[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant-immunotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant-immunotherapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,50,83,107,130,159,182,204,234,258,278,302],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100622713","phase-2-neoadjuvant-merkel-cell-carcinoma-therapy-tx-with-the-pd-1-inhibitor-cemiplimab-100622713",false,"NCT07387198","Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab","Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab - A Randomized, Double-blind, Placebo-controlled, Non-comparative Phase II Study","NeoMatryx","Inclusion criteria\n\n1. Patient has signed informed written consent.\n2. Patients is 18 years and older at time of signing of written informed consent\n3. Patient has diagnosis of Merkel cell carcinoma in clinical stage II, or in stage I with minimum diameter of 1 cm, with primary tumor already removed and a planned sentinel lymph nodes biopsy still pending.\n4. Patient has ECOG performance status 0-2.\n5. Patients has adequate laboratory parameters particularly for the blood count, renal and liver function parameters.\n\n   1. Absolute number of neutrophils ≥ 1.5 x 109\u002FL\n   2. Platelets ≥ 75 x 109\u002FL\n   3. Hemoglobin ≥ 9 g\u002FdL\n   4. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with Gilbert´s Disease and total bilirubin up to 3x ULN may be eligible after approval from trial's medical expert)\n   5. AST (SGOT) and ALT (SGPT) ≤ 3x ULN\n   6. AP ≤ 2.5x ULN\n   7. Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL\u002Fmin\n6. Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C1% per year during the treatment period and for at least 6 months after the last dose of Cemiplimab. Male patients must refrain from donating sperm during this same period. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy.\n7. Patient must be willing to allow translational work-up of tissue samples (PT, sentinel lymph node biopsy).\n\nExclusion criteria\n\n1. Patient has prior sentinel lymph node removal for the current MCC.\n2. Patients received prior treatment with immunotherapy (such as PD-1\u002FPD-L1 or CTL4) or any other systemic anti-tumor (MCC) therapy (incl. investigational therapies)\n3. Patient has active or a history of hematological neoplasms including chronic lymphocytic leukemia (CLL), irrespective if these require treatment or not.\n4. Patient had prior organ transplantation including allogenic stem-cell transplantation.\n5. Patient receives immunosuppressive concomitant medication, EXCEPT for the following:\n\n   i. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection).\n\n   ii. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent.\n\n   iii. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n6. Patient has known hypersensitivity to any component of the Cemiplimab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein.\n7. Patient has active autoimmune or inflammatory disorders.\n8. Patient has history of interstitial lung disease.\n9. Patient has active infection requiring systemic therapy.\n10. Patient has Active infection requiring systemic therapy, including uncontrolled HIV, HBV and HCV infection or diagnosis of immunodeficiency.\n\n    NOTE: Patients are eligible if:\n    * Patients have controlled HIV infection with CD4 counts is \\> 350 cells\u002FμL and viral load is undetectable \\[HIV RNA PCR\\]. Patients with controlled HIV infection must be monitored per local standards during the trial.\n    * Patients positive for HBV surface antigen have controlled HBV infection receiving anti-viral therapy and with undetectable serum viral load \\[HBV DNA PCR\\]. Patients with controlled infection must undergo periodic monitoring of HBV DNA and p must remain on anti-viral therapy for at least 6 months after last dose of Cemiplimab.\n    * Patients positive for HCV antibody have controlled HCV infection with undetectable viral load \\[HCV RNA PCR\\].\n11. Patent received vaccination with any live vaccine (e.g., intranasal flu vaccine) within 4 weeks before the first dose of Cemiplimab or planned vaccination with live vaccine during the trial\n12. Female patients, who are pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment. Female patients of childbearing potential must have a negative serum β-HCG pregnancy test result within 7 days prior to initiation of study treatment.\n13. Patient has evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the study medications, puts the patient at higher risk for treatment-related complications or may affect the interpretation of study results.