[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adebrelimab-shr-1316\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adebrelimab-shr-1316":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,64,95,118],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100634753","phase-2-efficacy-and-safety-of-low-dose-bevacizumab-plus-adebrelimab-combined-with-transarterial-chemoembolization-followed-by-hepatic-arterial-infusion-chemotherapy-tace-haic-as-first-line-treatment-for-unresectable-hepatocellular-carcinoma-a-single-arm-phase-2-trial-100634753",false,"NCT07543783","Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by Hepatic Arterial Infusion Chemotherapy (TACE-HAIC) as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Phase 2 Trial","Inclusion Criteria:\n\nWilling to participate and provide written informed consent. Age ≥ 18 years (on the day of signing informed consent). Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinical diagnosis of HCC according to AASLD criteria in patients with cirrhosis.\n\nEligible for TACE, including BCLC stage B or C, with unresectable HCC (excluding PVTT-Vp4 and extrahepatic metastasis).\n\nNo prior systemic therapy for HCC. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Child-Pugh score A or B7. No history of autoimmune disease. Life expectancy ≥ 3 months. At least one measurable lesion per RECIST v1.1 (spiral CT scan long diameter ≥ 10 mm or short diameter of enlarged lymph node ≥ 15 mm; lesions previously treated with locoregional therapy can be considered target lesions only if progression per RECIST v1.1 is clearly documented).\n\nAdequate hematologic, hepatic, and renal function within 7 days prior to enrollment:\n\nNeutrophils ≥ 1.5 × 10⁹\u002FL Platelets ≥ 50 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL ALT\u002FAST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN INR \\\u003C 2.3 or prothrombin time ≤ ULN + 6 seconds Albumin ≥ 30 g\u002FL Total bilirubin ≤ 3 × ULN Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be lactating; they and male participants must agree to use effective contraception during the study and for 6 months after study completion\n\nExclusion Criteria:\n\nKnown cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years, excluding cured localized tumors such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ.\n\nSevere allergy to iodine contrast precluding TACE-HAIC. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment.\n\nActive uncontrolled infection. Severe gastroesophageal varices; untreated or incompletely treated varices (with bleeding or high bleeding risk).\n\nBrain metastases or bone metastases requiring urgent surgical or radiation intervention.\n\nPregnant, suspected pregnancy, or breastfeeding. Current or recent use (within 10 days prior to study treatment) of aspirin (\\> 325 mg\u002Fday) or dipyridamole, ticlopidine, clopidogrel, or cilostazol.\n\nThromboembolic events within 6 months prior to study treatment, including cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n\nCongenital or acquired immunodeficiency. Myocardial infarction, severe\u002Funstable angina, or congestive heart failure within 12 months prior to study start.\n\nRenal insufficiency requiring dialysis. History of organ transplantation. Any other serious acute or chronic medical or psychiatric condition, or laboratory abnormality that would increase the risk of study participation or interfere with interpretation of results.","ALL","18 Years",{"count":18,"type":19},38,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","his is a single-arm, phase II clinical study evaluating the efficacy and safety of low-dose bevacizumab (7.5 mg\u002Fkg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Eligible participants will receive TACE followed by HAIC (oxaliplatin, leucovorin, and fluorouracil) and subsequent intravenous administration of adebrelimab and low-dose bevacizumab every 3 weeks. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. A total of 38 participants will be enrolled using Simon's two-stage optimal design (alpha=0.05, power=0.8). The study is sponsored by the Third Affiliated Hospital of Sun Yat-sen University. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd.",[25,26,27],"Adebrelimab (SHR-1316)","Bevacizumab","Hepatocellular Carcinoma (HCC)","NOT_YET_RECRUITING","2026-04-22",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":19},"2026-04-10",{"date":36,"type":19},"2029-08-31",{"name":38,"class":39},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100595664","phase-2-adebrelimab--chemotherapy-as-neoadjuvant-therapy-for-resectable-nsclc-100595664","NCT07035392","Adebrelimab + Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC","A Single-arm, Prospective, Multicenter Clinical Study of Adebrelimab in Combination With Chemotherapy Neoadjuvant Therapy to Resect Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. 