[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-colorectal-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,41,70,97,136,155,181,206,229,252,272,294,316,338,356,382,409,429,451],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644930","phase-3-a-randomized-open-label-controlled-multicenter-phase-iii-clinical-study-of-shr-a1811-in-combination-with-chemotherapy-and-bevacizumab-versus-standard-therapy-as-first-line-treatment-for-advanced-colorectal-cancer-100644930",false,"NCT07676162","A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer","A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With mFOLFOX6 (-1) and Bevacizumab Versus mFOLFOX6 in Combination With Bevacizumab as First-line Treatment for Advanced Colorectal Cancer.","Inclusion Criteria:\n\n1. Subjects voluntarily enroll in the study, sign informed consent, demonstrate good compliance and cooperate with follow-up visits.\n2. Aged between 18 and 75 years inclusive, male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Estimated survival expectancy ≥ 12 weeks.\n5. Histologically or cytologically confirmed colorectal adenocarcinoma.\n6. No prior systemic anti-tumor therapy.\n7. Tumor tissue specimen must be provided, either archived within 1 year prior to first study treatment or newly collected fresh specimen.\n8. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; the measurable lesion shall not have received prior local therapy such as radiotherapy.\n9. Adequate organ function with relevant laboratory tests completed within 7 days before the first study treatment.\n10. Male subjects with fertile female partners and fertile female subjects must use highly effective contraception throughout the study. Fertile female subjects must have a negative serum or urine human chorionic gonadotropin (HCG) test within 7 days prior to first study drug administration and shall not be breastfeeding.\n\nExclusion Criteria:\n\n1. Received systemic anti-tumor therapies (including investigational agents) or major surgery within 4 weeks prior to the first study drug administration; palliative radiotherapy within 2 weeks or surgery within 4 weeks before study treatment initiation.\n2. History of hypersensitivity to monoclonal antibodies or any component of the investigational products to be administered in this study.\n3. Pre-existing peripheral neuropathy of Grade \\>1.\n4. History of thromboembolic disease within 6 months or hemoptysis within 3 months before first study medication. Subjects with muscular venous thrombosis not requiring anticoagulation per investigator's assessment are eligible for enrollment.\n5. CT\u002FMRI evidence of tumor encasement or invasion of major blood vessels.\n6. Non-gastrointestinal bleeding within 6 months prior to first study drug administration, or active peptic ulcer disease.\n7. Uncontrolled hypertension, or medical history of hypertensive crisis or hypertensive encephalopathy.\n8. History of severe cerebrovascular disease.\n9. Unresolved toxicities and\u002For complications from prior interventions that have not recovered to baseline.\n10. Subjects with a history of or current leptomeningeal metastases, or active brain metastases.\n11. Known or suspected interstitial lung disease (ILD); moderate-to-severe pulmonary disease significantly impairing respiratory function or autoimmune\u002Fconnective tissue\u002Finflammatory diseases involving the lung within 3 months before first dosing that may interfere with detection or management of drug-related pulmonary toxicity. Subjects who developed ≥Grade 3 ILD during prior immune checkpoint inhibitor treatment are excluded.\n12. Symptomatic moderate to severe ascites; uncontrolled moderate or greater pleural or pericardial effusion.\n13. Bowel obstruction within 3 months prior to first study treatment, or prior intestinal stent placement with the stent remaining in situ at screening.\n14. Uncontrolled or severe cardiovascular disease, or unstable angina\u002Funstable arrhythmia occurring within 1 month before initiation of study treatment.\n15. Unexplained fever \\>38.5°C at screening or prior to first dose; severe infection (CTCAE Grade \\>2) within 4 weeks before study drug initiation; active pulmonary inflammation on baseline chest imaging, or clinical signs\u002Fsymptoms of infection requiring oral or intravenous antibiotics within 2 weeks before first dosing.\n16. Previous or concurrent diagnosis of other malignant malignancies.\n17. Active hepatitis B or active hepatitis C infection.\n18. History of immunodeficiency including positive HIV test, congenital\u002Facquired immunodeficiency disorders, or prior solid organ transplantation.\n19. Active pulmonary tuberculosis infection within 1 year prior to screening, or prior active pulmonary tuberculosis without standard anti-tuberculosis treatment even if diagnosed more than 1 year ago.\n20. Pregnant, breastfeeding females or females planning pregnancy during the study period.\n21. Uncontrolled psychiatric disorders, known alcohol abuse, illicit drug dependence, incarceration or other conditions that would preclude completion of study procedures.\n22. Any other conditions deemed inappropriate for study participation by the investigator, including clinically significant abnormal laboratory values, familial\u002Fsocial factors or other risks leading to premature study discontinuation or confounding study results.","ALL","18 Years","75 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.",[27],"Advanced Colorectal Cancer","NOT_YET_RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":21},"2026-07",{"date":36,"type":21},"2029-09",{"name":38,"class":39},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100601095","phase-2-standard-second-line-therapy-with-ongericimab-and-toripalimab-in-pmmrmss-colorectal-cancer-a-single-arm-phase-ii-trial-100601095","NCT07106034","Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR\u002FMSS Colorectal Cancer: a Single-arm Phase II Trial","Clinical Study of Second-Line Standard Therapy Combined With Ongericimab and Toripalimab in Patients With MSS\u002FpMMR Colorectal Cancer Following First-Line Treatment Failure","ONTOP","Inclusion Criteria:\n\n1. Subjects aged 18-75 years (inclusive of 18 and 75 years) at the time of signing the informed consent, regardless of gender.\n2. Histologically confirmed MSS\u002FpMMR colorectal or rectal cancer, who have progressed on first-line fluoropyrimidine - based combination therapy (including progression during maintenance therapy). If FOLFOXIRI was received in the first - line, screening is not allowed; if progression occurred during neoadjuvant\u002Fadjuvant therapy or within 6 months after the last dose, it is considered first-line treatment failure, and the patient is eligible for enrollment.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n4. Predicted survival ≥ 12 weeks.\n5. At least 1 measurable lesion according to RECIST 1.1 evaluation criteria.\n6. Adequate organ function；\n7. Female or male subjects with childbearing potential must agree to have no childbearing plans within 6 months after the end of the last dose during the study period and be willing to take highly effective contraceptive measures together with their partners. For female subjects with childbearing potential, the serum pregnancy test must be negative within 7 days before the first dose, and they must be non - lactating.\n8. Be able to provide a signed informed consent form, including complying with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal metastasis; presence of active brain metastasis, defined as untreated and\u002For having clinical symptoms, or requiring glucocorticoids or antiepileptic drugs to control related symptoms. For those who have received local treatments such as surgery or radiotherapy, if the screening - period imaging assessment shows no evidence of progression for at least four weeks and symptoms disappear (except for residual signs or symptoms related to brain metastasis), no glucocorticoid treatment is needed for at least 2 weeks, and the acute toxicities related to previous treatments have recovered, enrollment is allowed.\n2. Presence of pleural effusion, peritoneal effusion, or pericardial effusion with clinical symptoms or requiring repeated management (such as puncture or drainage).\n3. History of immunodeficiency disorders, including positive detection of human immunodeficiency virus (HIV), or known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n4. History of severe cardiovascular diseases, including but not limited to: myocardial infarction within 6 months before the first study drug administration, severe\u002Funstable angina pectoris, congestive heart failure (NYHA heart function class ≥2), severe supraventricular or ventricular arrhythmia, aortic aneurysm requiring surgical repair, any arterial thromboembolic event, grade 3 or above venous thromboembolic event, transient ischemic attack, cerebrovascular accident.\n5. Presence of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first drug administration.\n6. Severe infection within 28 days before the first study drug administration (CTCAE 5.0 ≥ grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active infection requiring intravenous anti-infection treatment or unexplained fever \\> 38.5°C within 2 weeks before the first study drug administration (judged by the researcher; fever caused by the tumor in the subject can be enrolled).\n7. Presence of active tuberculosis, hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive and HBV DNA higher than the lower limit of detection of the research center), hepatitis C (HCV Ab positive and HCV RNA higher than the lower limit of detection of the research center).\n8. History of another primary malignant tumor, except for those who have received radical treatment before the first administration of the study intervention, have no known active disease (for more than 5 years), and have a low potential recurrence risk (such as skin basal cell carcinoma and cutaneous squamous cell carcinoma that have received curative treatment).\n9. The following situations do not allow screening:\n\n   1. Screening period imaging shows that the tumor encircles important blood vessels or has obvious necrosis and cavity, and the researcher deems it may cause bleeding risk;\n   2. Clinical signs or symptoms of intestinal obstruction and\u002For gastrointestinal obstruction within 6 months before the first drug administration, including incomplete obstruction related to the underlying disease;\n   3. Presence of severe, unhealed, or ruptured wounds, active ulcers, or untreated fractures;\n   4. Clinically significant hemoptysis (≥1\u002F2 tea spoon) or tumor bleeding for any reason within 1 month before the first drug administration;\n   5. Presence of poorly controlled hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg), or history of hypertensive emergency or hypertensive encephalopathy;\n   6. Other situations judged by the researcher as unsuitable for receiving oral chemotherapy.\n10. Previous antineoplastic treatment toxicity has not recovered to grade 1 specified in CTCAE 5.0 or the level specified in the enrollment\u002Fexclusion criteria. Except for the following situations: if the researcher judges that the related toxicity is well-controlled and does not affect the safety and compliance of the subject using the study drug, screening is allowed.\n11. Previous occurrence of drug-related adverse events leading to permanent drug discontinuation during treatment with bevacizumab and similar drugs.\n12. Received the following drugs or treatments before the first drug administration:\n\n    1. Received chemotherapy, immunotherapy, radiotherapy, and other antineoplastic treatments within 21 days before the first drug administration; received oral fluoropyrimidines, small molecule targeted drugs, antineoplastic vaccines, and intravesical administration (such as BCG for bladder cancer) within 14 days before the first drug administration; started palliative radiotherapy for painful lesions within 7 days before the first drug administration;\n    2. Underwent needle biopsy or other minor surgeries (excluding placement of vascular access devices) within 28 days before the first drug administration;\n    3. Subjects who used systemic corticosteroids (≥10 mg prednisone equivalent per day) or other immunosuppressants for systemic treatment within 2 weeks before the first drug administration; inhalation or local use of corticosteroids or preventive medication (such as for infusion reaction\u002Fhypersensitivity reaction) is allowed;\n    4. Received any live vaccine or attenuated vaccine within 28 days before the first drug administration, or need to receive live vaccines during the study period.