[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dai, Guanghai\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,64,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100623108","phase-2-safety-and-efficacy-of-fruquintinib-plus-nab-paclitaxel-and-iparomlimab-and-tuvonralimab-injection-in-the-second-line-treatment-for-immunotherapy-experienced-advanced-gastric-cancer-100623108",false,"NCT07392346","Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer","A Prospective, Single-Arm, Phase Ⅱ Clinical Trial Evaluating Fruquintinib in Combination With Paclitaxel for Injection (Albumin-bound) and Iparomlimab and Tuvonralimab Injection as Second-Line Therapy in Advanced Gastric Cancer Patients Previously Received Immunotherapy","Inclusion Criteria:\n\n1. ≥ 18 years\n2. Pathologically or cytologically confirmed diagnosis of gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.\n3. Failure of first-line treatment with PD-1\u002FPD-L1 inhibitors\n4. With measurable lesions according to RECIST 1.1 criteria.\n5. ECOG performance status of 0-1\n6. Expected survival ≥3 months;\n7. Major organ functions meet the following requirements :\n\n   * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (no growth factors used within 14 days).\n   * Platelet count (PLT) ≥ 100,000\u002Fmm³ (100 × 10⁹\u002FL) (no correction therapy used within 7 days).\n   * Hemoglobin (Hb) ≥ 9 g\u002FdL (90 g\u002FL) (no correction therapy used within 7 days).\n   * Serum creatinine ≤ 1.5 × upper limit of normal (ULN).\n   * Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN).\n   * Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) levels ≤ 2.5 × upper limit of normal (ULN); ≤ 5 × upper limit of normal (ULN) for patients with liver metastases.\n   * Urinalysis is normal, or urine protein \\\u003C (++), or 24-hour urine protein level \\\u003C 1.0 g.\n8. Normal coagulation function, with no history of active bleeding or thrombotic diseases:\n\n   * International normalized ratio (INR) ≤ 1.5 × ULN.\n   * Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n   * Prothrombin time (PT) ≤ 1.5 × ULN.\n9. For patients with potential fertility, the following requirements must be met:\n\n   * Adopt a medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 3 months after the completion of study treatment.\n   * Serum human chorionic gonadotropin (β-HCG) test must be negative within 72 hours prior to study enrollment.\n   * Must not be breastfeeding.\n10. Patients must have provided written informed consent, and be willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. History of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of study medication.\n2. Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage.\n3. Hypersensitivity to any component of monoclonal antibodies, fruquintinib, or albumin-bound paclitaxel.\n4. Receipt of any of the following treatments:\n\n   1. Severe adverse reactions to prior immunotherapy.\n   2. Prior treatment with CTLA4 inhibitors.\n   3. Any study medication within 4 weeks prior to the first dose of study medication.\n   4. Concurrent enrollment in another clinical study (excluding observational studies or survival follow-ups of interventional studies).\n   5. Last dose of anti-cancer therapy ≤ 3 weeks prior to the first study medication, or fixed-field palliative radiotherapy ≤ 2 weeks prior to study intervention.\n   6. Corticosteroid use (\\>10 mg prednisone equivalent\u002Fday) within 2 weeks prior to study medication; the investigator may decide on eligibility in special cases. Inhaled\u002Ftopical steroids and adrenal replacement at \\>10 mg\u002Fday prednisone equivalent are permitted in the absence of active autoimmune diseases.\n   7. Anti-tumor vaccines or live vaccines within 4 weeks prior to study medication.\n   8. Major surgery or severe trauma within 4 weeks prior to study medication.\n5. Previous anti-tumor treatment toxicities not recovered to ≤ CTCAE Grade 1 (excluding alopecia) or the specified inclusion\u002Fexclusion criteria levels.\n6. Central nervous system metastases.\n7. History of active autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) or a history of such diseases (excluding vitiligo, or childhood asthma\u002Fallergies cured and requiring no intervention in adulthood; autoimmune hypothyroidism on stable thyroid replacement; type 1 diabetes on stable insulin).