[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colon-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colon-cancer-metastatic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100645154","phase-2-nimble-crc-neoimmunomodulation-before-leveraging-excision-in-colorectal-rectal-cancer-100645154",false,"NCT07677579","NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer","NIMBLE","Inclusion Criteria:\n\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. A signed informed consent must be obtained prior to conducting any study-specific procedures.\n* Male or female adult 18 to 80 years of age on day of signing informed consent.\n* Histological-confirmed adenocarcinoma of the colon that is amenable to curative intent resection.\n* Only participants with pMMR\u002FMSS CRC are eligible. Microsatellite status should be performed per local standard of practice. (e.g., IHC and\u002For PCR, next-generation sequencing). Subjects with unknown or indeterminate results for either test at the time of enrollment are not eligible.\n* Adequate organ and marrow function as defined below:\n* Absolute neutrophil count: ≥ 1,500\u002Fmcl\n* Platelets: ≥ 100,000\u002FmcL without transfusion within 2 weeks of screening laboratory sample collection\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). This may be up to 3x ULN if Gilbert's syndrome is documented.\n* AST and ALT ≤ 3 x institutional ULN.\n* Serum creatinine ≤ 1.5 x ULN and EGFR ≥ 40\n* ECOG performance status (PS) 0 or 1.\n* Urine protein-to-creatinine ratio ≤ 1mg\u002Fmg creatinine.\n* INR ≤ 1.5 and aPTT ≤ 1.2 x ULN\n* Measurable disease as determined by RECIST v1.1.\n* Sexually active fertile subjects and their partners must agree to use highly effective method of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (listed in addendum), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n* Through 186 days after the last dose of zanzalintinib or 120 days from retifanlimab (whichever is latest) for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib or retifanlimab (whichever is latest) for men\n* At least T3 disease or with pathologically enlarged local lymph nodes by pre-surgical imaging.\n\nExclusion Criteria:\n\n* Symptoms of clinical obstruction or impending clinical obstruction including severe constipation, nausea and vomiting, or other as deemed by the principal investigator.\n* Tumor invading GI-tract from external viscera\n* Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n* Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment\n* Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy within the last two years.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within 2 years prior to study treatment initiation unless NED for greater than 2 years or deemed to have no possibility of interference with the current study (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).\n* Receipt of any organ transplantation, including allogeneic stem cell transplantation\n* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, such as rheumatoid arthritis, which in the opinion of the Investigator might impair the subject's tolerance or ability to participate in the trial\n* Known severe hypersensitivity reactions to monoclonal antibodies or drug formulation components of retifanlimab or Zanalintinib\n* Subject is pregnant or breast feeding or planning to become pregnant while enrolled in the study, up to the final end of treatment visit\n* Congestive heart failure ≥ New York Heart Association (NYHA) class III.\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before start of study drug.\n* Uncontrolled cardiac arrhythmias.\n* Poorly controlled hypertension, defined as a blood pressure consistently above 140\u002F90 mmHg despite optimal medical management.\n* Persistent proteinuria of NCI-CTCAE Grade 3 or higher. Urine dipstick result of 3+ or abnormal, based on type of urine test strip used, is allowed if protein excretion (estimated by urine protein\u002Fcreatinine ratio on a random urine sample) is \\\u003C 3.5 g\u002F24 hr.\n* Non-healing wound, non-healing ulcer, or non-healing bone fracture.\n* Significant acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, malabsorption, or NCI CTCAE Grade ≥ 2 diarrhea of any etiology other then secondary to colon cancer.\n* Participants with an active, known or suspected autoimmune disease. -Participants with type I diabetes mellitus (T1DM), hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n* Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n* Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.\n* Participants using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption) may participate.\n* Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedications are permitted.\n* Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 7 days before first dose of study treatment\n* Has received a live vaccine within 28 days before the planned start of study treatment (mRNA vaccines not considered live vaccines).\n\nNote: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed\n\n* Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 180 days after the last dose of retifanlimab.\n* Participants with laboratory values at screening defined in Table 1.\n* Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment\n* Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\nNote: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n\n* Concomitant anticoagulation with oral anticoagulants and platelets inhibitors including the following Warfarin, Clopidogrel Acceptable anticoagulants include wow molecular weight heparin, aspirin, rivaroxaban, apixaban, edoxaban\n* Subjects must have discontinued non-accepted anticoagulant within 3 days or 5 half-lives prior to first dose of treatment (whichever is longer)\n* Any medical condition, patient characteristic or past medical history that in the opinion of the principal investigator that would interfere with the patient's safety or compliance while on trial\n* Any prior treatment with zanzalitinib or retifanlimab\n* Stroke or including TIA, MI, or other ischemic event within 6 months before first dose of study treatment\n* Known gastric or esophageal varices\n* Ascites, pleural effusions, or pericardial fluid requiring drainage in the last 4 weeks.