\n13. Used antiplatelet therapy or anticoagulant therapy for therapeutic purposes within 10 days before the first drug administration.\n14. Pregnant or lactating women.\n15. Presence of other severe physical or mental diseases or abnormal laboratory examinations, which may increase the risk of participating in the study, affect treatment compliance, or interfere with the study results, and are judged by the researcher as unsuitable for participating in the study.",{"count":50,"type":21},32,[52],"PHASE2","The ONTOP study is a prospective, single-arm, open-label phase II clinical trial. A total of 32 patients with advanced MSS\u002FpMMR colorectal cancer who have failed first-line treatment will receive second-line standard treatment combined with Ongericimab and toripalimab. Among them, patients who received irinotecan-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFOX. Patients who received oxaliplatin-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFIRI. Treatment will continue until disease progression, initiation of new anti-tumor treatment, active request of the subject, or determination by the investigator that study drug administration needs to be terminated. The primary study endpoint is the objective response rate (ORR), and the secondary study endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety, etc.",[27],[56,57,58,59],"Toripalimab","Ongericimab","colorectal cancer","pMMR\u002FMSS","RECRUITING",{"date":62,"type":32},"2026-06-26",{"date":64,"type":32},"2025-08-31",{"date":66,"type":21},"2028-07-31",{"name":68,"class":69},"Shanghai Pudong Hospital","OTHER",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":40},"100641248","phase-2-sintilimab-plus-gossypol-acetate-in-advanced-colorectal-cancer-100641248","NCT07656766","Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer","A Single-Arm, Open-Label, Exploratory Phase II Clinical Trial of Sintilimab Plus Gossypol Acetate in Patients With Advanced pMMR\u002FMSS Colorectal Cancer After Failure of at Least Two Prior Lines of Therapy","Inclusion Criteria:\n\n1. Written informed consent provided before any study-specific procedures.\n2. Age 18 to 75 years, male or female.\n3. Histologically or cytologically confirmed advanced colorectal adenocarcinoma.\n4. Confirmed pMMR\u002FMSS tumor status. Participants without documented MSI\u002FMMR status must undergo MSI or MMR testing during screening.\n5. Disease progression after at least two prior lines of standard therapy.\n6. Availability of tumor tissue suitable for pathological evaluation and biomarker analysis.\n7. ECOG performance status of 0 or 1 within 7 days before the first dose of study treatment.\n8. At least one measurable lesion according to RECIST version 1.1.\n9. Adequate hematologic, hepatic, renal, coagulation, and organ function as defined in the protocol.\n10. Female participants of childbearing potential must have a negative pregnancy test before initiation of study treatment and agree to use effective contraception during the study and for the protocol-specified period after the last dose.\n\nExclusion Criteria:\n\n1. Histology of small cell carcinoma, squamous cell carcinoma, or mixed carcinoma.\n2. dMMR\u002FMSI-H tumor status.\n3. Complete bowel obstruction or clinical conditions likely to progress to bowel obstruction.\n4. Suspected bowel perforation based on clinical symptoms or imaging.\n5. History of malignancy other than colorectal cancer within 3 years before screening, except malignancies with negligible risk of metastasis or death and treated with expected curative outcome.\n6. Active autoimmune disease, history of autoimmune disease, or immunodeficiency requiring systemic treatment, except protocol-allowed conditions.\n7. Significant cardiovascular disease within 3 months before initiation of study treatment, including New York Heart Association class II or higher heart disease, myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina.\n8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT.\n9. Severe chronic or active infection within 4 weeks before initiation of study treatment.\n10. Active tuberculosis infection or inadequately treated prior active tuberculosis.\n11. Active hepatitis B or hepatitis C infection as defined by protocol criteria.\n12. Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n13. History of leptomeningeal disease.\n14. Prior treatment with CD137 agonists, T-cell co-stimulatory agents, or immune checkpoint inhibitors, including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-TIGIT antibodies.\n15. Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives before initiation of study treatment, whichever is longer.\n16. Treatment with systemic immunosuppressive medications within 2 weeks before initiation of study treatment, except protocol-allowed medications.\n17. Prior allogeneic stem cell transplantation or solid organ transplantation.\n18. Receipt of a live attenuated vaccine within 4 weeks before initiation of study treatment or expected need for such vaccination during the study or within 5 months after the last dose of sintilimab.\n19. Major surgery or severe traumatic injury within 28 days before initiation of study treatment, abdominal surgery or abdominal intervention within 60 days before initiation of study treatment, or expected need for major surgery during the study.\n20. Receipt of any other investigational drug within 28 days before initiation of study treatment.\n21. Known contraindication, hypersensitivity, or severe allergic reaction to any study drug or its excipients.\n22. Pregnancy, breastfeeding, or intention to become pregnant during the study or within 5 months after the last dose of sintilimab.\n23. Any other disease, laboratory abnormality, social condition, or medical condition that, in the investigator's judgment, may compromise participant safety, interfere with study compliance, or affect interpretation of study results.",{"count":50,"type":21},[52],"This is a single-center, open-label, single-arm, exploratory phase II clinical trial designed to evaluate the preliminary efficacy and safety of sintilimab in combination with oral gossypol acetate in patients with advanced pMMR\u002FMSS colorectal cancer after failure of at least two prior lines of standard therapy. Eligible participants will have histologically or cytologically confirmed advanced colorectal adenocarcinoma, measurable disease according to RECIST version 1.1, ECOG performance status of 0 or 1, and adequate organ function. Participants will receive oral gossypol acetate once daily, followed by sintilimab administered intravenously every 3 weeks after a gossypol acetate lead-in period. The primary outcome is objective response rate assessed by RECIST version 1.1. Secondary outcomes include disease control rate, progression-free survival, overall survival, duration of response, and safety.",[27],[58,82,59,83,84,85,86,87],"metastatic colorectal cancer","sintilimab","PD-1 inhibitor","gossypol acetate","LRPPRC","immunotherapy","2026-06-22",{"date":90,"type":32},"2026-06-25",{"date":92,"type":21},"2026-07-15",{"date":94,"type":21},"2029-09-15",{"name":96,"class":69},"Peking University People's Hospital",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":116,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100617629","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-anti-tumor-activity-of-cbi-1214-t-cell-engager-in-participants-with-advanced-or-metastatic-mssmsi-l-colorectal-cancer-100617629","NCT07321106","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS\u002FMSI-L Colorectal Cancer","A Phase 1, First-in-human (FIH), Dose-Escalation and Dose-Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic Microsatellite Stable (MSS)\u002FMicrosatellite Instability Low (MSI-L) Colorectal Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Participant with MSS\u002FMSI-L CRC, who has exhausted at least one prior line of standard systemic therapy for their current malignancy.\n* Participant with genomic aberrations, including but not limited to BRAFV600E mutations and HER2 amplifications, for which FDA-approved targeted therapies are available, must:\n\n  * Have received prior treatment with applicable FDA-approved targeted therapies AND\n  * Either have experienced disease progression, be refractory, or be intolerant to directed molecular therapy.\n* Participant able to provide archival tissue sample or fresh biopsy tissue sample\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Participant whose CRC tumor tissues have been identified as dMMR or MSI-H\n* Known history of solid organ or tissue transplant; history of interstitial lung disease or non-infectious pneumonitis.\n* Untreated central nervous system (CNS) metastatic disease.\n* Active autoimmune disease that has required systemic treatment within the past 2 years (participants with hormone replacement therapy for adequately controlled endocrinopathy are allowed in the study).\n* History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.\n* Known seropositive for human immunodeficiency virus, hepatitis B surface antigen, or antibody to hepatitis C virus with confirmatory testing and requiring anti-viral therapy.\n* History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.\n* Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure \\>115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.\n* Congenital long QT syndrome or a corrected QT interval (QTc) ≥480 ms at screening (unless secondary to pacemaker or bundle branch block).\n* Active second primary malignancy within 3 years of Screening other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast",{"count":105,"type":21},80,[107],"PHASE1","This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)\u002FMicrosatellite Instability Low (MSI-L) Colorectal Cancer",[110,111,112,113,114,115,27],"Colorectal Cancer","Colorectal Cancer (CRC)","Colorectal (Colon or Rectal) Cancer","CRC","Metastatic Colon Cancer","Colon Cancer",[117,118,119,120,121,122,123,124,125],"Oncology","Solid Tumor","Phase 1","First-in-Human","Dose Escalation","Open-Label","T-Cell Engager","TCE","CartographyBio","2026-06-09",{"date":128,"type":32},"2026-06-10",{"date":130,"type":32},"2026-01-15",{"date":132,"type":21},"2029-10",{"name":134,"class":39},"Cartography Biosciences",8,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":40},"100544467","phase-2-open-label-phase-2-study-of-avutometinib-rafmek-clamp-in-combination-with-defactinib-fak-inhibitor-and-cetuximab-in-patients-with-unresectable-anti-egfr-refractory-advanced-colorectal-cancer-100544467","NCT06369259","Open-label Phase 2 Study of Avutometinib (RAF\u002FMEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer","Inclusion Criteria:\n\n• Provision of signed Informed Consent prior to any screening procedures being performed.\n\n* Non-English speaking participants will be eligible for participation with involvement of the MD Anderson Language Assistance department in the informed consent process (per MD Anderson SOP 04\\_Informed Consent Process).\n* Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation.\n\n  * Age ≥ 18 years at the time of informed consent.\n  * Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and\u002For metastatic disease that is measurable according to RECIST1.1 criteria.\n  * Mutation status at the time of colorectal cancer diagnosis performed on tumor tissue or circulating tumor\n\nDNA (prior to any anti-EGFR directed therapy):\n\n* KRAS, NRAS, EGFR ectodomain, BRAF V600E wild-type status\n\n  * Prior treatment with at least one systemic chemotherapy regimen for mCRC, or recurrence\u002Fprogression with development of unresectable or metastatic disease within 6 months of adjuvant chemotherapy for resected colorectal cancer.\n  * Prior treatment with:\n* anti-EGFR therapy (cetuximab or panitumumab) setting for at least 16 weeks with either CR or PR as best response, prior to progression • ECOG performance status ≤ 1.\n\n  • Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to day 1 of study. A washout period of at least 21 days is required between last chemotherapy dose and day 1 of study (provided the patient did not receive radiotherapy).\n\n  • Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 7 days is required between end of radiotherapy and day 1 of study.