18 years old ≤ age ≤ 70 years old, male or female not limited;\n2. ECOG PS score 0-1 points;\n3. Patients who have not received systematic treatment in the past and agree to undergo radical surgery; Patients without surgical contraindications judged by thoracic surgeons;\n4. Stage II, IIIA, or selective IIIB (T3N2M0 only) squamous or non squamous cell non-small cell lung cancer confirmed by histopathology or cytology and judged by researchers to be capable of undergoing R0 surgical resection for the purpose of cure. Disease staging should be based on the American Joint Committee on Cancer (AJCC)\u002FInternational Union Against Cancer (UICC) NSCLC staging system, 8th edition;\n5. There is sufficient tumor tissue to detect PD-L1 expression level and PD-L1 ≥ 1%;\n6. At least one measurable lesion (according to RECIST 1.1 criteria);\n7. The expected survival period is at least 12 weeks;\n8. Other major organs (liver, kidney, blood system, etc.) are functioning well:\n\n   * Hemoglobin ≥ 90g\u002FL (no blood transfusion, no use of hematopoietic factors, and no medication correction within 2 weeks before the first medication);\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n   * Platelet count ≥ 100 × 109\u002FL; Total bilirubin ≤ 1.5 times the upper limit of normal value;\n   * alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase ≤ 2.5 times the upper limit of normal values;\n   * Serum creatinine ≤ 1.5 times the upper limit of normal value; And the endogenous creatinine clearance rate is ≥ 60ml\u002Fmin; For patients who have not received anticoagulant therapy, the international normalized ratio (INR) of prothrombin time is ≤ 1.5, and the activated partial thromboplastin time (APTT) is ≤ 1.5 times the upper limit of normal.\n9. Expected to be completely resected;\n10. Good lung function can tolerate surgical treatment;\n11. Female participants with fertility must undergo a pregnancy test (serum or urine) within 72 hours before starting the study medication, and the result must be negative. They must also be willing to use a medically recognized and effective contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study period and within 90 days after the last administration of the study medication; For male participants whose partners are women of childbearing age, they must agree to use effective methods of contraception or have undergone surgical sterilization during the study period and within 90 days after the last study administration;\n12. The subjects voluntarily joined this clinical study and signed an informed consent form.\n\nExclusion Criteria:\n\n1. Previously received any anti-tumor treatment, including radiotherapy, chemotherapy, immunotherapy, and traditional Chinese medicine anti-tumor treatment (excluding treatment for malignant tumors that have been cured and have no recurrence or metastasis for ≥ 5 years);\n2. Non squamous cell carcinoma histological types of NSCLC with EGFR mutation positive or ALK positive subjects. Non squamous cell carcinoma subjects must undergo EGFR gene testing and ALK gene and\u002For immunohistochemical testing;\n3. Patients with distant metastases (including M1a, M1b, M1c);\n4. Suffering from any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy), tuberculosis); Skin diseases that have completely relieved childhood asthma and do not require any intervention or systemic treatment in adulthood (such as vitiligo, psoriasis, or hair loss) can be included, but patients who require medical intervention with bronchodilators cannot be included;\n5. Exclude evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, imaging confirmed active pneumonia, and severe impairment of lung function;\n6. Subjects who have received systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone or other equivalent hormones) or other immunosuppressive agents within 2 weeks prior to their first administration. In the absence of active autoimmune diseases, inhalation or topical use of corticosteroids is allowed, as well as adrenal hormone replacement therapy with a dose of ≤ 10 mg\u002Fday effective dose of prednisone;\n7. Imaging (CT or MRI) shows tumor invasion into large blood vessels or blurred boundaries with blood vessels; Or imaging (CT or MRI) shows the presence of any pulmonary cavities or necrotic lesions, as determined by the researcher;\n8. Individuals who have experienced arterial\u002Fvenous thrombotic events within the first 6 months of enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n9. Within the first 3 months of enrollment, there have been significant