-01-31",{"name":279,"class":76},"Fudan University",2,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100549007","phase-1-a-clinical-study-of-mk-2870-alone-or-with-other-treatments-to-treat-gastrointestinal-cancers-mk-9999-02a-100549007","NCT06428409","A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)","A Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has one of the following cancers:\n\n  * Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer\n  * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer\n  * Advanced and\u002For unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer\n  * Advanced and\u002For unresectable BTC and has not received prior therapy for the cancer\n* For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of severe eye disease\n* For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening",{"count":289,"type":22},220,[88,89],"Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:\n\n* About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it\n* How many people have the cancer respond (get smaller or go away) to treatment",[28,293,294],"Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer",{"date":135,"type":38},{"date":297,"type":38},"2024-06-20",{"date":299,"type":22},"2029-10-16",{"name":301,"class":45},"Merck Sharp & Dohme LLC",55,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":77},"100523866","locally-ablative-therapy-for-oligo-progressive-gastrointestinal-malignancies-livelong-100523866","NCT06101277","Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)","LIVELONG","Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed cancers:\n\n   1. Cohort A: (Cohort removed in protocol version 4.0)\n   2. Cohort B: Small bowel\n   3. Cohort C: Pancreatic and ampullary, colorectal, and appendiceal\n   4. Cohort D: (Cohort removed in protocol version 4.0)\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",{"count":311,"type":22},300,[58],"This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.",[315,28,181,316,317,127,318,319],"Small Bowel Cancer","Biliary Cancer","Gall Bladder Cancer","Extrahepatic Cholangiocarcinoma","Oligoprogressive",{"date":137,"type":38},{"date":322,"type":38},"2023-10-05",{"date":324,"type":22},"2039-09-15",{"name":326,"class":76},"University of California, Davis",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":77},"100577114","phase-3-sbrt--pd-1-monoclonal-antibody-in-unresectable-colorectal-liver-metastases-100577114","NCT06794086","SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases","SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)","SPARKLE-L","Inclusion Criteria:\n\n1. Written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulatory and institutional guidelines before any procedures related to the study protocol that are not part of routine care are performed.\n2. Patients with pMMR\u002FMSS colorectal adenocarcinoma;\n3. Age 18-75 years;\n4. Patients with histologically or cytologically confirmed colorectal cancer liver metastasis, with or without extrahepatic oligometastatic lesions, who are deemed by the hepatobiliary surgeon within the multidisciplinary team (MDT) to be ineligible for upfront R0 resection of liver metastases (unresectability is defined as one or more of the following conditions: ① Involvement of both left and right branches of the portal vein at the first hepatic hilum; ② Involvement of ≥2 hepatic veins at the second hepatic hilum; ③ No indication for upfront R0 resection\u002Fablation after MDT discussion);\n5. Liver metastases are measurable by imaging (based on RECIST 1.1 criteria), with a maximum diameter of ≤6 cm;\n6. Patients who have not previously received radiotherapy for liver metastases, or whose liver tissue near the planned irradiation site has not been previously irradiated, and who have at least 700 cc of liver volume outside the treatment area;\n7. Previous hepatectomy, systemic chemotherapy, or local ablation therapy, or hepatic arterial infusion pump chemotherapy is allowed, with a washout period of 2 weeks;\n8. Child-Pugh score Class A ;\n9. ECOG performance status 0-1;\n10. Peripheral blood counts and liver and renal function within allowable ranges (tested within 15 days before the start of treatment);\n11. No history of other malignancies, not pregnant or breastfeeding, and effective contraception should be used during the study period and for 6 months after the last dose;\n12. Life expectancy of ≥6 months.\n\nExclusion Criteria:\n\n1. Active hepatitis, cirrhosis, or Child-Pugh score Class B or C;\n2. Extrahepatic metastases: bone or brain metastases, or ≥3 unresectable lung metastases (according to the 8th edition of the UICC);\n3. Unmeasurable liver metastases;\n4. History of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n5. Patients who have participated in or are currently participating in other clinical trials within the past 4 weeks;\n6. History of prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapies;\n7. Severe electrolyte abnormalities;\n8. Presence of gastrointestinal diseases, such as active gastric or duodenal ulcers, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation (Note: Gastrointestinal fistulas that have not healed after surgical treatment, such as rectovesical, rectourethral, or rectovaginal fistulas, are exclusionary unless a stoma has been created and there are no active symptoms);\n9. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;\n10. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants unwilling to strictly practice contraception during the study, as well as their partners;\n11. Patients with active autoimmune deficiency diseases requiring systemic treatment within the past 2 years (i.e., use of immunomodulators, corticosteroids, or immunosuppressive drugs);\n12. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for over 3 years, or in situ cancers that can be cured with adequate treatment);\n13. Presence of severe ECG abnormalities or active coronary artery disease within 12 months before study entry, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n14. Patients with active infections (fever above 38°C due to infection);\n15. Patients with poorly controlled hypercalcemia, hypertension, or diabetes;\n16. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n17. Patients with psychiatric disorders affecting clinical management or a history of central nervous system diseases;\n18. Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n19. Presence of any CTCAE Grade 2 or higher toxicity from prior treatments that has not resolved (except for anemia, alopecia, and skin pigmentation);\n20. Any unstable medical condition that may affect patient safety or compliance with the study;\n21. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.","75 Years",{"count":337,"type":22},24,[25],"To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.",[28,341],"Liver Metastases",[343,344],"Stereotactic body radiation therapy","PD-1 Monoclonal Antibody","2026-06-29",{"date":219,"type":38},{"date":348,"type":38},"2025-04-10",{"date":350,"type":22},"2027-01-20",{"name":352,"class":76},"Jun Huang",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":380},"100615767","care-tool-study-aim-3-100615767","NCT07296887","CARE Tool Study Aim 3","Implement and Evaluate the CARE Tool in a Randomized Trial","Inclusion Criteria for Implementation champions:\n\n\\- Members of the cancer care team (e.g., physicians, nurses, research coordinators, financial navigators, social workers) that work with patients receiving treatment for gynecologic, lung, prostate, or colorectal cancer; or members of the billing team and employee of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital\n\nExclusion Criteria for Implementation champions:\n\n* Implementation champions are ineligible if they are non-employees of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital\n* Do not treat patients for gynecologic, prostate, lung, or colorectal cancer\n\nInclusion Criteria for Patients:\n\n* Age 18 and over\n* Primary or recurrent diagnosis of gynecologic, prostate, lung, or colorectal cancer in the last 12 months\n* Receiving cancer treatment from Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital\n* Self-reported ability to read and speak English\n\nExclusion Criteria for Patients:\n\n* Under the age of 18\n* Not diagnosed with gynecologic, prostate, lung, or colorectal cancer within the previous 12 months from recruitment\n* Not receiving care at Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital\n* Cannot give consent due to cognitive or emotional barriers",{"count":361,"type":22},430,[58],"This study is a multi-site randomized trial to study the implementation of the CARE Tool and evaluate the CARE Tool. The CARE Tool is a web-based tool that gives people information about cancer care costs, health insurance, and resources to help with costs. Overall, the study aims to help patients with cancer overcome barriers they face navigating insurance and accessing financial resources.",[365,63,62,28],"Gynecologic Cancer",[367,368,369,370,371],"Insurance","Insurance coverage","Cancer","Cost of medical care","Financial toxicity","2026-06-27",{"date":135,"type":38},{"date":375,"type":38},"2026-04-08",{"date":377,"type":22},"2028-07-31",{"name":379,"class":76},"Washington University School of Medicine",3,{"id":382,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":26,"conditions":385,"keywords":386,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":390,"leadSponsor":391,"locationsCount":392},"100633324",{"count":21,"type":22},[25],[28],[28,30,31,32,33],"2026-06-26",{"date":219,"type":38},{"date":40,"type":38},{"date":42,"type":22},{"name":44,"class":45},9,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":302},"100604692","phase-3-botensilimab--balstilimab-vs-best-supportive-care-as-therapy-in-chemo-refractory-unresectable-colorectal-adenocarcinoma-100604692","NCT07152821","Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma","Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial","BATTMAN","Inclusion Criteria:\n\n* Must have histologically confirmed colorectal adenocarcinoma that is not deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H).\n* Received and failed all prior available therapies, such that the standard of care for the patient would be best supportive care (BSC).\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1.\n* Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).\n* A life expectancy of ≥ 12 weeks at the time of study entry.\n* Must be ≥ 18 years of age.\n* Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.