[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-colorectal-cancer-mcrc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-colorectal-cancer-mcrc":416},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,56,104,137,166,194,218,239,262,282,310,338,363,385],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100586976","phase-1-a-clinical-study-of-arfolitixorin-in-patients-with-mcrc-100586976",false,"NCT06922383","A Clinical Study of Arfolitixorin in Patients With mCRC","A Phase 1b\u002F2 Study of Arfolitixorin as Part of 5-fluorouracil-based Treatment Regimens in the First-line Treatment of Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Signed ICF and ability to comply with protocol requirements.\n* Phase 1b: Histologically confirmed RAS mutant, MSS\u002FpMMR, colorectal adenocarcinoma with metastatic disease, eligible for first-line therapy with 5-FU, oxaliplatin, and bevacizumab regimen.\n\nPhase 2:\n\nHistologically confirmed, colorectal adenocarcinoma with metastatic disease, eligible for first-line therapy with 5-FU based backbones, i.e.:\n\n1. Patients with mutated RAS who are candidates for therapy with FOLFOX or FOLFIRI plus bevacizumab.\n2. Patients with WT RAS or WT BRAF and left-sided tumors who are candidates for therapy with FOLFOX or FOLFIRI plus cetuximab or panitumumab.\n\n   * Tumor specimen (formalin-fixed, paraffin-embedded \\[FFPE\\]) available.\n   * Acceptable hematologic laboratory values defined as:\n\na) Hemoglobin ≥90 g\u002FL. b) Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL. c) Platelets ≥100 × 109\u002FL.\n\n* Adequate organ function as defined by the following laboratory values:\n\n  1. Total serum bilirubin ≤1.5 × upper limit of normal (ULN).\n  2. ALT and AST ≤3 × ULN (≤5 × ULN in case of hepatic metastases).\n  3. Creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL\u002Fmin (as measured according to Cockcroft-Gault equation).\n* Age ≥18 years at the time of signing the ICF.\n* Radiographically measurable disease per RECIST (version 1.1) within 28 days of treatment allocation.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of \\>12 weeks.\n* Female patients must be surgically sterile, postmenopausal, or have negative results for a pregnancy test at screening, on a serum or urine sample obtained within 72 hours prior to initiation of study treatment.\n* Female patients of childbearing potential must agree to use highly effective contraceptive measures while on study treatment and for at least 15 months (or longer if according to local labels) after study treatment discontinuation. Highly effective methods are those that achieve a failure rate of less than 1% per year when used consistently and correctly (as per the Clinical Trial Coordination Group \\[CTCG\\] Recommendations related to contraception and pregnancy testing in clinical trials, Version 1.2, 07 Mar 2024).\n* Female patients should agree to refrain from egg cell donation while on study treatment and for at least 15 months after the last dose of study treatment.\n* Male patients with female partners of childbearing potential must agree to use adequate contraceptive measures while on study treatment and for at least 12 months (or longer if according to local labels) after study treatment discontinuation.\n* Male patients should agree to refrain from sperm donation while on study treatment and for at least 12 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Indication for any mCRC surgery or anti-cancer treatment other than study treatment, including but not limited to resection as confirmed by a MTB.\n* Concomitant malignancies or previous malignancies with less than a 2-year disease free interval at the time of signing consent. Patients with adequately treated basal or squamous cell carcinoma of the skin, or adequately treated carcinoma in situ (e.g., cervix) may enroll irrespective of the time of diagnosis. Patients with controlled, advanced prostate cancer are permitted. Ongoing adjuvant antihormonal therapy after breast or prostate cancer is permitted.\n* Prior 5-FU, oxaliplatin, irinotecan, bevacizumab, cetuximab, or panitumumab administration for mCRC.\n* More than 6 cycles (3 months) of oxaliplatin exposure during adjuvant treatment.\n* Known history of central nervous system (CNS) metastases or carcinomatous meningitis.\n* Receipt of any investigational product within 14 days or 5 half-lives prior to study treatment initiation, whichever is shortest. Note that participation in any other clinical study is not allowed as long as the patient is on study treatment.\n* Prior exposure to arfolitixorin.\n* Major surgery, or significant traumatic injury within 8 weeks of study treatment initiation.\n* Hypersensitivity to arfolitixorin, 5-FU, oxaliplatin or other platinum agent, irinotecan, bevacizumab, cetuximab or panitumumab, or to their excipients.\n* Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency test with a Clinical Pharmacogenetics Implementation Consortium (CPIC) activity score \\\u003C1.\n* Current evidence of any condition that could lead to higher risk or otherwise make participating in this study not in the best interest of the patient, including, but not limited to:\n\n  1. Myocardial infarction or unstable angina within the past 6 months.\n  2. Other structural heart disease (e.g., myocarditis, ventricular hypertrophy).\n  3. New York Heart Association (NYHA) functional classification Class II or greater.\n  4. QT prolongation syndrome \\>450 ms.\n  5. Slow or irregular ventricular rates; other serious arrhythmias requiring medication for treatment.\n  6. Left ventricular ejection fraction (LVEF) \\\u003C55%.\n  7. Active infection requiring i.v. antibiotics.\n  8. Ongoing drug or alcohol abuse.\n  9. Inadequately controlled hypertension (defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg). Initiation of antihypertensives is permitted provided adequate control is documented over at least 1 week before starting treatment.\n* Sensory peripheral neuropathy Grade ≥2.\n* Pregnancy or lactation.\n* Any medical condition, or ongoing treatment with contraindicated drugs, which in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities, or any psychological, familial, sociological or geographical condition that potentially hampers compliance with the study protocol and follow-up schedule.\n* BRAF-mutant or deficient in mismatch repair (dMMR)\u002Fmicrosatellite instability-high (MSI-H) mCRC.\n* Eligibility for treatment with FOLFIRINOX regimens.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a clinical research study taking place in Germany. Patients with colorectal cancer at a stage of the disease where metastases occur may take part in the study. A maximum of 90 people will participate in the study.\n\nThere is already a standard therapy for treatment of colorectal cancer. This therapy contains a combination of the medicines leucovorin, fluorouracil, oxaliplatin\u002Firinotecan and bevacizumab\u002Fcetuximab\u002Fpanitumumab.\n\nThe sponsoring company is developing the new therapy called arfolitixorin. In this study, patients with colorectal cancer will be given arfolitixorin instead of the standard treatment leucovorin. Different patients will receive treatment with different strengths (doses) of arfolitixorin. Treatment with fluorouracil, oxaliplatin\u002Firinotecan and bevacizumab\u002Fcetuximab\u002Fpanitumumab will also be administrated.\n\nThe researchers want to find out if arfolitixorin could have an advantage over the standard therapy with leucovorin. They also want to investigate which dose of arfolitixorin is the maximum tolerated dose and if arfolitixorin is safe to use.\n\nThe product being tested, arfolitixorin, like leucovorin, belongs to a group of substances called folates which are naturally occurring forms of a type of B vitamin. Folates are administered in combination with one or more chemotherapeutic agents to enhance their effect on cancer cells.\n\nThe main mechanism of action of arfolitixorin is the same as that of leucovorin when used together with fluorouracil. However, leucovorin must first be converted into the active form in the body, whereas arfolitixorin already is in the active form. Leucovorin does not work equally well in all patients. By bypassing the metabolic activation of arfolitixorin, it is assumed that arfolitixorin works in a larger number of patients and has a stronger and longer efficacy in cancer treatment together with fluorouracil.