[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bevacizimab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bevacizimab":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631409","phase-1-phase-1-study-of-sar445877-in-combination-with-folfox6-and-bevacizumab-as-first-line-treatment-for-microsatellite-stable-metastatic-colorectal-cancer-100631409",false,"NCT07500298","Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer","Eligibility Criteria\n\n1. Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.\n2. Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures.\n3. Age ≥18 years.\n4. Participants with histologically documented CRC with metastatic disease who have not received prior treatment in the metastatic setting. Participants who have received adjuvant FOLFOX must be 6 months from treatment at the time of enrollment.\n5. CRC documented as MSS by immunohistochemistry, next-generation sequencing, or polymerase chain reaction assay at any time prior to screening.\n6. Measurable disease per the RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Adequate organ and marrow function as defined below within 28 days of study treatment initiation:\n\n   * Hemoglobin \\>9.0 g\u002FdL\n   * Absolute neutrophil count ≥1500\u002FmL\n   * Platelets ≥100,000\u002FmL\n   * Total bilirubin ≤1.5 × institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.\n   * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤2.5 × institutional ULN. Transaminases up to 3 × ULN in the presence of liver metastases.\n   * Estimated glomerular filtration rate ≥50 mL\u002Fmin\u002F1.73 m² (Modification of Diet in Renal Disease Formula)\n   * For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen.\n9. Life expectancy ≥ 3 months.\n10. The effects of SAR445877 and FOLFOX\u002Fbevacizumab on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of the study treatment period, and for 9 months after completion of study treatment.\n\n    (Refer to Pregnancy Assessment Policy MD Anderson Cancer Center \\[MDACC\\] Institutional Policy # CLN1114). WOCBP includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n    * Postmenopausal (no menses in ≥12 consecutive months)\n    * History of hysterectomy or bilateral salpingo-oophorectomy\n    * Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy)\n    * History of bilateral tubal ligation or another surgical sterilization procedure\n    * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy, patient\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the duration of the study treatment period and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n11. Male participants must agree to use adequate contraception throughout the duration of the study treatment period and for 6 months after the last dose of study treatment\n12. WOCBP must have a negative serum pregnancy test within 3 days prior to first administration of study treatment.\n\nExclusion Criteria\n\n1. Pregnant or breastfeeding.\n2. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that requires\u002Frequired treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs. Participants with the following conditions are eligible: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.\n3. Participants who are receiving any other investigational agents.\n4. Receipt of a live-virus vaccination within 28 days prior to study treatment initiation. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).\n5. Participants with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 1 week prior to the first administration of study treatment. Physiologic replacement doses are allowed even if they are \\>10 mg of prednisone\u002Fday or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided they are not for the treatment of an autoimmune disorder. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are eligible to be enrolled in the study.\n6. Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome, unless most recent CD4 count exceeds 500 cells\u002Fmm3.\n7. Acute or chronic hepatitis B virus or hepatitis C virus infection.\n8. Previous solid organ or allogeneic hematopoietic stem cell transplant.\n9. Active brain or leptomeningeal metastases.\n10. Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.\n11. History of interstitial lung disease or severe obstructive pulmonary disease.\n12. Clinically significant cardiovascular\u002Fcerebrovascular disease.\n13. Left ventricular ejection fraction \\\u003C50% as measured by echocardiogram or multigated acquisition scan.\n14. Serious, non-healing wound, ulcer, or bone fracture.\n15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to first administration of study treatment.\n16. Evidence of bleeding or coagulopathy.\n17. Uncontrolled hypertension (\\>150\u002F100 mmHg).\n18. Urine dipstick of proteinuria \\>2+. Participants with \\>2+ proteinuria on dipstick analysis will undergo a 24-hour urine collection and must demonstrate \\\u003C1.0 g protein\u002F24 hours to be eligible.\n19. Known severe hypersensitivity reactions to monoclonal antibodies, any history of or recent (within 6 months) anaphylaxis.\n20. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.\n21. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n\n    \\-","ALL","18 Years",{"count":18,"type":19},41,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.",[25,26,27,28,29,30,31],"Phase 1","SAR445877","FOlfox6","Bevacizimab","First Line Treatment","Metastatic Colorectal Cancer (CRC)","Microsatellite Stable","RECRUITING","2026-05-29",{"date":35,"type":36},"2026-06-01","ACTUAL",{"date":38,"type":36},"2026-05-20",{"date":40,"type":19},"2032-12-27",{"name":42,"class":43},"M.D. Anderson Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100617915","phase-2-sintilimab-plus-bevacizumab-biosimilar-as-neoadjuvant-therapy-for-resectable-hepatocellular-carcinoma-100617915","NCT07324824","Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma","Sintilimab Combined With Bevacizumab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: A Single-Arm, Prospective Phase II Study","Inclusion Criteria:\n\n1. Able to provide informed consent and willing to sign an approved consent form;\n2. Aged ≥ 18 years;\n3. Clinically diagnosed or pathologically confirmed resectable hepatocellular carcinoma beyond the Milan criteria (CNLC Ib-IIa);\n4. No prior anti-HCC treatment;\n5. Child-Pugh class A.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n7. Expected survival time of \\> 6 months.