[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pmmrmss-adenocarcinoma-of-the-colon-or-rectum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pmmrmss-adenocarcinoma-of-the-colon-or-rectum":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100576916","phase-3-mfolfox6--bevacizumab--pd-1-monoclonal-antibody-vs-mfolfox6-in-locally-advanced-pmmrmss-crc-100576916",false,"NCT06791512","mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR\u002FMSS CRC","mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Versus mFOLFOX6 as Neoadjuvant Therapy for Locally Advanced pMMR\u002FMSS Colorectal Cancer: A Prospective, Multicenter, Randomized Phase III Study (BASKETIII)","BASKETⅢ","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the colon or upper rectum.\n2. Tumor biopsy immunohistochemical (IHC) identified pMMR, including all of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as proficient mismatch repair(pMMR), or microsatellite stable (MSS) identified through next-generation sequencing or polymerase chain reaction.\n3. Clinical staging of cT4NxM0, with or without positive mesorectal fascia (MRF), and with or without extramural vascular invasion (EMVI); imaging confirms that the lower margin of the tumor is located above the peritoneal reflection (colon or upper rectum).\n4. Staging method: All patients must undergo chest, abdominal, and pelvic contrast-enhanced CT, rectal palpation, and high-resolution MRI. Positive perienteric lymph nodes (LNs) are defined as LNs with a short diameter ≥10 mm or LNs exhibiting typical metastatic shape and MRI characteristics. When staging results are contradictory, clinical data must be re-evaluated and confirmed by the central evaluation group. Distant metastases must be excluded through chest and abdominal contrast-enhanced CT and pelvic contrast-enhanced MRI.\n5. No symptoms of intestinal obstruction, or obstruction successfully relieved by proximal colostomy.\n6. No history of colorectal surgery.\n7. No prior chemotherapy or radiotherapy.\n8. No history of biopharmaceutical treatments (e.g., monoclonal antibody ), immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies), or treatment with investigational drugs.\n9. Endocrine therapy history: Not restricted.\n10. Signed informed consent obtained.\n\nExclusion Criteria:\n\n1. Arrhythmias requiring anti-arrhythmic treatment (except β-blockers or Digoxin), symptomatic coronary artery disease, myocardial ischemia (myocardial infarction within the past 6 months), or congestive heart failure (CHF) \\> NYHA Class II.\n2. Severe hypertension that is not well controlled by medication.\n3. History of HIV infection or active chronic Hepatitis B or C (with high viral DNA load).\n4. Active tuberculosis (TB), ongoing anti-TB treatment, or anti-TB treatment within 1 year prior to trial screening.\n5. Other active severe infections as defined by NCI-CTCAE v5.0.\n6. Evidence of distant metastasis beyond the pelvic region.\n7. Blood dyscrasias or organ dysfunction.\n8. History of pelvic or abdominal radiotherapy.\n9. Multiple colorectal cancer or multiple primary tumors.\n10. Epilepsy requiring treatment (e.g., steroids or anti-epileptic drugs).\n11. History of other malignancies within the past 5 years.\n12. History of drug abuse, or medical, psychological, or social conditions that could interfere with patient participation or the evaluation of study results.\n13. Any active autoimmune disease or a history of autoimmune disease (including but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators).\n14. Administration of any live attenuated vaccine within 4 weeks prior to inclusion.\n15. Long-term use of immunosuppressants or systemic\u002Ftopical corticosteroids (dose \\>10 mg\u002Fday prednisolone or equivalent).\n16. Known or suspected allergy to any study-related drug.\n17. Any unstable condition that could compromise patient safety or compliance.\n18. Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.\n19. Refusal to provide signed informed consent.","ALL","18 Years","80 Years",{"count":21,"type":22},166,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Neoadjuvant immunotherapy has shown promising therapeutic effects in mismatch repair-deficient or microsatellite instability-high (dMMR\u002FMSI-H) colorectal cancer (CRC). However, for patients with mismatch repair-proficient or microsatellite stable (pMMR\u002FMSS) CRC, the efficacy of PD-1 monoclonal antibody remains limited. Enhancing the efficacy of immunotherapy in pMMR\u002FMSS CRC has become a key area of exploration. Additionally, for locally advanced (cT4NxM0) CRC patients, achieving R0 resection poses a significant challenge. Failure to achieve R0 resection often results in recurrence, severely impacting patient survival outcomes. Our previous phase II clinical study (BASKET Ⅱ) demonstrated that the neoadjuvant regimen of mFOLFOX6 combined with Bevacizumab and PD-1 monoclonal antibody significantly enhanced the immunotherapy sensitivity of locally advanced pMMR\u002FMSS CRC, leading to improved pathological complete response (pCR) rates and higher R0 resection rates. This prospective, multicenter, randomized phase III trial aims to evaluate whether the neoadjuvant regimen of mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody can further improve pCR rate, enhance survival outcomes, and maintain an acceptable safety profile compared to mFOLFOX6 alone in pMMR\u002FMSS locally advanced CRC patients.",[28,29],"Colorectal Cancer (CRC)","pMMR\u002FMSS Adenocarcinoma of the Colon or Rectum",[31,32,33,34,35],"Colorectal cancer","pMMR\u002FMSS","Neoadjuvant Therapy","PD-1 monoclonal antibody","mFOLFOX6","RECRUITING","2025-12-17",{"date":39,"type":40},"2025-12-24","ACTUAL",{"date":42,"type":40},"2025-01-18",{"date":44,"type":22},"2031-12-31",{"name":46,"class":47},"Jun Huang","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100598363","phase-1-study-of-gv20-0251-in-participants-with-solid-tumor-malignancies-100598363","NCT07070518","Study of GV20-0251 in Participants With Solid Tumor Malignancies","An Open-Label Phase 1\u002F2A Study of GV20-0251 in Participants With Advanced and\u002For Refractory Solid Tumor Malignancies","Inclusion Criteria:\n\n* Before conducting any study-specific procedures, voluntarily sign an informed consent form.