\n\nHowever, the efficacy of arfolitixorin has not yet been proven, and the substance has not been approved for the treatment of colorectal cancer. To date, arfolitixorin has been tested by around 420 volunteers and patients with colorectal cancer in different clinical studies. These studies have shown that arfolitixorin is safe and potentially can be of clinical benefit in patients with colorectal cancer when used in combination with fluorouracil, oxaliplatin and bevacizumab.\n\nIn the largest clinical study completed so far, arfolitixorin was shown to be equally effective compared to standard therapy with leucovorin, but not more effective. Additional results from this study suggested that the dose of arfolitixorin given did not deliver a sufficiently high amount of active substance into the tumor. Therefore, higher doses of arfolitixorin will be tested in this study to possibly achieve a better clinical effect. Further analyses also indicated that high accuracy regarding the timing and duration of the administration of the different treatments is important to achieve better efficacy of arfolitixorin.\n\nBased on the available data, and the risk and benefit assessments performed, the Sponsor deems that it is relevant to further investigate the safety and tolerability, as well as the efficacy of arfolitixorin when given in combination with fluorouracil, oxaliplatin\u002Firinotecan and bevacizumab\u002Fcetuximab\u002Fpanitumumab. The proposed study design is believed to address all the main previous findings with the purpose to increase the efficacy while maintaining an acceptable safety profile.\n\nThe study is divided into two parts. In the first part, up to five different doses of arfolitixorin will be investigated to find the maximum tolerated dose of arfolitixorin as well as the optimal duration time of administration.\n\nThe second part of the study will be based on the results from the first part. Two doses of arfolitixorin will be tested for safety, tolerability and anti-tumor effect. In the second part, participants will be randomly assigned to one of two dose groups or a control group (receiving the Standard of Care) using a computer program. This so-called randomization procedure is comparable to tossing a coin.\n\nAll patients that participate in the study will receive treatment every 2 weeks. The treatment will be given as an infusion into a vein. The number of treatment administrations that will be given is not predetermined but depends on the progression of the patient's disease.The treatment will continue every 2 weeks as long as the patient benefits from the treatment.\n\nDuring the study period, the patient's disease and potential response to treatment, including shrinkage of the tumor and\u002For improvement of symptoms, will be monitored by imaging examinations, using so-called computer tomography (CT) or magnetic resonance imaging (MRI). The patient's state of health will also be monitored by physical examinations, and laboratory tests of urine and blood, as well as assessment of any side effects.",[27],"Metastatic Colorectal Cancer (mCRC)",[29,30,31,32,33,34,35,36,37,38,39,40,41,42],"arfolitixorin","coloretal carcionoma","GI neoplasm","5,10-MTHF","tetrahydrofolate","folate","leucovorin","cetuximab","bevacizumab","panitumumab","VEGF inhibitor","EGFR inhibitor","oxaliplatin","irinotecan","RECRUITING","2026-06-25",{"date":46,"type":47},"2026-06-29","ACTUAL",{"date":49,"type":47},"2025-04-10",{"date":51,"type":20},"2029-12-31",{"name":53,"class":54},"Isofol Medical AB","INDUSTRY",3,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":67,"conditions":68,"keywords":82,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100461298","phase-2-pds01adc-in-combination-with-hepatic-artery-infusion-pump-haip-and-systemic-therapy-for-subjects-with-metastatic-colorectal-cancer-intrahepatic-cholangiocarcinoma-or-metastatic-adrenocortical-carcinoma-100461298","NCT05286814","PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n\nInclusion Criteria- All Cohorts\n\n* Participants must have a documented diagnosis of one of the following cancers:\n\n  * Metastatic colorectal cancer (mCRC)\n  * Intrahepatic cholangiocarcinoma (ICC)\n  * Adrenocortical carcinoma (ACC) with liver dominant disease\n* Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:\n\n  * mCRC: FOLFOX or FOLFIRI\n  * ICC: GemOx or FOLFOX\n  * ACC: GemOx\n* Age \\>= 18 years.\n* Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).\n\nNOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n* All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing.\n* Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C\u002FA\u002FP multiphase) amenable to placement of the HAIP.\n* Participant must sign the informed consent form to participate in this study.\n* HIV-positive participants may be considered for this study only if they have an undetectable viral load.\n* Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n* Participant's liver metastases must not be amenable to resection\u002Fablation to No Evidence of Disease (NED) in one stage.\n\nInclusion Criteria-Metastatic Colorectal Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).\n* Participants must have measurable liver metastatic disease.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \\> 60 mL\u002Fmin\u002F1.73 m2.\n\nInclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n* Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.\n* Participants must have radiographically measurable disease.\n* Disease must be considered unresectable at the time of preoperative evaluation.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C=1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 2,000\u002F mm\\^3\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\>= 75,000\u002F mm\\^3\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 mg\u002Fdl\n  * creatinine \\\u003C= 1.5 mg\u002Fdl\n\nInclusion Criteria-Adrenocortical Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as \"adrenocortical cancer\".\n* Participants must have received at least one line of systemic chemotherapy.\n* Participants must have measurable liver metastatic disease.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 X institutional upper limit of normal\n  * creatinine \\\u003C 2 X institutional upper limit of normal\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria- All Cohorts\n\nParticipants who are receiving any other investigational agents.\n\n* Participants who have previously received rIL-12.\n* Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:\n\n  * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;\n  * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \\\u003C= 10 mg of prednisone or equivalent per day;\n  * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.\n* History of organ transplant, except for transplants that do not require immunosuppression.\n* History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).\n* Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke \\\u003C 6 months prior to enrollment, myocardial infarction \\\u003C 6 months prior to enrollment, unstable angina, congestive heart failure (\\>= NYHA III) or serious cardiac arrhythmia requiring medication.\n* All conditions associated with significant necrosis of nontumor-bearing tissues.\n* Esophageal or gastroduodenal ulcers \\\u003C 6 months prior to treatment.\n* Active ischemic bowel disease.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.\n* Prior radiation to liver.\n* Participants with active Hepatitis B or C infection.\n* Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).\n* Any condition, including the presence of laboratory abnormalities and\u002For insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n\nExclusion Criteria-Metastatic Colorectal Carcinoma\n\n-Participants with incontrovertible radiographic evidence of disease outside of the colon\u002Frectum (primary) and liver given unlikelihood of benefit from liver-directed therapy.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.\n* Participants with a history of MSI-high results who need to be treated with check-point inhibitors.\n* Prior treatment with FUDR.\n\nExclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n-Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminate as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Prior treatment with FUDR.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n\nExclusion Criteria-Adrenocortical Carcinoma\n\n* Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n* Diagnosis of sclerosing cholangitis.\n* Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.\n* Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.","120 Years",{"count":65,"type":20},70,[24],"Background:\n\nOne way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\\\u003CTAB\\>\n\nObjective:\n\nTo see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers.\n\nEligibility:\n\nPeople aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nPregnancy test (if needed)\n\nTumor biopsy (if needed)\n\nElectrocardiogram\n\nComputed tomography (CT) scans\n\nParticipants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.\n\nAll participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.\n\nParticipants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks.\n\nParticipants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.\n\nParticipants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.",[69,70,71,72,73,74,75,76,77,78,79,80,81],"Metastatic Colorectal Cancer (Mcrc)","Intrahepatic Cholangiocarcinoma (Icc)","Intrahepatic Bile Duct Cancer","Colorectal Neoplasms","Colorectal Cancer","Cholangiocarcinoma","Bile Duct Neoplasms","Bile Duct Cancer","Adrenocortical Carcinoma (ACC)","Adrenal Cortical Carcinoma","Adrenal Gland Cancer","Adrenal Gland Neoplasms","Adrenal Cortex Neoplasms",[83,84,85,86,87,88,89,90,91,92],"Unresectable Liver Tumor","SMART System","Response Rates","Progression Free Survival (Pfs)","Patient Survival","Overall Survival (Os)","NHS-IL12","Mcrc","Icc","ACC","2026-06-09",{"date":95,"type":47},"2026-06-10",{"date":97,"type":47},"2022-10-24",{"date":99,"type":20},"2028-12-31",{"name":101,"class":102},"National Cancer Institute (NCI)","NIH",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":136},"100588251","randomized-controlled-trial-of-the-effects-of-combined-resistance-and-aerobic-exercise-on-health-related-quality-of-life-in-patients-undergoing-first-line-chemotherapy-for-metastatic-colorectal-cancer-reach-100588251","NCT06938971","Randomized Controlled Trial of the Effects of Combined Resistance and AerobiC Exercise on Health-related Quality of Life in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer (REACH)","Effects of Exercise Training on Health-related Quality of Life in Patients With Unresectable Metastatic Colorectal Cancer: A Multi-center Randomized Controlled Trial","REACH","Inclusion criteria:\n\n\\- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.\n\nExclusion criteria :\n\n* Pregnancy.\n* A life expectancy of \\\u003C 6 months.\n* Absolute contraindications to maximal exercise, as per the recommendations by the Danish Society of Cardiology.\n* ECOG (Eastern Cooperative Oncology Group) performance status \\> 2.\n* Inability to understand the Danish or English language.\n* Engagement in structured moderate-to-high aerobic exercise training for \\>30 min \\>1 times\u002Fweek for the past 3 months at the time of inclusion.",{"count":113,"type":20},150,[115],"NA","The primary objective of this trial is to compare the effects of 18 weeks structured exercise training versus on control on healt-related quality of life in patients with mCRC undergoing first-line chemotherapy.",[27],[119,120,121,122,123,124,125],"Exercise","Physical activity","Metastatic colorectal cancer","Colorectal cancer","Endurance training","Oncology","Chemotherapy","2026-05-08",{"date":128,"type":47},"2026-05-13",{"date":130,"type":47},"2025-05-16",{"date":132,"type":20},"2030-05-01",{"name":134,"class":135},"Rigshospitalet, Denmark","OTHER",4,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":103},"100606131","evaluation-of-a-diagnostic-test-to-identify-the-best-drugs-for-treatment-of-metastatic-colorectal-cancer-100606131","NCT07171554","Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer","Clinical Performance Study of a New Diagnostic Test for Drug Sensitivity Evaluation in Metastatic Colorectal Cancer","DSEE-CRC","Inclusion Criteria:\n\n* Willing and able to give written informed consent (for each part of the study) for participation in the clinical performance study.\n* Male or female patients, ≥18 years of age, with Eastern Cooperative Oncology Group (ECOG) performance status 0-1, who have metastatic lesions in the liver or peritoneum (or lymph nodes) that are radiologically assessable and can be biopsied, and who have recently failed 1st line systemic therapy (2nd line for patients with three standard therapy lines) for unresectable metastatic disease and will shortly commence a new line of standard therapy.\n* Patient is eligible for another line of tumour directed therapy on failure of the SoC.\n* Patient has the following laboratory values, as measured in serum\u002Fplasma within 14 days prior to signing of informed consent for participation in Part A and B, respectively, indicative of adequate organ function:\n\n  * Haemoglobin at least 10.0 g\u002FdL.\n  * Neutrophils at least 1.5 x109\u002FL (without current use of colony-stimulating factors).\n  * Platelets at least 100 x109\u002FL.\n  * AST\u002FALT no higher than 2xULN when patient does not have metastatic disease in the liver, or no higher than 5xULN when patient has metastatic disease in the liver.\n  * Bilirubin no higher than 1.5xULN when patient does not have metastatic disease in the liver, or no higher than 2xULN when patient has metastatic disease in the liver.\n  * Albumin no lower than 30 g\u002FL.\n  * INR within normal level.\n  * Creatinine no higher than 1.5xULN.\n* For Part A: the treating physician should follow contraceptive requirements described in the SmPC of respective treatment.\n* For Part B: women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the patient) or must agree to use a highly effective method of contraception with a failure rate of \\\u003C1 % to prevent pregnancy from at least 2 weeks prior to the screening visit of Part B to 4 weeks after the last administration of IMP in Part B. In addition, any male partner of a female participant must, unless he has undergone vasectomy, agree to use a condom from the screening visit of Part B until 4 weeks after the last administration of IMP in Part B.\n\nThe following are considered highly effective methods of contraception:\n\n* combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),\n* progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),\n* intrauterine device \\[IUD\\]or intrauterine hormone-releasing system \\[IUS\\]) WOCBP must refrain from donating eggs from the first IMP administration until 3 months after the last IMP administration. WOCBP with an exclusive male partner who has undergone vasectomy may chose not to use contraceptives.\n\nWomen of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone \\[FSH\\] \\>25 IU\u002FL is confirmatory). Male participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the first administration of IMP until 4 weeks after the last administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use contraceptive methods with a failure rate of \\\u003C 1% to prevent pregnancy (see above) from at least 2 weeks prior to the first administration of IMP to 4 weeks after the last administration of IMP.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C 3 months.\n* Planned treatment or treatment with another investigational drug or investigational device within 3 months prior to the day of the tumour sampling procedure.\n* Patients who are pregnant, or currently breastfeeding.\n* Investigator considers the patient unlikely to comply with clinical performance study procedures, restrictions and requirements.\n* Part B only: no µCAN report was generated from Part A.\n* Part B only: Patient is not eligible for trifluridine\u002Ftipiracil\u002Fbevacizumab combination therapy.",{"count":146,"type":20},75,[115],"DSEE-CRC is a top-tier Norwegian and Swedish public-private partnership for the development of µCAN, a unique patient-centric, therapy-guiding in vitro diagnostic test to improve cancer treatment outcomes for metastatic colorectal cancer patients. µCAN takes a cancer biopsy sample as input and combines proprietary patient-derived tumoroid culturing conditions with state of-the-art machine learning, and computer-vision guided fluorescence high- content drug screening and analysis, to identify the best therapeutical approach for clinical practice. DSEE-CRC will have a positive societal and financial impact and directly contributes to the Good Health and Well-being Sustainable Development Goals by delivering patient-tailored treatments, concurrently increasing cancer survivability rates, improving patients' quality of care, and reducing cancer treatment costs for healthcare providers.",[27],[151,152,153,154,155,156],"patient-derived tumoroids","in vitro diagnostics","drug screening","clinical performance study","randomized","metastatic colorectal cancer","2026-04-28",{"date":159,"type":47},"2026-04-30",{"date":161,"type":47},"2025-10-28",{"date":163,"type":20},"2029-06",{"name":165,"class":54},"Oncosyne AS",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":103},"100576577","fruquintinib-in-patients-with-metastatic-colorectal-cancer-100576577","NCT06787105","Fruquintinib in Patients With Metastatic Colorectal Cancer","Fruquintinib in Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter, Observational Study","FRUQUENT","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Indication and decision for therapy with fruquintinib in accordance with the current German SmPC of fruquintinib as monotherapy for patients with mCRC.