\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\>0.5 tsp (2.5ml) of red blood, or other history of significant bleeding within 12 weeks before first dose of study treatment\n* Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed)\n* Lesions invading or encasing any major blood vessels\n* Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness with the exception of subjects meeting all of the following criteria: (1) on stable anti-retroviral therapy; (2) CD4+ T cell count ≥ 200\u002FµL; and (3) an undetectable viral load. Note: HIV testing will be performed at screening if and as required by local regulation. Note: In order to be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose.\n* Requirement for hemodialysis or peritoneal dialysis.\n* Major surgery within 8 weeks, prior laparoscopic nephrectomy within 4 weeks, minor surgery within 5 days. Endoscopy with or without biopsy is not considered minor surgery. Subjects must have complete wound healing before first dose of study treatment.\n* Inability to swallow tablets or ingest a suspension either orally or by a NG or PEG tube.\n* Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.\n* Free T4 outside of the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after principal investigator approval.","ALL","18 Years","80 Years",{"count":20,"type":21},26,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II, single-arm, open-label trial evaluating the feasibility, safety, and preliminary activity of neoadjuvant Zanzalintinib (a VEGFR-targeting TKI) and Retifanlimab (an anti-PD-1 antibody) in patients with resectable stage II-III mismatch repair-proficient (pMMR) colon cancer. The study's primary objective is to determine the proportion of patients able to undergo curative-intent surgery within 14-35 days after completing two cycles (6 weeks) of neoadjuvant therapy. Secondary objectives include assessment of safety\u002Ftolerability and rates of pathologic response, including tumor regression grade (TRG). Two-year relapse-free survival (RFS) will also be evaluated.\n\nThis trial builds on emerging evidence from neoadjuvant immunotherapy studies-including in pMMR tumors-and the recently positive readout of STELLAR-303, which evaluated Zanzalintinib plus a PD-(L)1 inhibitor in refractory metastatic colorectal cancer. With a favorable safety profile, short treatment window, and rapid post-treatment pathologic readout, this study provides a low-risk opportunity to test whether immunotherapy-based neoadjuvant strategies can improve outcomes and potentially redefine management in early-stage, pMMR colon cancer.",[27],"Colon Cancer Metastatic","NOT_YET_RECRUITING","2026-06-24",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":21},"2026-08-30",{"date":36,"type":21},"2028-12-30",{"name":38,"class":39},"Northwell Health","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100624271","phase-2-upfront-trastuzumab-deruxtecan-plus-capecitabine-and-bevacizumab-for-patients-with-her-2-positive-metastatic-colorectal-cancer-100624271","NCT07407465","Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.","Phase II Single Arm Study of Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer: the CHIMERA Study.","CHIMERA","Inclusion Criteria:\n\n* Written informed consent obtained from the patient\u002Flegal representative before performing any protocol-related procedures, including screening evaluations.\n* Patient state to comply with all the study procedures and treatments. Patients must be accessible for treatment and follow-up. Patients registered for this trial must be treated and followed at the participating Centre.\n* Age ≥ 18 years at the time of informed consent.\n* ECOG Performance Status ≤ 2.\n* Life expectancy of ≥ 3 months.\n* Have histologically documented adenocarcinoma of the colon or rectum, which is initially metastatic or unresectable locally advanced.\n* Subjects must be willing to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks (or at least 25 freshly sectioned slides) for translational analyses (sampled before 1st treatment course). If archival tissue is not available for HER2 testing or for exploratory aims, then a newly obtained baseline biopsy of an accessible tumor lesion is required before Cycle 1 Day 1 timeframe. Biopsy must contain adequate tissue for analysis; the following biopsy types are acceptable: resection, excision, punch (skin lesions only) and core needle biopsies.\n* Presence of locally determined HER2 overexpression\u002Famplification defined as IHC 3+ or 2+\u002FISH amplified on archival\u002Fnewly obtained tumor tissue, according to the American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines for gastric\u002Fgastroesophageal cancer.\n* Have RAS known status and pMMR\u002FMSS status by standard local testing.\n* Have radiographically measurable disease per RECIST v1.1.\n* Have adequate hematological, hepatic, renal, cardiac and coagulation function, as defined below, obtained ≤ 7 days prior to enrollment (Cycle 1 Day 1):\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3. (Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1).\n  * Platelet count ≥ 100000\u002Fmm3. (Platelet transfusion is not allowed within 1 week prior to C1D1)\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 5 x ULN if liver metastases are present).\n  * Serum albumin ≥ 2.5 g\u002FdL.\n  * Creatinine clearance ≥ 60 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight).\n  * Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before enrollment.\n  * International normalized ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 x ULN.\n* Have had adequate washout period from previous treatment before screening, defined as:\n\n  * ≥ 4 weeks from major surgery.\n  * ≥ 4 weeks from radiation therapy, including palliative stereotactic radiation therapy to the chest.\n  * ≥ 3 weeks from anti-cancer chemotherapy \\[immunotherapy (non-antibody-based therapy)\\], retinoid therapy, hormonal therapy.