\n14. Patient has known substance abuse or other psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n15. Patient is legally incapacitated or has limited legal capacity","ALL","18 Years",{"count":20,"type":21},135,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study is a randomized, double blind, placebo-controlled, non-comparative phase II trial that investigates the efficacy of neoadjuvant anti-PD-1 antibody Cemiplimab treatment in patients with clinical stage I or II Merkel cell carcinoma who have have undergone primary tumour excision and are pending sentinel lymph node biopsy.",[27,28,29],"Merkel Cell Carcinoma, Stage I","Merkel Cell Carcinoma, Stage II","Neoadjuvant Immunotherapy",[31,32,33,34,35,36],"merkel cell carcinoma","sentinel lymph node","PD-1 antibody","skin cancer","Cemiplimab","MCC","RECRUITING","2026-06-18",{"date":40,"type":41},"2026-06-22","ACTUAL",{"date":43,"type":41},"2026-05-29",{"date":45,"type":21},"2031-07-31",{"name":47,"class":48},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","OTHER",14,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100641505","phase-2-yang-et-al-anti-pd-1ctla-4-dual-immunotherapy-for-larc-100641505","NCT07596290","Yang et al. Anti-PD-1\u002FCTLA-4 Dual Immunotherapy for LARC","Efficacy and Safety of Neoadjuvant Short-Course\u002FLong-Course Radiotherapy Combined With Anti-PD-1\u002FCTLA-4 Dual Immunotherapy for Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial (RADICAL Trial)","RADICAL","Inclusion Criteria:\n\n1. Age between 18 and 80 years; ECOG performance status 0-1;\n2. Histopathologically confirmed rectal adenocarcinoma via colonoscopy; pMMR or MSS phenotype;\n3. Rectal MRI stage II\u002FIII (excluding T4b); distal tumor margin ≤ 12 cm from the anal verge;\n4. Willingness to comply with study procedures; consent to use tissue and blood samples for medical research purposes;\n5. No prior history of radiotherapy, chemotherapy, or immunotherapy;\n6. No immune system diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, hyperthyroidism\u002Fhypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.);\n7. No severe cardiac, pulmonary, hepatic, or renal dysfunction; no jaundice or gastrointestinal obstruction;\n8. No concurrent acute infection;\n9. Baseline laboratory evaluations completed as required, with results obtained within 14 days before randomization, and laboratory values meeting the following criteria (per CTCAE 5.0):\n\n   * White blood cell count ≥ 2000\u002FμL;\n   * Neutrophil count ≥ 1500\u002FμL;\n   * Platelet count ≥ 100×10³\u002FμL;\n   * Hemoglobin ≥ 9.0 g\u002FdL;\n   * Serum creatinine ≤ 1.5×upper limit of normal (ULN) or creatinine clearance \\> 50 mL\u002Fmin (female: creatinine clearance = \\[140 - age (years)\\] × body weight (kg) × 0.85 \u002F (72 × serum creatinine (mg\u002FdL)); male: creatinine clearance = \\[140 - age (years)\\] × body weight (kg) × 1.00 \u002F (72 × serum creatinine (mg\u002FdL)));\n   * AST ≤ 3×ULN, ALT ≤ 3×ULN, total bilirubin ≤ 1.5×ULN;\n10. No psychiatric\u002Fpsychological disorders affecting social function;\n11. Negative serum pregnancy test (blood HCG) within 1 week before randomization for women of childbearing potential;\n12. Women of childbearing potential must agree to use effective contraception during the study period and for 5 months after the last dose of study drug;\n13. Male subjects who are sexually active with women of childbearing potential must agree to use effective contraception during the study period and for 7 months after the last dose of study drug, and must refrain from sperm donation during this period.\n\nExclusion Criteria:\n\n1. Multiple primary cancers or concurrent other malignant tumors;\n2. Patients requiring emergency surgery due to intestinal obstruction, intestinal perforation, gastrointestinal bleeding, etc.;\n3. Factors affecting oral drug absorption (e.g., inability to swallow, nausea\u002Fvomiting, diarrhea, intestinal obstruction, etc.);\n4. Any uncontrolled, severe concomitant diseases;\n5. Hypersensitivity to any component of the study drugs;\n6. Expected survival \\\u003C 5 years for any reason;\n7. Planned or previous organ\u002Fbone marrow transplantation;\n8. Treatment with immunosuppressants or corticosteroids within 1 month before enrollment;\n9. Central nervous system disorders that may impair ability to provide informed consent or comply with study procedures, as determined by the investigator;\n10. Other conditions that may prevent completion of study treatment (e.g., alcoholism, drug addiction, etc.);\n11. Pregnant or breastfeeding women.","80 Years",{"count":60,"type":21},342,[24,62],"PHASE3","This is a prospective, multicenter, randomized controlled trial aimed at comparing different radiotherapy fractionation regimens combined with sequential dual immunotherapy versus traditional chemoradiotherapy in neoadjuvant treatment for locally advanced rectal cancer (LARC). A total of 342 pMMR\u002FMSS LARC patients will be enrolled and randomly assigned in a 1:1:1 ratio to short-course radiotherapy (5×5Gy) followed by sequential dual immunotherapy (paromlimab + tuvonralimab + CAPEOX), long-course radiotherapy followed by sequential dual immunotherapy, or conventional long-course chemoradiotherapy. The primary endpoint is the complete response rate (pCR + cCR). Secondary endpoints include the proportion of patients adopting the \"watch-and-wait\" strategy, disease-free survival, overall survival, and safety. This study innovatively explores the synergistic mechanism of