\n* Prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF therapy, and if RAS wild-type, anti EGFR therapy.\n* Progression on or intolerance to treatment with either trifluridine\u002Ftipiracil and\u002For regorafenib.\n* Other criteria according to current SmPC.\n* Signed written informed consent.\\* \\* Patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. These patients cannot participate in the PRO assessments.\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first.\n* Contraindications according to current SmPC.",{"count":113,"type":20},"OBSERVATIONAL","FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies.\n\nTo this end, it will be analyzed how well patients respond to the therapy in the clinical routine. Further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with Fruquintinib.\n\nParticipants will be treated as decided by the treating physician and according to their routine practice.\n\nFRUQUENT is accompanied by a translational research project combining real-world clinical data with foundational research to stratify patient collectives in regards to the therapeutic benefit of fruquintinib.",[27],[179,180,181,182,183,184],"non-interventional","Fruzaqla","electronic QoL questionnaire","Real-world disease control rate","Later line","Fruquintinib","2026-03-31",{"date":187,"type":47},"2026-04-06",{"date":189,"type":47},"2025-02-17",{"date":191,"type":20},"2027-12",{"name":193,"class":54},"iOMEDICO AG",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100622872","phase-3-continuation-of-cetuximab-beyond-first-line-progression-in-metastatic-colorectal-cancer-100622872","NCT07389265","Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer","CAPRI-3 GOIM Study: Phase 3 Clinical Study to Evaluate the Use of Continuing Cetuximab Treatment Beyond First Line Progression in Molecular Selected Metastatic Colorectal Cancer Patients.","CAPRI-3 GOIM","Inclusion Criteria:\n\n1. Histologically proven diagnosis of colorectal adenocarcinoma.\n2. Diagnosis of metastatic disease.\n3. Efficacy of a first line therapy containing anti-EGFR drug with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or a prolonged (at least 6 months) stable disease.\n4. Progression to first line therapy.\n5. RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and\u002For related metastasis.\n6. RAS (NRAS and KRAS exon 2,3 and 4), BRAFV600E, PIK3CA, EGFR ECD wild-type and HER2 not amplified in liquid biopsy at the time of screening (according to NGS, Foundation\u002FRoche).\n7. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1).\n8. Male or female patients ≥ 18 years of age.\n9. ECOG Performance Status 0-1.\n10. Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters:\n\n    Bone marrow:\n    * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109\u002FL\n    * Hemoglobin (Hgb) ≥ 9 g\u002FdL\n    * Platelets ≥ 100 x 109\u002FL\n\n    Liver function:\n\n    • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN\n\n    Renal function:\n\n    • Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL\u002Fmin\n11. If female and of childbearing potential\\*, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\n\n    \\*A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n12. If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 6 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate.\n13. Signed informed consent obtained before screening.\n\nExclusion Criteria:\n\n1. Any contraindication to the use of cetuximab, bevacizumab, Irinotecan, 5-FU, oxaliplatin, folic acid.\n2. Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease.\n3. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix.\n4. Pregnancy (exclusion to be ascertained by a beta hCG test).\n5. Breastfeeding.\n6. Fertile women (\\\u003C2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.\n7. Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification).\n8. Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin.\n9. Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study.\n10. Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study.\n11. Known or clinically suspected brain metastases.\n12. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhea.\n13. Severe, non-healing wounds, ulcers or bone fractures.\n14. Marked proteinuria (nephrotic syndrome).\n15. Known DPD deficiency (specific screening not required).\n16. Known history of alcohol or drug abuse.\n17. A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study.\n18. Absent or restricted legal capacity.\n19. Patients with known dMMR or MSI-H tumors who are eligible for approved immune checkpoint inhibitor therapy will be excluded from the trial, unless ICI therapy is contraindicated or declined by the patient. This ensures alignment with current standard of care.",{"count":203,"type":20},480,[205],"PHASE3","The goal of this Phase 3 clinical trial is to evaluate whether continuing cetuximab treatment beyond first-line progression can improve outcomes in patients with metastatic colorectal cancer whose tumors are RAS and BRAF wild-type. The study will compare the effectiveness of chemotherapy given together with cetuximab versus chemotherapy given together with bevacizumab. Researchers aim to determine whether cetuximab continuation improves tumor response, progression-free survival, overall survival, and safety in this patient population.\n\nEligible participants are adults with metastatic colorectal cancer who have previously responded to first-line treatment with chemotherapy combined with an anti-EGFR antibody. Before starting therapy, patients will undergo molecular testing using liquid biopsy to confirm tumor characteristics. They will then receive chemotherapy with either cetuximab or bevacizumab every two weeks, and their disease will be monitored regularly with CT or MRI scans, laboratory tests, and clinical evaluations. During the study, patients will also provide biological samples for translational research.\n\nThis trial will enroll about 360 patients across sites in Italy and Spain and is designed to provide new evidence on whether cetuximab continuation beyond first-line treatment can offer a meaningful clinical benefit compared with standard therapy.",[27],"2026-02-04",{"date":210,"type":47},"2026-02-05",{"date":212,"type":47},"2025-10-01",{"date":214,"type":20},"2030-10",{"name":216,"class":135},"University of Campania Luigi Vanvitelli",41,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":237,"locationsCount":103},"100623048","phase-1-lpm6690176-in-combination-with-chemotherapy-and-bevacizumab-in-metastatic-colorectal-cancer-patients-with-ras-mutation-100623048","NCT07391566","LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation","Phase 1b\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LPM6690176 Capsules in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation","Inclusion Criteria:\n\n1. Able to provide a signed informed consent;\n2. Age ≥ 18 years and ≤ 75 years, both male and female;\n3. Histologically confirmed metastatic colorectal cancer (CRC) with RAS mutation;\n4. Prior therapies for colorectal cancer:\n\n(1 ) For phase 1b patients: who have failed or intolerable to prior first-line therapy; (2) For phase 2 patients: who have not received prior systemic therapy for metastatic colorectal cancer.\n\n5\\. At least one measurable lesion according to RECIST 1.1 criteria; 6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 7. Life expectancy≥ 6 months; 8. Adequate bone marrow and organ function; 9. Negative pregnancy test for women of childbearing potential. patients of childbearing potential should take effective contraceptive measures during study drug treatment and until 6 months after initiation of investigational product.\n\nExclusion Criteria:\n\n1. Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) who are suitable for immune checkpoint inhibitor therapy as assessed by the investigator;\n2. Malignant tumors other than mCRC within 5 years before signing the informed consent;\n3. Patients who did not recover from the AE of previous anti-tumor treatment to ≤ Grade 1;\n4. Patients with body cavity effusion requiring local treatment or poorly controlled effusion;\n5. Symptomatic brain metastasis, history of spinal cord compression or meningeal metastasis;\n6. Underwent other therapeutic surgery other than diagnosis, biopsy, drainage, or expected to require major surgery during the study, or had unhealed wound, ulcer or fracture.