\n8. Immunodeficiency history (including HIV-positive status, acquired\u002Fcongenital immunodeficiency, organ transplantation, or allogeneic bone marrow transplantation).\n9. Inadequately controlled cardiovascular symptoms\u002Fdiseases, including: (1) NYHA Class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular\u002Fventricular arrhythmias (uncontrolled with clinical intervention).\n10. Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein \\>1.0 g.\n11. Abnormal coagulation (INR \\>1.5×ULN or PT \\>ULN+4s), with bleeding tendency or thrombolytic\u002Fanticoagulant therapy (small-dose low-molecular-weight heparin or oral aspirin for prophylaxis permitted during the trial).\n12. Significant clinical bleeding or definite bleeding tendency within 3 months (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis). If baseline occult blood in stool is positive, re-testing is allowed; endoscopy may be performed based on clinical judgment if positive after re-testing.\n13. Active ulcers, unhealed wounds, or fractures.\n14. Hypertension inadequately controlled by anti-hypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg).\n15. Severe infection (CTCAE \\>Grade 2) within 4 weeks prior to study medication (e.g., severe pneumonia, bacteremia, infectious complications requiring hospitalization); baseline chest imaging showing active pulmonary inflammation, or infection symptoms\u002Fsigns requiring oral\u002FIV antibiotics within 2 weeks prior to study medication (excluding prophylactic antibiotics).\n16. History of interstitial lung disease (excluding radiation pneumonitis or non-infectious pneumonitis not treated with steroids).\n17. Active tuberculosis (confirmed by history\u002FCT) or history of active tuberculosis within 1 year prior to enrollment, or untreated active tuberculosis more than 1 year prior to enrollment.\n18. History of any other malignant tumor within 5 years prior to study medication (excluding low-risk tumors with \\>90% 5-year survival rate, e.g., adequately treated basal cell\u002Fsquamous cell skin cancer or cervical intraepithelial neoplasia).\n19. Pregnant or breastfeeding women.\n20. Other factors (e.g., concurrent severe diseases including mental illness, severely abnormal lab values, family\u002Fsocial factors) that may lead to forced withdrawal from the study, as determined by the investigator.","ALL","18 Years",{"count":19,"type":20},68,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Immunotherapy has established the new standard for first-line treatment of advanced or metastatic gastric cancer. However, current second-line options-predominantly consisting of targeted therapy plus chemotherapy or chemotherapy alone-confer only modest clinical benefit. Notably, pivotal phase III second-line trials (REGARD, RAINBOW, RAINBOW-Asia, FRUTIGA) exclusively enrolled patients who progressed on chemotherapy regimens; thus, high-quality evidence guiding second-line treatment specifically for immunotherapy-refractory patients remains scarce, representing a significant unmet medical need.\n\nAnti-angiogenic agents have demonstrated capacity to ameliorate the hypoxic, immunosuppressive tumor microenvironment while exerting synergistic anti-tumor effects when combined with immune checkpoint inhibitors. Exploratory studies evaluating immunotherapy combined with anti-angiogenic therapy plus chemotherapy in advanced gastric cancer patients after first-line failure have yielded encouraging efficacy signals (NCT03966118, NCT04982276), with objective response rates of 30-40% and median progression-free survival approaching 6 months.\n\nBased on this, the investigators aim to evaluate the efficacy and safety profile of fruquintinib combined with nab-paclitaxel and Iparomlimab and Tuvonralimab Injection (a novel bispecific antibody) as second-line treatment for patients with advanced gastric cancer who have experienced disease progression during or after first-line immunotherapy-containing regimens.",[26],"Gastric Cancer Adenocarcinoma Metastatic","RECRUITING","2026-02-09",{"date":30,"type":31},"2026-02-11","ACTUAL",{"date":33,"type":31},"2025-12-01",{"date":35,"type":20},"2028-11-30",{"name":37,"class":38},"Dai, Guanghai","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100576237","phase-1-liposomal-irinotecan--oxaliplatin--bevacizumab-versus-liposomal-irinotecan--5-fulv-100576237","NCT06782685","Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU\u002FLV","Liposomal