[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-microsatellite-stable-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-microsatellite-stable-colorectal-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100517068","phase-1-lb-100-pp2a-inhibitor-and-atezolizumab-pd-l1-inhibitor-in-metastatic-colorectal-cancer-patients-100517068",false,"NCT06012734","LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients","Phase Ib Study With the Combination of LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients - The CoLBAt Trial","CoLBAt","Inclusion Criteria:\n\n1. Signed Informed Consent Form (ICF);\n2. Age ≥ 18 years at time of signing ICF;\n3. Ability to comply with the study protocol;\n4. Histological or cytological confirmed colorectal cancer;\n5. Immunohistochemically confirmation of microsatellite stable (MSS) phenotype;\n6. Disease progression during treatment with standard of care;\n7. Measurable disease per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation;\n8. Able and willing to undergo blood sampling and tumour biopsies at baseline, if no adequate archival material is available, and during therapy;\n9. Availability of representative tumor specimen for exploratory biomarker research;\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n11. Life expectancy of at least 3 months;\n12. Negative HIV test at screening. Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200\u002FµL, and have an undetectable viral load;\n13. Negative hepatitis B test at screening;\n14. Negative hepatitis C virus test at screening;\n15. Adequate hematologic and end-organ function as defined by:\n\n    * Absolute neutrophil (segmented and bands) count ≥1.0×109\u002FL\n    * Lymphocyte count ≥0.5×109\u002FL\n    * Platelets≥100×109\u002FL\n    * Hemoglobin ≥5.6 mmol\u002FL\n    * AST≤2.5×ULN\n    * ALT≤2.5×ULN\n    * AP ≤2.5×ULN\n    * Bilirubin ≤1.5×ULN\n    * Estimated glomerular filtration rate ≥50 mL\u002Fmin by CKD-EPI\n    * Albumin ≥25 g\u002FL\n    * INR ≤1.5×ULN\n    * aPTT ≤1.5×ULN\n16. Negative pregnancy test (urine or serum) for female patients with childbearing potential.\n\nExclusion Criteria:\n\n1. Unable to follow study procedures;\n2. Patients using prohibited medication;\n3. Any unresolved grade ≥ 2 toxicities related to prior treatments (excluding alopecia) according to CTCAE version 5.0;\n4. Symptomatic or actively progressing central nervous system (CNS) metastases. Asymptomatic patients with treated or untreated CNS lesions are eligible, provided that all of the following criteria are met:\n\n   * Measurable disease, per RECIST v1.1, must be present outside the CNS;\n   * The patient has no history of intracranial haemorrhage or spinal cord haemorrhage;\n   * The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment;\n   * The patient has no ongoing requirement for corticosteroids as therapy for CNS disease;\n   * If the patient is receiving anti-convulsant therapy, the dose is considered stable;\n5. History of leptomeningeal disease;\n6. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a sta-ble regimen at study entry;\n7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. Patients with indwelling catheters are allowed;\n8. Uncontrolled symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\>12 mg\u002FdL, or corrected calcium greater than ULN);\n9. Active or history of auto-immune disease or immune deficiency;\n10. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field is permitted;\n11. Active tuberculosis;\n12. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina;\n13. Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study;\n14. History of malignancy within 2 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%);\n15. Severe infection within 4 weeks prior to initiation of study treatment;\n16. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics are eligible for the study;\n17. Prior allogeneic stem cell or solid organ transplantation;\n18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications;\n19. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab;\n20. Current treatment with anti-viral therapy for HBV;\n21. Treatment with investigational therapy within 28 days prior to initiation of study treat-ment;\n22. Prior treatment with CD137 agonists or immune checkpoint blockade therapies;\n23. Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment;\n24. Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment;\n25. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins;\n26. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the Atezolizumab formulation;\n27. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.","ALL","18 Years",{"count":20,"type":21},37,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This Phase Ib trial studies the side effects and best dose of LB-100 when given with atezolizumab for the treatment of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of the tumor to grow and spread. LB-100 has been shown to make anticancer drugs work better at killing cancer. LB-100 blocks a protein on the surface of cells called PP2A. Blocking this protein increases the stress signals for the tumor cells that express PP2A. Giving atezolizumab in combination with LB-100 may work better to treat metastatic colorectal cancer patients as the cancer cells that experience increased stress signals are more susceptible for the immunotherapy.",[27],"Metastatic Microsatellite-stable Colorectal Cancer",[29,30,31,32,33],"Gastrointestinal Neoplasms","Colorectal cancer","Metastatic colorectal cancer","Microsatellite