\n7. Current or previous uncontrolled concomitant non-gastrointestinal disease including, but not limited to myocardial infarction, unstable angina, coronary artery\u002Fperipheral artery bypass grafting, heart failure, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, serious arrhythmia, current uncontrolled hypertension, previous history of hypertensive crisis or hypertensive brain disease, tumor invasion into major blood vessels, interstitial lung disease, interstitial pneumonia, pulmonary interstitial fibrosis, reversible posterior leukoencephalopathy syndrome (RPLS), etc.;\n8. Current or past presence of the gastrointestinal abnormalities, including but not limited to active peptic ulcer, clinically significant gastrointestinal abnormalities prior to informed consent, active colitis, long-term anticoagulant therapy, antiplatelet therapy, etc.;\n9. Current or past significant risk of bleeding;\n10. Use of prohibited medication or therapy within the specified time;\n11. History of drug abuse or alcoholism;\n12. Known hypersensitivity to any component of any investigational product;\n13. Pregnant and lactating women;\n14. Other conditions that may increase the risk of the study or interfere with study results, in the judgment of the investigator.","75 Years",{"count":227,"type":20},99,[23,24],"This study is consist of phase 1b (dose escalation + safety run-in) and phase 2 (randomized, controlled). Phase 1b is planned to evaluate the safety and tolerability of LPM6690176 capsule in combination with chemotherapy and Bevacizumab in patients with RAS mutant metastatic colorectal cancer (mCRC), to observe the dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D); Phase 2 is planned to preliminarily evaluate the efficacy of LPM6690176 capsule in combination with chemotherapy + Bev vs. chemotherapy + Bev in patients with previously untreated, RAS mutant mCRC.",[27],"NOT_YET_RECRUITING","2026-02-02",{"date":234,"type":47},"2026-02-06",{"date":185,"type":20},{"date":99,"type":20},{"name":238,"class":54},"Luye Pharma Group Ltd.",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":225,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":4},"100611696","phase-2-phase-ii-basket-trial-zanidatamab-plus-tislelizumab-in-her2-positive-gi-tumors-union-her2-basket-100611696","NCT07243938","Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)","A Prospective, Multi-cohort Clinical Study to Explore the Preliminary Efficacy and Safety of Zanidatamab in Combination With Tislelizumab for HER2-Positive GI Tumors: the UNION-HER2-BASKET Study","Inclusion Criteria:\n\n* Clinical diagnosis of gastric cancer and colorectal cancer\n* Aged 18 to 75 years:\n* Able to sign a written informed consent form and understand and comply with the requirements and evaluation schedule of this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* HER2-Positive: Immunohistochemistry (IHC) 3+ or IHC 2+ with FISH+ or NGS testing for high expression\n* Locally advanced rectal cancer cohort:\n\n  1. Histopathologically confirmed rectal adenocarcinoma\n  2. Tumor tissue confirmed by immunohistochemistry (IHC) as pMMR (high expression of MLH1, MSH2, MSH6, and PMS2 proteins), or confirmed by PCR or NGS as MSI-L or MSS\n  3. Tumor lower margin ≤10 cm from anal margin confirmed by colonoscopy, digital rectal examination, or MRI\n  4. Clinical stage cT3-4N0M0\u002FcTanyN+M0 (TNM staging per UICC\u002FAJCC 8th edition; T and N stages assessed by MRI)\n  5. Patients with one or more risk factors identified by MRI assessment: T4, tumor involvement of the mesorectal fascia (high MRF expression), extramural vascular invasion (high EMVI expression), ≥4 regional lymph node metastases (cN2), high lateral lymph node expression, or tumor margin ≤5 cm from the anal verge with strong organ preservation intent\n  6. No prior antitumor therapy for rectal cancer (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; excludes traditional Chinese medicine\u002Fformulated Chinese medicine treatment)\n* Locally Advanced Gastric\u002FGastroesophageal Junction Cancer Cohort:\n\n  1. Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\n  2. Clinical stage III-IVa (i.e., TNM staging T3\\~4aN+M0 or T4bNanyM0, refer to UICC\u002FAJCC 8th edition)\n  3. No prior antitumor therapy for gastric or gastroesophageal junction adenocarcinoma (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; excludes traditional Chinese medicine\u002FChinese patent medicine treatment)\n* Advanced colorectal cancer cohort:\n\n  1. Histopathologically confirmed advanced colorectal cancer\n  2. Previous systemic anticancer therapy for metastatic colorectal cancer with documented failure, including fluoropyrimidine, oxaliplatin, irinotecan, cetuximab, or bevacizumab (excluding contraindications). Prior anti-HER2 therapy permitted\n  3. At least one measurable lesion defined according to RECIST 1.1\n  4. Expected survival \\> 3 months\n* Good organ function within ≤7 days prior to first study drug administration, as demonstrated by the following laboratory values:\n\n  1. No blood or platelet transfusions or growth factor support therapy within ≤14 days prior to blood sample collection during the screening period, and must meet:\n  2. ANC ≥ 1.5 x 10⁹\u002FL\n  3. Platelet count ≥ 100 x 10⁹\u002FL\n  4. Hemoglobin ≥ 90 g\u002FL\n  5. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN)\n  6. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases)\n  7. Serum total bilirubin ≤ 1.5 times ULN (≤ 3 times ULN for patients with liver metastases)\n  8. International Normalized Ratio (INR) ≤ 1.5 or Prothrombin Time ≤ 1.5 times ULN\n  9. Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN\n  10. Serum albumin ≥ 30 g\u002FL\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must be willing to use highly effective contraception during the trial and for 120 days after the last dose. Male subjects with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 120 days after the last dose.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible for inclusion in this study:\n\n* History of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ, provided complete remission was achieved at least 5 years prior to screening and no additional treatment is required or anticipated during the study period.\n* Any of the following cardiovascular criteria:\n\n  1. Cardiac chest pain occurring ≤28 days prior to the first study drug administration, defined as moderate pain limiting daily activities or exercise\n  2. Symptomatic pulmonary embolism within ≤28 days prior to the first dose of study drug\n  3. History of any acute myocardial infarction within ≤6 months prior to the first dose of study drug\n  4. History of any New York Heart Association (NYHA) Class III or IV heart failure within ≤6 months prior to the first dose of study drug\n  5. Any ventricular arrhythmia event of severity ≥ Grade 2 within ≤ 6 months prior to the first dose of the study drug\n  6. History of any cerebrovascular accident within ≤6 months prior to the first dose of the study drug\n  7. Corrected QT interval (QTc) (corrected using Fridericia's formula) ≥ 470 msec in females or ≥ 450 msec in males\n\n  i) Note: If any patient's initial ECG shows a QTc interval \\> 450 msec (male) or \\> 470 msec (female), a follow-up ECG will be performed to verify the result h) Left ventricular ejection fraction (LVEF) ≤50% as assessed by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO). Follow-up assessment must use the same modality as the baseline assessment\n* Any syncope or seizure occurring ≤28 days prior to the first study drug administration.\n* Active autoimmune disease requiring systemic treatment within the past 2 years.\n* Known history of human immunodeficiency virus (HIV) infection\n* Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \\> 500 IU\u002FmL) or active HCV carriers with detectable HCV RNA; Note: Inactive hepatitis B surface antigen (HBsAg) carriers and treated, stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL) are eligible for enrollment\n* History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary conditions, including pulmonary fibrosis, acute pulmonary disease, etc.\n* Severe chronic or active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first study drug dose. Note: Antiviral therapy is permitted for patients with viral hepatitis.