clinically significant bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc., or they are currently receiving thrombolytic or anticoagulant therapy;\n10. Prior to enrollment, there was a daily hemoptysis volume of 100mL or more or a high risk of hemoptysis determined by the researcher;\n11. Individuals with hypertension who cannot achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450ms for males and ≥ 470ms for females); According to NYHA standards, patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)\\\u003C50% as indicated by cardiac ultrasound examination;\n12. Individuals who have undergone other major surgeries or severe injuries within the two months prior to the start of this experiment;\n13. Urine routine examination indicates urinary protein ≥ (++), or 24-hour urine protein level ≥ 1g, or severe liver and kidney dysfunction;\n14. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n15. Allergic to the experimental drug;\n16. Merge with HIV infection or active viral hepatitis;\n17. Pregnant or lactating women; Subjects with fertility who are unwilling or unable to take effective contraceptive measures;\n18. Individuals with neurological disorders or mental illnesses who are unable to cooperate;\n19. Cervical carcinoma in situ, basal cell or squamous cell carcinoma that can be adequately treated, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery are excluded from concurrent malignant tumors occurring ≤ 5 years before enrollment;\n20. Researchers believe that there are other situations that are not suitable for inclusion.","70 Years",{"count":49,"type":19},32,[22],"This study is a single arm, prospective, multicenter clinical trial, and eligible patients will receive the following treatment regimen: Adebrelimab combined with chemotherapy.The study includes a screening period (from the signing of informed consent by the subjects to no more than 28 days before the first medication, imaging examinations are allowed to be performed within 28 days before the first medication, and tumor tissue biopsy is allowed to be archived within 6 months before the first medication), a treatment period (including neoadjuvant and surgical treatment), and a follow-up period (including safety follow-up and survival follow-up).",[25,53,54],"NSCLC","Chemotherapy","2025-06-24",{"date":57,"type":32},"2025-06-25",{"date":59,"type":19},"2025-06-20",{"date":61,"type":19},"2026-12-01",{"name":63,"class":39},"Zhangzhou Municipal Hospital",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100562754","phase-2-phase-2-trial-of-adjuvant-adebrelimab-combined-with-capecitabine-in-high-risk-resected-cholangiocarcinoma-achieve-100562754","NCT06607276","Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE","A Phase 2, Randomized, Controlled, Multicenter Study of Adjuvant Adebrelimab Combined With Capecitabine in Resected Cholangiocarcinoma With High-risk Factors: ACHIEVE","ACHIEVE","Inclusion Criteria:\n\n1. Patients must sign an informed consent form;\n2. Ages 18-75, both genders eligible;\n3. ECOG performance status score (PS score) of 0 or 1;\n4. Patients with histologically confirmed cholangiocarcinoma (including intrahepatic cholangiocarcinoma and hilar cholangiocarcinoma), who have undergone R0 resection and have high-risk factors for recurrence;\n\n   High-risk factors are defined as follows:\n\n   Intrahepatic cholangiocarcinoma ( Single tumor \\> 5 cm, multiple tumors, liver capsule breach, vascular invasion, regional lymph node metastasis) Hilar cholangiocarcinoma (Tumor invasion into surrounding tissues, vascular invasion, regional lymph node metastasis)\n5. No evidence of recurrence or metastatic lesions on imaging within 28 days prior to randomization;\n6. No prior systemic anti-cancer therapy (including radiotherapy, chemotherapy, targeted therapy, immunotherapy) before curative resection;\n7. Laboratory test values within 7 days prior to the first dose of study medication meet the following criteria:\n\n   Complete blood count: (except for hemoglobin, no blood transfusion or use of granulocyte colony-stimulating factor \\[G-CSF\\], no medication correction within 2 weeks prior to screening):\n\n   Absolute neutrophil count ≥1.5×109\u002FL; Platelets ≥75×109\u002FL; Hemoglobin ≥90 g\u002FL;\n\n   Biochemical tests:\n\n   Serum albumin ≥30g\u002FL; Serum total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN; Serum creatinine ≤1.5×ULN; or Cr clearance rate \\>50 mL\u002Fmin International normalized ratio (INR) ≤1.2 or prothrombin time (PT) exceeding the normal control range by ≤2 seconds; Urine protein \\<2+ (if urine protein ≥2+, a 24-hour (h) urine protein quantification can be performed, and a 24h urine protein quantification of \\<1.0g is eligible for enrollment);\n8. Life expectancy of more than 6 months.