\n* Participants must have adequate organ and marrow function measured within 14 days prior to randomization.\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French.\n* Participant consent must be appropriately obtained in accordance with applicable local and national regulatory requirements.\n* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrolment.\n* Participants of childbearing potential or partners of participants of childbearing potential must have agreed to use a highly effective contraceptive method\n\nExclusion Criteria:\n\n* Participants 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 may be eligible for this trial, however, consultation with CCTG in advance of enrolment is required.\n* A history of primary immunodeficiency, solid organ transplant or allogeneic bone marrow transplant.\n* Current or prior use of immunosuppressive medication within 7 days before the first dose of study drugs, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease that has required systemic treatment within 2 years of the start of study drug.\n* Active or uncontrolled intercurrent illness.\n* Active brain metastases or leptomeningeal metastases.\n* Receipt of live attenuated vaccination administered within 30 days prior to randomization.\n* Lactating women who choose to breast feed.\n* Any active disease condition which would render the protocol treatment dangerous or impair the ability of the participant to receive protocol therapy.\n* Any condition that does not permit compliance with the protocol.\n* Receipt of anti-cancer chemotherapy or biologic therapy within the lesser of i) 21 days, or ii) the usual cycle length of the regimen prior to the first planned dose of study drug.\n* Receipt of radiotherapy or investigational agents within four weeks of first planned dose of study drug.\n* Any unresolved toxicity (≥ CTCAE grade 2) from previous anti-cancer therapy.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* History of partial or complete bowel obstruction within the last 3 months prior to study enrolment, signs\u002Fsymptoms of bowel obstruction or known radiologic evidence of impending obstruction.\n* Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the last 4 weeks or ≥ 4 times within the last 3 months or ≥ 1 time within the last 2 weeks or requiring diuretics within 2 weeks prior to study enrolment.\n* Active or ongoing diarrhea of CTCAE grade 2 or higher.\n* Tumour is mismatch repair deficient (dMMR) or microsatellite instability- high (MSI-H) per a standard local testing method.\n* Prior exposure to anti-PD-1\u002FPD-L1\u002FCTLA-4 therapy.",{"count":402,"type":22},834,[25],"This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions include: Is their quality of life better? Do their tumours slow in growth or possibly shrink in size? Are there markers in their tumour or blood that can predict whether they achieve any of these benefits? In addition, the study is done to confirm the safety of these immunotherapy drugs and to determine how long it takes for the body to metabolize them.",[28],{"date":345,"type":38},{"date":408,"type":38},"2026-03-31",{"date":410,"type":22},"2029-06-30",{"name":412,"class":413},"Canadian Cancer Trials Group","NETWORK",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":420,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":424,"phases":4,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":280},"100570982","smarter-using-blood-samples-to-improve-fit-based-colorectal-cancer-screening-100570982","NCT06714318","SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening","Inclusion Criteria:\n\n* Participation in the colorectal cancer screening program.\n\nExclusion Criteria:\n\n* Participants are excluded if a colonoscopy is not completed unless this is due to a colorectal cancer obstruction.","50 Years","74 Years",{"count":423,"type":22},1000,"OBSERVATIONAL","The project aims to investigate whether colorectal cancer screening can be improved using blood tests, thereby reducing the number of unnecessary colonoscopies. The Danish colorectal cancer screening program was implemented in 2014, and currently, all individuals aged 50-74 are invited every two years to participate. Those who test positive for hidden blood in their stool are referred for a colonoscopy. More than a third of the approximately 25,000 colonoscopies performed annually in the screening program can be classified as unnecessary, as they reveal a normal colon. This results in avoidable and unpleasant procedures for individuals and strains healthcare resources.