different radiotherapy fractionations with dual immunotherapy, optimizes the timing of immunotherapy initiation, and constructs a clinical-imaging-pathology multimodal efficacy prediction model, aiming to advance LARC treatment from empirical to precision therapy while achieving organ and function preservation.",[65,66,29],"Locally Advanced Rectal Adenocarcinoma","Neoadjuvant Chemoradiation",[68,69,70,71,72],"Locally advanced rectal cancer","Neoadjuvant chemoradiation","Anti-PD-1\u002FCTLA-4 Dual Immunotherapy","Short-course radiotherapy","Long-course rediotherapy","NOT_YET_RECRUITING","2026-06-16",{"date":76,"type":41},"2026-06-17",{"date":78,"type":21},"2026-07-15",{"date":80,"type":21},"2030-12-31",{"name":82,"class":48},"Beijing Friendship Hospital",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100632575","phase-2-a-prospective-single-arm-exploratory-study-of-the-safety-and-efficacy-of-neoadjuvant-treatment-with-ql1706-an-anti-pd-1anti-ctla-4-bispecific-antibody-in-resectable-stage-ib-and-iia-hepatocellular-carcinoma-with-high-recurrence-risk-100632575","NCT07515469","A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1\u002FAnti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk","A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With Iparomlimab and Tuvonralimab Injection, an Anti-PD-1\u002FAnti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk","Inclusion Criteria:\n\n* Patients voluntarily participate in this study and sign the informed consent form.\n* Aged 18 to 75 years, male or female.\n* ECOG Performance Status (PS) score of 0 to 1.\n* Child-Pugh liver function classification: Grade A.\n* Histopathologically confirmed primary hepatocellular carcinoma (HCC), and the lesions meet the surgical resection indications specified in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition).\n* Preoperatively, evaluated by the investigator, with high recurrence risk factors, meeting at least one of the following: Stage IB: Single tumor with maximum diameter \\> 5 cm; 2-3 tumors with maximum tumor diameter ≤ 3 cm；Stage IIA: 2-3 tumors with maximum tumor diameter \\> 3 cm.\n* According to the RECIST 1.1 criteria, the patient has at least one measurable lesion (measurable lesion with a long diameter ≥ 10 mm on CT\u002FMRI scan or lymph node lesion with a short diameter ≥ 15 mm on CT\u002FMRI scan, and the measurable lesion has not received local treatment such as radiotherapy or cryotherapy).\n* Expected survival time ≥ 6 months\n* possess normal and sound organ function\n* Females of childbearing age must agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the medication period and within 6 months after the end of medication; serum or urine pregnancy test is negative within 7 days before study enrollment, and must be a non-lactating patient; males must agree to use contraceptive measures during the study period and within 6 months after the end of the study.\n* The subject has good compliance and is willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapy.\n* Known hilar cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar carcinoma; other active malignant tumors except HCC within 5 years or concurrently.\n* Hypertension that cannot be well controlled with antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.\n* The subject has a history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) or concurrent malignant tumors.\n* Previous treatment with Iparomlimab and Tuvonralimab or other PD-1\u002FPD-L1\u002FCTLA-4 inhibitors; known previous allergy of the subject to macromolecular protein preparations or any component of Iparomlimab and Tuvonralimab.\n* The subject has any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or asthma that was completely relieved in childhood and does not require any intervention in adulthood can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.\n* The subject is using immunosuppressants, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose \\> 10 mg\u002Fday prednisone or other hormones with equivalent efficacy), and continues to use them within 2 weeks before enrollment.\n* Clinically symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage.\n* Uncontrolled clinical symptoms or diseases of the heart, such as: Heart failure of NYHA Class II or above；Unstable angina pectoris；Myocardial infarction within 1 year；Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n* The patient currently (within 3 months) has esophageal varices, active gastroduodenal ulcer, ulcerative colitis, portal hypertension and other digestive tract diseases, or active bleeding from unresected tumors, or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.\n* Previous or current severe bleeding (bleeding \\> 30 ml within 3 months), hemoptysis (\\> 5 ml of fresh blood within 4 weeks) or thromboembolic events (including stroke events and\u002For transient ischemic attack) within 12 months.\n* The subject has an active infection or unexplained fever \\> 38.5 ℃ during screening or before the first dose (fever caused by tumor can be included as judged by the investigator).