[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ivonescimab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ivonescimab":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,65,89,120,146],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100588370","phase-2-phase-ii-trial-of-ivonescimab-in-previously-treated-patients-with-advanced-clear-cell-renal-cell-carcinoma-100588370",false,"NCT06940518","Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma","Inclusion Criteria\n\n1. Participants with histologically or cytologically confirmed metastatic\u002Fadvanced clear cell RCC with a clear cell component who have received at least one prior line of systemic treatment in the advanced or metastatic setting, including a PD-1\u002FPD-L1 checkpoint inhibitor administered in metastatic\u002Fadvanced setting.\n\n   1. Participants in cohort 1 must have not received a treatment containing a VEGF- or HIF2a(- directed agent in prior treatment lines of treatment for metastatic\u002Fadvanced RCC\n   2. Participants in cohort 2 must have had progression on or after at least one prior line of treatment containing a VEGF-directed agent in prior lines of therapy\n2. Participants must have had evidence of disease progression on or after last treatment regimen received.\n3. Participants who received HIF-2ƒ¿ inhibitors in prior lines of therapy are eligible in cohort 2 but not cohort 1.\n4. Participants who received adjuvant immune checkpoint inhibitor are eligible, provided that they had progression while on adjuvant therapy, in which case they would be enrolled in cohort 1. Participants who recur after completing adjuvant therapy should receive a PD-1\u002FPD-L1 checkpoint inhibitor in the advanced\u002Fmetastatic setting to be eligible.\n5. Participants must have at least one measurable site of disease per RECIST version 1.1. This is defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). For non-lymph node tumor lesions, they must be a minimum size of ≥ 10 mm. For malignant lymph node lesions, they must be at least ≥ 15 mm in short axis with conventional techniques or ≥10 mm with more sensitive techniques such as MRI or spiral CT scan. If the participant has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.\n6. ECOG performance status ≤2\n7. Age ≥ 18 years\n8. Participants must have adequate organ and marrow function prior to study entry as defined below:\n9. INR and PT ≤ 1.5 x ULN and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5 ULN (unless abnormalities are unrelated to coagulopathy). Therapeutic anticoagulation is permitted if: on a stable dose of low molecular weight heparin (LMWH) for \\> 2 weeks (14 days) at the time of enrollment or on a direct oral anticoagulant (DOAC) for \\> 2 weeks at time of enrollment.\n10. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n11. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n12. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Patients who are Hepatitis C virus antibody positive (HCV Ab\n\n    +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n13. Participants with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.\n14. The effects of Ivonescimab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy\n\n    \\# CLN1114). This includes all female participants , between the onset of menses (as early as 8years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). iv. History of bilateral tubal ligation or another surgical sterilization procedure.\n15. Female participants of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) before study entry. Pregnancy test must be repeated on the day of first infusion, if test performed \\> 14 days before starting study drug.\n16. Female participants of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab. Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab.\n\n    1. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial 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.\n\n       * Ability to understand and the willingness to sign a written informed consent document for this clinical trial and the companion Trials LAB02-152 and PA17-0577\n\nExclusion Criteria:\n\n1. Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or postradiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early stage prostate adenocarcinoma with negligible risk of metastasis or death.\n2. Major surgical procedures or serious trauma within 4 weeks prior to enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.\n3. Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after adequate oral antihypertensive therapy.\n4. History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:\n\n   o Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots).\n\n   Transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n   * Nasal bleeding \u002Fepistaxis. Bloody nasal discharge is allowed.\n   * Hematuria associated with urinary obstruction. Microhematuria or macrohematuria not associated with urinary obstruction are allowed.\n   * Radiologically documented evidence of major blood vessel encasement with narrowing of the vessel that the investigator determines will pose a significantly increased risk of bleeding.\n5. History of major diseases prior to enrollment, specifically:\n\n   * Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification . grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n   * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to enrollment.