\n\nThe project seeks to reduce the number of these unnecessary colonoscopies by investigating whether blood biomarkers can identify individuals at very low risk of colorectal cancer after a positive stool test for hidden blood. By utilizing blood tests, screening could become more personalized, precise, and resource-efficient for the healthcare system.",[28],{"date":345,"type":38},{"date":429,"type":38},"2024-12-02",{"date":431,"type":22},"2028-09",{"name":433,"class":76},"Vejle Hospital",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":441,"enrollmentInfo":442,"targetDuration":4,"studyType":424,"phases":4,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":280},"100523658","circulating-tumor-dna-ctdna-as-a-predictive-biomarker-for-immunotherapy-in-advanced-or-locally-advanced-dmmrmsi-h-colorectal-patients-100523658","NCT06098560","Circulating Tumor DNA (ctDNA) as a Predictive Biomarker for Immunotherapy in Advanced or Locally Advanced dMMR\u002FMSI-H Colorectal Patients","Study on the Clinical Potential of Circulating Tumor DNA in Advanced or Locally Advanced dMMR\u002FMSI-H Colorectal Patients Treated With Immunotherapy","Inclusion Criteria:\n\n\\- advanced or locally advanced dMMR\u002FMSI-H colorectal cancer Expected to receive\u002Fbe receiving immune checkpoint inhibitor therapy ECOG performance score is 0-1, life expectancy ≥12 weeks\n\nExclusion Criteria:\n\n\\- The presence of other uncured malignancies Patients with one or more serious concomitant systemic diseases that, in the investigator's opinion, impair the patient's ability to complete the study Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy","80 Years",{"count":174,"type":22},"dMMR\u002FMSI-H colorectal cancer patients are the dominant population of immunotherapy\u002Fneoadjuvant immunotherapy, but imaging evaluation of immunotherapy efficacy is insufficient. There are some cases, although no disease remission was found on imaging,pathological complete response (pCR) was confirmed after surgery. Meanwhile,previous studies have shown that dynamic changes in ctDNA can help assess immunotherapy efficacy. Therefore, we propose to conduct a multicenter, prospective, observational clinical study to explore the efficacy prediction and monitoring value of ctDNA in immunotherapy for advanced or locally advanced dMMR\u002FMSI-H colorectal cancer.",[28],{"date":219,"type":38},{"date":447,"type":38},"2023-10-30",{"date":449,"type":22},"2026-12",{"name":451,"class":45},"Geneplus-Beijing Co. Ltd.",{"id":453,"slug":4,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":90,"conditions":456,"keywords":457,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":461,"leadSponsor":462,"locationsCount":112},"100644475",{"count":86,"type":22},[88,89],[92,93,94,95,28,96],[98,99,93,100,101,102,103],"2026-06-25",{"date":387,"type":38},{"date":107,"type":22},{"date":109,"type":22},{"name":111,"class":45},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":424,"phases":4,"briefSummary":473,"conditions":474,"keywords":487,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":472,"type":22},2000,"This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[369,245,475,476,477,28,478,479,480,481,482,483,484,485,486],"Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","Endometrial Cancer","Head and Neck Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer","Melanoma (Skin Cancer)",[245,488,489,369,490,491,492,493,494,495],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy",{"date":345,"type":38},{"date":498,"type":38},"2025-04-14",{"date":500,"type":22},"2038-04",{"name":489,"class":45},8,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":77},"100644797","clinical-utility-of-ctdna-in-detecting-resistance-mechanisms-and-delivering-precision-medicine-to-cancer-patients-100644797","NCT07673861","Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients","Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine: A Tumour Agnostic Study","CURTAIN","Inclusion Criteria\n\nAll cohorts:\n\n* Age ≥18 years old\n* Ability to provide written informed consent\n* Presence of metastatic or unresectable disease\n* Being reviewed and treated through medical oncology service at Royal Marsden Hospital\n\nCohort 1: Locally Advanced\u002FMetastatic NSCLC\n\n* Oncogene-addicted NSCLC (i.e. ESCAT Tier 1 oncogenic drivers: EGFR\u002FALK\u002FROS1\u002FRET\u002FMET\u002FBRAF\u002FNTRK\u002FHER2\u002FKRAS), AND\n* Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent\n\nCohort 2: Locally Advanced\u002FMetastatic GIST\n\n* Locally advanced\u002Fmetastatic gastrointestinal stromal tumour (GIST), AND\n* Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent\n\nCohort 3: Metastatic Colorectal Cancer\n\n• Metastatic colorectal cancer, left sided, RAS wild type, HER2 any status, AND\n\n* If HER2 negative or unknown: progressive disease on systemic anti-cancer therapy (SACT) with an anti-EGFR agent (e.g. cetuximab) within the 6 weeks prior to consent\n* If HER2 positive: progressive disease on first line systemic anti-cancer therapy (SACT) +\u002F- an anti-EGFR agent within the 6 weeks prior to consent\n\nCohort 4: Locally Advanced\u002FMetastatic BTC\n\n* Identified targetable mutation (IDH1 mutation\u002FHER2 amplification\u002FFGFR2 fusion or rearrangement\u002FNTRK fusion\u002FBRAF V600E mutation\u002FMMR deficiency \\[dMMR\\]), AND\n* Progressive disease on targeted therapy (any line) demonstrated within the 6 weeks prior to consent\n\nCohort 5: Advanced\u002FMetastatic ovarian cancer\n\n* Diagnosis of advanced\u002Fmetastatic high-grade ovarian cancer, AND\n* Known BRCA status, AND\n* Progressive disease on a PARP-inhibitor (with or without bevacizumab) following platinum-based therapy in the 1st line maintenance setting, within the 6 weeks prior to consent\n\nExclusion Criteria\n\nAll cohorts:\n\n* Medically unstable to commit to sampling required for the study\n* ECOG performance status ≥3",{"count":512,"type":22},100,[58],"ctDNA stands for circulating tumour DNA. As ctDNA is released by tumour cells into the blood stream, taking a blood sample and analysing it for ctDNA, can provide a lot of useful information about a patient's cancer. In certain situations, ctDNA can be used to screen for or detect cancer early, to aid clinical decisions about which treatment to give a patient, to provide information about if a cancer has become resistant to treatment, or provide information about how much cancer may be left after treatment (residual disease).