Irinotecan in Combination With Oxaliplatin and Bevacizumab Versus Liposomal Irinotecan in Combination With 5-FU\u002FLV for the Second-line Treatment of Advanced Pancreatic Cancer","Inclusion Criteria:\n\n1. Age 18 to 75 years old;\n2. Patients with pancreatic cancer diagnosed by histopathology or cytology;\n3. Unresectable disease assessed by multidisciplinary and imaging;\n4. Subjects who have received prior failed first-line therapy, and recurrence within 6 months of the end of (neo)adjuvant therapy is considered a first-line treatment failure;\n5. Subjects who have not received platinum-containing or irinotecan drugs for prior first-line therapy;\n6. Patients with at least one evaluable lesion according to RECIST v1.1;\n7. ECOG score of 0-2;\n8. Expected survival ≥ 3 months;\n9. Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, hemoglobin ≥90 g\u002FdL, platelets (PLT) ≥100×10\\^9\u002FL, and white blood cells (WBC) ≥3.0×10\\^9\u002FL;\n10. Liver function: alanine aminotransferase (ALT), alanine aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), or ≤5×ULN if liver metastases are present, total bilirubin\\\u003C1.5 ULN;\n11. Renal function: serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL\u002Fmin (according to the Cockcroft-Gault formula);\n12. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5 × ULN;\n13. Patients with biliary obstruction should receive adequate biliary drainage; and\n14. Adverse reactions arising from prior therapy must be restored to grade 1 or baseline according to CTCAE 5.0 (with the exception of toxicities such as alopecia, grade 2 or lower peripheral neuropathy, which can be enrolled with no safety risk in the judgment of the investigator);\n15. Non-pregnant or lactating females; females\u002Fmales of childbearing potential should use effective contraception during the study and for 6 months after completion of study treatment;\n16. Patients are compliant, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and basal cell carcinoma of the skin);\n2. Uncontrollable pleural effusion or ascites;\n3. Any known brain metastasis or meningeal metastasis;\n4. Concomitant use of a potent CYP3A4 inducer within 3 weeks prior to the first dose, or concurrent use of a potent CYP3A4 inhibitor or potent UGT1A1 inhibitor within 3 weeks prior to the first dose;\n5. Patients undergoing major organ surgery (except needle biopsy, central venous catheterization, port catheterization, stent placement for relief of biliary obstruction, percutaneous hepato-biliary drainage, cholecystostomy) or elective surgical procedures scheduled within 4 weeks prior to the first dose of study drug;\n6. Systemically treated active, uncontrolled bacterial, viral, or fungal infections, defined as persistent signs\u002Fsymptoms associated with the infection that do not improve despite appropriate antibiotics, antiviral therapy, and\u002For other treatments;\n7. Subjects with congenital or acquired immunodeficiency, such as HIV-infected individuals or active hepatitis (transaminases do not meet the inclusion criteria, Hepatitis B : HBV DNA ≥ 1000 IU\u002Fml; Hepatitis C : HCV RNA ≥ 1000 IU\u002Fml); chronic hepatitis B viral carriers, with HBV DNA \\\u003C 2000 IU\u002Fml, who must be concurrently receiving antiviral during the trial period treatment before enrollment;\n8. Presence of serious concomitant diseases: those with diabetes mellitus that cannot be well controlled by glucose-lowering drugs, difficult-to-control hypertension, severe cardiovascular and cerebral vascular disease, renal failure, hepatic failure, uncontrolled epilepsy, central nervous system disease or history of mental disorders, those with a clear tendency to gastrointestinal bleeding, intestinal paralysis, intestinal obstruction, etc;\n9. \\>grade 1 diarrhea with an increase in the number of bowel movements \\>4 times per day compared to baseline; moderate to severe increase in stoma discharge; limited instrumental activities of daily living or even limited spontaneous activities of daily living; life-threatening; requiring urgent treatment;\n10. Those with serum albumin ≤ 3 g\u002FdL;\n11. Those who had participated in other clinical studies within 4 weeks prior to enrollment;\n12. Patients assessed by the investigator to be unsuitable for participation in the