\n6. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollment.\n\n   * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to enrollment.\n   * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment.\n7. Symptomatic CNS metastases, leptomeningeal disease, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrolmment, or potential need for CNS radiation within the first cycle of ivonescimab.\n\n   o Participants with treated\u002Fstable brain metastases are allowed on protocol if they had brain metastases that received CNS-directed therapy, such as surgery or treatment with radiosurgery or Gamma knife, without recurrence or edema for at least 1 month (4 weeks). Participants actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible. Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone . 10 mg daily or equivalent).\n8. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic inflammatory diarrhea).\n9. Participants who are receiving any other investigational agents.\n10. Active autoimmune disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to enrollment. However the following will be allowed:\n\n    * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n    * Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted.\n11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n12. Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, severe sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B or C).\n13. Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic. Participants managed with indwelling catheters (e.g., PleurX) are allowed.\n14. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab or other agents used in study. This includes known history of severe hypersensitivity to other monoclonal antibodies.\n15. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n16. Participants with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrollment. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n17. Pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5.0.\n18. Pregnant women are excluded from this study because ivonescimab is a bispecific agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ivonescimab, breastfeeding should be discontinued if the mother is treated with ivonescimab.\n\n    These potential risks may also apply to other agents used in this study.\n19. Participant is breastfeeding or plans to breastfeed during the study.\n20. Participants with persistent grade ≥ 2 adverse events per NCI CTCAE v5.0 from prior systemic therapies that would confound timely detection of immune-related adverse events due to ivonescimab or otherwise hinder patient participation in the clinical trial.\n21. History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the participants participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ccRCC.",[25,26],"Ivonescimab","Clear Cell Renal Carcinoma","RECRUITING","2026-08-18",{"date":30,"type":31},"2026-08-20","ACTUAL",{"date":33,"type":31},"2025-07-02",{"date":35,"type":19},"2030-01-19",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":39},"100650909","a-phase-ii-study-of-ivonescimab-combined-with-intraperitoneal-paclitaxel-in-patients-with-high-grade-metastatic-appendiceal-adenocarcinoma-aa-100650909","NCT07753824","A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)","Inclusion Criteria\n\n* Age 18 years and above. There will be no upper age restriction\n* ECOG performance status 0-2\n* Participants must have histologically confirmed diagnosis of unresectable metastatic AA. The determination of appendiceal origin may rely on pathologic features combined with clinical or radiographic evidence in the event that the appendix remains in situ.\n* Participants will have undergone no more than two prior lines of systemic therapy. The last dose of systemic therapy will have been no less than 2 weeks prior to initiation of therapy.\n* Participants must have adequate nutrition and normal bowel motility and function as evidenced by albumin \\> 3.0 and no history of intestinal bypass or diverting enterostomy.\n* Demonstrate adequate organ function as determined by the following requirements:\n\n  o Hematology\n* No use of any blood components and cell growth factor supportive therapy within 7 days prior to initiation of study treatment\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm3 (ANC ≥ 1000\u002Fmm3 for African American participants)\n* Platelet count ≥ 100 × 109\u002FL (100,000\u002Fmm3)\n* Hemoglobin ≥ 9.0 g\u002FdL.\n\n  o Kidney:\n* Creatinine clearance\\* (CrCL) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by body surface area \\[BSA\\] is not required for eGFR). \\*CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org).\n* Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g\n\n  o Liver:\n* Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for participants with confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 x ULN\n* Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN\n* Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial thromboplastic time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to participants who are not on therapeutic anti-coagulation. Participants receiving therapeutic anti-coagulation should be on a stable dose\n* The effects of PTX and Ivonescimab on the developing human fetus are unknown. Taxane agents are known to be teratogenic. Additionally, based on Ivonescimab's mechanism of action, it may cause fetal harm if administered to a pregnant woman. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 6 months after the last dose of Ivonescimab. (Refer to Pregnancy Assessment Policy UT MD Anderson Institutional Policy # CLN1114). This includes all female participants, 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\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months)\n  * History of hysterectomy or bilateral salpingo-oophorectomy\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who 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 (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial 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.\n* Unsterilized male participants having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 6 months after last dose of Ivonescimab or chemotherapy. Male participants with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of treatment period until 6 months after last dose of Ivonescimab.\n* Female participants of childbearing age must have a negative serum pregnancy test result before enrollment and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Ability to understand and the willingness to sign a written informed consent document\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria\n\n* Metastases outside the peritoneal cavity, with exception of limited metastases to the thoracic cavity and\u002For limited retroperitoneal lymphadenopathy\n* Previous surgery that would preclude safe diagnostic laparoscopy with port placement\n* Current presence of significant radiographic or clinical\u002Fradiographic manifestations of gastrointestinal obstruction. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment\n* Recent history (within the last 30 days) of large volume ascites requiring repeated paracenteses. Large-volume ascites that has resolved with prior systemic therapies is not considered Exclusionary.\n* Unresolved clinically significant toxicity of greater than or equal to NCI CTCAE v. 6.0 grade 2 attributed to any prior therapies (excluding anemia, lymphopenia, alopecia, skin pigmentation).\n* Other prior malignancy unless the participant has undergone curative therapy with no evidence of disease recurrence within 3 years prior to enrollment. The following malignancies will be allowed without the 3-year interval after adequate treatment: basal cell or squamous cell carcinoma of skin, superficial bladder cancer, in situ cervical cancer, other in situ cancers, prostate cancer with a Gleason score ≤6 that does not need therapy or other local tumors that are considered cured\n* Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period for an interventional study.\n* Palliative local therapy for non-target lesions and non-specific immunomodulatory therapy (such as interleukin, interferon, thymus peptide, tumor necrosis factor, etc.) within 2 weeks before the first dose.\n* Any prior clinically significant or active autoimmune disease requiring systemic therapy (e.g., with disease- modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy or immunomodulatory agents \\[e.g., infliximab or IVIG\\]) within 2 years prior to enrollment; however, replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n* History of major diseases before enrollment, specifically:\n\n  * Unstable angina, myocardial infarction, CHF (New York Heart Association \\[NYHA\\] classification ≥Grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia)\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, fistula, intra-abdominal abscesses, or ≥ Grade 3 acute gastrointestinal bleeding within 6 months before enrollment\n  * History of any grade arterial thromboembolic event (ATE), Grade 3 and above venous thromboembolism (VTE), as specified in NCI CTCAE6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollmentAcute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrollment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Severe infection within 4 weeks prior to enrolment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the Investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B).\n* Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the Investigator). Minor local procedures within 3 days prior to enrollment (excluding central venous catheterization and port implantation).\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:\n\n  * Clinically significant gastrointestinal bleeding such as hematochezia of approximately 1 tablespoon or more per day or any episodes of melena or documented acute hemoglobin drop of more than 1 gm in 2 weeks prior to enrollment\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of fulldose anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* History of non-infectious pneumonia requiring systemic corticosteroids. History of or current interstitial lung disease\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Participants with known active tuberculosis (TB) and suspected active TB need to be ruled out by clinical examination.\n* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled\n* Participants with active hepatitis B are required to have stable or declining levels of hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for 1 month prior to enrollment. All active hepatitis C participants (hepatitis C virus \\[HCV\\] positive with HCV RNA levels above the lower limit of detection) are excluded.