\n  * ≥ 4 weeks from antibody-based anti-cancer therapy\n  * ≥ 2 weeks or 5 half-lives (whichever is longer) from targeted agent- and small molecule-based therapy\n  * ≥ 6 weeks from nitrosureas or mitomycin C\n  * ≥ 1 week from TKIs approved for treatment of patients with non-small-cell lung cancer (baseline CT must be completed after discontinuation of TKI)\n  * \\> 2 weeks from chloroquine\u002Fhydroxychloroquine\n  * ≥ 2 weeks from cell-free and Concentrated Ascites Reinfusion Therapy (CART), peritoneal shunt or drainage of ascites, pleural or pericardial effusion.\n* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta- human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of IP. Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1. From the time of screening and must agree to continue using such precautions for 7 months after the last dose of investigational product (IP). Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n* Female participants must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study.\n* Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period, by employing protocol-recommended methods. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of randomization\u002Fenrollment, throughout the study and for 4 months after the last dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Preservation of sperm should be considered prior to enrollment in this study.\n\nExclusion Criteria:\n\n* Have previously received any systemic anticancer therapy for CRC in the metastatic\u002Flocally advanced unresectable setting or have participated in any interventional clinical trial for CRC in the metastatic\u002Flocally advanced unresectable setting. Subjects may have received prior fluoropyrimidine with or without oxaliplatin for CRC in the adjuvant or neoadjuvant setting if it was completed \\> 6 months before enrollment.\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.\n* Have previously been treated with an anti-HER2 agent and\u002For a topoisomerase I inhibitor.\n* Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medications.\n* Have substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, 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 (MI) within 6 months before enrollment, 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 undergo a cardiologic consultation before enrollment to rule out MI.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening 12-lead ECG.\n* Symptomatic arterial hypertension or uncontrolled arterial hypertension, as determined by the investigator.\n* Have a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.).\n* Any autoimmune, connective tissue, or inflammatory disorders (e.g., Rheumatoid arthritis, Sjögren's, sarcoidosis etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for patients who are included in the study.\n* Prior pneumonectomy (complete).\n* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n* Have unresolved toxicities from previous anticancer therapy, defined as toxicity (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\> 2 for at least 3 months before enrollment\u002Fcycle 1 day 1 and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy such as: chemotherapy-induced neuropathy and fatigue.\n* Patients with known hypersensitivity to the study drug or to its excipients.\n* Patients with known hypersensitivity to other monoclonal antibodies.\n* Pregnant or breastfeeding female patients, or patients who are planning to become pregnant. Sexually active men not willing to use adequate contraception during whole study period.\n* Previous or concurrent malignancy within 3 years of study entry. Exceptions are adequately resected non-melanoma skin cancer, curatively treated in-situ diseases, and other solid tumors that have been curatively treated.\n* Presence of any of the following dihydropyrimidine dehydrogenase (DPYD) polymorphism, based on local laboratory testing: DPYD 2a (c.1905+1G\\>A); DPYD13 (c.1679 T\\>G); DPYD D949V (c.2846 A\\>T). French and German patients may undergo baseline uracilemia assessment as detailed below in spite of polymorphism testing.\n* Have a history of transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to enrollment (Cycle 1 Day 1).\n* Have a history of a significant bleeding event (e.g., bleeding needing medical intervention) within 6 months prior to enrollment (Cycle 1 Day 1) unless the source of bleeding has been definitively treated.\n* Have a history of GI perforation within 12 months prior to enrollment (Cycle 1 Day 1).\n* Major surgical procedure or significant traumatic injury ≤ 28 days prior to enrollment (≤ 56 days for hepatectomy, open thoracotomy or major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Prior organ transplantation, including allogenic stem-cell transplantation.\n* Known history of HIV infection.\n* Active infection including tuberculosis, hepatitis B, hepatitis C. Patients positive for hepatitis C (HCV) antibody are eligible only if HCV RNA polymerase chain reaction (PCR) is negative. 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 if meeting the following criteria:\n\n  * HBsAg negativity (for more than 6 months off anti-viral treatment).\n  * Anti-HBc positivity (IgG or total Ig).\n  * Absence of cirrhosis or fibrosis on prior imaging or biopsy.\n  * Absence of HCV co-infection and no history of HCV co-infection.\n  * Access to a local HBV expert during and after the study Patients meeting all abovementioned criteria must be closely monitored for HBV reactivation.\n* Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP\n* Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements.\n* Use of any disallowed drugs (see Section 7.5).\n\nAdditional exclusion criteria for France and Germany:\n\n* Patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (uracilemia ≥ 16 ng\u002FmL)\n* Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.",{"count":49,"type":21},42,[24],"The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic\u002Flocally advanced unresectable colorectal cancer",[53,54,55,56,57,27,58],"Colorectal Cancer","Colorectal Adenocarcinoma","Rectal Adenocarcinoma","Rectal Cancer, Adenocarcinoma","Rectal Cancer, Metastatic","Colon Cancer Adenocarcinoma",[60,61,62,63,64,65],"colorectal cancer","HER-2 positive","Trastuzumab-deruxtecan","Capecitabine","Bevacizumab","mCRC","RECRUITING","2026-02-15",{"date":69,"type":32},"2026-02-17",{"date":71,"type":32},"2025-10-20",{"date":73,"type":21},"2027-10-20",{"name":75,"class":39},"Gruppo Oncologico del Nord-Ovest",28]