\n\n  • Adequate hematologic status: Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL; Hemoglobin (Hgb) ≥ 9 g\u002FdL with or without transfusions; Platelets (PLT) ≥ 100 x 109\u002FL without transfusions\n\n  • Adequate liver function:\n* ALT and AST ≤3 × ULN, or ≤5 × ULN in the presence of liver metastases\n* Total bilirubin ≤ 1.5 × ULN and \\\u003C 1.5 mg\u002FdL\n* Note: Participants with hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the principal investigator. • Adequate renal function: Serum Creatinine ≤ 1.5 x ULN, or calculated creatinine clearance (measured via 24-hour urine collection) ≥ 40 mL\u002Fmin at screening\n\n  * QTc interval ≤ 480 ms (preferably the mean from triplicate ECGs)\n  * Able to take oral medications.\n  * Because the teratogenicity of cetuximab is not known, the participant, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods). Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment\n  * Willing and able to participate in the trial and comply with all trial requirements.\n  * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent may be included after consultation with the medical monitor.\n\nExclusion Criteria:\n\n1. History of grade 3 or 4 allergic reaction or intolerability attributed to cetuximab or panitumumab.\n2. History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, or if the patient had red meat allergy\u002Ftick bite history.\n3. Previously exposed to ERK1\u002F2, MEK or BRAF inhibitor\n4. Any known symptomatic brain metastasis\n5. Note: Participants previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Known brain metastases must be stable for ≥ 4 weeks, with imaging (e.g., magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\]) demonstrating no current evidence of progressive brain metastases at screening.\n6. Known leptomeningeal disease\n7. A history or current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).\n8. Previous or concurrent malignancy within 3 years of study entry, with the following exceptions: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy; other solid tumors treated curatively without evidence of recurrence for at least 3 years prior to study entry.\n9. Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:\n\n1\\. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) \\\u003C12 months prior to screening, 2. Symptomatic chronic heart failure (i.e., Grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and\u002For conduction abnormality \\\u003C6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia, 3. The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n\n4\\. Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mm Hg, despite current therapy.\n\n10\\. The participant has active systemic bacterial or fungal infection (requiring intravenous (IV) antibiotics and\u002For antifungals at time of initiating study treatment).\n\n11\\. Know Human Immunodeficiency Virus (HIV) that is active and or\u002Frequires therapy 12. Active hepatitis B or hepatitis C infection\n\n1\\. Active HBV is defined as any of the following: i) HBsAg(+), HBV DNA \\>200 IU\u002FmL (36 copies\u002FmL) ii) HBsAg(+), HBV DNA ≤200 IU\u002FmL and persistent or intermittent elevation of ALT\u002FAST and\u002For liver biopsy showing chronic hepatitis with moderate or severe necroinflammation. iii) Note: Participants who are HBsAg(-), HBcAb(+) are eligible and should be monitored\u002Ftreated as per local standard of care. 2. Active HCV is defined as: i) HCV antibody positive; AND ii) Presence of HCV RNA. 13. Impaired gastrointestinal function or disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption).\n\n14\\. Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n\n15\\. Major surgery ≤ 6 weeks prior to starting study drug or failure to recover from side effects of such procedure at the discretion of the treating investigator.\n\n16\\. Systemic anti-cancer therapy within 4 weeks of the first dose of study intervention or within 5 half-lives of the previous drug, whichever is longer.\n\n17\\. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n\n18\\. History of Rhabdomyolysis 19. Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.",{"count":143,"type":21},33,[52],"To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.",[27],{"date":148,"type":32},"2026-06-11",{"date":150,"type":32},"2025-02-24",{"date":152,"type":21},"2029-02-01",{"name":154,"class":69},"M.D. Anderson Cancer Center",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100579420","phase-2-evaluation-of-rbs2418-in-patients-with-advanced-metastatic-and-progressive-colorectal-cancer-100579420","NCT06824064","Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer","A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of RBS2418 Plus Best Supportive Care (BSC) in Subjects With Advanced, Metastatic, and Progressive Colorectal Cancer","VISTA-1","Inclusion Criteria:\n\n1. At least 18 years of age on the day of signing informed consent.\n2. Male and female subjects with advanced, metastatic, progressive CRC who have received, been ineligible for, intolerant to, or declined all approved standard of care (SOC) therapies for metastatic CRC, as per local SOC treatment regimens. Additionally, subjects must have documented PD based on two scans performed within 2 to 4 months of study initiation.\n3. Have histologically or cytologically confirmed CRC diagnosis based on pathology report.\n4. Willing to submit a pre-treatment tissue sample (archival, or fresh tissue if archival is not available).\n\nExclusion Criteria:\n\n1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy, systemic immunotherapy, or radiation therapy within 2 weeks prior to the first dose of study treatment; or if subject has not recovered (i.e., ≤ to Grade 1 or returned to baseline level) from AEs due to a previously administered agent; the following exceptions are allowed:\n\n   * Palliative radiotherapy for bone metastases or soft tissue lesions should be completed \\>7 days prior to the first dose of study treatment.\n   * Hormone-replacement therapy or oral contraceptives.\n   * Subjects with Grade 2 neuropathy or Grade 2 alopecia.\n2. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.\n3. Malignancies other than indications open for enrollment within 3 years prior to Day 1, except for those with negligible risk of metastasis or death treated with expected curative outcome, undergoing active surveillance, or treatment-naïve for indolent tumors.",{"count":164,"type":21},150,[52],"RBS2418 is a specific immune modulator that works through the inhibition of ectonucleotide pyrophosphatase\u002Fphosphodiesterase 1 (ENPP1) and is designed to lead to anti-tumor immunity by protecting endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis and leading to the activation of antigen-presenting cells followed by T cell activation. The hypothesis is that RBS2418 versus placebo will be generally safe, well-tolerated, immunogenic, and will lead to anti-tumor responses in adult subjects for the treatment of advanced, metastatic, and progressive colorectal cancer (CRC).",[168,27],"Metastatic Colorectal Cancer",[170],"Advanced, Metastatic, Progressive Colorectal Cancer","2026-05-15",{"date":173,"type":32},"2026-05-18",{"date":175,"type":32},"2025-01-17",{"date":177,"type":21},"2027-12",{"name":179,"class":39},"Riboscience, LLC.",5,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100635853","phase-3-folicolor-trial-following-therapy-response-through-liquid-biopsy-in-metatstatic-colorectal-cancer-patients-100635853","NCT07558083","FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients","FOLICOLOR","Inclusion Criteria:\n\n* Man or woman ≥ 18 years of age at the time the informed consent is obtained\n* ECOG performance status of 0-2\n* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease\n* There should be at least 1 uni-dimensionally measurable (min. 10mm) using conventional crosssectional imaging techniques (CT or MRI scan). Lesion must not be chosen from a previously irradiated field, unlessnthere has been documented disease progression in that field after irradiation and prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization\n* Adequate hematology, renal, hepatic and coagulation function (at treating physician's discretion)\n* Adequate blood results for treatment (at treating physician's discretion)\n* Starting a first line treatment\n\nExclusion Criteria:\n\n* History of prior or concurrent central nervous system metastases\n* History of other malignancy, except:\n\nMalignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician.\n\nAdequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease.\n\nAdequately treated cervical carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer\n\n* Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)\n* Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer ≤ 6 months prior to randomization with the following exceptions: Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of rectal cancer.\n* Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities.",{"count":164,"type":21},[24],"The FOLICOLOR trial aims to evaluate whether a liquid biopsy-guided follow-up strategy can improve outcomes in patients with unresectable, metastatic colorectal cancer (mCRC) receiving first-line systemic treatment. The approach uses NPY methylation-based circulating tumor DNA (ctDNA) analysis from blood samples to monitor treatment response and guide clinical decision-making. Eligible patients are adults diagnosed with unresectable, metastatic colorectal cancer who are starting first-line treatment. The primary goal is to demonstrate a clinically meaningful benefit, particularly in terms of quality of life (QoL) and reduction of treatment-related toxicity, by allowing earlier and more personalized therapeutic adjustments based on liquid biopsy findings.",[27],[193,194,195],"NPY Methylation","Liquid Biopsy","advanced colorectal cancer patients","2026-04-22",{"date":198,"type":32},"2026-04-30",{"date":200,"type":32},"2021-08-16",{"date":202,"type":21},"2031-08",{"name":204,"class":69},"University Hospital, Antwerp",9,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":40},"100561412","phase-2-tl938-and-trastuzumab-for-patients-with-her2-positive-metastatic-colorectal-cancer-100561412","NCT06589830","TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer","A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Age 18 years old and above, male or female;\n2. Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;\n3. At least one measurable lesion;\n4. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;\n5. A minimum life expectancy of \\>3 months;\n6. Adequate bone marrow reserve, hepatic, renal, and coagulation function;\n7. Other inclusion criteria apply for participating in the Study. -\n\nExclusion Criteria:\n\n1. Prior anti-HER2 targeting therapy;\n2. Any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \\>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment;\n3. Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);\n4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;\n5. Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;\n6. Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible;\n7. Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast;\n8. Any active infection which has not been controlled at screening;\n9. Other exclusion criteria apply for participating in the Study. -",{"count":105,"type":21},[52],"This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.",[217,27],"Colorectal Cancer Metastatic",[117,219,110,220],"TL938","HER2",{"date":222,"type":32},"2026-04-28",{"date":224,"type":32},"2025-05-13",{"date":226,"type":21},"2027-10",{"name":228,"class":39},"Suzhou Teligene Ltd.",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":40},"100623052","phase-2-clinical-study-on-the-first-line-treatment-of-advanced-colorectal-cancer-with-simultaneous-infusion-of-levozolinate-for-injection-and-5-fu-100623052","NCT07391618","Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU","A Study to Evaluate the Efficacy and Safety of a First-line Treatment for Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU","Inclusion Criteria:\n\n1. The subjects voluntarily joined this study and signed the informed consent form.\n2. Age: 18 to 75 years old, gender not limited;\n3. ECOG PS score: 0-2 points\n4. Patients with unresectable or metastatic colorectal cancer confirmed by histology or cytology, where the primary tumor location and the status of RAS and BRAF are known;\n5. No previous treatment for unresectable or metastatic lesions has been received;\n6. There is at least one measurable lesion in accordance with the RECIST 1.1 standard;\n7. In the pre-treatment examination indicators, there was no serious hematopoietic function abnormality, and the functions of the heart, lungs, liver and kidneys were basically normal.