\n* Known hypersensitivity to any component of any of the study drugs; known history of severe hypersensitivity reactions to other monoclonal antibodies.\n* History or current evidence of any condition (medical \\[including AEs from prior anti- cancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including current substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the participant to participate, in the opinion of the treating Investigator\n* Pregnant women are excluded from this study because both paclitaxel and Ivonescimab have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued.\n* Participant is breastfeeding or plans to breastfeed during the study.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":47,"type":19},30,[22],"To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).",[51,25,52,53,54,55],"Phase II","Intraperitoneal","Paclitaxel","High Grade Metastatic","Appendiceal Adenocarcinoma","NOT_YET_RECRUITING","2026-08-13",{"date":59,"type":31},"2026-08-17",{"date":61,"type":19},"2027-01-16",{"date":63,"type":19},"2032-11-28",{"name":37,"class":38},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":20,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":39},"100650089","phase-2-stomp-out-a-phase-2-study-to-evaluate-the-effects-of-ivonescimab-in-patients-with-unresectablemetastatic-adrenocortical-carcinoma-acc-or-unresectable-pheochromocytomaparaganglioma-ppgl-100650089","NCT07743138","STOMP OUT: A Phase 2 Study To Evaluate The Effects Of Ivonescimab In Patients With Unresectable\u002FMetastatic Adrenocortical Carcinoma (ACC) Or Unresectable Pheochromocytoma\u002FParaganglioma (PPGL)","Eligibility Criteria\n\n1. 18 years of age or older. Because no dosing or adverse event data are currently available on the use of Ivonescimab in participants \\\u003C18 years of age, children are excluded from this study.\n2. Histological confirmation of ACC or PPGL. Histological confirmation of ACC based on either: i). Weiss Score of ≥ 3 in participants who had earlier surgical resection (Lin-Weiss-Bisceglia system will be used for oncocytic ACC) OR ii). biopsy results compatible with ACC in the context of clinical setting highly suggestive of ACC (adrenal mass \\> 4 cm invading surrounding organs or associated with distant metastases).\n3. Locally advanced or metastatic disease not amenable to surgery\n4. Participants must have measurable disease per RECIST v1.1. Participants must have a visceral or soft tissue metastasis measuring at least 10mm by the longest axis with CT scan or MRI. Nodal metastases must measure at least 15mm by short axis. Bone metastases require a soft tissue component with the longest axis being at least 10 mm to be considered measurable.\n5. Progressive disease per RECIST v1.1 as determined by the investigator within the 12 months preceding study enrollment\n6. Assessment of all known disease sites, eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, and\u002For FDG-PET scan within 28 days before the first dose of ivonescimab\n7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n8. Life expectancy of at least 3 months\n9. Organ and marrow function and laboratory values as follows within 48 hours prior to the first dose of ivonescimab:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n   2. Platelets ≥ 100,000\u002Fmm3\n   3. Hemoglobin ≥ 9 g\u002FdL, and no blood transfusion or erythropoietin stimulating agent is allowed within 7 days of enrollment.\n   4. Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to participants who are not on therapeutic anti-coagulation. Participants receiving therapeutic anticoagulation should be on a stable dose\n   5. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For participants with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For participants with liver metastases, AST and ALT ≤ 5 × ULN\n   7. Serum albumin ≥ 2.8 g\u002Fdl\n   8. Serum creatinine ≤ 1.5 ´ ULN or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:\n\n      Male: CrCl (mL\u002Fmin) = (140 - age) × wt (kg) \u002F (serum creatinine × 72) Female: Multiply above result by 0.85\n   9. Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1\n10. Capable of understanding and complying with the protocol requirements and has signed the informed consent document.\n11. Female participants of childbearing potential must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.\n12. Female participants of childbearing potential must have a negative pregnancy test at screening.\n\n    Female of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopausal is defined as amenorrhea ≥ 12 consecutive months. Note: females who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.\n13. Female participant of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 daysafter the last dose of the ivonescimab.\n14. Unsterilized male participants having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male participants with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab\n\nExclusion Criteria\n\nA subject who meets any of the following criteria is ineligible for the study:\n\n1. Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 4 weeks of the start of the previous cycle or had received previous targeted therapy including small molecular tyrosine kinase inhibitors such as belzutifan, cabozantinib or lenvatinib within 2 weeks before the first dose of study treatment.\n2. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n3. Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.