\n\nThe aim of this trial is to establish the clinical utility of implementing ctDNA testing in cancer patients with a view to enhance the delivery of personalised care within the National Health Service in the United Kingdom (UK).\n\nOne hundred patients will be recruited, with 20 from each of the following cancer types:\n\n* Non-small cell lung cancer\n* Gastrointestinal stromal tumours\n* Colorectal cancer\n* Biliary tract cancer\n* Ovarian cancer.\n\nPatients must be aged 18 or over, must have had progressive disease whilst receiving anti-cancer treatment, and must be being treated at The Royal Marsden.\n\nPatients will have a blood sample taken and analysed using the Marsden360 ctDNA test. The results of the test will be looked at by The Royal Marsden Genomic Tissue Advisory Board (GTAB), and for each individual patient, the GTAB will determine if having a ctDNA test helped to personalise their care by:\n\n* Aiding the identification of a genomically-matched standard of care therapy\n* Aiding the identification of a genomically-matched clinical trial (based in the UK)\n* Offering additional prognostic information not otherwise available through standard of care testing\n* Negating the need for a tissue biopsy.",[516,517,28,294,94],"Non Small Cell Lung Cancer","Gastrointestinal Stromal Tumor (GIST)","2026-06-24",{"date":345,"type":38},{"date":521,"type":38},"2025-05-23",{"date":523,"type":22},"2026-12-31",{"name":525,"class":76},"Royal Marsden NHS Foundation Trust",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":533,"sex":18,"minAge":534,"maxAge":421,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":4},"100644984","precision-navigation-to-improve-community-cancer-screening-participation-a-dual-cohort-cluster-randomized-trial-100644984","NCT07676383","Precision Navigation to Improve Community Cancer Screening Participation: A Dual-Cohort Cluster Randomized Trial","Effectiveness and Mechanisms of a Precision Navigation Intervention to Improve Community Cancer Screening Participation: A Dual-Cohort Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 45 to 74 years.\n2. Permanent resident of a participating community, defined as having lived in the community for at least 6 months during the past 12 months.\n3. Participating in the urban cancer screening program.\n4. Identified by the program risk assessment questionnaire as being at high risk for at least one of the following cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer.\n5. Has not yet completed the corresponding free clinical screening test for the high-risk cancer type or types.\n6. Able to complete electronic questionnaires and read intervention materials independently or with assistance. Paper materials and staff explanation will be provided for participants who do not use smartphones.\n7. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Previously diagnosed with any of the target cancers, including lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer.\n2. Severe cognitive impairment, severe mental illness, or other conditions that prevent the participant from receiving the intervention or completing study questionnaires.\n3. Planning to be away from the community for a long period during the next 6 months, defined as cumulative absence of more than 3 months.\n4. Currently participating in another interventional study that may affect cancer screening behavior.",true,"45 Years",{"count":536,"type":22},1500,[58],"This study will evaluate whether a precision navigation intervention can help community residents at high risk for cancer complete recommended cancer screening. The study will be conducted in communities participating in an urban cancer screening program in China.\n\nEligible participants will be adults aged 45 to 74 years who are permanent residents of participating communities and have been identified as being at high risk for at least one of five cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer. Participants must not have completed the corresponding free clinical screening before enrollment.\n\nThis is a dual-cohort, cluster randomized controlled trial. Communities, rather than individual participants, will be assigned to one of three groups: a precision navigation group, a usual health education group, or a waiting control group. Participants will be classified into two cohorts according to the number of cancers for which they are assessed as high risk. Cohort A will include participants at high risk for three or more cancers, and Cohort B will include participants at high risk for one or two cancers.