\n\n   1. Hemoglobin (Hb) ≥70 g\u002FL;\n   2. White blood cell count (WBC) ≥3.0×109\u002FL; Neutrophil count (NEUT) ≥1.5×109\u002FL;\n   3. Platelet count (PLT) ≥100×109\u002FL;\n   4. Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level ≤2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level ≤1.5 times the upper limit of the normal value (ULN). Total bilirubin (TBIL) ≤1.5 times the upper limit of the normal value (ULN).\n8. The expected survival period is more than three months.\n\nExclusion Criteria:\n\n1. Those who have been confirmed to be allergic to the test drug and\u002For its excipients;\n2. Those with contraindications to chemotherapy;\n3. Colorectal cancer patients with MSI-H or dMMR;\n4. Pregnant or lactating women;\n5. There is a history of other malignant tumors in the past;\n6. Those with systemic internal diseases and mental disorders who are not suitable for chemotherapy;\n7. Patients who were determined by the researchers to be unsuitable for inclusion in this study.",{"count":237,"type":21},583,[52],"Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer",[27],[242],"levozolinate","2026-01-29",{"date":245,"type":32},"2026-02-06",{"date":247,"type":32},"2025-05-15",{"date":249,"type":21},"2029-12",{"name":251,"class":69},"Chinese PLA General Hospital",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100606673","phase-1-assessment-of-the-dose-safety-and-efficacy-of-serine-combined-with-fluorouracil-drugs-100606673","NCT07178613","Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs","Inclusion Criteria:\n\n1. Age ≥ 18 years (inclusive), male or female;\n2. Patients with advanced colorectal cancer confirmed by histopathological or cytological examination, eligible for standard first-line treatment with fluorouracil-containing regimens.\n3. Patients must have at least one measurable lesion.\n4. ECOG performance status ≤ 2.\n5. Expected survival ≥ 3 months;\n6. Major organ functions are essentially normal, with laboratory tests meeting the following criteria:\n\n   Hematology (no transfusion of blood or blood products within 7 days prior to testing; no use of G-CSF or other hematopoietic growth factors for correction):\n\n   Absolute neutrophil count ≥1.5×10⁹\u002FL ; Platelets ≥75×10⁹\u002FL ; Hemoglobin ≥90 g\u002FL;\n\n   Renal:\n\n   Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \\>60 mL\u002Fmin\u002F1.73 m² (Cockcroft-Gault formula);\n\n   Liver:\n\n   Serum total bilirubin \\\u003C1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C2.5×ULN or ≤5×ULN (for subjects with liver metastases); Albumin (ALB) ≥30 g\u002FL;\n\n   Coagulation Function:\n\n   International Normalized Ratio (INR) or Prothrombin Time (PT) \\\u003C 1.5×ULN. If the subject is receiving anticoagulant therapy, PT is acceptable as long as it falls within the therapeutic range for the anticoagulant drug.\n\n   Cardiovascular System:\n\n   Ejection Fraction (EF) 55%-70%; QTc Interval: Male ≤440ms; Female ≤450ms.\n7. Serum pregnancy tests for female subjects of childbearing potential during the screening period must be negative. Female\u002Fmale subjects with reproductive potential must be willing to use reliable contraception throughout the study period (i.e., from signing the informed consent form until 90 days after the last study drug administration), including but not limited to: abstinence, male partner having undergone vasectomy, female sterilization, effective intrauterine device (IUD), and effective contraceptive medication.\n8. Patients voluntarily participate in this study, sign informed consent forms, and demonstrate good compliance.\n\nExclusion Criteria:\n\n1. Trial Participation Restrictions: Currently participating in or having received investigational drug\u002Fdevice treatment within the past 4 weeks;\n2. Prior Fluorouracil-Based Therapy Restrictions: History of ≥Grade 3 toxicity (e.g., myelosuppression, gastrointestinal toxicity) following prior fluorouracil-based therapy, deemed unsuitable for re-administration by the investigator;\n3. Recent Surgery Restriction: Undergone major surgery (excluding diagnostic biopsy) within 28 days prior to first dosing, or scheduled for surgery during the study period;\n4. Metabolic and Nutritional Status Restriction: Presence of severe malnutrition (BMI \\\u003C 18.5 or serum albumin \\\u003C 30 g\u002FL), or inability to supplement serine orally (e.g., malabsorption syndrome, short bowel syndrome); Known serine metabolism disorders (e.g., PHGDH\u002FPSAT1 gene mutation-related diseases);\n5. Concurrent severe disease restrictions: Severe cardiovascular disease (NYHA Class III\u002FIV heart failure, myocardial infarction within 6 months, uncontrolled hypertension \\>150\u002F100 mmHg); severe respiratory disease (COPD, GOLD Stage ≥3, interstitial lung disease); Active infection (requiring systemic antibiotic\u002Fantiviral therapy);\n6. Active HIV\u002Fviral hepatitis: HIV-positive status, or active hepatitis B (HBV-DNA ≥ 2000 IU\u002FmL), or active hepatitis C (HCV-RNA positive); (Note: Patients with HBV-DNA \\\u003C 2000 IU\u002FmL receiving antiviral therapy may be enrolled);\n7. Neurological disorders: Uncontrolled brain metastases (with intracranial hypertension or neurological symptoms), or history of severe psychiatric illness\u002Fsubstance abuse (impeding treatment compliance);\n8. Allergy history: Known allergy to fluorouracil-based drugs or serine supplements;\n9. Pregnancy\u002Flactation: Pregnant or lactating women (patients of childbearing potential must use highly effective contraception);\n10. Other conditions deemed ineligible by the investigator: Any concomitant conditions or laboratory abnormalities that may interfere with study results, increase risk, or compromise patient safety.",{"count":259,"type":21},20,[107],"This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration.\n\nSecondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.",[27],"2025-09-10",{"date":265,"type":32},"2025-09-17",{"date":267,"type":21},"2025-11",{"date":269,"type":21},"2026-02",{"name":271,"class":69},"The First Affiliated Hospital of Xinxiang Medical College",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":279,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":40},"100582785","phase-1-trial-of-proagio-in-advancedmetastatic-colorectal-cancer-100582785","NCT06867822","Trial of ProAgio in Advanced\u002FMetastatic Colorectal Cancer","A Phase I\u002FIb Trial of ProAgio, an Anti-avb3 Integrin Cytotoxin, in Combination With 5-fluorouracil , Irinotecan and Bevacizumab for Advanced\u002FMetastatic Colorectal Cancer (ProAgio in CRC)","Inclusion Criteria:\n\n1. Be ≥18 years of age at the time of consent.\n2. Histologic or cytologic diagnosis of colorectal adenocarcinoma (CRC)\n3. Patients with advanced or metastatic CRC\n4. Performance status, ECOG: 0, 1\n5. For dose escalation phase: patients with CRC where FOLFIRI+ bevacizumab is considered appropriate standard therapy (previously treated with FOLFOX based regimen in advanced\u002Fmetastatic CRC is allowed). For dose expansion phase: patients must not have received 5FU-based therapy previously for metastatic disease. Patients who received FOLFOX\u002FCAPOX regimens in the neoadjuvant\u002Fadjuvant setting are allowed if recurrence free survival is at least 1 year or longer since completion of adjuvant therapy.\n6. Presence of a metastatic lesion that can be safely biopsied for correlative assays (Only for FOUR patients enrolling on the dose expansion phase).\n7. Patient must meet the following laboratory values at the screening visit:\n\n   * Absolute Neutrophil Count ≥1.5 x 109\u002FL\n   * Platelets ≥100 x 109\u002FL\n   * Hemoglobin (Hgb) ≥9 g\u002FdL\n   * Creatinine Clearance ≥60 mL\u002Fmin using Cockcroft-Gault formula\n   * Total bilirubin ≤1.5 x ULN\n   * Aspartate transaminase (AST) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if AST ≤5.0 x ULN\n   * Alanine transaminase (ALT) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if ALT ≤5.0 x ULN\n   * Urine dipstick reading for proteinuria \\\u003C 2+. Participants having ≥ 2+ proteinuria on urine dipstick testing at baseline will undergo a 24-hour urine collection for quantitative assessment of proteinuria and must demonstrate \\\u003C 1 g of protein in 24 hours. Participants with urine protein ≥ 1 g per 24 hours will be ineligible\n8. Blood pressure \\\u003C=160\u002F100 mm Hg\n9. Presence of measurable disease by RECIST 1.1 criteria within 28 days prior to the first dose of study treatment.\n10. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0- 1 (Appendix A-Performance Status Criteria).\n11. Normal ECG defined as the following: QTcF at screening \\\u003C450 ms (male subjects), \\\u003C460 ms (female subjects)\n12. Before enrollment, a woman must be either:\n\n    1. Not of childbearing potential: postmenopausal (\\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \\>40 IU\u002FmL); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy.\n    2. Of childbearing potential and practicing (during the study and for 6 months after receiving the last dose of study agent for women and 3 months after receiving the last dose of study agent for men)) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods; true abstinence (when this is in line with the preferred and usual lifestyle of the subject).\n    3. Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above.\n13. A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin \\[β-hCG\\]) or urine pregnancy test at screening.\n14. During the study and for 6 months after receiving the last dose of study agent, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction.\n15. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug.\n16. Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written informed consent and privacy language as per HIPAA must be obtained from the subject or legally authorized representative (if applicable) prior to any study- related procedures\n17. Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing and able to adhere to the prohibitions and restrictions specified in this protocol. Informed consent must be obtained before performing any study specific procedures.\n18. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study\n19. Subject agrees not to participate in another interventional study while receiving study drug in present study\n\nExclusion Criteria:\n\n1. Prior exposure to FOLFIRI chemotherapy\n2. Clinically significant peripheral neuropathy (\\>=Grade 3 per CTCAE 5.0)\n3. Any untreated central nervous system (CNS) lesion. However, subjects are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥4 weeks after treatment.\n4. Allogenic bone marrow or solid organ transplant\n5. Known history or current interstitial lung disease or non-infectious pneumonitis\n6. Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion.\n7. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen.\n8. Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: DPD testing is not mandatory as part of the trial and can be performed at the discretion of treating provider per local requirements)\n9. Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment\n10. Infection with human immunodeficiency virus (HIV)-1 or HIV-2. (Exception:\n\n    Participants with well-controlled HIV \\[ie, CD4 \\> 350\u002Fmm3 and undetectable viral load\\] are eligible.)\n11. Active hepatitis, including the following:\n\n    1. Acute or chronic hepatitis B (Exception: Participants who are hepatitis B surface antigen \\[HbsAg\\] positive are eligible if they have hepatitis B virus (HBV) DNA less than 500 IU\u002FmL or 2,500 copies\u002FmL). Note: Participants with detectable HbsAg or detectable HBV DNA should be managed per institutional or local standards. Participants beginning antiviral agents at screening should be treated for \\> 2 weeks prior to expected date of C1D1.\n    2. Infection with hepatitis C (Exceptions: \\[i\\] Participants who have no history of curative viral treatment and are documented to be viral load negative are eligible; \\[ii\\] Participants who have completed curative viral therapy ≥ 12 weeks prior to expected date of C1D1, and viral load is negative are eligible.)\n12. Severe chronic or active infections requiring systemic parenteral antibacterial, antifungal or antiviral therapy; or any other potentially life-threatening viral or bacterial infection (participants on oral antibiotics must complete the planned course of treatment prior to expected date of C1D1).\n13. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half-lives before enrollment or is currently enrolled in the treatment stage of an investigational study.