\n* Patients with objective evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.\n* The subject has congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria; for hepatitis B: HBV DNA ≥ 10⁴\u002Fml; for hepatitis C: HCV RNA ≥ 10³\u002Fml); chronic hepatitis B virus carriers with HBV DNA \\\u003C 2000 IU\u002Fml (\\\u003C 10⁴ copies\u002Fml) can be enrolled only if they receive antiviral treatment during the trial.\n* Live vaccine接种 within 4 weeks before study medication or likely to be vaccinated during the study period.\n* The subject has a known history of psychotropic drug abuse, alcoholism or drug addiction.\n* The investigator deems that the subject should be excluded from this study, for example, as judged by the investigator, the subject has other factors that may lead to the forced termination of the study in the middle, such as other serious diseases (including mental diseases) requiring combined treatment, severe laboratory test abnormalities, or family or social factors that may affect the safety of the subject or the collection of data and samples.","75 Years",{"count":92,"type":21},30,[24],"This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).",[96,97,29],"HCC - Hepatocellular Carcinoma","Iparomlimab and Tuvonralimab Injection","2026-03-31",{"date":100,"type":41},"2026-04-07",{"date":102,"type":21},"2026-05-30",{"date":104,"type":21},"2030-10-30",{"name":106,"class":48},"Tianjin Medical University Cancer Institute and Hospital",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":114,"targetDuration":116,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":128,"locationsCount":4},"100621690","comparison-of-the-effect-of-surgical-resection-based-on-lesion-extent-before-and-after-neoadjuvant-therapy-in-patients-with-stage-ii-iiib-non-small-cell-lung-cancer-a-single-center-real-world-open-label-study-100621690","NCT07373899","Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study.","Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study","Inclusion Criteria:\n\n* Histologically confirmed NSCLC; ② Achieved resectable criteria after neoadjuvant immunotherapy (± chemotherapy); ③ Originally required total lung resection or combined lobectomy based on the size and extent of the lesion, but after neoadjuvant treatment, the condition was suitable for minimally invasive resection; ④ Age ≥ 18 years; ⑤ ECOG score 0-1; ⑥ Complete imaging, pathological and follow-up data.\n\nExclusion Criteria:\n\n* ① Disease progression (PD) after neoadjuvant therapy; ② Those who still require total lung resection or combined lobectomy and whose scope cannot be reduced; ③ During the operation, it is found that R0 resection is impossible; ④ Severe cardiopulmonary dysfunction or other complications make them intolerant to surgery.",{"count":115,"type":21},354,"5 Years","OBSERVATIONAL","This study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR) after immunotherapy induction. The study plans to enroll patients suitable for surgery as assessed by radiomics evaluation and multidisciplinary team (MDT) discussion, and will assign them to the modified surgery group and the conventional surgery group based on patient preference. The resection scope in the modified surgery group is more limited compared to conventional surgery, aiming to maximize preservation of pulmonary function while ensuring oncological safety. This study will systematically evaluate the impact of different resection scopes on patient prognosis after neoadjuvant immunotherapy, providing clinical evidence for exploring individualized surgical strategies for non-small cell lung cancer in the era of immunotherapy.",[120,29,121],"Carcinoma, Non-Small-Cell Lung","Surgery","2026-01-20",{"date":124,"type":41},"2026-01-28",{"date":126,"type":21},"2026-01-01",{"date":80,"type":21},{"name":129,"class":48},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100503634","phase-2-efficacy-and-safety-of-tislelizumab-in-combination-with-disitamab-vedotin-as-neoadjuvant-therapy-for-her2-positive-high-risk-upper-tract-urothelial-carcinoma-utuc-100503634","NCT05837806","Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)","A Single-arm, Open Clinical Trial of Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)","Inclusion Criteria:\n\n1. Radiographically(CT, MRI or PET-CT, etc.) and histologically confirmed diagnosis of localized HER-2 expressing upper urothelial carcinoma( (cT1-4N0-2M0, HER-2 immunohistochemistry (IHC) ≥ 1+); high risk disease (according to EAU Guidelines for UTUC); planning to receive radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA).\n2. Male or female aged 18 years and above;\n3. Expected survival time greater than 12 weeks;\n4. An ECOG status score of 0-2;\n5. Agree to provide specimens of blood, urine, and tissue examination (for detection of MRD, PD-L1 expression, HER2 expression, tumor mutation load, immunohistochemistry, DNA and RNA detection, etc.);\n6. The level of organ function must meet the following requirements:\n\n   * hematological indicators: absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 80 × 10\\^9\u002FL, hemoglobin ≥ 6.0 g\u002FdL (can be maintained by symptomatic treatment)\n   * hepatic function: total bilirubin ≤ 1.5 times the upper limit of normal, and glutathione and glutamic oxalacetic transaminase ≤ 2.5 times the upper limit of normal;\n   * renal function: GFR ≥ 15 ml\u002Fmin;\n   * Subjects voluntarily joined the study, signed an informed consent form, were compliant, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Live attenuated vaccines, other than COVID-19 vaccine, received within 4 weeks prior to treatment or scheduled to be received during the study period\n2. Active, known or suspected autoimmune disease;\n3. Known history of primary immunodeficiency;\n4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n5. Female patients who are pregnant or breastfeeding\n6. Untreated acute or chronic active hepatitis B or C infection. Patients who are receiving antiviral therapy with monitoring of viral copy number and are eligible for enrollment as determined by the physician on an individual patient basis;\n7. Previous use of immunosuppressive drugs, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg\u002Fday prednisolone or equivalent pharmacologic physiologic doses of other corticosteroids), within 4 weeks prior to initiation of therapy\n8. Known or suspected allergy history to tislelizumab and disitamab vedotin.\n9. With a clear history of active tuberculosis.\n10. Prior PD-1\u002FPD-L1\u002FCTLA-4 antibody or other immunotherapy;\n11. Those who are participating in other clinical studies\n12. Men of reproductive potential or women with the potential to become pregnant who are not using reliable contraception\n13. Uncontrolled co-morbidities, including but not limited to\n\n    * HIV-infected individuals (HIV-positive);\n    * Severe infections that are active or poorly controlled clinically (including patients in the period of neocoronavirus infection)\n    * Evidence of the presence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension \\[i.e., defined as greater than or equal to CTCAE grade 2 hypertension despite medication\\]).",{"count":138,"type":21},21,[24],"Neoadjuvant chemotherapy treatment can be used for specific UTUC patients, especially for highly staged and\u002For grade tumors, such as kidneys with potentially decreased renal function after RNU. Neoadjuvant therapy is a series of treatments administered preoperatively for UTUC, mainly chemotherapy, and in recent years, novel therapies of immunotherapy have emerged. Since conventional cisplatin neoadjuvant regimens also require high preoperative renal function, neoadjuvant therapy regimens such as immunotherapy provide more effective and feasible treatments for patients who are intolerant to current cisplatin chemotherapy regimens. The aim of this study was to explore the efficacy and safety of the combination of disitamab vedotin, a human epidermal growth factor receptor-2 (HER-2) targeted ADC, and tislelizumab, a humanised PD-1 ICIs, as neoadjuvant treatment for non-metastatic, high-risk, HER-2 expressing UTUC. In our study, patients enrolled will receive neoadjuvant tislelizumab plus disitamab-vedotin therapy followed by radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA) .",[29],[143,144,145,146,147,148],"neoadjuvant therapy","UTUC","immunotherapy","upper tract urothelial carcinoma","PD-1","ADC","2025-12-26",{"date":151,"type":41},"2025-12-31",{"date":153,"type":41},"2022-12-30",{"date":155,"type":21},"2027-12-30",{"name":157,"class":48},"Tianjin Medical University Second Hospital",1,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100610745","phase-2-neoadjuvant-sbrt-and-tislelizumab-immunotherapy-plus-anlotinib-for-resectable-egfr-wild-type-nsclc-100610745","NCT07231575","Neoadjuvant SBRT and Tislelizumab (Immunotherapy) Plus Anlotinib for Resectable EGFR Wild-type NSCLC","Preoperative Stereotactic Body Radiotherapy and Tislelizumab (Immunotherapy) Plus Anlotinib for Operable Stage IB to III EGFR Wild-type Non-small Cell Lung Cancer（STATION）","Inclusion Criteria:\n\n1.18 years or older 2. Eastern Cooperative Oncology Group performance status: 0 or 1 3. Clinical stage IB to IIIB (T3-4N2) Resectable NSCLC 4. Adequate cardiopulmonary and haematological function.\n\nExclusion Criteria:\n\n1. Known EGFR-sensitising mutations and EML4-ALK fusions\n2. Concomitant malignancy, history of another cancer within the past 3 years.