\n8. Sufficient organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Known as cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and hepatic fibrolamellar carcinoma;\n2. History of organ transplantation or hepatic encephalopathy\n3. Pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage\n4. History of esophageal or gastric variceal bleeding caused by portal hypertension within the past 6 months; Documented severe (Grade 3) varices identified by endoscopy within 3 months prior to enrollment; Evidence of portal hypertension and assessed by the investigator as being at high risk of bleeding.\n5. Arterial and venous thromboembolic events in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism history;\n6. Any life-threatening bleeding event occurring within the past 3 months;\n7. Severe bleeding tendency, coagulopathy, or ongoing thrombolytic therapy.\n8. Chronic requirement for medications that inhibit platelet function, such as aspirin (\\>325 mg\u002Fday), dipyridamole, or clopidogrel.\n9. Uncontrolled hypertension, defined as systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg despite optimal medical management; history of hypertensive crisis or hypertensive encephalopathy.\n10. Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] Functional Class II-IV); symptomatic or poorly controlled arrhythmias; history of congenital long QT syndrome; or corrected QT interval (QTc) \\>500 ms at screening (calculated using Fridericia's formula).\n11. History of gastrointestinal perforation and\u002For fistula, intestinal obstruction (including incomplete obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic persistent diarrhea within the past 6 months.\n12. Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to enrollment; presence of unhealed wounds, ulcers, or fractures; or tissue biopsy or other minor surgical procedure within 7 days prior to enrollment, excluding venous catheterization for intravenous infusion.\n13. Past or current history of pulmonary diseases including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severe impairment of lung function.\n14. Active acute or chronic hepatitis B or C infection, defined as: hepatitis B virus (HBV) DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL; hepatitis C virus (HCV) RNA \\>10³ copies\u002FmL; or concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies.\n15. Active tuberculosis (TB); ongoing anti-TB treatment; or anti-TB treatment completed within 1 year prior to the initiation of study treatment.\n16. Human immunodeficiency virus (HIV) infection (positive for HIV 1\u002F2 antibodies); known syphilis infection.\n17. Severe active infection or infection with poor clinical control.\n18. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to enrollment. Substitution therapy (e.g., thyroid hormone, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) is permitted. A history of known primary immunodeficiency is excluded. Patients with isolated positive autoimmune antibodies must be evaluated by the investigator to confirm the absence of underlying autoimmune disease.\n19. Use of immunosuppressive drugs within 4 weeks prior to enrollment, excluding intranasal, inhaled, or other topical corticosteroids, or systemic corticosteroids at physiological doses (i.e., ≤10 mg\u002Fday of prednisone or equivalent). Temporary use of corticosteroids for the management of dyspnea related to asthma, chronic obstructive pulmonary disease (COPD), or other conditions is permitted.\n20. Administration of live-attenuated vaccines within 4 weeks prior to enrollment or planned administration of live-attenuated vaccines during the study period.\n21. Use of immunomodulatory agents (including thymosin, interferons, or interleukins) within 2 weeks prior to enrollment, excluding local administration for the control of pleural effusion or ascites.\n22. Uncontrolled\u002Funcorrectable metabolic disorders, other non-malignant organ\u002Fsystemic diseases, or cancer-related sequelae that pose a high medical risk and\u002For introduce uncertainty in survival assessment.\n23. Diagnosis of other malignant tumors within 5 years prior to enrollment, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For curatively resected carcinoma in situ. For malignant tumors diagnosed more than 5 years prior to drug administration, pathological or cytological confirmation of recurrent or metastatic lesions is required.\n24. Prior receipt of any anti-angiogenic agents, anti-PD-1 antibodies, anti-PD-L1\u002FL2 antibodies, anti-CTLA-4 antibodies, or other immunotherapies.\n25. Known hypersensitivity to sintilimab, bevacizumab formulations, or their excipients; or history of severe hypersensitivity reactions to other monoclonal antibodies.\n26. Receipt of treatment in other clinical trials within 4 weeks prior to enrollment.\n27. Pregnant or breastfeeding female patients.\n28. Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory findings that, in the investigator's judgment, would: increase the risk associated with study participation or study drug administration; interfere with the interpretation of study results; or render the patient ineligible for study participation.",{"count":53,"type":19},37,[55],"PHASE2","Surgical resection is the preferred therapeutic modality for patients with resectable hepatocellular carcinoma (HCC). However, the recurrence rate of HCC remains up to 70%. Neoadjuvant therapy for HCC could potentially reduce the risk of postoperative recurrence and prolong overall survival. Nevertheless, there is no standard neoadjuvant treatment regimen for HCC to date. In recent years, targeted therapy and immunotherapy are proved to improve the prognosis of advanced HCC patients. Previous study (ORIENT-32) has confirmed that, compared with sorafenib, sintilimab combined with bevacizumab biosimilar can delay tumor progression, reduce the risk of death, and exhibit a favorable safety profile in patients with advanced HCC. Therefore, we conducted a prospective, single-arm phase II study to investigate the efficacy of sintilimab combined with a bevacizumab biosimilar as neoadjuvant therapy in patients with resectable HCC beyond the Milan criteria.",[58,59,60,28],"Hepatocellular Carcinoma","Neoadjuvant Therapy","Sintilimab","2026-01-15",{"date":63,"type":36},"2026-01-16",{"date":65,"type":36},"2026-01-14",{"date":67,"type":19},"2030-01",{"name":69,"class":43},"Sun Yat-sen University"]