\n* Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent \\>10 mg\u002Fday) or other immunosuppressive agents within ≤14 days prior to the first dose of study drug\n* Hypersensitivity to any component of tislelizumab, zanidatamab，capecitabine, S-1, oxaliplatin, or any component of the container\n* Any major surgery requiring general anesthesia within ≤28 days prior to the first dose of study drug\n* Bleeding, thrombotic disorders, or use of anticoagulants (e.g., warfarin) or similar agents requiring therapeutic INR monitoring within 6 months prior to the first dose of study drug\n* History of allogeneic stem cell transplantation or organ transplantation\n* Live vaccine administration within ≤28 days prior to the first study drug dose. Note: Seasonal influenza vaccines, broadly classified as inactivated vaccines, are permitted. Inactivated COVID-19 vaccines are permitted. mRNA COVID-19 vaccines are not permitted. Intranasal influenza vaccines are live vaccines and are not permitted.\n* Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the participant is in the follow-up period of an interventional study\n* Inability to swallow tablets or diseases significantly affecting gastrointestinal function\n* Pregnant or lactating women\n* Other conditions deemed ineligible by the investigator.\n* Locally Advanced Rectal Cancer Cohort:\n\n  1. Previous treatment for rectal cancer, or clinical or imaging evidence of existing or potential distant metastasis\n  2. Clinical or imaging evidence of intestinal obstruction, gastrointestinal perforation with bleeding, prior abdominal abscess, or recent (within 3 months) occurrence of gastrointestinal perforation, abdominal abscess, or intestinal obstruction; or investigator assessment indicating high risk of perforation or bleeding\n  3. Assessed by the investigator as initially unresectable or unable to tolerate surgery\n  4. Patient assessed by the investigator as having factors rendering them unsuitable for radiotherapy\n  5. The patient has ≥2 concurrent colorectal cancer lesions\n  6. Patient has contraindications for MRI examination\n* Locally Advanced Gastric\u002FGastroesophageal Junction Cancer Cohort:\n\n  1. Previous treatment for gastric\u002Fgastroesophageal junction cancer, or clinical\u002Fimaging evidence of existing or potential distant metastasis\n  2. Clinical or imaging evidence of intestinal obstruction, gastrointestinal perforation, or bleeding; prior abdominal abscess; or recent (within 3 months) gastrointestinal perforation, abdominal abscess, or intestinal obstruction; or investigator assessment indicating high risk of perforation or bleeding\n  3. Initial inoperability as assessed by the investigator, or inability of the patient to tolerate surgery\n* Advanced colorectal cancer cohort:\n\n  1. Patients with any prior histopathological or hematological ctDNA testing demonstrating mismatch repair gene deficiency (dMMR) or microsatellite instability (MSI-H)\n  2. Presence of active leptomeningeal disease or uncontrolled brain metastases. Patients with previously treated brain metastases may be eligible if imaging shows stability, confirmed by repeat imaging demonstrating no progression for at least 4 weeks (Note: repeat imaging must occur during the study screening period).",{"count":65,"type":20},[24],"This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy\u002Fradiotherapy for patients with HER2-positive locally advanced or metastatic gastrointestinal tumors.",[250,251,27,252],"Locally Advanced Rectal Cancer (LARC)","Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Neoadjuvant Therapy","2025-11-21",{"date":255,"type":47},"2025-11-24",{"date":257,"type":20},"2026-01-15",{"date":259,"type":20},"2031-06-01",{"name":261,"class":135},"Tao Zhang",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":225,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":278,"leadSponsor":280,"locationsCount":4},"100603260","phase-3-the-study-of-jmt101-combined-with-irinotecan-as-a-3rd-line-treatment-in-metastatic-colorectal-cancer-100603260","NCT07134205","The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer","A Randomized, Open-label, Multicenter Phase III Clinical Study of JMT101 in Combination With Irinotecan in Third-line and Beyond Treatment of Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Age ranged from 18 to 75 years old (inclusive), regardless of gender;\n* 2\\. Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR\u002FMSI-H;\n* 3\\. Tumor tissue available for central laboratory testing;\n* 4\\. Metastatic colorectal cancer with disease progression after 2nd line treatment; previously received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan; patients are allowed to previously receive EGFR and\u002For VEGF inhibitors, but not allowed to previously receive regorafenib, fruquintinib;\n* 5\\. Measurable disease according to RECIST1.1;\n* 6\\. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;\n* 7\\. Life expectancy ≥3 months\n* 8\\. Adequate main organs and bone marrow function.\n* 9\\. Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Participants who have been systematically treated with an EGFR inhibitor (such as cetuximab) within 4 months prior to the first dose of study drug.\n* 2\\. Central nervous system metastasis or meningeal metastasis;\n* 3\\. Patients with high risk of bleeding due to tumor invasion of important arteries;\n* 4\\. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;\n* 5\\. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;\n* 6\\. Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug;\n* 7\\. Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, etc. within 21 days before the first dose of the study drug; radiotherapy within 2 weeks before the first dose of the study drug; Chinese medicine or Chinese patent medicine with anti-tumor effect within 1 week before the first dose of the study drug;\n* 8\\. Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;\n* 9\\. Use of immunosuppressive medications within 14 days prior to the first dose of study drug;\n* 10\\. Those who use strong CYP3A4 inducers within 14 days before the first administration of the study drug, or those who use strong CYP3A4 inhibitors or strong UGT1A9 inhibitors within 2 week, or those who cannot suspend the use of the above drugs during the study;\n* 11\\. Have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug;\n* 12\\. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;\n* 13\\. Have a history of serious cardiovascular disease;\n* 14\\. Previous or current presence of interstitial pneumonia\u002Flung disease;\n* 15\\. History of autoimmune diseases;\n* 16\\. A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;\n* 17\\. Have infectious diseases requiring systemic anti-infective treatment;\n* 18\\. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;\n* 19\\. Known presence of hypersensitivity or intolerance to any component of EGFR monoclonal antibody, irinotecan hydrochloride injection, regorafenib and its excipients;\n* 20\\. Women during lactation or pregnancy; women with fertility tested positive for blood pregnancy within 7 days prior to enrollment in the trial;\n* 21\\. Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration;\n* 22\\. Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.",{"count":270,"type":20},252,[205],"This is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer.",[27],"2025-08-14",{"date":276,"type":47},"2025-08-21",{"date":212,"type":20},{"date":279,"type":20},"2028-10-01",{"name":281,"class":54},"Shanghai JMT-Bio Inc.",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":103},"100565673","dhf-20-1839-2-clinical-performance-study-protocol-for-therascreen-kras-rgq-pcr-kit-100565673","NCT06645236","DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit","Interventional IVD Study Testing DNA From Tumor Tissue Biopsies From mCRC Patients to Determine KRAS G12C Mutation Status for the Inclusion in the Amgen Clinical Trial, 20210081 for the Clinical Performance of Therascreen® KRAS RGQ PCR Kit","Inclusion Criteria:\n\n* Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue tested for the presence of KRAS G12C mutation under the proposed performance study.