\n14. A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 150 days after the last dose of study agent.\n15. Subject has had a major surgical procedure ≤ 28 days prior to randomization. Subject without complete recovery from a major surgical procedure ≤ 14 days prior to randomization\n16. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.\n17. Subject has psychiatric illness or social situations such as incarceration that would preclude study compliance, per investigator judgment\n18. Patients with a history of perforation, fistula, life-threatening gastrointestinal bleeding, proteinuria (\\>1 gm\u002F24 hours), wound healing issues\n19. Subject has significant cardiovascular disease, including any of the following:\n\n    1. Congestive heart failure (defined as New York Heart Association \\[NYHA\\] Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident (CVA), or hypertensive crisis within 6 months prior to randomization;\n    2. History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes);\n    3. History or family history of congenital long QT syndrome\n    4. Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for \\> 1 month prior to randomization are eligible.)\n    5. Deep venous thrombosis\u002Fpulmonary embolism (within last 6 months) unless adequately treated with therapeutic anticoagulation.","19 Years",{"count":281,"type":21},27,[107],"This is an open-label Phase I\u002FIb dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced\u002Fmetastatic CRC. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab. The trial will estimate the RP2D of ProAgio when combined with FOLFIRI + bevacizumab, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. Accelerated titration BOIN design will enroll patients with the 4 combination dose levels.\n\nSubjects will be selected based on following criteria: previously untreated advanced\u002Fmetastatic CRC, ECOG performance status (0-1), and adequate organ functions. Subjects with recent surgeries, history of recent thromboembolic events or significant cardiovascular disease will be excluded.\n\nOnce the MTD and RP2D of ProAgio with FOLFIRI have been identified, an expansion cohort of 12 subjects with advanced\u002Fmetastatic CRC will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.",[27,168],"2025-08-18",{"date":287,"type":32},"2025-08-24",{"date":289,"type":32},"2025-07-17",{"date":291,"type":21},"2028-07",{"name":293,"class":69},"University of Alabama at Birmingham",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100584134","phase-2-a-phase-2-study-evaluating-the-safety-and-efficacy-of-js207-with-or-without-js015-in-combination-with-chemotherapy-in-patients-with-colorectal-cancer-100584134","NCT06885385","A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer","An Open-label, Multicenter, Phase 2 Clinical Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy (XELOX) as First-line (1L) Treatment in Patients With MSS\u002FpMMR Advanced Colorectal Cance","Inclusion Criteria:\n\n1. Subjects aged 18 to 75 (inclusive) at the time of signing the consent form, both male and female\n2. Colorectal adenocarcinoma or rectal adenocarcinoma with histological or cytological Qualification, according to the 8th edition of the AJCC colorectal cancer TNM staging stage IV, MSS\u002FpMMR (a qualified report of MSS or pMMR detected by a local laboratory must be provided), and no previous systemic anti-tumor therapy for advanced disease; for patients who have received neoadjuvant or adjuvant systemic therapy, the last treatment to relapse or progression takes more than 12 months\n3. ECOG score is 0 or 1\n4. Estimated survival ≥ 12 weeks\n5. According to the RECIST v1.1 evaluation standard, there is at least one measurable lesion\n6. Good organ function\n7. Female or male subjects with fertility must agree to have no family planning during the study period and voluntarily use effective contraception with significant others within 6 months after the end of the last medication. Female subjects with fertility (WOCBP) must have a negative serum pregnancy test within 7 days before the first medication and be non-lactating (see section 10.3 for specific contraceptive measures and WOCBP definitions)\n8. The patient participated voluntarily, gave full informed consent, signed a written ICF, and had good compliance\n\nExclusion Criteria:\n\n1. Previously received PD-1 or programmed cell death ligand 1 (PD-L1) inhibitor therapy; or previously received DKK1 inhibitor therapy (only for cohort 2 subjects)\n2. Received the following medications or treatments before the first dose Within 28 days before the first dose, major surgery and radiotherapy (palliative radiotherapy for local bone\u002Fbrain lesions, allowed to be completed within 14 days before the first dose) were performed. Within 7 days before the start of the study, coarse needle aspiration biopsy or other minor surgery was performed, excluding the placement of vascular infusion devices.\n\n   Within 14 days before the first medication, antiplatelet therapy such as aspirin (≥ 325 mg\u002Fday), clopidogrel (≥ 75 mg\u002Fday), or anticoagulant therapy for therapeutic purposes have been used.\n\n   Patients who have received systematic treatment with corticosteroids (\\> 10 mg prednisone or equivalent dose per day) or other immunosuppressants for more than 1 week before the first dose are allowed to use inhaled or topical steroids or ≤ 10 mg\u002Fday systemic prednisone and equivalent doses of similar drugs for treatment.\n\n   D) Have received any live vaccine or attenuated live vaccine within 28 days before the first dose, or expect to receive live vaccine or attenuated live vaccine during the study period (limited to patients in combination therapy studies);\n3. The toxicity of previous anti-tumor treatment has not been restored to the level specified in CTCAE v5.0 or the level specified in the inclusion\u002Fexclusion criteria, except for the following cases: the relevant toxicity that has been judged by the investigator to be well controlled and does not affect the safety and compliance of the patient with the study drug can be screened after qualification with the sponsor\n4. Digestive tract perforation, fistula, abdominal abscess, and digestive system ulcerative diseases or a history thereof within 6 months prior to the first medication (the investigator may consider inclusion if the ulcer condition is stable)\n5. There are pleural effusion, abdominal effusion or pericardial effusion with clinical symptoms that require repeated treatment (puncture or drainage, etc.)\n6. History of interstitial lung disease or previous history of non-infectious pneumonia treated with corticosteroids, or evidence of active pneumonia on screening imaging\n7. Severe, unhealed or open wounds, active ulcers, or untreated fractures (excluding old fractures evaluated by researchers as not requiring clinical intervention)\n8. Evidence of obvious bleeding tendency or severe coagulation dysfunction,Have a history of gastrointestinal bleeding within the 6 months prior to enrollment, or have a clear tendency towards gastrointestinal bleeding (including severe esophageal-gastric varices with bleeding risk, locally active gastrointestinal ulcer lesions, and persistent positive fecal occult blood),Clinically significant hemoptysis or tumor bleeding for any reason within 28 days before the first medication.Screening period imaging shows that the tumor surrounds important blood vessels or has obvious necrosis and cavities, and the researchers believe that it may cause bleeding risks\n9. Presence of poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy\n10. Severe cardiovascular and cerebrovascular diseases, including but not limited to: myocardial infarction, severe\u002Funstable angina pectoris, congestive heart failure (New York Heart Association \\[NYHA\\] heart function classification ≥ 2), clinically significant supraventricular or ventricular arrhythmia requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis\u002Fembolism events, grade 3 or above (CTCAE v5.0) venous thrombosis\u002Fembolism events, transient cerebral ischemic attack, cerebrovascular accident; left ventricular ejection fraction (LVEF) \\\u003C 50% in cardiac ultrasound examination. The corrected QT interval (QTc) is \\> 480 ms (calculated using the Fridericia method. If the QTc is abnormal, it can be detected three times continuously every 2 minutes and the average value is taken)\n11. There is active Central Nervous System metastasis. If the patient has received radiotherapy or surgery in the past, the imaging examination within 4 weeks before the first medication shows that the brain metastasis is stable and there is no aggravation or new neurological symptoms. Hormonal therapy has been stopped two weeks before the first medication, and screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, screening is not allowed regardless of treatment\n12. Severe infection (CTCAE v5.0 \\> 2) occurred within 28 days before the first study administration, such as severe pneumonia, bacteremia, and comorbidities requiring hospitalization; or active infection requiring systemic anti-infective treatment or fever of unknown cause \\> 38.5 ℃ occurred within 2 weeks before the first study administration (according to the investigator's judgment, subjects with fever caused by tumors can be enrolled);\n13. Active tuberculosis, hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive and HBV DNA higher than 1000 copies\u002Fml or 200 IU\u002Fml), hepatitis C (hepatitis C antibody \\[HCVAb\\] positive and HCV RNA higher than the lower limit of the research center)\n14. Have a history of immunodeficiency diseases, including a positive test for human immunodeficiency virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n15. Active autoimmune diseases that require systemic treatment (e.g. corticosteroids or immunosuppressive drugs) within 2 years before the first medication, including but not limited to: systemic systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However, thyroid, adrenal or pituitary gland dysfunction that can be controlled only with hormone replacement therapy, type 1 diabetes, psoriasis or vitiligo that do not require systemic treatment, childhood asthma\u002Fallergies that have been cured are allowed to be screened\n16. Have a history of another primary malignant tumor, except for malignant tumors (such as basal cell carcinoma and squamous cell carcinoma of the skin that have received potential curative treatment) that have received radical treatment before the first dose of the study intervention and have no known active disease (more than 5 years) and low potential recurrence risk\n17. Patients who have other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, affect treatment adherence, or interfere with the study results, and are judged by the investigator to be unsuitable for participation in this study",{"count":302,"type":21},60,[52],"This study is an open label, multicenter Phase II clinical trial aimed at evaluating the safety and efficacy of JS207 with or without JS015 in combination with chemotherapy (XELOX) as a first-line treatment for advanced colorectal cancer with MSS\u002FpMMR. The study was divided into two cohorts: Cohort 1 was JS207 combined with XELOX, and Cohort 2 was JS207 combined with JS015 and XELOX.",[27],"2025-06-17",{"date":308,"type":32},"2025-06-24",{"date":310,"type":32},"2025-04-23",{"date":312,"type":21},"2027-02-13",{"name":314,"class":69},"Shanghai Junshi Bioscience Co., Ltd.",2,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":40},"100592966","phase-2-a-study-of-cetuximab-combined-with-envolimab-and-mfolfox6-in-subjects-with-advanced-colorectal-cancer-100592966","NCT07000305","A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer","Cetuximabβ Combined With Envolimab and mFOLFOX6 as First-line Treatment for RAS\u002FBRAF Wild-type, MSS, Unresectable , Metastatic Colorectal Cancer: A Single-arm, Multi-center, Phase II Trail","SUPβORT","Inclusion Criteria:\n\n1. have agreed and signed an informed consent form (ICF) and are willing and able to comply with planned visits, study treatments, laboratory tests and other experimental procedures.\n2. At the time of signing the ICF, patients must be ≥18 years of age and have a life expectancy of ≥12 weeks in either males or females.\n3. Histologically or cytologically confirmed RAS and BRAF wild-type, MSS type colorectal adenocarcinoma.\n4. Advanced or metastatic colorectal cancer (AJCC\u002FUICC stage IV) clearly defined by imaging, with at least one measurable lesion that meets the requirements of the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1).