trial.","75 Years",{"count":49,"type":20},138,[51,23],"PHASE1","Purpose of the study Phase I study: to explore the optimal dose combination of irinotecan liposome + oxaliplatin + bevacizumab regimen, irinotecan liposome + oxaliplatin Phase II study: to evaluate the safety and efficacy of the second-line treatment regimen of irinotecan liposome combined with oxaliplatin and bevacizumab compared to the second-line treatment regimen of irinotecan liposome combined with 5-FU\u002FLV in advanced pancreatic cancer Sample size 138 cases Phase I Crawl, sample size 9-18 cases. Phase II randomized controlled clinical study, historical data NAPOLI-1 study, ORR of 8.8% for irinotecan liposome + 5-FU\u002FLV, planned trial arm ORR upgrade to 25%, calculated at 60 cases in each arm.\n\nSubject population Patients with advanced pancreatic cancer diagnosed after failure of first-line therapy, confirmed by histopathology or cytopathology, who meet the inclusion criteria and do not meet the exclusion criteria.\n\nPhase I design:\n\nLiposomal irinotecan + oxaliplatin + bevacizumab, 2-week regimen Liposomal irinotecan: start exploring with 50mg\u002Fm2 dose, preset 50mg\u002Fm2, 60mg\u002Fm2, 2 dose groups, 90min IV infusion, d1; Oxaliplatin: explored from 60mg\u002Fm2 dose, preset 60mg\u002Fm2, 85mg\u002Fm2, 2 dose groups, IV infusion, d1; Bevacizumab: 5 mg\u002Fkg, i.v., d1; Phase II study design.\n\nTrial group:\n\nIrinotecan liposomal: RP2D, i.v., 90min, d1; Oxaliplatin: RP2D, i.v., d1; Bevacizumab: 5mg\u002Fkg, i.v., d1; Cycles every 2 weeks until disease progression or intolerable; imaging every 3 treatment cycles\u002F1.5 months.\n\nControl:\n\nLiposomal irinotecan: 70 mg\u002Fm2 IV for 90 min, d1; Calcium folinate: 400 mg\u002Fm2, IV infusion over 30 min, d1; 5-FU: 2400 mg\u002Fm2, continuous IV infusion over 46h; Cycles every 2 weeks until disease progression or intolerable; imaging every 3 treatment cycles\u002F1.5 months.\n\nNotes:\n\nIf the duration of irinotecan liposome infusion can be extended appropriately based on the patient\\'s clinical response; if the patient withdraws from the trial due to intolerance of toxicity (e.g., neurotoxicity or myelotoxicity) induced by one of the drugs, follow up is required until PFS and OS.\n\nTranslated with DeepL.com (free version)",[54],"Advanced Pancreatic Cancer (Part 1)","2025-01-16",{"date":57,"type":31},"2025-01-20",{"date":59,"type":31},"2024-06-23",{"date":61,"type":20},"2027-03",{"name":37,"class":38},2,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},"100570562","phase-2-phase--clinical-study-of-surufatinib-combined-with-gemcitabine-and-cisplatin-plus-durvalumabpembrolizumab-regimen-in-the-treatment-of-advanced-biliary-tract-cancer-100570562","NCT06708858","Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab\u002FPembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n1. Patients with biliary tract cancer who are clearly diagnosed by pathology, are unable to undergo radical surgery or have local\u002Fdistant metastasis (allowing surgical treatment after successful transformation).\n2. Have at least 1 lesion that can be measured according to RECIST v1.1 (more than 1cm on CT or MRI).\n3. Have not received systematic anti-tumor therapy before.\n4. Expected survival greater than 3 months;\n5. Age 18-75 years old, male and female;\n6. Body weight \\> 40kg;\n7. ECOG 0-1\n8. Total peripheral blood white blood cells \\> 2×109\u002FL;\n9. Bone marrow reserve and liver and kidney function (as demonstrated by the following laboratory tests prior to initial treatment) :\n\n   Neutrophil absolute value ≥ 1,000\u002Fmm3; Hemoglobin \\> 8g\u002FdL; Platelet count \\> 80,000\u002Fmm3; Glutamic pyruvic transaminase\u002Fglutamic oxalacetic transaminase \\\u003C 3×ULN; Serum creatinine \\\u003C 3×ULN. Total bilirubin level \\\u003C 3×ULN.\n10. No obvious genetic disease;\n11. Liver function child-pugh A ;\n12. Women of childbearing age (15 to 49 years) must undergo a pregnancy test with a negative result within 7 days before starting treatment and have effective contraception within 120 days after the last cycle of treatment.\n13. The previous treatment for the tumor has ended for at least 4 weeks, and the adverse reactions of the previous treatment have basically recovered (according to the CTCAE5.0 standard ≤ Grade 1, except hair loss).