\n\nExclusion Criteria:\n\n* There is no separate inclusion and exclusion criteria for the performance study.",{"count":290,"type":20},600,[115],"To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.",[27],[295,296,297,298,299,300],"Metastatic Colorectal Cancer","therascreen","KRAS G12C","sotorasib","Clinical Performance Study","Companion Diagnostic","2025-08-12",{"date":303,"type":47},"2025-08-15",{"date":305,"type":47},"2023-12-22",{"date":307,"type":20},"2030-10-31",{"name":309,"class":54},"QIAGEN Gaithersburg, Inc",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":103},"100589097","phase-2-efficacy-and-safety-of-hydroxychloroquine-combined-with-methotrexate-capecitabine-and-bevacizumab-vs-regorafenib-in-participants-with-refractory-metastatic-colorectal-cancer-with-mutations-in-ras-genes-100589097","NCT06949982","Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes","A Randomized Trial To Compare Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Versus Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes","x-МАР","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Provide written informed consent\n* Age ≥ 18 years\n* Histologically confirmed diagnosis of colorectal cancer (CRC) with distant metastases.\n* Presence of mutations in the KRAS or NRAS gene.\n* Participants must have previously treated for metastatic colorectal cancer and experienced disease progression during receiving at least 2 lines of systemic chemotherapy in combination with antiangiogenic agents.\n* Patient has previously received oxaliplatin- and irinotecan-containing regimens and developed resistance to these chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York Heart Association Class III\u002FIV congestive heart failure, ventricular arrhythmias.\n* Stroke and\u002For transient ischemic attack within 6 months prior to screening;\n* Uncontrolled hypertension\n* History of previous malignancies except non-melanoma skin cancers, or in situ cervical or breast cancer unless a complete remission was achieved at least 2 years prior to randomization AND no additional therapy is required during the study period. Patients having hepatic involvement of cancer should be excluded as per investigator assessment.\n* Patients with CNS metastases are eligible only if the metastases are adequately treated.\n* Absolute neutrophil count (ANC) \\\u003C1.5×109\u002FL, platelet count \\\u003C100×109\u002FL, or hemoglobin \\\u003C9.0 g\u002FdL.\n* Serum total bilirubin \\>1.5 × the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin \\\u003C2 X ULN, and normal AST\u002FALT are eligible;\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 × ULN;\n* Serum creatinine \\>1.5 × ULN.\n* History of a thromboembolic event\n* Presence of any allergic reactions to components of the study drugs\n* Concomitant medications with a known risk of causing QT prolongation and\u002For Torsades de Pointes.\n* Any anti-cancer systemic therapy, radiation therapy\n* Women who are pregnant or lactating;\n* Presence of unresolved adverse events of grade 2 or higher toxicity, according to CTCAE v5.0 criteria, from prior therapy (except for alopecia or neurotoxicity grade≤2).\n* Any other serious or uncontrolled medical disorder, active infection, physical examination finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a patient's ability to comply with the study requirements, substantially increase risk to the patient, or impact the interpretability of study results.",{"count":319,"type":20},60,[24],"This study will evaluate efficacy and safety of hydroxychloroquine combined with methotrexate, capecitabine and bevacizumab versus regorafenib in participants with refractory metastatic colorectal cancer with mutations in KRAS or NRAS genes. The hypotheses of this study are that a combination of hydroxychloroquine, methotrexate, capecitabine, and bevacizumab (compared to regorafenib) prolongs progression-free survival and overall survival, and also increases rates of objective responses and disease control.",[27,72],[324,325,326,327,328],"Refractory metastatic colorectal cancer","Hydroxychloroquine","Regorafenib","KRAS mutation","NRAS mutation","2025-04-30",{"date":331,"type":47},"2025-05-04",{"date":333,"type":47},"2025-03-17",{"date":335,"type":20},"2027-10",{"name":337,"class":135},"Sergey Orlov, MD",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":21,"phases":347,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":103},"100563823","early-phase-1-a-clinical-trial-evaluating-the-safety-and-efficacy-of-intravenous-hnf4-srrna-in-treating-metastatic-crc-patients-100563823","NCT06621173","A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients","A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α SrRNA for the Treatment of Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Males or females, aged 18 years or older.\n2. Patients with histologically confirmed colorectal cancer that has been determined to be unresectable or metastatic.\n3. Colorectal cancer subjects who are unsuitable or unable to tolerate standard systemic therapy, or who have received standard systemic therapy but have disease progression based on RECIST (version 1.1) criteria, including chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted therapies with anti-VEGF\u002FEGFR monoclonal antibodies.\n4. Patients with confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue, who have been treated with immune checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) and are assessed with disease progression.\n5. According to the RECIST (version 1.1) criteria, there are measurable target lesions suitable for repeated measurements for assessment.\n6. Life expectancy of 12 weeks or more.\n7. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.\n8. Males with fertility and females of childbearing potential are willing to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation. Females of childbearing age, including premenopausal females and within 2 years after menopause, must have a negative serum pregnancy test result within 7 days prior to the first dose of study treatment.\n9. Subjects who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria were excluded from participation in this study\n\n  1. Patients who have undergone standard adjuvant chemotherapy after tumor resection, and have experienced recurrence or metastasis within 6 months after discontinuing the medication, and have not received standard systemic therapy.\n  2. Clinical or imaging indications suggest the current presence of intestinal obstruction, perforation, or bleeding; or those who, upon investigator assessment, are at a higher risk of perforation or bleeding.\n  3. Inadequate liver function：serum bilirubin \\> 3 × the upper limit of normal (ULN), or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \\> 5 × ULN.\n  4. Inadequate renal function defined as creatinine \\>1.5 × ULN or calculated creatinine clearance \\< 40 mL\u002Fmin.\n  5. Absolute neutrophil count (ANC) \\< 1.5×109\u002FL, or Platelets \\< 50×109\u002FL, or Hemoglobin \\< 9.0 g\u002FdL.\n  6. International normalized ratio (INR) \\> 2.0.\n  7. Patients with confirmed tumor brain metastases.\n  8. Poorly controlled hypertension, diabetes or other serious heart or lung diseases, or with serious dysfunction.\n  9. Patients who have received local or systemic anti-tumor treatments such as immunotherapy, targeted therapy, and chemotherapy within 4 weeks, or radiation therapy within 3 weeks, except for treatment regimens assessed as disease progression according to RECIST v1.1.\n  10. All toxicities related to prior locoregional or systemic anti-tumor treatments are still grade 2 or more (except for hair loss and other events that have been judged tolerable by researchers).\n  11. Uncontrolled active infection (eg, lung infections, or abdominal infections).\n  12. History of malignancy other than CRC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate \\> 90%), such as adequately treated early gastric carcinoma, carcinoma in situ of the cervix, non-melanoma skin carcinoma, or localized prostate cancer.\n  13. Having an active autoimmune disease that requires systemic treatment within the past 2 years.\n  14. Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent \\>10mg\u002Fday) or other immunosuppressive drugs within 14 days prior to the first administration of the investigational drug.\n  15. Patients with a history of organ transplantation.\n  16. Hepatitis B virus DNA greater than 500 IU\u002Fml, or hepatitis C virus RNA greater than 100 IU\u002Fml.\n  17. Positive for human immunodeficiency virus (HIV).\n  18. Pregnant\u002Flactating women, or women with the possibility of pregnancy.\n  19. Individuals who have participated in other drug trials within 4 weeks.\n  20. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.",{"count":346,"type":20},9,[348],"EARLY_PHASE1","This trial is a single-arm, open-label, exploratory first-in-human clinical study designed to evaluate the safety and tolerability of HNF4α srRNA injection in patients with locally unresectable or metastatic colorectal cancer, and to preliminarily explore its effectiveness in treating metastatic colorectal cancer.",[27],[352,353],"colorectal cancer","Hepatocyte nuclear factor 4α","2025-04-21",{"date":356,"type":47},"2025-04-24",{"date":358,"type":47},"2024-11-12",{"date":360,"type":20},"2026-09",{"name":362,"class":135},"Shanghai Changzheng Hospital",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":369,"targetDuration":371,"studyType":175,"phases":4,"briefSummary":372,"conditions":373,"keywords":374,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":384},"100568261","agmt-metastatic-colorectal-cancer-registry-mcrc-third-line-and-beyond-100568261","NCT06678919","AGMT Metastatic Colorectal Cancer Registry (mCRC) Third Line and Beyond","Inclusion Criteria:\n\n* patients ≥ 18 years with tissue-based diagnosis of mCRC\n* ≥ 2 prior lines of palliative systemic therapy including 5-FU, irinotecan, oxaliplatin, anti-VEGF, anti-EGFR (in case of RAS\u002FBRAF wildtype), anti-PD1- therapy (in case of MSI\u002FMMRd) . (Exception: Patients who have received mFOLFOXIRI +\u002F- anti-VEGF or anti- EGFR- 1L therapy or patients with ineligibility to receive 5-FU, oxaliplatin or irinotecan can be included after 1st line.)\n\nExclusion Criteria:\n\n* Due to the non-interventional design of this registry, there are no specific exclusion criteria",{"count":370,"type":20},500,"10 Years","Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States and Europe. Although selected patients with oligometastatic CRC undergo systemic therapy and surgery\u002Flocal ablative therapy in curative intent, the treatment approach for the majority of metastatic CRC (mCRC) patients remains palliative with a median overall survival (OS) ranging between 9-38 months depending on various prognostic and predictive factors. Particularly in advanced stages (in the third line of therapy and beyond), interesting and promising results have recently been achieved with various treatment approaches. The aim of this registry is to establish a disease-specific registry to evaluate the treatment landscape of patients with mCRC who have already received at least two lines of therapy.",[27],[375],"colorectal","2025-04-09",{"date":49,"type":47},{"date":379,"type":47},"2024-10-31",{"date":381,"type":20},"2034-12",{"name":383,"class":135},"Arbeitsgemeinschaft medikamentoese Tumortherapie",7,{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":21,"phases":394,"briefSummary":395,"conditions":396,"keywords":404,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":103},"100513809","phase-2-xelox-bev-tislelizumab-for-first-line-treatment-of-msspmmr-ras-mutated-mcrc-100513809","NCT05970302","XELOX +Bev +Tislelizumab for First-line Treatment of MSS\u002FpMMR RAS-mutated mCRC","XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS\u002FpMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study.","Inclusion Criteria:\n\n1. Histologically confirmed initially unresectable MSS\u002FpMMR-type RAS-mutant metastatic colorectal adenocarcinoma;\n2. ECOG score of 0 or 1;\n3. Ability to swallow oral medications;\n4. Have at least one measurable lesion (according to RECIST v1.1 standard);\n5. No anti-tumor treatment has been received after recurrence and metastasis;\n6. Neoadjuvant or adjuvant chemotherapy containing fluorouracil drugs is allowed before or after radical resection of colorectal cancer, but the treatment needs to be completed for ≥ 6 months; if oxaliplatin is used in neoadjuvant or adjuvant chemotherapy, it includes The oxaliplatin regimen needs to be completed for ≥12 months;\n7. Adequate organ function: On the premise of no component blood transfusion within 14 days: white blood cells ≥ 3.5\\*10\\^9\u002FL and neutrophils ≥ 1.5\\*10\\^9\u002FL, hemoglobin ≥ 90g\u002FL, platelets ≥ 100\\* 10\\^9\u002FL; serum bilirubin ≤ 1.5 times the normal value, alanine aminotransferase (ALT) ≤ 2.5 times the normal value, aspartate aminotransferase (AST) ≤ 2.5 times the normal value; Urinary protein \\\u003C2+. Or urine protein 2+ but 24-hour urine protein quantity ≤ 1 g; serum creatinine ≤ 1.5 times of normal value, creatinine clearance rate ≥ 60ml\u002Fmin; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);\n8. Expected survival period ≥ 3 months;\n9. Patients fully understand this research, voluntarily participate in this clinical trial and sign an informed consent;\n10. Women with reproductive potential (\\\u003C 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.\n\nExclusion Criteria:\n\n1. Previously received bevacizumab or anti-CTLA4, anti-PD-1\u002FPD-L1 therapeutic antibodies or pathway-targeted drugs;\n2. Received radiotherapy within 4 weeks before the evaluation;\n3. Symptomatic peripheral neuropathy \\> grade 2 (CTCAE5.0 standard);\n4. Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;\n5. HIV-positive and other immunodeficiency diseases;\n6. Active hepatitis B or hepatitis C (except for those who have been infected or cured before, that is, HBsAg negative and hepatitis B core antigen anti-HBc antibody positive; except for hepatitis C patients whose HCV RNA is negative by PCR);\n7. Existing autoimmune diseases or other diseases that require immunosuppressant treatment, except for type 1 diabetes; except for hypothyroidism that only requires hormone replacement therapy; skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia areata); inhaled or topical steroids or equivalent steroids in excess of 10 mg prednisone per day, except for inactive autoimmune disease on adrenal replacement therapy;\n8. Received systemic hormone therapy or treatment with a daily dose of more than 10 mg prednisone equivalent dose or other forms of immunosuppressive treatment within 7 days, but inhaled or topical steroids or daily application of more than 10 mg prednisone, etc. Except for inactive autoimmune diseases treated with adrenal replacement therapy with potent steroids;\n9. Have a history of organ transplantation;\n10. Uncontrolled central nervous system (CNC) metastasis (symptomatic or metastatic sites are midbrain, pons, medulla or spinal cord) or other central nervous system diseases;\n11. Those who have undergone major surgery, open biopsy or obvious traumatic trauma within 1 month, or who may need major surgery during the study period; those who have undergone open biopsy or obvious traumatic trauma, or may need major surgery during the study period;\n12. Combined with other malignant tumors other than intestinal cancer (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors has been completed for more than 1 year, and there is no clinical and imaging evidence of recurrence or progression except);\n13. Combined active and refractory infection;\n14. Cardiovascular diseases with clinical significance, such as cardiovascular accident (CVA) (≤ 6 months before treatment), myocardial infarction (≤ 6 months before treatment), unstable angina, chronic heart failure of NYHA ≥ 2 (CHF), uncontrolled arrhythmia; uncontrolled hypertension; thromboembolic or bleeding events within 6 months before treatment;\n15. Evidence of causing coagulation disease;\n16. With dysphagia, active peptic ulcer, complete or incomplete intestinal obstruction, active gastrointestinal bleeding, perforation, malabsorption syndrome or uncontrollable gastrointestinal inflammatory disease (such as Crohn's disease or ulcerative colon inflammation);\n17. Severe unhealed wounds\u002Fulcers or severe fractures;\n18. Any serious acute or chronic medical condition that may affect the patient's participation in the study or interfere with the interpretation of the study results;\n19. There are mental illnesses, serious social and psychological illnesses, or researchers believe that there are factors that may affect research compliance;\n20. Pregnant or lactating women;\n21. No therapeutic anticoagulant or antiplatelet drugs or NSAIDs (aspirin ≤ 325 mg\u002Fday allowed);\n22. Severe allergic reaction to the test drug;\n23. Reluctance to use alternative therapies such as (but not limited to) bisphosphonates if receiving RANKL inhibitors (eg, denosumab).",{"count":393,"type":20},52,[24],"The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS\u002FpMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a \"hot tumor\" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.",[397,398,399,400,401,27,402,403],"Tislelizumab","Bevacizumab","Oxaliplatin","Capecitabine","MSS\u002FpMMR","RAS-mutated","First-Line",[405,406],"Single-arm","Phase II","2023-07-21",{"date":409,"type":47},"2023-08-01",{"date":411,"type":47},"2023-07-07",{"date":413,"type":20},"2026-07",{"name":415,"class":135},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","Metastatic Colorectal Cancer (MCRC)"]