\n5. no prior systemic therapy (including epidermal growth factor receptor inhibitors such as cetuximab or panitumumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, and anti-CTLA-4 antibodies) directed against advanced or metastatic colorectal cancer, but are allowed to receive a maximum of one cycle of the mFOLFOX6 regimen prior to enrollment ; Adjuvant\u002Fneoadjuvant therapy is considered a first-line systemic therapy for advanced or metastatic disease if recurrence or metastasis occurs during or within 6 months of completion of adjuvant or neoadjuvant chemotherapy.\n6. an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1.\n7. have appropriate organ function during the screening period:\n8. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study drug administration and be willing to use a medically approved highly effective contraceptive measure (e.g., IUD, birth control pills, or condoms) during the study period and for 3 months after final study drug administration; for male subjects whose partner is a female of childbearing potential, he\u002Fshe should be surgically sterilized or agree to use a medically approved highly effective contraceptive measure (e.g., IUD, birth control pills, or condoms) during the study period and for 3 months after final study drug administration. 3 months after the final study dose.\n9. Participation in other clinical trials during the study period is not permitted.\n\nExclusion Criteria:\n\n1. previous or concurrent other active malignancies (except for malignancies that have been curatively treated and have been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).\n2. Current gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator.\n3. Thrombotic or embolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis within 12 months prior to enrollment in the study.\n4. Myocardial infarction, severe\u002Funstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure within 12 months prior to study entry.\n5. systemic antibiotic use for ≥ 7 days within 4 weeks prior to study entry or unexplained fever \\> 38.5°C during screening\u002Fprior to first dose (fever due to oncologic causes is eligible for enrollment at the discretion of the investigator).\n6. Presence of hydrothorax, ascites, or pericardial effusion uncontrolled with effective therapy within 14 days prior to study entry.\n7. Presence of any prior treatment-induced, unabated adverse event Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) Grade 2 or greater toxicity (excluding anemia, alopecia, and skin hyperpigmentation).\n8. Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonia).\n9. Human Immunodeficiency Virus (HIV) infection or known Acquired Immune Deficiency Syndrome (AIDS), untreated active hepatitis (Hepatitis B, defined as HBV-DNA ≥ 500 IU\u002Fml; and Hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with Hepatitis B and Hepatitis C.\n10. Known or suspected history of allergy to any of the drugs of interest used in the study.\n11. Pregnant or lactating women.\n12. Women of childbearing potential (\\\u003C 2 years after last menstrual period) or men of childbearing potential who are not using or refuse to use an effective non-hormonal contraceptive.\n13. Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the study results, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.",{"count":325,"type":21},42,[52],"A study of Cetuximabβ combined with Envolimab and mFOLFOX6 in Subjects with Advanced Colorectal Cancer",[27],"2025-05-29",{"date":331,"type":32},"2025-06-02",{"date":333,"type":21},"2025-05-20",{"date":335,"type":21},"2028-05-20",{"name":337,"class":69},"Tao Zhang",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":352,"leadSponsor":354,"locationsCount":40},"100580534","phase-2-a-multicenter-open-phase-iib-clinical-study-to-evaluate-the-efficacy-and-safety-of-b1962-injection-in-the-treatment-of-advanced-colorectal-cancer-100580534","NCT06838546","A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Colorectal Cancer","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be eligible for enrollment in this study:\n\n1. Voluntary participation in the study and provision of signed and dated informed consent;\n2. Aged 18 to 75 years (inclusive) at the time of signing informed consent;\n3. Patients with distant metastasis or unresectable locally advanced colorectal cancer who have disease progression or intolerable toxicities after previous standard treatment must include oxaliplatin, irinotecan and fluorouracil-based drugs in previous standard treatment regimen;\n4. Histologically or cytopathologically confirmed adenocarcinoma of the colon or rectum, including adenocarcinoma of the appendix;\n5. Willingness to comply with protocol-specified visits, study treatment, laboratory tests, and other study-related procedures and requirements;\n6. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;\n7. Expected survival time of more than 3 months;\n8. Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST v1.1 criteria;\n9. Adequate organ and bone marrow function:\n\n   Hematologic system (no transfusion, no G-CSF use, no medication correction within 2 weeks prior to screening): absolute neutrophil count (ANC) ≥ 1.5 × 10 9\u002FL, platelets (PLT) ≥ 75 × 10 9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL; Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0 × ULN, aspartate aminotransferase (AST) ≤ 3.0 × ULN; for patients with liver metastasis: ALT ≤ 5.0 × ULN, AST ≤ 5.0 × ULN; albumin ≥ 30 g\u002FL; Renal function: creatinine within normal range, or creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated according to Cockcroft-Gault formula); Cockcroft-Gault formula is: Ccr (ml\u002Fmin) = \\[(140-age) × weight (kg)× F\\]\u002F\\[serum creatinine (mg\u002Fdl) × 72\\] (F = 1 for males and 0.85 for females) Urine protein was qualitatively 0, ±, or \\\u003C 0.5 g\u002F24 hours. All patients with urine protein(±) in urinalysis must have a 24-hour urine collection and must demonstrate urine protein \\\u003C 0.5 g\u002F24 hours.\n\n   Coagulation: prothrombin time (PT) ≤ 1.5 × ULN or international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Fertile subjects agree to use highly effective contraception from signing the ICF and to avoid pregnancy during the study and for 3 months after the last dose (male or female subjects)\n\n    * Females of childbearing potential must be non-lactating and agree to use highly effective contraception from signing the ICF, and must practice contraception during the study and for 3 months after the last dose; blood pregnancy results (human chorionic gonadotropin hCG) must be negative within 7 days prior to enrollment;\n    * Females of non-childbearing potential (ie, physiologically incapable of becoming pregnant), including those who have been surgically sterilized (having undergone bilateral oophorectomy, bilateral tubal ligation, or hysterectomy), or who have been postmenopausal for ≥ 12 months prior to Screening (amenorrhea not due to treatment).\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from the study:\n\n1. Prior therapy targeting PD- (L) 1 and VEGF\u002FVEGFR, including concurrent use of anti-PD-1\u002FPD-L1 monoclonal antibody in combination with drugs targeting VEGF\u002FVEGFR, or anti-PD-1\u002FVEGF or anti-PD-L1\u002FVEGF bispecific antibodies or bispecific fusion proteins, or sequential use of anti-PD-1\u002FPD-L1 monoclonal antibody and drugs targeting VEGF\u002FVEGFR;\n2. Received the last systemic anti-tumor treatment (biological agent therapy, etc.) within 4 weeks before the first dose, hormone anti-tumor treatment within 2 weeks before the first dose, non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, thalidomide, tumor necrosis factor, etc.) within 2 weeks before the first dose, and received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first dose;\n3. Received systemic anti-tumor therapy in other clinical studies within 4 weeks prior to the first dose;\n4. Radiotherapy or surgery within 4 weeks prior to the first dose and diagnostic biopsy within 7 days prior to the first dose;\n5. Patients who have received live or attenuated vaccines within 4 weeks before screening or plan to receive live or attenuated vaccines during the study;\n6. Known hypersensitivity to the study drug or any of its components, or previous severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies or bispecific antibodies;\n7. Adverse reactions from prior anticancer therapy that have not recovered to NCI-CTCAE v5.0 grade ≤ 1 (except alopecia, etc. for which the investigator considers there is no safety risk);\n8. Prior therapy with ≥ Grade 1 proteinuria, or prior bleeding event ≥ Grade 2 related to drugs targeting VEGF\u002FVEGFR, or prior therapy with ≥ Grade 3 hypertension or ≥ Grade 3 immune-related adverse event.\n9. Known brain and\u002For leptomeningeal metastases;\n10. Patients with pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, or pleural effusion, pericardial effusion or ascites that cannot be controlled by treatment of primary disease, anti-tuberculosis, anti-infection, diuretics or requires repeated drainage once every 3 weeks or more frequently;\n11. Complete or incomplete bowel obstruction or risk of bowel obstruction reported on imaging studies, presence of intra-abdominal abscess, or history of inflammatory bowel disease (eg, Crohn 's disease, ulcerative colitis);\n12. Screening imaging showed tumor encasing vital vessels or obvious necrosis and cavity, and the investigator judged that entering the study would cause bleeding risk, or tumor invading vital organs (such as heart and pericardium, trachea, esophagus) or risk of esophagotracheal fistula or esophagopleural fistula , ulcerated colorectal cancer or tumor infiltrating the full thickness of intestinal wall, or other lesions involving the gastrointestinal tract with bleeding or gastrointestinal fistula and gastrointestinal perforation risk;\n13. Known history of human immunodeficiency virus (HIV) infection (HIV 1\u002F2 antibody positive) or acquired immunodeficiency syndrome-related diseases, or other immunodeficiency diseases;\n14. Positive hepatitis B surface antigen (HBsAg), and HBV DNA higher than the upper limit of normal value of the detection unit; or positive hepatitis C antibody (HCV-Ab) and HCV-RNA quantification \\> the upper limit of normal value of the detection unit; or known active syphilis infection;\n15. Fever of unknown origin \\> 38.5℃; or bacterial, viral, fungal infections and other pathogen infections (such as mycoplasma, parasites, etc.) requiring systemic treatment; or uncontrolled active infections such as tuberculosis;\n16. History of significant cardiovascular disease, including but not limited to: malignant arrhythmia requiring clinical intervention; or acute coronary syndrome (myocardial infarction and angina pectoris) or coronary artery bypass grafting within 6 months before the first dose; or congestive heart failure meeting New York Heart Association (NYHA) functional class II or higher criteria; or left ventricular ejection fraction (LVEF) \\\u003C 50%; poor compliance with standard treatment for hypertension or antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy; major vascular disease (e.g., aortic aneurysm requiring surgery);\n17. Patients suffering from coagulation disorders, bleeding disorders, or other bleeding risks judged by the investigator, such as skin wounds, surgical sites, wound sites, severe mucosal ulcers, fractures, intestinal fistulas without complete healing, or active gastric or duodenal ulcers, gastrointestinal bleeding, esophageal and gastric varices, gastrointestinal perforation within 6 months before the first dose;\n18. Pulmonary hemorrhage\u002Fhemoptysis (daily bleeding\u002Fhemoptysis volume ≥ 2.5ml) within 4 weeks prior to the first dose of study drug;\n19. Arterial or venous thrombosis, or stroke or transient ischemic attack within 6 months prior to the first dose of study drug;\n20. Unstable anticoagulant or thrombolytic therapy within 14 days of the first dose of study drug;\n21. Chronic treatment with aspirin (\\> 325 mg\u002Fday) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function, or thienopyridines such as ticlopidine, clopidogrel, or phosphodiesterase inhibitors such as dipyridamole, cilostazol within 14 days of the first dose of study drug;\n22. Diabetes mellitus and thyroid diseases not stably controlled by drug therapy, such as hyperthyroidism;\n23. Current or past idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, etc.; severe dyspnea, pulmonary insufficiency or continuous oxygen inhalation for any reason;\n24. Active autoimmune diseases or history of autoimmune diseases requiring systemic treatment within 2 years before screening, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis or glomerulonephritis;\n25. Systemic corticosteroid therapy (prednisone \\> 10 mg\u002Fday or equivalent of the same class) or systemic therapy with other immunosuppressive agents within 14 days prior to the first dose of study drug;\n\nExceptions:\n\n1. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid therapy with minimal systemic absorption;\n2. Short-term (≤ 7 days) corticosteroid prophylaxis (eg, allergy to contrast agents) or treatment of non-autoimmune allergic diseases (eg, delayed hypersensitivity caused by contact allergens); 26.Prior organ or hematopoietic stem cell transplant; 27.History of other neoplasms within 5 years prior to screening, except cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, who had undergone successful radical surgery; 28.History of substance abuse or mental disorder; Other serious systemic diseases or laboratory abnormalities or compliance problems or other reasons considered unsuitable for this study by the investigator.",{"count":105,"type":21},[52],"This is a multicenter, randomized, open-label, two-stage Phase IIb clinical study to evaluate the efficacy and safety of B1962 in the treatment of advanced colorectal cancer.\n\nThe subjects were patients with distant metastasis or unresectable locally advanced colorectal cancer who had previously failed oxaliplatin, irinotecan, fluorouracil-based drugs therapy containing disease progression or intolerable toxic side effects.\n\nTwo dose groups were investigated:\n\nDose group 1: B1962 35 mg\u002Fkg, intravenous infusion, Q2W, Dose group 2: B1962 45 mg\u002Fkg, intravenous infusion, Q2W.",[27],"2025-02-17",{"date":350,"type":32},"2025-02-20",{"date":150,"type":21},{"date":353,"type":21},"2027-01-31",{"name":355,"class":39},"Tasly Biopharmaceuticals Co., Ltd.",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":362,"targetDuration":364,"studyType":365,"phases":4,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":40},"100562277","the-role-of-18f-fdg-and-68ga-fapi-petct-in-the-diagnosis-and-the-efficacy-evaluation-of-advanced-colorectal-cancer-peritoneal-metastasis-withwithout-other-metastases-100562277","NCT06601075","The Role of 18F-FDG and 68Ga-FAPI PET\u002FCT in the Diagnosis and the Efficacy Evaluation of Advanced Colorectal Cancer (peritoneal Metastasis With\u002Fwithout Other Metastases)","Inclusion Criteria:\n\n1. Histologically confirmed colorectal cancer, clinical or other imaging suspicion of peritoneal metastasis with or without other distant metastases.\n2. Patients voluntarily enrolled in this study by signing an informed consent form\n3. Age ≥ 18 years\n4. Expected life expectancy ≥ 3 months\n5. Adequate organ and bone marrow function\n6. Willingness to adhere to the study protocol and follow-up programme\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and carcinoma in situ of cervix\n3. Severe mental disease, uncontrolled epilepsy, or central nervous system disease\n4. Subjects with current concurrent interstitial pneumonitis or interstitial lung disease, or subjects with previous interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or subjects with other conditions that may interfere with the judgement and management of immune-related pulmonary toxicity, e.g., pulmonary fibrosis, organising pneumonia (e.g., occlusive bronchiectasis), pulmonary fibrosis, organising pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, Drug-associated pneumonia, idiopathic pneumonia, active pneumonia, or severe pulmonary impairment on CT; and active tuberculosis",{"count":363,"type":21},30,"3 Years","OBSERVATIONAL","This study aims to investigate the value of 18F-FDG and 68Ga-FAPI PET\u002FCT in evaluating the outcome of conversion therapy and the prognosis of advanced colorectal cancer (peritoneal metastasis with\u002Fwithout other metastases)",[27],[369,370,371,372],"68Ga-FAPI PET\u002FCT","diagnosis","advanced colorectal cancer","efficacy evaluation","2025-01-20",{"date":375,"type":32},"2025-01-22",{"date":377,"type":21},"2025-02-01",{"date":379,"type":21},"2029-03-31",{"name":381,"class":69},"Ruijin Hospital",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":396,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":40},"100567282","phase-2-shr-a1811-combined-with-apatinib-in-the-treatment-of-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-and-colorectal-cancer-100567282","NCT06666166","SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer","Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer","Inclusion Criteria:\n\n1. Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;\n2. Age 18-75 years, including 18 and 75 year, male and female;\n3. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;\n4. Has a life expectancy of greater than 3 months;\n5. Cohort A: Has histologically confirmed diagnosis of unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;\n6. Cohort B: Has histologically confirmed diagnosis of unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;\n7. There must be a measurable target lesion that meets the RECIST 1.1 criteria;\n8. The function of major organs meets the following criteria(not transfused, not using haematopoietic factors and not corrected with drugs within 14 days):\n\n   1. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   2. PLT ≥100×10\\^9\u002FL;\n   3. Hb≥9g\u002FdL;\n   4. ALB≥3.0g\u002FdL;\n   5. total bilirubin ≤1.5 x ULN;\n   6. ALT\u002FAST ≤ 2.5 x ULN (When there is liver metastasis, ALT\u002FAST ≤ 5 x ULN);\n   7. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL\u002Fmin (according to Cockcroft-Gault formula);\n   8. prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n   9. Echocardiography （ECHO）\u002FCardiac radionuclide scan （MUGA showed i.LVEF≥50%);\n   10. Urine routine results showed that urine protein \\\u003C1+; For patients with urine protein ≥2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification \\\u003C1g should be performed.\n9. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose and agree to use a highly effective method of contraception for the duration of the study up to 6 months after the last administration of study drug. Male subjects whose partner is a female of childbearing potential must agree to use a highly effective method of contraception for the duration of the study up to 6 months after the last administration of study drug.\n\nExclusion Criteria:\n\n1. Patients with meningeal metastases; Or patients with brain metastases that have not been treated with surgery or radiation, but those who have been stable for at least one month after treatment and have stopped using steroid drugs (such as 10mg\u002Fday prednisone or other equivalent hormones) for more than 2 weeks except;\n2. Uncontrolled pleural effusion or ascites;\n3. There are serious concomitant diseases: such as serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, hematopoietic disease, endocrine disease, cachexia, etc;\n4. Previously received antibody drug conjugate therapy containing topoisomerase I inhibitors, such as trastuzumab deruxtecan (DS-8201), etc; Subjects underwent surgery (except diagnostic surgery), radiotherapy, chemotherapy, macromolecular targeted therapy or immunotherapy within 4 weeks before the first dose of the study drug；Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) whose last dose is less than 5 half-life period or 4 weeks (whichever is shorter) from the first dose; Subjects received palliative radiotherapy or local treatment less than 2 weeks after completion of treatment and before the first dose;\n5. Subjects who have been treated with live vaccine or attenuated vaccine within 1 month prior to the first dose;\n6. Subjects requiring systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to first dose, excluding nasal spray or inhaled corticosteroids.\n7. The toxicity caused by previous anti-tumor treatments has not recovered to ≤ CTCAE grade 1 (excluding hair loss; according to the researcher's judgment, some tolerable chronic grade II toxicity can be excluded);\n8. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); Active bleeding (such as local active ulcer lesions and fecal occult blood≥ ++), with a history of gastrointestinal bleeding within 6 months;\n9. Abnormal coagulation function (INR\\>1.5 or prothrombin time (PT)\\>ULN+4 seconds or APTT\\>1.5 × ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy;\n10. Subjects were co-administered a potent CYP3A4 or CYP2D6 inhibitor or inducer within 3 weeks prior to first dosing;\n11. Factors affecting oral administration of medications such as inability to swallow, chronic diarrhoea and intestinal obstruction;\n12. Any active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy)); and skin disorders (e.g., vitiligo, psoriasis, or alopecia) in which asthma has been in complete remission in childhood and has required no intervention in adulthood or in which systemic therapy is not required.subjects with autoimmune mediated hypothyroidism treated with thyroid replacement hormone at a stable dose and type I diabetes patients treated with insulin at a stable dose can be included;\n13. Subjects with immunodeficiency disease, such as HIV infection, congenital or acquired immune dysfunction, organ transplantation；\n14. Uncontrolled heart clinical symptoms or diseases, such as (1) New York Heart Association class II or higher heart failure; (2) unstable angina pectoris; (3) Myocardial ischaemia within 1 year; (4) Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n15. Complicated severe infection within 30 days prior to first dose, including but not limited to infection complications that require hospitalization, bacteremia, severe pneumonia, etc; active infections that have received therapeutic intravenous antibiotics within 2 weeks prior to the first dose. Subjects receiving prophylactic antibiotic treatment (such as preventing urinary tract infections) can be enrolled;\n16. Subjects with active hepatitis B (HBsAg positive with HBV DNA ≥ 500 IU\u002Fml), hepatitis C (hepatitis C antibody positive with HCV-RNA above the lower limit of detection of the analytical method);\n17. Evidence of previously clinically significant lung diseases, including but not limited to interstitial pneumonitis, pneumonitis, pulmonary fibrosis and radiographic pneumonia (Excluding radioactive changes do not require treatment), or suspected subjects with this type of diseases founded during the screening period;\n18. Allergy to any investigational drug or its excipients;\n19. Concomitant other malignancies ≤5 years prior to enrollment, except adequately treatable carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localised prostate cancer, and ductal carcinoma;\n20. Serious physical or mental illnesses or laboratory abnormalities. Any condition which, in the opinion of the Investigator, may be detrimental to the subject or result in the subject's inability to meet or perform the requirements of the study.",{"count":390,"type":21},28,[52],"To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.",[394,395,27],"Advanced Gastric Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma",[397,398,371,399],"apatinib","advanced gastric or gastroesophageal junction adenocarcinoma","SHR-A1811","2024-10-29",{"date":402,"type":32},"2024-10-30",{"date":404,"type":21},"2024-12",{"date":406,"type":21},"2028-12",{"name":408,"class":69},"Yunpeng Liu",{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":427,"locationsCount":40},"100550359","early-phase-1-chemokine-and-co-stimulatory-molecule-modified-mesenchymal-stem-cells-for-the-treatment-of-advanced-colorectal-cancer-100550359","NCT06446050","Chemokine and Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer","CXCL Chemokine and TNF Superfamily Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer","Inclusion Criteria (Participants must meet all of the following selection criteria in order to participate in this study):\n\n1. Age less than 18 years old (including 18 years old), regardless of gender;\n2. Patients with metastatic or locally advanced colorectal cancer confirmed by pathological histology or cytology;\n3. According to the Efficacy Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there are very few measurable tumor lesions;\n4. Individuals who have progressed or are intolerant to standard treatment in the past, or patients who refuse standard treatment;\n5. Severe abnormalities in the fluid system, liver and kidney function: lymphocyte count ≥ 0.8 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, hemoglobin ≥ 9g\u002FdL, platelet count ≥ 75 × 10\\^9\u002FL; Alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 3 times ULN, creatinine ≤ 1.5 times ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, international standardized mean value (INR) ≤ 1.5 times ULN;\n6. Eastern Cooperative Oncology Group (ECOG) score 0-2;\n7. Patients with fertility must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) during the trial period and at least 12 weeks after the last treatment;\n8. Patients who have not undergone any other adoptive immune cell therapy or stem cell therapy within two years;\n9. The patient is willing to participate and sign an informed consent form in writing.