[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-colorectal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-colorectal-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,86,112,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100642329","phase-2-hrx215-a-first-generation-mkk4-inhibitor-drug-for-the-treatment-of-patients-with-colorectal-liver-metastasis-after-undergoing-a-portal-vein-embolization-100642329",false,"NCT07612007","HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization","Phase 2B Study to Determine Efficacy of HRX215, a First Generation MKK4 Inhibitor Drug, in Improving Regeneration of the Remnant Liver After Portal Vein Embolization (PVE) of Colorectal Liver Metastasis (CRLM)","Inclusion Criteria:\n\n* REGISTRATION: Adults 18-90 years\n* REGISTRATION: Individuals with metachronous colorectal carcinoma liver metastases (CRCLM) after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease\n* REGISTRATION: Measurable intrahepatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) and considered resectable by multidisciplinary tumor board with at least one senior hepatic surgeon\n* REGISTRATION: Available CT suitable for volumetric studies on FLR ≤ 21 days\n* REGISTRATION: Clinical indication for PVE prior to major hepatectomy as evaluated by at least one senior hepatic surgeon\n* REGISTRATION: Estimated life expectancy ≥ 3 months as evaluated and approximated by a senior hepatic surgeon\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* REGISTRATION: Platelets ≥ 100,000\u002Fmm\\^3 (≤ 15 days prior to registration)\n* REGISTRATION: Polynuclear neutrophils ≥ 1000\u002Fmm\\^3 (≤ 15 days prior to registration)\n* REGISTRATION: Hemoglobin ≥ 9 g\u002FdL (≤ 15 days prior to registration) (post-transfusion participants can be included)\n* REGISTRATION: Creatinine ≤ 1.5 x upper limit of normal (ULN) (≤ 15 days prior to registration)\n* REGISTRATION: Bilirubin ≤ ULN (≤ 15 days prior to registration)\n* REGISTRATION: Albumin ≥ 3 g\u002FdL (≤ 15 days prior to registration)\n* REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 15 days prior to registration)\n* REGISTRATION: International normalized ratio ≤ 1.5 (≤ 15 days prior to registration)\n* REGISTRATION: Of note, a slight deviation from normal ranges of liver function tests, circulating cell counts, and kidney function can be assumed after systemic neoadjuvant chemotherapy prior to PVE (Field et al., 2008; Takamoto et al., 2010; Lock et al., 2017), which is accounted for in the above list. These parameters at inclusion will then serve as patient baseline\n* REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. Serum or urine human chorionic gonadotropin test is suitable. Can be done with a home test and results reported by participant to the site\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* RANDOMIZATION: Adults 18-90 years\n* RANDOMIZATION: Individuals with metachronous CRCLM after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease\n* RANDOMIZATION: Estimated life expectancy ≥ 3 months as evaluated and approximated by a senior hepatic surgeon\n* RANDOMIZATION: Measurable intrahepatic disease as defined by RECIST and considered resectable by multidisciplinary tumor board with at least one senior hepatic surgeon\n* RANDOMIZATION: Available CT suitable for volumetric studies on FLR ≤ 21 days\n* RANDOMIZATION: Scheduled for PVE prior to major hepatectomy\n\nExclusion Criteria:\n\n* REGISTRATION: Cirrhosis or clinical ascites\n* REGISTRATION: Patients with synchronous CRCLM and scheduled staged approach (i.e., resection of metastatic hepatic disease after PVE followed by resection of the colorectal primary in a second operation)\n* REGISTRATION: Any liver cancer other than CRLM\n* REGISTRATION: Contraindications to imaging or perioperative management:\n\n  * Allergy\u002Fcontraindication to iodine contrast\n  * Anticoagulation with heparin\u002Fantivitamin K (AVK) that cannot be interrupted for 48 hours\n  * Antiplatelet therapy (e.g., clopidogrel) that cannot be interrupted for 5 days\n* REGISTRATION: Inability to discontinue cytochrome P450 (CYP)2D6 inhibitor concomitant medication from start of trial treatment to day 28\n* REGISTRATION: Inoperability due to underlying chronic diseases and co-morbidities as assessed by the hepatobiliary surgeon during screening visit\n* REGISTRATION: Anticipated need to start adjuvant chemotherapy prior to completion of 28 day treatment period\n* REGISTRATION: Positive test at screening for active hepatitis B virus (HBV)\u002Fhepatitis C virus (HCV), defined as history