\n4. Active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to first dose of study treatment however the following will be allowed:\n\n   1. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is permitted.\n   2. Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted\n   3. Psoriasis requiring topical treatment only, vitiligo, history of Hashimoto's thyroiditis, Grave's disease, history of radiographic diagnosis of rheumatoid arthritis without active therapy is allowed.\n5. Received radionuclide treatment (i.e. I 131 meta-iodo- benzyl guanidine) within 3 months of the first dose of study treatment\n6. Receipt of any other type of investigational agent within 28 days before the first dose of study treatment.\n7. The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs.\n8. Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease Note: Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n9. Live vaccine or live attenuated vaccine within 4 weeks prior to planned first dose of study treatment , or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n10. Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C)\n11. Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 6.0\n12. Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Participants managed with indwelling catheters (eg, PleurX) are allowed.\n13. History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n14. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n15. Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.\n16. Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n17. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n18. Participants with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to randomization. All participants with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n19. Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n20. History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the participant to participate, in the opinion of the treating investigator\n21. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution\n22. The subject has experienced any of the following:\n\n    1. clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\n    2. hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment\n    3. any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment\n23. Radiographic evidence of cavitating pulmonary lesion(s)\n24. Tumor invading or encasing any major blood vessels with the exception of tumor thrombus associated with the primary tumor or located within the renal\u002Fadrenal vein or vena cava.\n25. Evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of ivonescimab\n26. Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n    a. Cardiovascular disorders including i. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to first dose of study treatment ii. Congestive heart failure (CHF): New York Heart Association (NYHA) Class II, Class III or Class IV at the time of screening iii. Concurrent uncontrolled hypertension defined as sustained BP \\> 150 mm Hg systolic, or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment iv. Any history of congenital long QT syndrome v. Any of the following within 12 months before the first dose of study treatment:\n    * unstable angina pectoris\n    * clinically-significant cardiac arrhythmias\n    * stroke (including TIA, or other ischemic event)\n    * myocardial infarction\n    * CTCAE grade 3 or higher venous thromboembolism\n    * Unstable vascular disease (e.g. aortic aneurysm at risk of rupture, Moyamoya disease that required hospitalization) b. Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including: i. Any of the following within 6 months before the first dose of study treatment\n    * intra-abdominal tumor\u002Fmetastases invading GI mucosa\n    * active peptic ulcer disease; participants must be completely recovered\n    * inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis; participants must be completely recovered from these conditions\n    * abdominal fistula\n    * gastrointestinal perforation\n    * bowel obstruction or gastric outlet obstruction\n    * intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with ivonescimab even if the abscess occurred more than 6 months before the first dose of study treatment. c. Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy\n27. Pregnant or breastfeeding.\n28. A previously identified allergy or hypersensitivity to components of the study treatment formulation.\n29. Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n30. Evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment except for cured nonmelanoma skin cancer, cured in situ cervical carcinoma, or evidence of localized adenocarcinoma of the prostate Gleason score 6 (3+3) or 7 (3+4 or 4+3) undergoing active surveillance.\n31. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality which, in the judgment of the investigator, would have made the participant inappropriate for entry into this study.",{"count":72,"type":19},20,[22],"To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL.",[51,25,76,77,78,79,80],"Evaluate","Unresectable\u002FMetastatic Adrenocortical Carcinoma","ACC","Unresectable Pheochromocytoma","PPGL","2026-07-29",{"date":83,"type":31},"2026-08-03",{"date":85,"type":19},"2027-02-07",{"date":87,"type":19},"2030-05-01",{"name":37,"class":38},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100646820","objective-response-rate-of-ivonescimab-with-chemotherapy-in-locally-advanced-resectable-oral-and-oropharyngeal-squamous-cell-carcinoma-100646820","NCT07686575","Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Histopathologically diagnosed as oral squamous cell carcinoma (OSCC) or oropharyngeal squamous cell carcinoma (OPSCC)\n2. Patients staged according to the AJCC criteria (8th edition) as locally advanced (Stage III\u002FIVA oral cancer, HPV-negative oropharyngeal cancer, or Stage II\u002FIII HPV-positive oropharyngeal cancer) and assessed by the investigators as resectable.