\n14. Voluntarily enrolled in the group and signed informed consent, followed the experimental treatment plan and visit plan, and could cooperate to observe adverse events and efficacy.\n\nExclusion Criteria:\n\n1. Join another clinical study at the same time, unless it is during the follow-up period of an observational (non-interventional) or supportive care clinical study or interventional study.\n2. Obstructive jaundice (bilirubin \\> 1.5 ULN) with inadequate biliary drainage.\n3. Absolute neutrophil count (ANC) \\\u003C1×109\u002FL or platelet \\\u003C80×109\u002FL or hemoglobin \\\u003C 8g\u002FdL (based on the normal value of the clinical trial center)\n4. Serum total bilirubin was 5 times higher than the upper limit of the normal reference range;\n5. ALT, AST or ALP above 5 times the upper limit of the normal reference range;\n6. Known active central nervous system metastatic and\u002For cancerous meningitis; Patients with previously treated BMS may participate provided they are stable (there is no evidence of imaging progression at least 4 weeks before the first dose of trial treatment, and any neurological symptoms have returned to baseline levels), there is no evidence of new or expanded BMS, and there is no evidence of new or expanded BMS. And no use of hormones greater than 10mg prednisone per day or equivalent for at least 14 days prior to trial treatment.\n7. Toxicity of previous anticancer treatment has not returned to grade 0 or 1 level (except hair loss);\n8. Uncontrolled mass pleural effusion or massive ascites\n9. Organ failure; Heart: Grade III and grade IV; Liver: reached Child-Pugh liver function grade B and C; Kidney: renal failure and uremia stage; Lungs: Symptoms of severe respiratory failure; Brain: A person with a disorder of consciousness.\n10. History of heart disease:\n\n1\\) Patients with pre-existing arrhythmias with prolonged PR, QTc and\u002For QRS; 2) Acute myocardial infarction or congestive heart failure within 6 months; 3) Patients with long QT syndrome; 4) Patients who have been treated with antiarrhythmic drugs (e.g. quinidine IA, amiodarone III, sotalol); 11. Patients who have undergone major surgery within 4 weeks prior to the start of study treatment, or who expect to undergo major surgery (other than surgery for diagnostic purposes) during the study period; 12.HIV antibody positive, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 13. Uncontrolled co-morbidity, including but not limited to persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or mental illness\u002Fsocial conditions, will limit compliance with study requirements. Substantially increases the risk of developing AEs or impairs a patient's ability to give written informed consent.\n\n14\\. Patients with a history of Parkinson's disease or epilepsy, or who had a history of transient ischemic attacks, stroke, or traumatic brain injury with disturbance of consciousness in the 12 months prior to the study; 15. CTCAE2 grade infection that does not respond to treatment or CTCAE grade \\> 2 active clinically serious infection.\n\n16\\. Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who require treatment.\n\n17\\. Known or suspected prior allergy or hypersensitivity to any investigational drug or to any investigational drug excipient (duvaliumab, Sofantinib, Pabolizumab).\n\n18\\. Chronic diseases requiring immunological agents or hormone therapy; 19. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 20. Participated in a non-anti-PD1 \u002FL1 antibody based clinical trial within the past 30 days.\n\n21\\. Patients with rare heritability should not participate in this clinical study.\n\nExit criteria\n\nIf any of the following events occur, the patient must withdraw from the study:\n\n1. Patient voluntary withdrawal\n2. Ineligibility discovered after enrollment\n3. Poor compliance, failure to adhere to the protocol\n4. Occurrence of adverse events (AE) or serious adverse events (SAE) where the investigator determines or the patient and family prefer not to continue treatment\n5. Pregnancy\n6. Inability to complete treatment according to the protocol after adjustment for grade 3\u002F4 adverse events\n7. Unforeseen, intolerable adverse reactions\n8. Medical or ethical reasons impacting the continuation of the study",{"count":71,"type":20},35,[23],"This phase II trial studies how well gemcitabine, cisplatin and durvalumab\u002FPembrolizumab