\n3. Current or previous use of immunosuppressive medication,active autoimmune disease, and interstitial lung disease or idiopathic pulmonary fibrosis on a screening radiographic scan",{"count":167,"type":21},39,[24],"The neoadjuvant strategy of immunotherapy combined with chemotherapy has been recommended for resectable or potentially resectable tumors without driver-gene alterations.However, the AE of chemotherapy is more than 40%，which bring fear to the patients，especially for those who cannot tolerate or refuse chemotherapy.Several studies indicated that the strategies of chemo-free ,such as the combination of immunotherapy with antiangiogenic therapy or with SBRT, were safe and well tolerated, without increasing adverse reactions. Both of them have a promising efficacy with a manageable toxicity profile in patients with resectable NSCLC. The investigators aim to assess the activity and safety of neoadjuvant SBRT and immunotherapy plus antiangiogenic therapy in patients with resectable NSCLC.",[29,171,172],"NSCLC","Chemo-free Therapy","2025-11-15",{"date":175,"type":41},"2025-11-18",{"date":177,"type":21},"2025-11-10",{"date":179,"type":21},"2032-05-30",{"name":181,"class":48},"Sun Yat-sen University",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":158},"100591238","phase-2-a-prospective-single-arm-phase-ii-clinical-study-of-tislelizumab-combined-with-anlotinib-and-platinum-based-doublet-perioperative-therapy-for-resectable-stage-ii-iiib-driver-gene-negative-nsclc-100591238","NCT06977828","A Prospective, Single-arm, Phase II Clinical Study of Tislelizumab Combined With Anlotinib and Platinum-based Doublet Perioperative Therapy for Resectable Stage II-IIIB Driver Gene-negative NSCLC","Inclusion Criteria:\n\n* Fully understand and voluntarily sign the informed consent for this study;\n* Age ≥18 years old and ≤75 years old, male or female;\n* Patients with histologically or cytologically confirmed resectable stage II-IIIB non-small cell lung cancer;\n* ECOG 0-1;\n* No EGFR sensitive mutation, ALK or ROS1 fusion mutation was confirmed by tissue genetic testing before enrollment.\n* Had not received any previous systemic treatment for non-small cell lung cancer;\n* Patients with normal organ function within 7 days before enrollment met the following criteria:\n\n  1. Blood routine test (no blood transfusion history within 14 days) :\n  2. Hemoglobin (HB)≥90g\u002FL; Absolute neutrophil count (ANC)≥1.5×109\u002FL; j Platelet count (PLT)≥80×109\u002FL.\n  3. Biochemical test results met the following criteria:\n\n     Total bilirubin (TBIL)≤1.5 ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 ULN, or 5 ULN if liver metastasis occurs; Serum creatinine (Cr)≤1.5 ULN or creatinine clearance (CCr)≥60mL\u002Fmin. Left ventricular ejection fraction (LVEF)≥50%; Urine routine examination showed urine protein \\\u003C 2+ or 24-hour urine protein \\\u003C 1g; Serum amylase and lipase ≤ ULN.\n* Male or female patients of childbearing potential voluntarily use an effective method of contraception, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. during the study and for 6 months after the last study medication. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnophorectomy, or radioactive ovarian irradiation).\n\nExclusion Criteria:\n\n* The pathological types of the patients were mixed with components of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor and mesenchymal tumor.\n* Central, caenorrhea squamous cell carcinoma or hemoptysis non-small cell lung cancer (hemoptysis \\>50 mL\u002F day);\n* The tumor is surrounded by large blood vessels, and there is a potential risk of hemoptysis after anlotinib treatment;\n* Presence of symptomatic or clinically significant thyroid dysfunction at screening (hypothyroidism controlled only with thyroid hormone replacement could be included);\n* Patients who have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (prednisone at a dose of \\>10mg\u002F day or other equivalent efficacy hormone) and continue to use it within 2 weeks before the first dose;\n* Active autoimmune disease requiring systemic therapy (e.g., disease-modifying medications, corticosteroids, or immunosuppressive agents), including but not limited to inflammatory bowel disease such as ulcerative colitis or Crohn's disease, occurred within 2 years before enrollment; Diverticulitis; Celiac disease; Systemic lupus erythematosus; Sarcoidosis syndrome or Wegener syndrome (granulomatosis with polyangiitis); Graves' disease; Rheumatoid arthritis; Multiple sclerosis; Vasculitis; Glomerulonephritis; Antiphospholipid syndrome; Hypophysitis; Uveitis and so on. Alternative therapies (e.g., thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) were not considered systemic treatments. Patients who were positive for autoimmune antibodies were eligible for enrollment after investigator evaluation to confirm the absence of autoimmune disease requiring systemic treatment. ;\n* Vaccination or attenuated vaccine within 4 weeks before enrollment;\n* Received approved or investigational systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy, and traditional Chinese medicine therapy (traditional Chinese medicine therapy with clear indications for anti-tumor, after a 3-week washout period can also be enrolled);\n* Participated in clinical trials of other drugs not yet approved or marketed in China and received treatment with corresponding drugs within 4 weeks before enrollment;\n* Patients who underwent major surgery or unhealed wounds, ulcers, or fractures within 4 weeks before enrollment;\n* International normalized ratio (INR) \\>1.5 or activated partial prothrombin time (APTT) \\>1.5×ULN; twelve