\n\nParticipants in the precision navigation group will receive a personalized navigation report matched to their risk profile. The report will explain the screening tests most relevant to them, help them understand screening choices, and provide practical steps to support screening completion. Participants in the usual health education group will receive general cancer screening education materials. Participants in the waiting control group will not receive active screening promotion during the main intervention period, but will receive general education materials after the primary assessment.\n\nThe main outcome is whether participants complete the recommended cancer screening during follow-up. The study will also assess changes in screening-related decision conflict, anxiety, self-efficacy, and behavioral intention. A subgroup of participants will provide blood samples before and after the intervention to explore possible biological mechanisms related to stress, inflammation, and screening behavior.\n\nThe results may help improve community-based cancer screening programs and provide evidence for using personalized navigation strategies to increase screening participation among high-risk populations.",[540,62,61,28,541,483],"Cancer Screening","Upper Gastrointestinal Cancer",{"date":219,"type":38},{"date":544,"type":22},"2026-06",{"date":546,"type":22},"2027-02",{"name":548,"class":76},"Hunan Cancer Hospital",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":533,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":424,"phases":4,"briefSummary":559,"conditions":560,"keywords":564,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":77},"100644983","oral-fecal-and-intratumoral-microbiome-atlas-in-colombian-patients-with-advanced-solid-tumors-receiving-first-line-immunotherapy-100644983","NCT07676461","Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy","Atlas of the Oral, Fecal and Intratumoral Microbiome of Colombian Patients With Advanced Solid Tumors Candidates for First-Line Immunotherapy - Initial Phase of a Project With Latin American Projection","ATLAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer.\n* Candidate for first-line immunotherapy per current clinical guidelines.\n* Available FFPE tumor block in institutional or reference pathology archive.\n* Able to provide saliva and stool samples at V0 and follow-up.\n* ECOG performance status within protocol limits; life expectancy over 3 months.\n* Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents.\n\nInclusion Criteria (healthy controls)\n\n* No prior cancer diagnosis.\n* No active autoimmune disease; no inflammatory bowel disease.\n* No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.\n\nExclusion Criteria:\n\n* Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).\n* Probiotics or prebiotics within 30 days.\n* Chronic proton-pump inhibitors for more than 3 continuous months.\n* Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.\n* Pregnancy or lactation.\n* BMI under 18.5 or over 40 kg\u002Fm².\n* Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).\n* Invasive dental treatment within 3 months.\n* Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.\n* Inability to ensure 12-month clinical follow-up.",{"count":558,"type":22},150,"This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia. It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical and head-and-neck cancer) who receive first-line immunotherapy as standard of care, and compares them with healthy volunteers. Using multi-omics (HiFi metagenomics, 16S, tumor RNA-Seq and untargeted metabolomics), the study aims to identify microbial signatures associated with treatment response and survival, building the initial Colombian cohort of a Cancer Microbiome Atlas with Latin American projection.",[561,28,61,562,563],"Gastric Cancer","Cervical Cancer","Head and Neck Cancer (H&N)",[565,369,245,566,567,568,569,570],"Microbiome","Tumor microenvironment","Biomarkers","Metagenomics","Transcriptomics","Metabolomics",{"date":219,"type":38},{"date":573,"type":38},"2026-06-11",{"date":575,"type":22},"2029-08-30",{"name":577,"class":76},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":18,"minAge":585,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":611,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":640,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":647},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":311,"type":22},[88,89],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[590,591,592,593,62,94,480,63,28,61,594,595,481,317,596,597,598,599,600,601,602,603,604,605,93,606,607,608,609,610],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Other Cancer","Locally Advanced","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":387,"type":38},{"date":642,"type":38},"2020-10-29",{"date":644,"type":22},"2027-12-31",{"name":646,"class":45},"PMV Pharmaceuticals, Inc",77,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":23,"phases":656,"briefSummary":657,"conditions":658,"keywords":660,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":77},"100609835","transanal-irrigation-for-the-management-of-early-low-anterior-resection-syndrome-lars-100609835","NCT07219745","Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)","Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS): A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n1. Adults (≥18 years-old) patients who underwent a LAR for any indication via open, laparoscopic, robotic, or