\n\nExclusion Criteria:\n\n1. Pathological diagnosis of mixed hepatocellular carcinoma and other non-hepatic extra-bile duct cholangiocarcinoma or ampulla of Vater malignant tumor components;\n2. History of prior systemic treatment;\n3. History of or concurrent other malignancies, excluding non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma that have been adequately treated;\n4. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; history of active tuberculosis infection more than 1 year prior to enrollment without proper anti-tuberculosis treatment or tuberculosis is still active;\n5. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener\\'s granulomatosis, Sjogren\\'s syndrome, Guillain-Barre syndrome, or multiple sclerosis;\n6. Requirement for long-term systemic corticosteroids (dosage equivalent to \\>10mg prednisone\u002Fday) or any other form of immunosuppressive treatment. Subjects using inhaled or topical corticosteroids may be included;\n7. Severe cardiopulmonary or renal dysfunction;\n8. Inadequately controlled arterial hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) (based on the average of ≥2 blood pressure readings), allowing the achievement of the above parameters through the use of antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy;\n9. Within 3 months prior to enrollment, significant clinical bleeding symptoms or a clear tendency to bleed; abnormal coagulation function (PT \\>14s), tendency to bleed, or undergoing thrombolytic or anticoagulant therapy;\n10. HBV DNA \\>2000 IU\u002Fml, active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection);\n11. Active infection requiring systemic treatment;\n12. Human immunodeficiency virus (HIV, HIV1\u002F2 antibody) positive;\n13. History of psychiatric medication abuse, alcoholism, or drug addiction;\n14. History of allergy to study medication;\n15. Other factors deemed by the investigator to potentially affect subject safety or trial compliance. Such as severe diseases requiring concurrent treatment (including psychiatric diseases), severe laboratory test abnormalities, or other family or social factors.","75 Years",{"count":74,"type":19},122,[22],"Biliary tract malignancies (BTC) are malignant tumors that originate from the epithelium of the bile ducts. Currently, the optimal treatment for biliary tract malignancies is radical surgical resection. In recent years, with the advancement of imaging technology and surgical techniques, there has been certain progress in the diagnosis and treatment of biliary tract malignancies. However, the surgical resection rate and long-term survival rate after surgery are still not satisfactory, and the high postoperative recurrence rate is an important factor affecting the long-term survival of patients. Therefore, there is an urgent need to explore new postoperative adjuvant treatment plans to reduce postoperative tumor recurrence, which is of great significance for extending the survival of patients with biliary tract malignancies. In the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant treatment of biliary tract malignancies (BTC). However, in clinical practice, the use of capecitabine or tegafur for postoperative patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a huge unmet need in the clinical adjuvant treatment after surgery for biliary tract malignancies. Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.",[78,25],"Cholangiocarcinoma Cancer",[80,81,82,83],"Adebrelimab","capecitabine","Cholangiocarcinoma","Adjuvant Therapy","RECRUITING","2025-01-14",{"date":87,"type":32},"2025-01-16",{"date":89,"type":32},"2024-09-20",{"date":91,"type":19},"2027-09-20",{"name":93,"class":39},"The First Affiliated Hospital with Nanjing Medical University",4,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":72,"enrollmentInfo":101,"targetDuration":4,"studyType":20,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100554992","phase-2-a-phase-ii-trial-of-perioperative-adebrelimab-combined-with-xelox-in-resectable-locally-advanced-gastricgastroesophageal-junction-cancer-gcgejc-100554992","NCT06506292","A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric\u002FGastroesophageal Junction Cancer (GC\u002FGEJC)","Inclusion Criteria:\n\n1. Patients voluntarily enrolled in the study and signed an informed consent form\n2. 