Electrolyte abnormalities that were judged by the investigator to be clinically significant;\n* Patients have drug-uncontrolled hypertension defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* The patient has any current disease or condition that affects drug absorption or the patient is unable to take anlotinib orally;\n* Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigators;\n* Patients with evidence or history of significant bleeding tendency within 3 months before enrollment (bleeding \\>30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (\\>5 mL of fresh blood within 4 weeks) or thromboembolic events (including stroke events and\u002For transient ischemic attack) within 12 months;\n* Grade 1 or above myocardial ischemia, myocardial infarction or severe arrhythmia (including QTc≥450 ms(male), QTc≥ 470ms(female) and NYHA class 1 or above congestive heart failure;\n* Other malignant tumors in the past 5 years, excluding basal cell or squamous cell carcinoma of the skin after radical resection, or carcinoma in situ of the cervix;\n* Severe active or uncontrolled infection (≥CTCAE v5.0 grade 2 infection);\n* Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis (known hepatitis B virus (HBV) carriers must rule out active HBV infection, defined as HBV DNA positivity (\\>1×104 copies \u002FmL or \\>2000 IU\u002Fml); Known hepatitis C virus (HCV) infection and HCV RNA positive (\\>1×103 copies \u002FmL), or other hepatitis, liver cirrhosis\\] (excluding patients with previous antiviral treatment, the relevant test results returned to normal);\n* Tuberculosis that is active or currently in need of medical intervention, including but not limited to tuberculosis;\n* A history of acute or chronic pancreatitis, pancreatic surgery, or risk factors that may increase the risk of pancreatitis;\n* Has not fully recovered from any intervention-induced toxicity and\u002For complications before enrollment (i.e., \\> grade 1 or not recovered to baseline required levels);\n* Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n* Received blood transfusion, blood products, and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;\n* Brachytherapy (radioactive seed implantation) within 60 days before enrollment;\n* Known response to tislelizumab and\u002For chemotherapy of choice (non-squamous NSCLC: pemetrexed plus cisplatin or carboplatin; Squamous NSCLC: allergic reaction to the active ingredient and\u002For any excipients of paclitaxel or albumin paclitaxel plus cisplatin or carboplatin);\n* Any other medical condition, clinically significant metabolic, physical or laboratory abnormality, medical history, disease, treatment or laboratory abnormality that may interfere with the results of the trial or prevent the subject from participating fully in the study, in the investigator's judgment, There is a reason to suspect that the patient has a disease or condition (e.g., having seizures and requiring treatment) that would be inappropriate for the study drug, that would affect the interpretation of the study results, or that the investigator believes that participation in the study would not be in the subject's best interest;\n* The presence of any clinically significant systemic disease that is judged by the investigator to require treatment, including but not limited to thyroid disease (patients with stable thyroid function after hormone replacement therapy can be enrolled), organ transplant recipient, history of mental illness, and history of drug abuse\u002Faddiction, alcohol or drug abuse;\n* Local or systemic disease that is not caused by malignancy, or a secondary reaction to cancer, and may result in a high medical risk and\u002For uncertainty in the evaluation of survival.",{"count":189,"type":21},40,[24],"The goal of this clinical trial is to learn if tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy works to treat for resectable stage II-IIIB driver gene-negative NSCLC. It will also learn about the safety of tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy.\n\nThe main questions it aims to answer are:\n\n1. Does tislelizumab combined with anlotinib and platinum-based doublet perioperative therapy can increase pCR rate as well as MPR rate、EFS、DFS、ORR、OS for resectable stage II-IIIB driver gene-negative NSCLC?\n2. Is tislelizumab combined with anlotinib and platinum-based doublet perioperative therapy safe?