transanal total mesorectal excision, with creation of a diverting loop ileostomy,\n2. have confirmed anastomotic healing demonstrated by flexible sigmoidoscopy and CT scan with rectally-administered water soluble contrast or gastrograffin enema,\n3. are planned for an ileostomy closure operation, and\n4. are in the first 12 months post-LAR operation\n\nExclusion Criteria:\n\n1. Inability to comprehend English or Spanish or provide informed consent (Note: after the English documents are approved, the study team plans to obtain a Spanish consent and study documents),\n2. ongoing chemotherapy or radiotherapy, and\n3. ongoing anastomotic complication.",{"count":174,"type":22},[58],"Transanal irrigation (TAI) has shown to improve fecal incontinence and increase quality of life in patients with low anterior resection syndrome (LARS). This trial is a small study being conducted to determine whether a larger trial is feasible. Investigators are also doing this research to see if TAI impacts quality of life and improves bowel function within the early post-operative period (1-12 months).\n\nThis treatment is designed for participants to have more control over their bowel movements and reduce the dependency on immediate access to the toilet.",[28,659],"Low Anterior Resection Syndrome",[661,662,659,663],"Transanal irrigation","Peristeen Transanal Irrigation System","LARS","2026-06-23",{"date":458,"type":38},{"date":667,"type":22},"2026-10",{"date":669,"type":22},"2027-11",{"name":671,"class":76},"Case Comprehensive Cancer Center",{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":4,"eligibilityCriteria":678,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":23,"phases":681,"briefSummary":682,"conditions":683,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":688,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":693,"locationsCount":695},"100541015","phase-1-beamion-bcgc-1-a-study-to-find-a-suitable-dose-of-zongertinib-used-alone-and-in-combination-with-other-treatments-to-test-whether-it-helps-people-with-different-types-of-her2-cancer-that-has-spread-100541015","NCT06324357","Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread","Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)","Inclusion criteria:\n\n* Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF)\n* Cohorts A to K and Cohort O: Documented Human epidermal growth factor receptor 2 overexpressing and\u002For amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC).\n* Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression\u002Famplification according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) gastric cancer guidelines and according to the result of local testing.\n* For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue\n* History of prior treatment lines in palliative setting:\n\n  * For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K and O documented investigator assessed progression after HER2-directed treatment for unresectable locally advanced or metastatic disease (For Cohorts D, H, I (I-ext), J (J-ext) - patients must have been pretreated with trastuzumab deruxtecan (T-DXd) and have progressed or have been intolerant to previous T-DXd).\n  * For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy. Patients must have had at least one prior line of therapy for locally advanced unresectable disease or metastatic disease (adjuvant and neoadjuvant therapy excluded) and documented disease progression or recurrence of disease during or following their latest line of therapy. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.\n* Presence of at least one measurable lesion according to RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n* Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n* Previous treatment with:\n\n  * Any small molecule HER2 inhibitor in the palliative setting in Cohorts D, E, F, H, L, L-ext, M, and N. In Cohort D allowed in up to 15 patients in each dose level (DL).\n  * T-DXd in Cohorts E and F. In Cohort E allowed in up to 15 patients in each DL.\n  * trastuzumab emtansine (T-DM1) in the palliative setting in Cohort D and H. In Cohort H allowed in up to 15 patients in each DL.\n  * Capecitabine in Cohort D and H. In Cohort D allowed in up to 15 patients in each DL\n* Presence of uncontrolled and\u002For symptomatic brain metastases, or leptomeningeal disease\n* Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) \\>470 msec.\n* Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age.\n* Ejection fraction \\\u003C50% or the lower limit of normal of the institutional standard within 28 days prior to randomization\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening Further exclusion criteria apply.",{"count":680,"type":22},768,[88,89],"This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.\n\nIn this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.\n\nDuring the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT\u002FMRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.",[684,685,686,687,28],"Metastatic Breast Cancer","Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Esophageal Adenocarcinoma",{"date":518,"type":38},{"date":690,"type":38},"2024-06-03",{"date":692,"type":22},"2029-01-08",{"name":694,"class":45},"Boehringer Ingelheim",108]