[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-colorectal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-colorectal-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100641439","phase-2-neoadjuvant-botensilimab-and-balstilimab-for-the-treatment-of-advanced-resectable-colorectal-cancer-nest3-100641439",false,"NCT07595874","Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3","A Phase II Novel Exploratory Study to Test Neoadjuvant Immunotherapy Combinations in Patients With Resectable Colon Cancer (NEST3)","NEST3","Inclusion Criteria:\n\n* Documented informed consent of the participant and Legally Authorized Representative (when applicable)\n\n  * Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines\n* Agreement to allow the use of tissue from past and future surgery and standard of care biopsies\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed or cytologically confirmed colorectal adenocarcinoma. Patients with high grade dysplasia on histology plus unequivocal endoscopic or radiological evidence of invasive cancer are eligible.\n\nPatients diagnosed with rectal cancer who will be treated like colon cancer with curative-intent surgery first and no radiation are also eligible, including:\n\n* Upper rectum or rectosigmoid considered as non-rectal and not undergoing neoadjuvant treatment\n* The tumor component should not extend to less 12 cm from the anal verge.\n* Any patient with rectal cancer for whom radiotherapy is not advised is included in this protocol (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation)\n\n  * Microsatellite stability by mismatch repair by immunohistochemistry, polymerase chain reaction and\u002For other Clinical Laboratory Improvement Amendments (CLIA) certified next generation sequencing. Only patients with mismatch repair proficient or microsatellite stable (pMMR\u002FMSS) tumors are allowed to enroll in the study\n  * Candidate for and planning a curative resection. Must have surgeon identified\n  * T4, N+ (American Joint Committee on Cancer \\[AJCC\\] TNM staging criteria), or both by central radiographic assessment.\n* Note: Patients with T3N0 stage IIA are excluded. Stage IIB, IIC, IIIA, IIIB, and IIIC are included. Patients with stage IV disease are excluded\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n  * Platelets ≥ 75,000\u002Fmm\\^3\n* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n\n  * Hemoglobin ≥ 8 g\u002FdL\n* NOTE: Red blood cell transfusions are permitted. Patients should not have active clinically significant bleeding requiring regular transfusions. Iron infusions are also allowed\n\n  * Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, in which case the liver function tests must meet the other eligibility in the protocol)\n  * Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n  * Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Creatinine clearance of ≥ 40 mL\u002Fmin per the Cockcroft-Gault formula\n  * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n  * Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 9 months for women, and at least 6 months for men, after the last dose of oxaliplatin therapy. If patients discontinue oxaliplatin more than 9 months (females) or 6 months (males) before discontinuation of balstilimab and\u002For botensilimab, females and males of childbearing potential must use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of balstilimab and\u002For botensilimab.\n* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* The following are acceptable birth control methods for this study: Surgical sterilization (tubal ligation or hysterectomy for women, or vasectomy for men), double-barrier methods (i.e. condoms, diaphragm, cervical cap, or sponge, used together with spermicidal gel or foam), intrauterine device (IUD) (i.e. Progestin, Copper), or hormonal contraceptives (birth control patches, implants, pills, rings, or injections)\n\nExclusion Criteria:\n\n* Any treatment for colorectal cancer prior to enrollment that includes (but not limited to) chemotherapy, surgery, radiation, immunotherapy and\u002For biological therapy.\n\n  * Note: Surgical intervention e.g. a diverting ostomy to relieve an obstruction from colorectal cancer, those patients will be allowed to enter the study as long as no distant metastatic disease\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Prior allogeneic organ transplantation\n* Herbal medications that require a prescription or are anti-cancer\n* Other active malignancy. Patients 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 regimen are eligible for this trial. Please note: patients with more than 1 colorectal cancer tumor at diagnosis (as long as no stage IV disease) are allowed to participate. Pathologic response to each of the tumors will be examined\n* Active acute colonic obstruction. Patients whose obstruction is relieved by a successful defunctioning stoma are allowed once recovered to a fitness level consistent with the other eligibility criteria\n* Clinically significant uncontrolled illness\n* Females only: Pregnant or breastfeeding\n* Prior allergic reaction or hypersensitivity to any of the study drug components\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs (excluding hypothyroidism, vitiligo, and psoriasis that is controlled with topical management)\n* History or current evidence of any condition, co-morbidity, therapy, that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator\n* Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) are eligible. Serological testing for HIV at screening is not required\n* Uncontrolled infection with hepatitis B virus. Patients who are receiving or who have received anti-HBV therapy are eligible. Serological testing for HBV at screening is not required\n* Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible. Serological testing for HCV at screening is not required\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Advanced Colon Adenocarcinoma","Advanced Colorectal Adenocarcinoma","Advanced Rectal Adenocarcinoma","Stage IIB Colon Cancer AJCC v8","Stage IIB Rectal Cancer AJCC v8","Stage IIC Colon Cancer AJCC v8","Stage IIC Rectal Cancer AJCC v8","Stage IIIA Colon Cancer AJCC v8","Stage IIIA Rectal Cancer AJCC v8","Stage IIIB Colon Cancer AJCC v8","Stage IIIB Rectal Cancer AJCC v8","Stage IIIC Colon Cancer