stable","Immune checkpoint inhibitors","RECRUITING","2026-06-26",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":38},"2024-06-18",{"date":42,"type":21},"2028-07",{"name":44,"class":45},"The Netherlands Cancer Institute","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100498303","phase-3-comparing-chidamidesintilimabbev-with-standard-second-line-folfiribev-in-advanced-msspmmr-mcrc-100498303","NCT05768503","Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS\u002FpMMR mCRC","Chidamide+Sintilimab+Bevacizumab Versus Standard Second-Line Therapy of FOLFIRI+Bevacizumab in Subjects With Advanced Microsatellite Stable (MSS\u002FpMMR) Colorectal Cancer Who Have Failed Oxaliplatin-Containing First-Line Therapy","Inclusion Criteria:\n\n1. Locally advanced unresectable or metastatic colorectal adenocarcinoma (excluding mixed adenosquamous carcinoma and other pathological types) confirmed by pathological histology or cytology.\n2. Diagnosis of pMMR confirmed by PCR for microsatellite stability (MSS) or low microsatellite instability (MSI-L), or by immunohistochemistry for DNA mismatch repair (MMR) proteins, including MLH1, MSH2, MSH6 and PMS2 protein expression, which result in no protein deletion.\n3. Patients who have failed first-line oxaliplatin-containing standard therapy and have imaging evidence (e.g., CT scan) or clinical evidence (e.g., cytology report of new ascites or pleural effusion) of disease progression during or after treatment; patients whose intolerance of toxicity has led to discontinuation of first-line oxaliplatin-containing standard therapy may be enrolled; relapse within 180 days after the last dose of oxaliplatin-containing adjuvant therapy.\n4. There is at least one measurable lesion according to RECIST v1.1.\n5. ECOG PS score is in the range of 0\\~1.\n6. Subjects who have signed a written informed consent form and who are able to comply with the visits and related procedures specified in the protocol.\n7. Aged ≥ 18 years old and ≤ 75 years old.\n8. Expected survival time ≥ 18 weeks.\n9. Female subjects of childbearing age or male subjects whose sexual partners are at childbearing age are required to take effective contraception measures throughout the treatment period and for 6 months after the treatment (see section 4.3 of the protocol).\n10. Subjects having adequate organ and bone marrow functions with laboratory test values within 7 days prior to enrollment meeting the following requirements (no blood components, cell growth factors, albumin, and other corrective therapy drugs are allowed to be given within the first 14 days of obtaining laboratory tests), as follows:\n\n1\\) Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; platelet count (PLT) ≥ 100×109\u002FL; hemoglobin level (HGB) ≥ 9.0 g\u002FdL.\n\n2\\) Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in subjects without liver metastases, and ALT and AST ≤ 5.0 × ULN in subjects with liver metastases; serum albumin ≥ 25 g\u002FL.\n\n3\\) Renal function: serum creatinine (Cr) ≤ 1.5 x ULN. 4) Patients with routine urine results showing urine protein \\\u003C2+ or routine urine testing showing urine protein ≥ 2+ at baseline should undergo 24-hour urine collection and 24-hour urine protein quantification \\\u003C 1 g.\n\n5\\) Coagulation function: international normalized ratio (INR) ≤ 1.5×ULN and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\nExclusion Criteria:\n\n1. Prior exposure to any anti-PD-1 antibody, anti-PD-L1 antibody, HDAC inhibitor, or irinotecan.\n2. Receiving any investigational drug within 4 weeks prior to the first dose of the study drug.\n3. Concurrent participation in another interventional clinical study, except in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study.\n4. Receiving the last dose of antitumor therapy (chemotherapy, targeted therapy, tumor immunotherapy, or tumor embolization) within 3 weeks prior to the first dose.\n5. Receiving radiotherapy within 4 weeks prior to the first dose.\n6. Patients who have received radiotherapy more than 4 weeks prior to the first dose with any radiotherapy-related toxic reactions, such as radiation pneumonia, radiation hepatitis, radiation enteritis, including clinical symptoms only, or requiring glucocorticoid therapy.\n7. Use of immunosuppressive drugs within 4 weeks prior to the first dose, excluding topical glucocorticoids by nasal spray, inhalation or other routes or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg\u002Fday prednisone or equivalent doses of other glucocorticoids).\n8. Receiving live attenuated vaccine within 4 weeks prior to the first dose or planning to receive during the study period.\n9. Major surgical procedure (craniotomy, thoracotomy or open heart surgery) or unhealed wound, ulcer or fracture within 4 weeks prior to the first dose.\n10. Presence of toxicity (excluding alopecia, non-clinically significant and asymptomatic laboratory abnormalities) from prior antineoplastic therapy not recovered to ≤ grade 1 by NCI common terminology criteriafor adverse events (CTCAE) Version 5.0 (NCI CTCAE Version 5.0) prior to the first dose.\n11. Known presence of symptomatic CNS metastases and\u002For carcinomatous meningitis. Subjects with prior treatment for brain metastases may participate in the study provided that the brain metastases have remained stable for at least 4 weeks prior to the first dose of study treatment; and that neurological symptoms have recovered to ≤ grade 1 by NCI CTCAE version 5.0.