of seropositivity for hepatitis B virus (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy), i.e., positive test for anti-hepatitis B core antigen and negative test for anti-hepatitis B surface antibody. Ongoing, non-cured hepatitis C virus (HCV) infection. Likewise, autoimmune hepatitis will be excluded based on serological \\[antinuclear antibodies (ANA), smooth muscle antibodies (SMA), and biochemical parameters AST and ALT\\], patients with serological and\u002For biochemical findings suggestive of probable autoimmune hepatitis will be excluded\n* REGISTRATION: Legal incapacity (persons in custody or under guardianship)\n* REGISTRATION: Deprived of liberty subject (by judicial or administrative decision)\n* REGISTRATION: Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social, or psychological reasons\n* REGISTRATION: Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception. Participants of childbearing potential must use highly effective contraception (hormonal methods, intrauterine device (IUD)\u002Fintrauterine system (IUS), bilateral tubal occlusion, or vasectomized partner) during treatment and for a defined post-treatment period of 30 days. True abstinence is acceptable if consistent with lifestyle. Barrier methods alone are insufficient unless combined. Male participants with partners of childbearing potential must use condoms and avoid sperm donation during and after treatment\n* REGISTRATION: Any of the following prior therapies:\n\n  * Major surgical procedures ≤ 3 weeks prior to registration\n  * Bevacizumab as part of systemic cancer treatment ≤ 2 weeks prior to registration\n* REGISTRATION: Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Chemotherapy\n  * Immunotherapy\n  * Targeted therapies\n  * Other investigational agents\n  * Radiation therapy\n  * Major surgical procedures\n* REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm in the neoadjuvant setting or during active treatment phase of this study (adjuvant treatment after active treatment phase is completed does not apply)\n* REGISTRATION: Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy at time of study inclusion or within the past five years with the exception of basal cell carcinoma or carcinoma in situ of the cervix. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria\n* REGISTRATION: History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias","ALL","18 Years","90 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase IIb trial tests the effect of HRX215 in treating patients with colorectal cancer that has spread from where it first started to the liver (liver metastasis) after undergoing a portal vein embolization (PVE). Currently, surgery to remove the tumor (hepatectomy) remains the only potential treatment for cure. However, less than 30% of patients are considered resectable (can be removed by surgery) at the time of diagnosis. The risk of liver failure and other complications rise with larger areas liver that is removed during surgery. Therefore, the potential for surgery is determined by the amount of liver that will remain after resection. PVE is a standard strategy to increase the potential for resection. A PVE is a procedure that blocks the portal vein (a blood vessel that carries blood to the liver) to prevent flow of blood to the tumor. HRX215 targets and binds to MKK4, a protein found on liver cells plays a part in cellular growth and prevents liver repair and regrowth of cells and tissue. Blocking the activity of MKK4 may help prevent liver failure, protect liver cells and improve liver mass. Giving HRX215 after a PVE may help improve the rate of liver regrowth and increase the likelihood of hepatectomy in patients with colorectal liver metastasis.",[27,28,29,30],"Metastatic Colorectal Carcinoma","Metastatic Malignant Neoplasm in the Liver","Resectable Colorectal Carcinoma","Stage IV Colorectal Cancer AJCC v8","NOT_YET_RECRUITING","2026-06-10",{"date":34,"type":35},"2026-06-12","ACTUAL",{"date":37,"type":21},"2026-09-01",{"date":39,"type":21},"2028-08-01",{"name":41,"class":42},"Mayo Clinic","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":43},"100348926","intravital-microscopy-in-human-solid-tumors-100348926","NCT03823144","Intravital Microscopy in Human Solid Tumors","Intravital Microscopy (IVM) in Human Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2\n* Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)\n* Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic\n* Subject must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent\n* Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity to fluorescein\n\nExclusion Criteria:\n\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\n* Renal dysfunction as defined as a glomerular filtration rate (GFR) \\\u003C 45\n* Liver dysfunction as defined by Child-Pugh score \\> 5, or liver function test (LFT)'s 1.5 x above normal range\n* Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein\n* Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigators' opinion deems the patient unsuitable (e.g., abnormal electrocardiography \\[EKG\\], including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test)\n* Any condition that excludes surgical resection as the standard of care for the patient",{"count":52,"type":21},85,[54],"NA","This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.",[57,58,59,27,60,61,62,63,29,64,65,66,30,67,68,69,70,71,72,73,74,75,76],"Solid Tumor, Adult","Clinical Stage IV Gastric Cancer AJCC v8","Malignant Solid Neoplasm","Metastatic Gastric Carcinoma","Metastatic Primary Malignant Brain Neoplasm","Metastatic Sarcoma","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Resectable Liver and Intrahepatic Bile Duct Carcinoma","Resectable Pancreatic Carcinoma","Resectable Sarcoma","Anatomic Stage IV Breast Cancer AJCC v8","Malignant Brain Neoplasm","Metastatic Breast Carcinoma","Metastatic Liver Carcinoma","Metastatic Pancreatic Carcinoma","Resectable Brain Neoplasm","Resectable Breast Carcinoma","Resectable Gastric Carcinoma","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Pancreatic Cancer AJCC v8","RECRUITING","2026-05-29",{"date":80,"type":35},"2026-06-02",{"date":82,"type":35},"2019-02-28",{"date":84,"type":21},"2027-09-30",{"name":41,"class":42},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":43},"100504220","phase-2-pre-operative-targeted-treatments-in-molecularly-selected-resectable-colorectal-cancer-unicorn-100504220","NCT05845450","Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)","Window-of-opportunity Umbrella Platform Trial of Short-course Pre-operative Targeted Treatments in Patients With Molecularly Selected and Resectable Primary Colorectal Cancer: the UNICORN Study","Inclusion Criteria:\n\nGeneral inclusion criteria\n\n* Provide a signed and dated informed consent document.\n* Age ≥ 18 years at time of informed consent.\n* ECOG PS of 0 and 1.\n* Histologically confirmed colorectal cancer adenocarcinoma that is judged as initially resectable with elective surgery aimed at radical intent with R0 margins as per multidisciplinary team assessment.\n* Radiological stage cT3-4, N0-2, M0 using computed tomography (CT) as in the pivotal FOxTROT study.\n* Patients with rectal cancer candidate for R0 resection, not requiring pre-operative radiotherapy based on multidisciplinary team assessment, with the following characteristics on high-resolution thin slice (3 mm) contrast-enhanced magnetic resonance imaging (MRI):\n\n  * ≤ T3a defined at the MRI (perivisceral fat infiltration \\\u003C2 mm) and clinical N0\n  * Upper-medium, defined as tumors with distal margin ≥ 5 cm from the anal verge.\n  * Absence of mesorectal fascia invasion, as defined as a distance ≥ 1 mm between tumor and the mesorectal fascia.\n* Able to provide enough archival FFPE tumor specimen that is already available from initial diagnostic procedures for the purpose of molecular pre-screening.\n* Presence of one of the selected molecular profile\u002Falteration after central pre-screening and necessary for the assignment to a matching treatment cohort.\n* No prior systemic treatment for colorectal cancer or neoadjuvant radiation therapy for rectal cancer.\n* Adequate bone marrow function (absolute neutrophil count ≥ 1.5 × 109\u002FL; platelet count ≥ 100 × 109\u002FL; hemoglobin ≥ 9.0 g\u002FdL)\n* Adequate renal function characterized by serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL\u002Fmin at screening.\n* Adequate hepatic function (serum total bilirubin ≤ 1.5 × ULN and \\\u003C 2 mg\u002FdL. Note: Patients who have a total bilirubin level 1.5 × ULN will be allowed if their indirect bilirubin level is ≤ 1.5 × ULN; Alanine aminotransferase and\u002For aspartate aminotransferase ≤ 2.5 × ULN).\n* Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n* Subjects and their partners must be willing to avoid pregnancy during the trial and until a specific time interval after the last trial treatment: 7 months for female and 4 for male patients after last dose of trastuzumab-deruxtecan, 3 months for durvalumab, botensilimab and balstilimab and 2 months for panitumumab. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the Investigator (barrier contraceptive measure or oral contraception).\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nSpecific inclusion criteria for each Cohort\n\nCOHORT 1: pMMR\u002FMSS status and HER2-positive status and LVEF ≥ 50% within 28 days before enrolment, international normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN\n\nCOHORT 2: Proofread domain mutations in POLE or POLD1 associated with ultra-mutated status, i.e. tumor mutational burden \\>100 Mut\u002FMb.\n\nCOHORT 3: pMMR\u002FMSS status and wild-type status for RAS and BRAF, absence of molecular predictors of resistance (PRESSING panel negative), Left-sided and rectal primary tumor location, according to the specific inclusion criterion regarding rectal tumors.\n\nCOHORT 4: pMMR\u002FMSS status and absence of HER2 overexpression\u002Famplification, absence of POLE\u002FD1 proof-read domain pathogenic mutation associated with ultra-mutated status and absence of KRAS G12C mutation.\n\nCOHORT 5: pMMR\u002FMSS status and absence of of HER2 overexpression\u002Famplification, absence of POLE\u002FD1 proof-read domain pathogenic mutation associated with ultra-mutated status.\n\nCOHORT 6: dMMR\u002FMSI-H status and absence of POLE\u002FD1 proof-read domain pathogenic mutation associated with ultra-mutated status.\n\nCOHORT 7: dMMR\u002FMSI-H status and absence of POLE\u002FD1 proof-read domain pathogenic mutation associated with ultra-mutated status.\n\nCOHORT 8: pMMR\u002FMSS status and KRAS G12C mutation, absence of HER2 overexpression\u002Famplification and wild-type status for BRAF.\n\nCOHORT 9: pMMR\u002FMSS status and absence of of HER2 overexpression\u002Famplification, absence of POLE\u002FD1 proof-read domain pathogenic mutation associated with ultra-mutated status, absence of KRAS G12C mutation.\n\nCOHORT 10: pMMR\u002FMSS status and absence of of HER2 overexpression\u002Famplification, absence of POLE\u002FD1 proof-read domain pathogenic mutation associated with ultra-mutated status, absence of KRAS G12C mutation.\n\nCOHORT 11: pMMR\u002FMSS status and wild-type status for RAS and BRAF, absence of molecular predictors of resistance (PRESSING panel negative except for MET alterations - MET amplifications and mutations are allowed), Left-sided and rectal primary tumor location, according to the specific inclusion criterion regarding rectal tumors.\n\nCOHORT 12: pMMR\u002FMSS status and wild-type status for RAS and BRAF, absence of molecular predictors of resistance (PRESSING panel negative except for MET alterations - MET amplifications and mutations are allowed), Right-sided primary tumor location.\n\nCOHORT 1 of UNICORN part 2 (to enroll sequentially after completion of cohort 10): pMMR\u002FMSS status and absence of molecular characteristics allowing enrollment in cohorts 1,2 and 8 (i.e HER2 overexpression\u002Famplification, POLE\u002FD1 proof-read domain pathogenic mutation associated with ultra-mutated status, absence of KRAS G12C mutation. Patients with tumor characteristics of EGFR dependency (regardless of MET) will be eligible for cohort 1 of UNICORN part 2 only after completion of cohort 11 or 12 (depending on primary tumor sidedness) and upon discussion with the Sponsor\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\n* Distant metastases at any site, as defined by negativity of chest\u002Fabdomen\u002Fpelvis contrast-enhanced computed tomography (CT).\n* Risk criteria for obstructing disease at radiology or endoscopy as defined in the pivotal FOxTROT study.\n* Need to receive neoadjuvant radiation or chemoradiation in patients with rectal cancer.\n* Patients with known hypersensitivity to the study drug of the assigned cohort or to its excipients or to drugs belonging to the same drug class.\n* Previous or concurrent malignancy within 2 years of study entry.\n* Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following: history of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤ 6 months prior to start of study treatment; symptomatic congestive heart failure (i.e., Grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and\u002For conduction abnormality ≤ 6 months prior to start of study treatment, except atrial fibrillation and paroxysmal supraventricular tachycardia.\n* Known history of HIV infection.\n* Active infection including tuberculosis, hepatitis B, hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible only in case of negativity of HBV DNA. Patients positive for hepatitis C (HCV) antibody are eligible only if PCR is negative for HCV RNA.