18-75 years old, male and female gender are not limited\n3. Gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction as determined by pathologic histology\n4. Clinical staging of II-III\u002FT3-4aNxM0 (AJCC 8th edition cTNM staging of gastric cancer)\n5. Clinically judged to be surgically resectable\n6. have at least one measurable lesion (according to the requirements of RECISTv1.1, the long diameter of spiral CT scan of this measurable lesion is ≥10mm or the short diameter of enlarged lymph node is ≥15mm)\n7. No other anti-tumor therapy has been received\n8. ECOG score:0\\~1\n9. Good function of major organs\n10. No active hepatitis B virus (HBV) infection\n11. Women of childbearing potential must have had a negative blood pregnancy test within 3 days prior to randomization and be willing to use an appropriate method of contraception during the trial and for 6 months after completion of treatment. For men, surgical sterilization or agreement to use an appropriate method of contraception during the study and for 3 months after completion of treatment.\n\nExclusion Criteria:\n\n1. patients who are pregnant or breastfeeding\n2. Received prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy\n3. other malignant tumor (except basal or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) within the past 5 years\n4. Uncontrolled pleural effusion, pericardial effusion or ascites\n5. Clinically determined to be inoperable or with distal metastasis\n6. Severe cardiovascular disease, such as symptomatic coronary artery disease, class ≥II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, within 12 months prior to enrollment.\n7. Complicated upper gastrointestinal tract obstruction\u002Fbleeding or digestive dysfunction or malabsorption syndrome\n8. History of gastrointestinal perforation in the 6 months prior to enrollment\n9. Severe uncontrolled co-infection or other severe uncontrolled concomitant disease, moderate or severe renal impairment\n10. Have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Grade II or higher cardiac insufficiency according to the New York Heart Association (NYHA) criteria (see Appendix 5) or cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) \\< 50%; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year prior to the initiation of study treatment; (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc\\>450ms (men); QTc\\>470ms (women) (QTc interval calculated by the Fridericia formula; in case of QTc abnormality, three consecutive measurements can be taken at 2-minute intervals and averaged)\n11. have an allergic reaction to the drugs used in the study\n12. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding topical glucocorticosteroids by nasal, inhalational, or other routes or physiologic doses of systemic glucocorticosteroids (i.e., no more than 10 mg\u002Fday of prednisone or equivalent doses of other glucocorticosteroids), or use of hormones for the prevention of contrast allergy\n13. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n14. current concomitant interstitial pneumonitis or interstitial lung disease, or a prior history of interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or other conditions that may interfere with the determination and management of immune-related pulmonary toxicity such as pulmonary fibrosis, mechanized pneumonitis (e.g., occlusive bronchiectasis), pneumonias, drug-associated pneumonias, idiopathic pneumonias, or active pneumonitis as seen on screening chest computed tomography (CT) maps Evidence of or severely impaired lung function in subjects with a history of radiation pneumonitis in the permitted radiation field, active tuberculosis\n15. presence of active autoimmune disease or history of autoimmune disease with potential for relapse (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism \\[subjects who can be controlled by hormone replacement therapy only are eligible for enrollment\\]); subjects with a dermatological condition that does not require systemic treatment such as vitiligo psoriasis, alopecia areata, controlled type I diabetes mellitus treated with insulin or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; asthmatics requiring medical intervention with bronchodilators may not be included\n16. Immunosuppressive or systemic hormone therapy for immunosuppression within 14 days prior to initiation of study treatment (doses \\>10 mg\u002Fday of prednisone or other equipotent hormone)\n17. severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia; therapeutic antibiotics given orally or intravenously within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or exacerbation of COPD are eligible for study participation))\n18. Patients with congenital or acquired immune deficiency (e.g., HIV-infected)\n19. Use of immunosuppressive medications within 4 weeks prior to the first dose of study drug\n20. live attenuated vaccine within 4 weeks prior to the first dose or plan to receive live attenuated vaccine during the study period\n21. previous treatment with other anti-PD-1 antibodies or other immunotherapy against