\n3. Age 18 to 80 years\n4. Complete blood count (CBC): White blood cell (WBC) count ≥3×10⁹\u002FL; Platelet (PLT) count ≥75×10⁹\u002FL; Hemoglobin (Hb) concentration ≥80g\u002FL\n5. Liver function: Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN)\n6. Kidney function: Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fmin\n7. Patients must have adequate function of vital organs (including cardiac, pulmonary, thyroid, and other organs) and a general condition that allows tolerance of the treatment regimen of this study.\n8. Sign the Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n1. Pregnancy or lactation (for female participants)\n2. A history of epilepsy or mental illness that is not effectively controlled\n3. Unresolved toxicities of grade \\> 2 per CTCAE criteria resulting from prior anticancer therapy\n4. Other conditions deemed unsuitable for study participation by the investigators, including patients with autoimmune diseases or those at high risk of bleeding due to various causes","80 Years",{"count":72,"type":19},"OBSERVATIONAL","To investigate the neoadjuvant chemoimmunotherapy regimen of Ivonescimab combined with chemotherapy (Paclitaxel plus Cisplatin\u002FCarboplatin) for the treatment of locally advanced resectable oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma.",[100,101,102,25],"HNSCC","OSCC","OPSCC",[25,104,105,106,107,108,109],"oral microbiome","tumor regression grade","paracancerous tissue microbiota","pathological regression extent","tumor tissue microbiota","Salivary microbiota","2026-07-06",{"date":112,"type":31},"2026-07-07",{"date":114,"type":31},"2026-01-26",{"date":116,"type":19},"2028-08-30",{"name":118,"class":38},"Zhujiang Hospital",2,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":20,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":39},"100622544","phase-1-a-prospective-multicenter-phase-ibii-trial-of-ivonescimab-ak112-combined-with-albumin-paclitaxel-and-cisplatin-as-neoadjuvant-therapy-for-escc-100622544","NCT07385001","A Prospective, Multicenter, Phase Ib\u002FII Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC","Phase Ib\u002FII Trial of Atezolizumab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Informed Consent: Written informed consent must be obtained before any study-related procedures are initiated.\n* Age and Gender: Participants must be between 18 and 75 years of age, inclusive of both 18 and 75 years, and may be either male or female.\n* Diagnosis and Stage: Participants must be histologically confirmed to have resectable, locally advanced esophageal squamous cell carcinoma (ESCC) with the following criteria:-T1 N1-N3 M0 or T2-T4a N0-N3 M0 (with T2 ≥ 2 cm or poorly differentiated).\n* Lymph Node Status: No suspicious lymph nodes in the neck region (excluding lymph nodes in the upper thoracic esophageal area) as per neck ultrasound or enhanced CT scan; no evidence of systemic metastasis on imaging.\n* R0 Resectability: The participant is expected to achieve R0 resection.\n* Measurable Lesion: At least one measurable tumor lesion must be present.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected Survival: The participant is expected to have a survival duration of at least 3 months.\n* Thyroid Function: Normal thyroid function is defined as a thyroid-stimulating hormone (TSH) level within the normal range. Participants with baseline TSH levels outside the normal range may still be eligible if total T3 (or free T3) and free T4 levels are within the normal range.\n* Organ Function: Laboratory results must meet the following criteria:\n\nHematology (no blood transfusion or blood component or granulocyte colony-stimulating factor treatment within 14 days): Neutrophil count (NEU) ≥ 1.5 × 10⁹\u002FL (1,500\u002Fmm³); Platelet count (PLT) ≥ 100 × 10⁹\u002FL (100,000\u002Fmm³); Hemoglobin ≥ 90 g\u002FL.\n\nLiver: Total bilirubin (TBil) ≤ 1.5 × upper limit of normal (ULN); or for participants with TBil \\\u003C 1.5 × ULN, direct bilirubin must be within the normal range; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n\nRenal: Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (using the Cockcroft-Gault formula).\n\nCoagulation: International Normalized Ratio (INR) ≤ 1.5; Prothrombin time (PT) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n\nCardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n* Pregnancy Testing and Contraception: For screening-period eligible female participants of reproductive age, a serum pregnancy test must be negative. Female or male participants of reproductive capacity must be willing to use a reliable contraceptive method throughout the study period (i.e., from the date of informed consent to 90 days after the last dose of study drug), including but not limited to: abstinence, vasectomy in the male partner, sterilization in the female, effective intrauterine devices, and effective oral contraceptives.