\n* Be able and willing to participate throughout the entire study period and comply with study procedures.\n* participants ≥18 years of age\n* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)\n* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression\n* ECOG performance status of 0 or 1 before C1D1\n* Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters\n* Women of childbearing potential (WOCBP) and men must agree to use adequate contraception\n\nExclusion Criteria:\n\n* Participants with acute leukemia or CLL\n* Participant with heart disease (NYHA ≥ Level II), myocardial infarction within the past 6 months, or unstable arrhythmia\n* Fridericia-corrected QT interval (QTcF) \\> 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days before C1D1\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.\n* History of major organ transplant and\u002For a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Major surgery within 28 days prior to the first dose of study medication\n* Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions.\n* History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.\n* Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.\n* Active substance abuse\n* Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy",{"count":57,"type":22},350,[59,60],"PHASE1","PHASE2","This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.",[63,64,65,66,29,67,68,69,70],"Solid Tumor Cancer","Adult Refractory Cancer","Endometrial Carcinoma (EC)","Squamous Head and Neck Carcinoma","Non-Small Cell Lung Cancer","Melanoma","HCC - Hepatocellular Carcinoma","Small Cell Lung Cancer","2025-12-01",{"date":73,"type":40},"2025-12-03",{"date":75,"type":40},"2025-07-11",{"date":77,"type":22},"2028-09-16",{"name":79,"class":80},"GV20 Therapeutics","INDUSTRY",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100490692","phase-1-a-study-of-gv20-0251-monotherapy-and-gv20-0251-in-combination-with-pembrolizumab-in-participants-with-solid-tumor-malignancies-100490692","NCT05669430","A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies","An Open-Label Phase 1\u002F2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and\u002For Refractory Solid Tumor Malignancies","Inclusion Criteria:\n\n* Participants ≥18 years of age\n* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy\n* Refractory or intolerant to standard therapy(ies)\n* Must have received, be not eligible or decline standard of care therapy\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)\n* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression\n* ECOG performance status of 0 or 1\n* Life expectancy of ≥ 12 weeks in Parts A and C and ≥ 24 weeks in Parts B and D\n* Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment (Parts A, B, C and D) and on-treatment (Parts A and B), if clinically feasible\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years\n* Laboratory test results within the required parameters\n* Women of child bearing potential (WOCBP) and men must agree to use adequate contraception\n* Parts B, C and D may include the following tumor types:\n\n  * Endometrial carcinoma\n  * Squamous head and neck carcinoma\n  * Cutaneous melanoma\n  * Non-small cell lung cancer\n  * Proficient MMR (pMMR)\u002FMSS adenocarcinoma of the colon or rectum (Parts C and D only)\n\nParts A, B, C and D Exclusion Criteria:\n\n* Participant with acute leukemia or CLL (Parts A and B only)\n* Participant with heart disease or unstable arrhythmia\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* History of major organ transplant\n* History of a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication\n* Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication\n* Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication\n* Radiation for symptomatic lesions must have been completed prior to the first dose of study medication\n* Participants with liver metastases unless approved by the Sponsor\n* Any history of an immune related ≥ Grade 3 AE attributed to prior cancer immunotherapy\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1\n* Has received radiation therapy to the lung that is higher than 30 Gy within 6 months prior to C1D1 for NSCLC (Parts C and D only)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1 (Parts C and D only)\n* Has severe hypersensitivity ( ≥ Grade 3) to Pembrolizumab and\u002For any of its excipients (Parts C and D only)\n* Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease (Parts C and D only)\n* Has a condition, therapy, laboratory abnormality, or circumstance that could confound study results or interfere with full participation, making it unsuitable for the participant, as determined by the treating Investigator (Parts C and D only)\n* Active substance abuse",{"count":89,"type":22},365,[59,60],"This is a Phase 1\u002F2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.",[93,94,65,66,29,95,67],"Solid Tumor, Adult","Refractory Cancer","Cutaneous Melanoma",[97],"GV20-0251","2025-02-11",{"date":100,"type":40},"2025-02-13",{"date":102,"type":40},"2023-03-23",{"date":104,"type":22},"2027-09-05",{"name":79,"class":80},13]