\n* Other severe acute or chronic diseases that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study.\n* Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements.\n* Women in pregnancy or lactation condition. Women with child-bearing potential or sexually-active men not willing to use adequate contraception during whole study period.\n* Use of any disallowed drugs.\n\nSpecific exclusion criteria for each Cohort:\n\nCOHORT 1:\n\n* Previous treatment with a DXd-containing ADC or any anti-HER2 agent.\n* Has LVEF\\\u003C 50% within 28 days before enrolment.\n* Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening. (eg, pulmonary emboli within 3 months of the enrolment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.).\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the enrolment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.).\n* Any autoimmune, connective tissue, or inflammatory disorders where there is documented, or a suspicion of, pulmonary involvement at the time of Screening.\n* Prior pneumonectomy.\n* Has substance abuse or any other medical conditions that may interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n* Patients with a medical history of myocardial infarction within 6 months before randomization\u002Fenrolment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out myocardial infarction.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\>450 msec (males) based on average of the screening triplicate12-lead ECG.\n* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n\nCOHORT 2, 4, 5, 6, 7, 10 and Cohort 1 of UNICORN part 2:\n\n* History of autoimmune diseases or history of bone marrow or organ transplantation that requires immunosuppressive therapy.\n* History of active primary immunodeficiency.\n* Any condition requiring systemic treatment with corticosteroids at doses equal or superior to 10 mg daily of prednisone or equivalents, or other immunosuppressive drugs within 14 days from the inclusion in the study.\n* Administration of live vaccines within 4 weeks from the inclusion in the study. Note: patients, if enrolled, should not receive live vaccine while receiving study drug(s) and up to 30 days after the last dose of study drug(s).\n* Prior treatment with anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents.\n\nCOHORT 3 and 8\n\n* History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.\n* Magnesium below the LNL.\n* Prior treatment with an EGFR inhibitor.\n\nCOHORT 8:\n\n* Patients who are unable to take a drug by mouth or previous clinical conditions or surgical resection that may affect the absorption of the study drug.\n* Use of CYP3A4 or P-gp substrates with a narrow therapeutic window within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer.\n* Use of any herbal medications\u002Fsupplements.\n* Tumors with KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations, except KRAS G12C.\n* Prior treatment with a KRAS G12C inhibitor.\n\nCOHORT 9 and 10:\n\n* Prior treatment with EP4 receptor antagonists.\n* Inability to swallow medications.\n* Presence of portal hypertension and\u002For oesophageal varices.\n* Known severe gastritis, duodenal or gastric ulcer, or any other condition that may lead to bleeding or perforation.\n\nCOHORTS 11 and 12:\n\n* Prior treatment with an anti-EGFR and\u002For MET inhibitor.\n* History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan\n* Clinically active infectious liver disease\n* Any ophthalmologic condition that is clinically unstable",{"count":94,"type":21},197,[24],"This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents\u002Fcombinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.",[98,29],"Colorectal Cancer",[100,101,102],"targeted treatment","molecular alterations","platform trial","2026-03-10",{"date":105,"type":35},"2026-03-12",{"date":107,"type":35},"2023-05-11",{"date":109,"type":21},"2028-05",{"name":111,"class":42},"Gruppo Oncologico del Nord-Ovest",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":43},"100423664","an-investigational-scan-intravoxel-incoherent-motion-diffusion-weighted-imaging-for-the-evaluation-of-colorectal-cancer-liver-metastases-treatment-response-100423664","NCT04796818","An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response","Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging","Inclusion Criteria:\n\n* Patients with treatment-naive resectable CLM, who will start chemotherapy with oxaliplatin with fluorouracil (5-FU)\u002Fleucovorin (FOLFOX), irinotecan with 5-FU\u002Fleucovorin (FOLFIRI), or a combination, such as fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI), with