\n\nExclusion Criteria (Subjects with any of the following characteristics are not eligible to participate in this study):\n\n1. Individuals with a history of allergies to biological agents or allergies to any ingredients used for cell culture;\n2. Pregnant or lactating individuals;\n3. Expected shelf life of more than 3 months;\n4. Active infections that require systemic treatment or uncontrollable infections;\n5. The adverse reactions of previous anti-tumor treatments have not yet recovered to Common Terminology Criteria for Adverse Events 4.03 (CTCAE4.03) level evaluation ≤ 1 level (excluding hair loss);\n6. Have a history of severe cerebrovascular diseases, including but not limited to ventricular arrhythmias that require clinical intervention; Within 6 months, there have been acute coronary syndrome, myocardial infarction, congestive heart failure, stroke, or other Grade III or higher cardiovascular events; The New York Heart Association (NYHA) Heart Function Rating ≥ Grade II or Left Ventricular Ejection Score (LVEF) \\\u003C50%; Poor control of hypertension despite standard treatment (systolic blood pressure \\>150mmHg, diastolic blood pressure \\>90mmHg);\n7. A history of severe pulmonary parenchyma or pulmonary vascular related diseases, including but not limited to high-risk individuals for venous thromboembolism (VTE) (Padua score ≥ 4), as outlined in the Chinese Consensus of Cardiopulmonary Resuscitation Experts on Venous Thromboembolism Cardiac Arrest (CA) Guidelines; Or oxygen may be needed to maintain sufficient blood oxygen saturation (≥ 95%);\n8. Patients with clinical symptoms of central nervous system metastasis and\u002For cancerous meningitis (patients with stable brain metastasis can be grouped), and those suspected of central nervous system or leptomeningeal metastasis need CT\u002FMRI examination to rule them out;\n9. Individuals with clinically confirmed autoimmune diseases (excluding thyroiditis);\n10. Individuals with HIV infection; Individuals with acute Epstein-Barr virus (EBV) or cytomegalovirus (CMV) virus infection;\n11. Patients with active replication of hepatitis B virus (DNA \\> 1000 cps\u002FmL), hepatitis C patients;\n12. Individuals who have received allogeneic bone marrow transplantation in the past;\n13. Immunosuppressive subjects, including known immunodeficiencies; Within 14 days before the first dose of cell therapy and during the study period, those who require systemic use of steroid drugs (prednisone \\>10mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressants (excluding those who have recently or recently used systemic steroids, or short-term use of steroid drugs for preventive treatment);\n14. Known to have alcohol or drug dependence;\n15. The researcher assessed that there may be medical history or disease, treatment or abnormal experimental values that may hinder the full participation of the subjects in this clinical study, or other situations that are not suitable for participation in this clinical study.",{"count":363,"type":21},[418],"EARLY_PHASE1","The aim of this study is to assess the safety and efficacy of human umbilical cord-derived allogenic mesenchymal stem cells (MSCs) engineered to express antitumor chemokine and co-stimulatory molecule. Following systemic administration, these cells are able to migrate into solid tumors such as colorectal tumors. Once enriched in the tumor, they will attract peripheral lymphocytes consisting of T and natural killer (NK) cells, and simultaneously stimulate the infiltrated lymphocytes for persistent and enhanced antitumor immunity. Thus, this MSC-based treatment provides a potentially effective and targeted immunotherapeutic strategy for tumors with unfavorable immune microenvironment and possibly poor response to immune checkpoint blockade (ICB).\n\nDuring this investigator-initiated trial (IIT), colorectal cancer patients will receive modified MSCs every 21 days via intravenous infusion. Increasing does will be tested in the initial cohort and an optimal dose will be chosen for the remaining patients.",[27],"2024-06-04",{"date":423,"type":32},"2024-06-06",{"date":425,"type":32},"2023-06-21",{"date":177,"type":21},{"name":428,"class":69},"Shanghai East Hospital",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":40},"100513255","cetuximab-in-combination-with-dabrafenib-and-tislelizumab-in-braf-mutated-treatment-of-advanced-colorectal-cancer-100513255","NCT05963087","Cetuximab in Combination With Dabrafenib and Tislelizumab in BRAF Mutated Treatment of Advanced Colorectal Cancer","Cetuximab in Combination With Dabrafenib and Tislelizumab in BRAF Mutated Treatment of Advanced Colorectal Cancer: a Prospective, Exploratory, Phase II Clinical Study","Inclusion Criteria:\n\n* 1\\. Histopathological diagnosis of advanced colorectal cancer; 2. Previous first-line standard treatment failed or could not tolerate first-line standard treatment; 3. BRAF V600E mutation (NGS or ARMS-PCR assay); 4.18 years old≤ Age≤75 years old; 5. PS score 0-1; 6. At least one measurable or evaluable lesion according to RECIST v1.1; 7. Baseline color Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥60%; 8. Has adequate organ and bone marrow function; 9. Expected survival ≥12 weeks 10. Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age are required to take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period 11. Sign a written informed consent and be able to comply with the visit and related procedures required by the program;\n\nExclusion Criteria:\n\n* 1\\. Malignant diseases other than colorectal cancer diagnosed within 5 years prior to first administration (excluding radical treatment)Carcinomas in situ with sexual resection); 2. Currently participating in the intervention clinical study treatment, or receiving other study drugs or using study devices within 4 weeks before the first dose; 3. Previous treatment with BRAF inhibitors, MEK inhibitors, anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that target another stimulus or synergically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration; 5. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 6. Were receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to initial administration of the study 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation 8. Known allergy to any monoclonal antibody formulation ingredient (grade 3 or above allergic reaction) 9. Has not fully recovered from toxicity and\u002For complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss); 10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive); 11. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); 12. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 13. Received live vaccine within 30 days prior to the first dose (cycle 1, day 1); 14. Pregnant or lactating women; 15. The presence of any serious or uncontrolled systemic disease 16. Medical history or evidence of disease that may interfere with test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.",{"count":437,"type":21},22,[439],"NA","To explore the efficacy and safety of Cetuximab in combination with dabrafenib and Tislelizumab in BRAF mutated treatment of advanced colorectal cancer",[27],"2023-07-19",{"date":444,"type":32},"2023-07-27",{"date":446,"type":21},"2023-08",{"date":448,"type":21},"2026-06",{"name":450,"class":69},"Zhejiang Cancer Hospital",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":457,"targetDuration":4,"studyType":22,"phases":458,"briefSummary":459,"conditions":460,"keywords":461,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":4},"100467263","phase-2-efficacy-safety-and-exploratory-clinical-study-of-bevacizumab-combined-with-oxaliplatin-and-tas-102-in-first-line-treatment-of-advanced-colorectal-cancer-100467263","NCT05364489","Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer","Inclusion Criteria:\n\n1. age: ≥18 years and ≤75 years;\n2. ECOG score 0\\~1 points;\n3. advanced colorectal cancer patients\n4. According to RECIST1.1 criteria, there is at least one measurable target lesion, and tumor imaging evaluation is performed within 28 days before the first dose;\n5. Expected survival time ≥ 12 weeks;\n6. Major organ function is normal, that is, the following criteria are met:\n\n（1）Routine blood examination standards must meet: ANC ≥1.5×109\u002FL; PLT≥90×109\u002FL; Hb ≥90g\u002FL (no blood transfusion within 14 days); (2) Biochemical tests should meet the following criteria: ALB≥30g\u002FL; (no ALB transfusion within 14 days); TBIL≤Upper limit of normal (ULN); ALT and AST≤2.5 times upper limit of normal (ULN), if liver metastasis , then ALT and AST≤5ULN; alkaline phosphatase≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance rate≥50mL\u002Fmin (CockcroftGault formula); (3) Cardiac ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) QT interval (QTcF) corrected by Fridericia method of 18-lead ECG in females \\\u003C470 ms; 7. For premenopausal or surgically sterilized female patients: Consent to abstinence or use of effective contraception during treatment and for at least 7 months after the last dose of study treatment; 8. Voluntarily joined the study and signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients who have received first-line standard therapy;\n2. Previous antitumor therapy or radiation therapy for any malignant tumor;\n3. concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;\n4. Has undergone major surgical procedures not related to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;\n5. Serious heart disease or discomfort, including but not limited to the following:\n\n   * Diagnosed history of heart failure or systolic dysfunction (LVEF \\\u003C 50%)\n   * High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \\>100 bpm, significant ventricular arrhythmia (eg, ventricular tachycardia), or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV blocklag)\n   * Angina pectoris requiring antianginal drug treatment\n   * Clinically significant heart valve disease\n   * ECG showing transmural myocardial infarction\n   * Poorly controlled hypertension (systolic \\> 180 mmHg and\u002For diastolic \\> 100 mmHg)\n6. Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;\n7. Known history of allergies to the drug components of this regimen; history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n8. Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study drug;\n9. Serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition in which the patient is considered unsuitable for participation in this study by the investigator.\n\nDropout\u002FRejection Criteria:\n\n1. The efficacy and\u002For safety evaluation cannot be performed due to the medication not prescribed in this protocol;\n2. Participating in other anti-tumor treatments while participating in this study will be assessed by the investigator as affecting the efficacy evaluation.\n\nTermination criteria:\n\n1. The subject withdraws informed consent and requests to withdraw;\n2. During the course of the study, the subject has a pregnancy event;\n3. Subjects who cannot tolerate toxicity;\n4. Disease progression;\n5. Other circumstances in which the investigator considers it necessary to withdraw from the study.",{"count":259,"type":21},[52],"This study is a single-arm, prospective, open-label observational clinical study to evaluate the efficacy and safety of Bevacizumab combined with Oxaliplatin and TAS-102 in patients with advanced unresectable rectal cancer.",[27],[113,462,463,464,465],"Bevacizumab","Oxaliplatin","TAS-102","first-line treatment","2022-05-16",{"date":468,"type":32},"2022-05-20",{"date":470,"type":21},"2022-06-15",{"date":472,"type":21},"2027-06-15",{"name":474,"class":69},"The First Affiliated Hospital of Zhengzhou University"]