\n12. Active autoimmune disease requiring systemic therapy (e.g., use of disease-relieving drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are allowed. A known history of primary immunodeficiency. For patients with only positive autoimmune antibodies, the presence of autoimmune diseases should be confirmed at the discretion of the investigator.\n13. Patients who are known to have active tuberculosis and are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to the first dose.\n14. Known to have interstitial lung disease requiring steroid hormone therapy.\n15. Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA ≥ 200 IU\u002FmL or ≥ 103 copies\u002FmL) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive).\n16. Infected with human immunodeficiency virus (HIV) (HIV 1\u002F2 antibody positive), known to be infected with syphilis.\n17. Severe infections that are in the active phase or poorly controlled in clinical practice. Serious infection, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia, within 4 weeks prior to the first dose.\n18. Significant malnutrition, such as the need for intravenous supplemental nutrient solutions; except for malnutrition corrected more than 4 weeks prior to the first dose.\n19. Symptomatic congestive heart failure (New York Heart Association class II-IV); symptomatic or poorly controlled arrhythmias.\n20. Uncontrolled arterial hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) even with standard treatment.\n21. Any arterial thromboembolic event including myocardial infarction, pulmonary embolism, and unstable angina within 6 months prior to enrollment.\n22. A history of deep vein thrombosis or any other serious thromboembolism (implantable IV port or catheter-derived thrombosis, or superficial vein thrombosis is not considered \"serious\" thromboembolism) within 3 months prior to enrollment.\n23. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe cirrhosis.\n24. A history of gastrointestinal perforation and\u002For fistula in the previous 6 months; a history of peptic ulcer, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, abdominal abscess, or long-term chronic diarrhea. Post-intestinal stent implantation.\n25. \\> 3 loose stools per day at baseline, suggesting a predisposition to colon or small bowel disease with uncontrollable symptoms.\n26. A history of allergy or known intolerance to atropine sulfate or loperamide or the appropriate antiemetic in combination with FOLFIRI.\n27. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer and can lead to higher medical risk and\u002For uncertainty in survival evaluation.\n28. A known history of inherited bleeding tendency disorders or coagulation disorders\n29. Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion therapy, surgical or local treatment, or ongoing drug therapy.\n30. A high risk of bleeding as determined by the investigators: cirrhosis with severe esophagogastric fundic varices, intermittent or persistent non-fatal bleeding events (including but not limited to intermittent bloody stools or positive occult blood due to primary intestinal lesions, intermittent hemoptysis due to pulmonary metastases).\n31. Cerebrovascular accident (including transient ischemic attack) in the previous 6 months.\n32. Use of aspirin (\\>325 mg\u002Fday) or other NSAIDs known to inhibit platelet function for 10 consecutive days within 10 days prior to the first dose.\n33. Treatment with oral or parenteral anticoagulants or thrombolytics for 10 consecutive days within 10 days prior to the first dose. However, prophylactic use of anticoagulants is allowed.\n34. Pleural fluid, ascites, and pericardial effusion with clinical symptoms or requiring drainage, except for small amounts of pleural fluid, small amounts of ascites, and small amounts of pericardial effusion without clinical symptoms on imaging only.\n35. A history of other primary malignancies, except: malignancies in complete response for at least 2 years prior to enrollment and requiring no other treatment during the study period; adequately treated non-melanoma skin cancer or malignant freckled nevus with no evidence of disease recurrence; adequately treated carcinoma in situ with no evidence of disease recurrence.\n36. A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n37. Known to be allergic to any monoclonal antibody component.\n38. Female subjects in the pregnancy or lactating period.\n39. A history of alcohol or drug abuse.\n40. Other acute or chronic illnesses, psychiatric disorders, or abnormal laboratory test values that may result in the following outcomes: increasing the risk associated with study participation or study drug administration, or interfering with the interpretation of study results and, at the investigator's discretion, classifying the patient as ineligible for participation in this study.","75 Years",{"count":56,"type":21},176,[58],"PHASE3","This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy and safety of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy in subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy. The primary purpose is to compare the progression-free survival (PFS) of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy for colorectal cancer, with a planned enrollment of 176 subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy.",[27],[62,63,64,65,66,67],"Colorectal Cancer","Microsatellite Stable","Chidamide","Sintilimab","PD-1","Bevacizumab","2023-03-13",{"date":70,"type":38},"2023-03-14",{"date":72,"type":38},"2023-03-01",{"date":74,"type":21},"2027-01",{"name":76,"class":45},"Sun Yat-sen University",12]