and surufatinib work in treating participants with advanced Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Whether if adding surufatinib to a standard of care can bring addition benefit needs to be explored.",[75],"Advanced Biliary Tract Cancer","2024-11-26",{"date":78,"type":31},"2024-11-27",{"date":80,"type":31},"2024-08-15",{"date":82,"type":20},"2027-07",{"name":37,"class":38},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":39},"100568749","phase-2-safety-and-efficacy-of-fruquintinib-plus-chidamide-and-sintilimab-in-the-third-and-later-line-treatment-of-msspmmr-metastatic-colorectal-cancer-100568749","NCT06685276","Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS\u002FpMMR Metastatic Colorectal Cancer","A Prospective Single-arm Phase Ib\u002FII Study on the Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS\u002FpMMR Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Fully understand this study and voluntarily sign the informed consent form;\n2. Age between 18-75 years inclusive;\n3. Patients with histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma;\n4. Failure of standard second-line systemic treatment with measurable lesions;\n5. Tumor tissue tested for microsatellite stability (MSS) or low microsatellite instability (MSI-L) by PCR, or confirmed pMMR by immunohistochemistry for DNA mismatch repair (MMR) protein (including MLH1, MSH2, MSH6, and PMS2 protein expression);\n6. ECOG performance status of 0-2, with no deterioration within 7 days;\n7. BMI≥18;\n8. Expected survival ≥3 months;\n9. Major organ functions meet the following requirements (no use of any blood components and growth factors within 14 days before enrollment):\n\n   * Absolute neutrophil count ≥1.5×109\u002FL, white blood cells ≥4.0×109\u002FL;\n   * Platelets ≥100×109\u002FL;\n   * Hemoglobin ≥90g\u002FL;\n   * Total bilirubin TBIL ≤1.5 times ULN;\n   * ALT and AST ≤5 times ULN;\n   * Urea\u002FBUN and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL\u002Fmin);\n   * Left ventricular ejection fraction (LVEF) ≥50%;\n   * Corrected QT interval by Fridericia's formula (QTcF) \\\u003C470 milliseconds.\n   * INR ≤1.5×ULN, APTT ≤1.5×ULN.\n10. Women of childbearing age must use effective contraception;\n11. Good compliance and cooperation with follow-up.\n\nExclusion Criteria:\n\n1. Unable to comply with the study protocol or procedures;\n2. Pregnant or breastfeeding women;\n3. Concurrent with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmias, and heart failure;\n4. Previous treatment with small molecule tyrosine kinase inhibitors for metastatic disease;\n5. Previous treatment with romidepsin;\n6. Previous treatment with immune checkpoint inhibitors for metastatic disease;\n7. Uncontrollable severe concurrent infections;\n8. Acute myocardial infarction, acute coronary syndrome, or CABG within 3 months before the first treatment;\n9. Subjects allergic to the study medication or any of its excipients;\n10. Known human immunodeficiency virus (HIV) infection. Known clinically significant liver disease history, including viral hepatitis \\[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (\\>1×10\\^4 copies\u002FmL or \\>2000 IU\u002FmL); known hepatitis C virus (HCV) infection and HCV RNA positive (\\>1×10\\^3 copies\u002FmL)\\];\n\n12\\. Patients whom the investigator deems inappropriate for inclusion in this study.",{"count":92,"type":20},46,[23],"The prognosis of most patients with unresectable locally advanced or metastatic colorectal cancer (CRC) remains poor despite the advancements in chemotherapy and target therapy.\n\nCAPability-01 trial investigated the potential efficacy of combining the programmed cell death protein-1 (PD-1) monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide with or without the anti-vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab in patients with unresectable chemotherapy-refractory locally advanced or metastatic microsatellite stable\u002Fproficient mismatch repair (MSS\u002FpMMR) colorectal cancer.\n\nBased on the previous findings of CAPability-01, we will further evaluate the efficacy and safety of sintilimab and chidamide in combination with fruquintinib in the same setting.",[96],"Colorectal Cancer Metastatic","2024-11-17",{"date":99,"type":31},"2024-11-20",{"date":101,"type":31},"2024-08-16",{"date":103,"type":20},"2026-12",{"name":37,"class":38},""]