AJCC v8","Stage IIIC Rectal Cancer AJCC v8","RECRUITING","2026-06-29",{"date":43,"type":44},"2026-07-01","ACTUAL",{"date":46,"type":21},"2026-12-27",{"date":48,"type":21},"2027-05-27",{"name":50,"class":51},"City of Hope Medical Center","OTHER",11,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100558781","engage-psychosocial-intervention-for-cancer-symptoms-100558781","NCT06555588","Engage Psychosocial Intervention for Cancer Symptoms","Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer","Engage","Inclusion Criteria:\n\n* Receiving cancer care at 1) a Duke Cancer Network (DCN) clinic; or 2) the Duke Cancer Institute (DCI) and live in a rural county at least 60 miles from Duke\n* Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer\n* Worst pain, fatigue, or distress rated at \\>\u002F= 3 out of 10 in the past 7 days for at least 2 symptoms\n* MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale average score of \\>\u002F= 3 out of 10 in the past 7 days\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower\n* At least 18 years old\n* Ability to speak and read English\n* Hearing and vision that allows for successful completion of telehealth sessions\n\nExclusion Criteria:\n\n* Significant cognitive impairment indicated in medical chart or during telephone screening on a mental status questionnaire\n* Serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation\n* Participation in the last 6 months in Cognitive-Behavioral Therapy or Acceptance and Commitment Therapy for cancer symptom management\n* Enrollment in hospice at screening",{"count":62,"type":21},190,[64],"NA","The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.",[67,68,69,70,28],"Advanced Breast Cancer","Advanced Prostate Cancer","Advanced Lung Cancer","Advanced Colorectal Carcinoma",[72,73,74,75,76,77,78],"Acceptance and Commitment Therapy","Cognitive Behavioral Therapy","Pain management","Fatigue management","Symptom management","Telehealth","Psychosocial intervention","2026-03-12",{"date":81,"type":44},"2026-03-16",{"date":83,"type":44},"2025-06-11",{"date":85,"type":21},"2028-11",{"name":87,"class":51},"Duke University",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100574010","phase-1-an-open-label-multicenter-single-arm-clinical-study-on-the-use-of-doxorubicin-liposome-in-combination-with-capox-and-bevacizumab-regimen-for-first-line-treatment-of-advanced-colorectal-adenocarcinoma-with-smad4r361hc-mutation-100574010","NCT06753721","An Open-label, Multicenter, Single-arm Clinical Study on the Use of Doxorubicin Liposome in Combination With CapOX and Bevacizumab Regimen for First-line Treatment of Advanced Colorectal Adenocarcinoma With SMAD4R361H\u002FC Mutation.","Inclusion Criteria:\n\n1. The patient voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance;\n2. Age 18 years or older (inclusive), regardless of gender;\n3. Histologically and\u002For cytologically confirmed unresectable colorectal adenocarcinoma;\n4. For left-sided colon cancer or rectal cancer patients, must be non-RAS wild-type;\n5. Non-dMMR\u002FMSI-H;\n6. SMAD4R361H\u002FC mutation;\n7. No prior history of systemic chemotherapy;\n8. ECOG performance status of 0 or 1;\n9. Hematological tests (within 14 days without blood transfusion): neutrophil absolute count ≥ 1.5 × 10⁹\u002FL, platelet count ≥ 100 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FL;\n10. Liver function tests (AST and ALT ≤ 3 × ULN, bilirubin ≤ 1.5 × ULN; if liver metastasis is present, AST and ALT ≤ 5 × ULN);\n11. Renal function (serum creatinine ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60 mL\u002Fmin);\n12. Both male and female subjects of reproductive age must use effective contraception.\n\nExclusion Criteria:\n\n1. Patients with known contraindications to Doxorubicin liposome, Oxaliplatin, Capecitabine, or Bevacizumab;\n2. Patients who have received radiotherapy or any anti-tumor treatments (chemotherapy, targeted therapy, immunotherapy, radiofrequency ablation, traditional Chinese medicine with anti-tumor indications, immunomodulators, or tumor embolization, etc.);\n3. Patients who have had other malignancies within the past 5 years or have concurrent malignancies (except for cured skin basal cell carcinoma and carcinoma in situ of the cervix);\n4. Patients who have experienced significant clinical bleeding symptoms, obvious bleeding tendency, or hemoptysis within 3 months prior to treatment, or who have had venous\u002Fthrombotic events such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within the previous 6 months; or require long-term anticoagulation treatment with warfarin or heparin, or require long-term antiplatelet therapy (aspirin ≥300 mg\u002Fday or clopidogrel ≥75 mg\u002Fday);\n5. Patients with active cardiovascular diseases within 6 months before treatment, including myocardial infarction, severe\u002Funcontrolled angina. Echocardiography showing left ventricular ejection fraction \\\u003C50%, or poorly controlled arrhythmia;\n6. Known history of primary immunodeficiency virus infection;\n7. Patients with active or uncontrolled severe infections;\n8. Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities, and based on the investigator's judgment, there is reasonable suspicion that the patient has a condition or disease that is unsuitable for the use of the study drug;\n9. Any situation that, in the investigator's opinion, could pose a risk to the patient receiving study drug treatment, interfere with the assessment of the study drug's safety, or affect the interpretation of results.",{"count":96,"type":21},13,[98,24],"PHASE1","This is a prospective, single-arm clinical study designed to evaluate the 6-month progression-free survival rate (6-month PFS rate) of Doxorubicin liposome combined with CapOX and Bevacizumab regimen as first-line treatment for advanced colorectal adenocarcinoma with SMAD4R361H\u002FC mutation. The study plans to recruit 13 patients. After receiving 8 cycles of induction therapy, patients whose efficacy is evaluated as complete response (CR), partial response (PR), or stable disease (SD) (according to RECIST 1.1) will enter maintenance therapy.",[28],"NOT_YET_RECRUITING","2024-12-23",{"date":104,"type":44},"2024-12-31",{"date":104,"type":21},{"date":107,"type":21},"2027-06-01",{"name":109,"class":51},"Nanfang Hospital, Southern Medical University"]