PD-1\u002FPD-L1;\n22. permitted palliative radiotherapy to non-target lesions for symptom control, which must have been completed at least 2 weeks prior to initiation of study treatment use, with no recovery from radiotherapy-induced adverse events to ≤ CTCAE grade 1\n23. received other experimental drug therapy within 28 days prior to initiation of study treatment\n24. In the judgment of the investigator, the patient has other factors that may affect the results of the study or cause this study to be forced to be terminated in midstream, such as alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the patient\\'s safety.",{"count":102,"type":19},25,[22],"To observe and evaluate the efficacy and safety of adebrelimab combination chemotherapy regimen in the perioperative treatment of surgically resectable gastric cancer\u002Fadenocarcinoma of the gastroesophageal junction.",[25,106,107],"XELOX","GC\u002FGEJC","2024-07-11",{"date":110,"type":32},"2024-07-17",{"date":112,"type":32},"2024-07-01",{"date":114,"type":19},"2027-08-01",{"name":116,"class":39},"Tianjin Medical University Cancer Institute and Hospital",1,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":72,"enrollmentInfo":124,"targetDuration":4,"studyType":20,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":117},"100551004","phase-1-phase-ibii-clinical-study-of-adebrelimab-in-combination-with-decitabine-albumin-bound-paclitaxel-and-gemcitabine-for-the-first-line-treatment-of-metastatic-pancreatic-cancer-100551004","NCT06454448","Phase Ib\u002FII Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n1\\. Age 18-75 years old, male or female; 2. Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer); 3. Have not received any anti-tumor therapy (including chemotherapy, targeted, immunotherapy, etc.); 4. Must have at least one measurable lesion as a target lesion (according to RECIST v1.1 criteria); the target lesion should not have received localized treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred and meets RECIST1.1 criteria); 5. ECOG: 0 to 1; 6. Expected survival ≥ 3 months; 7. Good major organ function, i.e., the following criteria are met (in the absence of receiving any blood components, cell growth factors within 14 days prior to randomization):\n\n1. Neutrophils ≥1.5\\*109\u002FL; platelets ≥80\\*109\u002FL; hemoglobin ≥9g\u002Fdl; serum albumin ≥3g\u002Fdl;\n2. Total bilirubin ≤ 1.5 times the upper limit of normal value (biliary obstruction allows biliary drainage); ALT and AST ≤ 3 times the upper limit of normal value (for patients with hepatic metastases, it can be relaxed to ≤ 5 times the upper limit of normal value);\n3. Serum creatinine ≤1.5 times the upper limit of normal value, creatinine clearance ≥50ml\u002Fmin;\n4. INR ≤1.5 times the upper limit of normal value and APTT ≤1.5 times the upper limit of normal value (for the use of a stable dose of anticoagulation therapy, such as low molecular heparin or warfarin, and the INR is within the expected therapeutic range of anticoagulants can be screened);\n5. Electrocardiogram: QTcF ≤450ms (men), ≤470ms (women);\n6. Cardiac ultrasound: LVEF (left ventricular ejection fraction) ≥50%; 8. Women of childbearing potential must have had a negative blood pregnancy test within 3 days prior to randomization and be willing to use an appropriate method of contraception during the trial and for 6 months after completion of treatment. For men, this should be surgical sterilization or agreement to use an appropriate method of contraception for the duration of the study and for 3 months after completion of treatment; 9. Subjects voluntarily enroll in this study by signing an informed consent form.\n\nExclusion Criteria:\n\n1. patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors;\n2. patients with known central nervous system metastases;\n3. severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);\n4. the presence of third interstitial fluid (e.g., massive pleural fluid) that could not be stabilized (without interventional therapy after drain removal) except for ascites within 2 weeks before randomization;\n5. Patients with clinically symptomatic ascites who require puncture or drainage or who have received ascites drainage within the previous 3 months (except for imaging that shows only a small amount of ascites that is manageable but not accompanied by clinical symptoms);\n6. current concomitant interstitial pneumonia or interstitial lung disease, or a prior history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis that may interfere with the determination and management of immune-related pulmonary toxicity, mechanized pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonitis, idiopathic pneumonitis, or active pneumonia or severely