or without a biologic agent\n* Patients with at least 1 colorectal liver metastasis measuring at least 1 cm\n* Patients with anticipated follow-up before and after surgery at MD Anderson\n\nExclusion Criteria:\n\n* Patients who have already received preoperative chemotherapy for the CLM or will undergo radiation therapy, ablative therapies, or other non-surgical therapies directed at the liver\n* Patients allergic to gadolinium\n* Patients with pacemakers\n* Greater than 400 pounds in weight",{"count":120,"type":21},70,[54],"This trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (IVIM DWI). IVIM DWI is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.",[27,28,29,30,124,125,126],"Stage IVA Colorectal Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2026-01-12",{"date":129,"type":35},"2026-01-14",{"date":131,"type":35},"2020-08-12",{"date":133,"type":21},"2026-01-31",{"name":135,"class":42},"M.D. Anderson Cancer Center",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100602608","minimal-residual-disease-testing-for-the-early-detection-of-cancer-recurrence-in-resectable-stage-ii-iv-colorectal-cancer-patients-100602608","NCT07125729","Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients","ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison","Inclusion Criteria:\n\n* Documented written informed consent of the participant\n* Age: ≥ 18 years\n* Diagnosis of stage II, III or IV colorectal cancer (any gender) if enrolled post-operatively. If a treatment naïve patient is enrolled pre-operatively and determined to be pathological stage I, the patient will be replaced\n* Patient who are to undergo a curative intent surgery or have undergone a curative resection and are presenting for surveillance\n* Patient identified as an appropriate candidate for Signatera® testing as a standard of care MRD surveillance assay\n* Patient willingness to continue Signatera® assay every 3 months for 2 years in the first 2 years after resection and every 6 months for years 3, 4, 5 after resection, as performed by standard of care testing. In addition, the patients should be willing to provide blood samples for Haystack MRD testing at the same intervals of Signatera®, along with willingness to allow access to archival tissue to allow for Haystack MRD assay personalization. Surveillance with ctDNA should be initiated between 3 to 10 weeks from surgery\n* Adequate availability of archival tissue or anticipated pathological viable tissue. All untreated primary resection would be expected to have adequate tissue. Patients with resected metastatic disease should have either previously resected primary that is amenable for tumor informed MRD testing or should have adequate archival metastasectomy samples\n* Patients with total neoadjuvant therapy (TNT) for rectal cancer and complete clinical response with plans of watchful waiting may also be enrolled as long as there is adequate tissue from prior endoscopic biopsies to allow for Signatera® and Haystack MRD assays\n\nExclusion Criteria:\n\n* Inability to safely provide sequential blood samples\n* Clinical evidence of unresected metastatic disease\n* Inability to give informed consent",{"count":144,"type":21},150,[54],"This clinical trial compares minimal residual disease (MRD) testing with the Haystack blood test (assay) to the Signatera® assay for the early detection of the cancer returning (cancer recurrence) in patients with stage II-IV colorectal cancer (CRC) that can be removed by surgery (resectable). MRD testing looks for evidence of remaining tumor following treatment that is only apparent using highly sensitive techniques. There are few effective tools available outside of imaging to identify CRC patients with MRD who may be at the highest risk for cancer recurrence after surgery. Early detection of CRC recurrence after surgery is important, as it may increase the chance of curative (ability to cure) outcomes for patients with cancer recurrence. Currently, the Signatera assay is used to monitor whether CRC recurs after surgery, however it is not a very sensitive test. Early work with the Haystack assay suggests it may be more sensitive than the Signatera assay, which may be more effective for the early detection of cancer recurrence in patients with resectable stage II-IV CRC.",[29,148,149,30],"Stage II Colorectal Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","2025-08-10",{"date":152,"type":35},"2025-08-15",{"date":154,"type":35},"2025-07-12",{"date":156,"type":21},"2028-01-09",{"name":158,"class":42},"City of Hope Medical Center",13]