\n* Compliance: The participant must be willing and able to comply with the study schedule, including visits, treatment regimen, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n* History of Other Malignancies: Participants who have had any other malignancy within 5 years prior to enrollment are excluded, except for those with localized or in situ malignancies such as basal or squamous cell carcinoma, superficial bladder cancer, cervical or breast intraepithelial neoplasia, or other conditions that are considered curable with local therapy.\n* Prior Treatment with PD-1\u002FPD-L1 Inhibitors or Other Immune-Modulating Drugs: Participants who have previously received treatment with PD-1\u002FPD-L1 inhibitors or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40) or anti-angiogenic agents (e.g., bevacizumab, endostar) are excluded.\n* Systemic Non-Specific Immune Modulation: Participants who have received systemic non-specific immune-modulating therapy (e.g., interleukins, interferons, thymopentin) within 2 weeks prior to the first dose of study drug, or who have used traditional Chinese medicine or herbal preparations with anti-tumor indications within 2 weeks prior to the first dose, are excluded.\n* Active Autoimmune Disease Requiring Systemic Treatment: Participants with active autoimmune diseases requiring systemic treatment (e.g., using disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) are excluded. Substitutive treatments (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered as systemic treatment.\n* Brainstem, Meningeal, or Spinal Metastasis or Compression: Participants with brainstem, meningeal, or spinal metastasis, or with evidence of compression, are excluded.\n* Significant Pleural, Pericardial, or Peritoneal Effusion: Participants with clinically significant pleural, pericardial, or peritoneal effusions requiring diuretic therapy and\u002For repeated drainage are excluded.\n* Gastrointestinal Obstruction or Complications Within 6 Months of First Dose: Participants with a history of clinically significant gastrointestinal obstruction, perforation, intra-abdominal abscess, or fistula formation within 6 months prior to the first dose of study drug are excluded.\n* Active Inflammatory Gastrointestinal Diseases: Participants with active inflammatory gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, radiation enteritis, hemorrhagic enteritis, chronic diarrhea) are excluded.\n* Tumor Encircling Major Vessels or Severe Necrosis\u002FHemorrhage: Participants with imaging findings showing tumor encircling major vessels, significant necrosis, or cavitation, and whose researchers determine that entry into the study would pose a bleeding risk, are excluded.\n* Interstitial Lung Disease ≥ Grade 2: Participants with interstitial lung disease ≥ Grade 2 are excluded.\n* Severe Cardiovascular Disease:\n\nUncontrolled hypertension or pulmonary hypertension; Unstable angina pectoris, myocardial infarction within 6 months prior to the first dose of study drug, coronary artery bypass grafting, or stent implantation; Chronic heart failure with NYHA functional class ≥ 2; Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n\n* Severe arrhythmias requiring drug treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), such as QTcF \\> 450 msec in males or \\> 470 msec in females, complete left bundle branch block, or third-degree heart block; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 4 weeks prior to the first dose of study drug.\n* Severe Infection Within 4 Weeks Prior to First Dose: Participants with a history of severe infection (e.g., sepsis, bacteremia, or severe pneumonia) within 4 weeks prior to the first dose of study drug, or who have received systemic antimicrobial therapy for an active infection (excluding antiviral treatment for hepatitis B or C) within 2 weeks prior to the first dose, are excluded.\n* Active Tuberculosis or Syphilis: Participants with known active tuberculosis (TB) or syphilis are excluded. Suspected TB cases must be ruled out with clinical evaluation.\n* Positive HIV Antibody or Active Hepatitis B or C:","75 Years",{"count":129,"type":19},45,[131,22],"PHASE1","A Prospective, Multicenter, Phase Ib\u002FII Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma",[134,25,135],"Esophageal Squamous Cell Carcinoma","Neoadjuvant",[135,134],"2026-01-29",{"date":139,"type":31},"2026-02-03",{"date":141,"type":19},"2026-01-28",{"date":143,"type":19},"2028-01-28",{"name":145,"class":38},"Tang-Du Hospital",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":127,"enrollmentInfo":153,"targetDuration":4,"studyType":20,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100594630","phase-2-ak112-plus-folfiri-versus-bevacizumab-plus-folfiri-as-second-line-treatment-of-msspmmr-metastatic-colorectal-cancer-100594630","NCT07021950","AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS\u002FpMMR Metastatic Colorectal Cancer","Ivonescimab (AK112) Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS\u002FpMMR Metastatic Colorectal Cancer: a Randomized, Controlled, Multicenter Phase II Study","Inclusion Criteria:\n\n1. Voluntarily sign written informed consent\n2. Agree to provide tumor and blood samples for biomarker detection\n3. Age ≥18 and ≤75 years at enrollment, regardless of gender\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n5. Expected survival ≥3 months\n6. Pathologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma\n7. Confirmed MSS\u002FpMMR-type CRC by immunohistochemistry (IHC), PCR, or NGS\n8. Intolerance to oxaliplatin-containing standard first-line therapy, disease progression, or recurrence within \\\u003C 6 months after oxaliplatin adjuvant therapy\n9. Adequate organ function (last 14 days without intervention):\n\n   1. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL without granulocyte colony-stimulating factor1.\n   2. Platelets ≥100×10⁹\u002FL without transfusion1.\n   3. Hemoglobin \\>9 g\u002FdL without transfusion or erythropoietin1.\n   4. Total bilirubin ≤1.5×ULN1.\n   5. AST\u002FALT ≤2.5×ULN1.\n   6. Serum creatinine ≤1.5×ULN and creatinine clearance (Cockcroft-Gault) ≥60 mL\u002Fmin1.\n   7. INR or PT ≤1.5×ULN1.\n   8. Normal thyroid function (TSH within normal range; if TSH abnormal, FT3\u002FFT4 must be normal)1.\n10. For HBV\u002FHCV-infected subjects:Chronic HBV: Undetectable viral load under suppressive therapy if required; HCV: Stable status; ongoing antiviral therapy must continue if applicable;Co-infection of HBV and HCV is excluded (prior HCV infection with negative RNA is acceptable)\n11. Females of childbearing potential: Negative pregnancy test (urine\u002Fserum) within 3 days prior to first dose. Effective contraception from screening until 120 days after last dose\n12. Non-sterilized males: Effective contraception from screening until 120 days after last dose Willing and able to comply with study visits, treatment, and procedures\n\nExclusion Criteria:\n\n* 1.Known as MSI-H or dMMR status 2.History of or concurrent malignancies within 3 years, except cured local tumors (e.g., basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ) 3.Current or prior central nervous system (CNS) or leptomeningeal metastases 4.Proteinuria ≥2+ on dipstick\u002Furinalysis or 24-hour urine protein ≥1.0 g (patients with 1+ proteinuria require confirmation via 24-hour urine collection) 5.Unresolved toxicities from prior therapy exceeding NCI CTCAE v5.0 Grade 1 (except alopecia or neuropathy ≤Grade 2) 6.Gastrointestinal perforation ≤1 year before enrollment or a history of GI perforation 7.Prior irinotecan treatment (including irinotecan injection or liposomal irinotecan) 8.Prior anti-angiogenic small molecule targeted therapy (e.g., fruquintinib) 9.Concurrent participation in an interventional clinical trial or use of investigational drugs\u002Fdevices ≤4 weeks before the first dose 10.Current or prior non-infectious pneumonitis or interstitial lung disease requiring systemic corticosteroids 11.Active autoimmune disease requiring systemic therapy within 2 years (e.g., disease-modifying agents, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin) is permitted 12.History of immunodeficiency, positive HIV antibody test, or long-term use of systemic corticosteroids\u002Fimmunosuppressants (short-term steroids for COPD or allergies allowed) 13.Active tuberculosis (confirmed or suspected requiring exclusion) or syphilis infection 14.Severe infection (e.g., sepsis, pneumonia requiring hospitalization) ≤4 weeks before the first dose or active infection requiring systemic anti-infectives ≤2 weeks (excluding HBV\u002FHCV antivirals) 15.Significant bleeding history (e.g., hemoptysis ≥1 teaspoon of blood, gastrointestinal bleeding) ≤1 month or antiplatelet\u002Fanticoagulant therapy ≤10 days before the first dose 16.Active\u002Fpast inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea) 17.Uncontrolled comorbidities (e.g., metabolic disorders, peptic ulcers, psychiatric conditions affecting compliance) 18.Cardiac history: myocardial infarction, NYHA Class ≥2 heart failure, unstable angina ≤12 months; arterial\u002Fvenous thromboembolism ≤6 months; uncontrolled hypertension (SBP \\>150 mmHg or DBP \\>90 mmHg) 19.Prior immune therapy (checkpoint inhibitors, CAR-T, etc.) targeting tumor immunity 20.Major surgery ≤30 days before\u002Fafter the first dose or minor surgery ≤3 days before the first dose (excluding IV catheter placement) 21.Live\u002Fattenuated vaccines ≤30 days before the first dose or planned during the study; inactivated vaccines permitted 22.History of allogeneic organ or hematopoietic stem cell transplantation 23.Hypersensitivity to study drug components or monoclonal antibodies 24.History of psychiatric disorders, substance abuse, or alcoholism 25.Pregnancy or lactation 26.Any current or past disease, therapy, or abnormal laboratory finding that may confound study results, interfere with full study participation, or compromise the participant's best interest by continuing in the study Conditions that may confound results or pose undue risk (e.g., leukemoid reaction (WBC \\>20×10⁹\u002FL), ≥10% weight loss ≤3 months)",{"count":154,"type":19},130,[22],"This study is a multicenter, open-label phase II trial conducted to assess the safety and antitumor activity of Ivonescimab (AK112) plus FOLFIRI versus bevacizumab plus FOLFIRI as second-line treatment in subjects with MSS\u002FpMMR metastatic colorectal cancer who have experienced intolerance to oxaliplatin-containing first-line therapy or disease progression, or recurrence within 6 months after oxaliplatin adjuvant therapy.",[158,25],"Colorectal Cancer","2025-06-06",{"date":161,"type":31},"2025-06-15",{"date":163,"type":19},"2025-08-10",{"date":165,"type":19},"2028-12-31",{"name":167,"class":38},"Sun Yat-sen University"]