impaired pulmonary function as demonstrated by chest CT at the Screening Period Subjects; active tuberculosis;\n7. the presence of active autoimmune disease or a history of autoimmune disease with potential for relapse \\[including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (subjects who can be controlled by hormone replacement therapy only are eligible for enrollment)\\]; subjects who have a skin disease that does not require systemic treatment such as vitiligo, psoriasis, alopecia that Controlled type I diabetes mellitus receiving insulin therapy or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be enrolled;\n8. known peripheral neuropathy (CTCAE ≥ grade 3);\n9. a serious infection (CTCAE \\> grade 2) within 4 weeks prior to randomization, such as severe pneumonia, bacteremia, or complications of infection requiring hospitalization; signs and symptoms of infection requiring intravenous antibiotic therapy (except for prophylactic use of antibiotics) within 2 weeks prior to randomization;\n10. received any of the following treatments: 1) Immunosuppressive or systemic hormone therapy for immunosuppression within 2 weeks prior to randomization (dose \\>10 mg\u002Fday prednisone or other equipotent hormone); 2) Radiation therapy within 2 weeks prior to randomization; 3) Major surgery (e.g., open thoracic surgery, open abdominal surgery, etc.) within 4 weeks prior to randomization; 4) Received any other clinical study medication within 4 weeks prior to randomization, unless it was an observational (non-interventional) clinical study or an interventional clinical study follow-up.\n11. abnormal coagulation, bleeding tendency or undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (≤100mg\u002Fday), low molecular heparin (enoxaparin 40mg\u002Fday and other low molecular heparin at its equivalent dose) is allowed;\n12. patients with cardiac clinical conditions or diseases that are not well controlled, such as (1) NYHA class 2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 6 months, and (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;\n13. malignancy other than pancreatic cancer within 5 years prior to randomization, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell carcinoma of the skin;\n14. known hypersensitivity to PD-L1, albumin paclitaxel, gemcitabine, decitabine, and any of the components of the above products;\n15. known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection;\n16. previous history of definite neurological or psychiatric disorders, including epilepsy or dementia;\n17. Subjects who, in the judgment of the investigator, have other factors that may cause them to be forced to terminate the study midway, such as non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, grossly abnormal values of clinically significant laboratory tests, familial or social factors that may affect the safety of the subject or the collection of trial data.",{"count":125,"type":19},20,[127,22],"PHASE1","Pancreatic cancer is a kind of digestive system tumor with extremely high malignancy and poor prognosis. Although the trend of benefit from immunotherapy in combination with chemotherapy is currently reflected in several exploratory studies, the overall efficacy is still relatively limited.\n\nDysregulation of epigenetic mechanisms, which is common in cancer, leads to down-regulation of genes involved in tumor antigen processing or presentation, resulting in immune evasion and thus affecting the efficacy of immunotherapy. Epigenetic inhibitors may enhance the efficacy of immunotherapy by enhancing antigenicity and presentation of tumor-associated antigens, reprogramming the tumor microenvironment to counteract immunosuppression, and reversing cytotoxic T-cell depletion. Thus, decitabine-promoted immunotherapeutic sensitization is a potential therapeutic avenue for mPDAC patients that warrants further exploration in clinical trials. Taking into account the characteristics of pancreatic cancer immunophenotype, exploring combination therapy regimens that enhance anti-tumor immune response and improve the efficacy of immunotherapy has become an urgent clinical problem.\n\nThis study is a prospective, single-arm, single-center, phase IB\u002FII clinical study exploring the efficacy and safety of adebrelimab in combination with decitabine, albumin-bound paclitaxel, and gemcitabine in the first-line treatment of metastatic pancreatic cancer. The primary study endpoints are DLT, RP2D and ORR. Secondary study endpoints are OS, PFS, DCR, DoR and safety.",[25,130,131],"Decitabine","Metastatic Pancreatic Cancer","2024-06-26",{"date":134,"type":32},"2024-06-28",{"date":136,"type":32},"2024-06-15",{"date":138,"type":19},"2026-11",{"name":116,"class":39}]