\n\nParticipants with histologically or cytologically confirmed NSCLC, potentially resectable, driver gene negative (II- IIIB stage), and without prior systemic treatment, who have signed the informed consent, will be screened for inclusion. After receiving 4 cycles of tislelizumab combined with anlotinib and platinum-based doublet chemotherapy, the subjects will be evaluated by a multidisciplinary team (MDT) to determine whether to proceed with radical surgical resection. The surgery will be performed within 3 to 7 weeks after the last neoadjuvant treatment. Postoperatively, patients will be divided into two subgroups based on the pathological results: For patients with postoperative pathological pCR, tislelizumab monotherapy will be used for maintenance treatment; For patients with postoperative pathological non-pCR, tislelizumab combined with anlotinib will be used for maintenance treatment. Both groups will continue treatment until disease progression as defined by RECIST 1.1, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other situations specified in the protocol that require treatment cessation, whichever occurs first. The maximum treatment duration is 12 months. Survival and safety assessments will be continuously conducted thereafter.",[193,29,194],"NSCLC (Non-small Cell Lung Cancer)","Adjuvant Immunotherapy","2025-06-26",{"date":197,"type":41},"2025-06-29",{"date":199,"type":21},"2025-07-20",{"date":201,"type":21},"2028-12-31",{"name":203,"class":48},"The First Affiliated Hospital with Nanjing Medical University",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":213,"conditions":214,"keywords":218,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100587268","safety-efficacy-and-survival-outcomes-of-neoadjuvantinduction-immunotherapy-in-surgical-and-radiotherapeutic-management-of-non-small-cell-lung-cancer-100587268","NCT06926179","Safety, Efficacy, and Survival Outcomes of Neoadjuvant\u002FInduction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer","Safety, Efficacy, and Survival Outcomes of Neoadjuvant\u002FInduction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer: A Multicenter Real-World Study","Inclusion Criteria:\n\n1. Histologically confirmed non-small cell lung cancer (NSCLC), regardless of the presence of EGFR or ALK sensitive driver gene mutations;\n2. Clinical staging of IA-IIIC according to the AJCC 8th Edition before neoadjuvant treatment;\n3. Received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy);\n4. Assessed as resectable or potentially resectable by surgical experts prior to treatment.\n\nExclusion Criteria:\n\n1. Confirmed M1 disease;\n2. History of previous lung malignancy or other metastatic malignant tumors;\n3. Participation in other randomized controlled trials involving neoadjuvant treatment;\n4. Significant missing clinical data.",{"count":212,"type":21},500,"This multicenter retrospective real-world study aims to evaluate the safety, efficacy and survival outcomes of neoadjuvant\u002Finduction immunotherapy in patients with non-small cell lung cancer (NSCLC). The study covers diverse treatment pathways, including surgery, definitive radiotherapy, and non-surgical strategies. It addresses gaps in existing trials by establishing a comprehensive cohort spanning neoadjuvant\u002Finduction therapy, perioperative management, and follow-up, providing real-world evidence to support treatment decisions in both operable and inoperable cases.",[215,29,216,217],"Lung Cancer (NSCLC)","Radiotherapy","Lung Surgery",[219,220,221,222,223],"lung cancer","neoadjuvant immunotherapy","real-world study","radiotherapy","thoracic surgery","2025-04-11",{"date":226,"type":41},"2025-04-16",{"date":228,"type":41},"2024-12-01",{"date":230,"type":21},"2028-03-31",{"name":232,"class":48},"Peking University Cancer Hospital & Institute",4,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":158},"100571012","phase-2-low-dose-radiotherapy-combined-with-sintilimab-and-chemotherapy-as-neoadjuvant-therapy-for-stage-ii-iii-nsclc-100571012","NCT06714708","Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC","SPARK: Safety and Efficacy of Low Dose Radiotherapy Combined With Sintilimab and Platinum Based Chemotherapy as Neoadjuvant Therapy for Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients who meet all of the following inclusion criteria are eligible for inclusion in this study:\n\n  1. Sign a written Informed Consent Form (ICF) and be able to comply with the visit and related procedures specified in the protocol.\n  2. Age ≥ 18 years old.\n  3. Primary non-small cell lung cancer (including adenocarcinoma and squamous cell carcinoma) diagnosed by cytology or histology.\n  4. According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification 8th edition (AJCC8) TNM staging classification of lung cancer, the clinical staging is IIB (primary tumor\\>4cm), IIIA, or IIIB (resectable N2 only) stage. Resectable N2 refers to non bulk (defined as a short diameter less than 3cm), discrete, or single site N2 involvement. If clinically suspected as N2 or N3, pathological confirmation is required.\n  5. Non squamous NSCLC subjects need to undergo genetic testing to confirm the absence of EGFR sensitive mutations and ALK rearrangements. Squamous NSCLC subjects are not required to undergo genetic testing, but subjects with known EGFR sensitive mutations and ALK rearrangements should not be included in the study.\n  6. Considered suitable for radical resection surgery.\n  7. The lung function meets the criteria for planned lung resection (FEV1 ≥ 50% predicted value, MVV ≥ 50% predicted value), and there are no surgical contraindications.\n  8. Can provide sufficient tissue specimens that meet the requirements for PD-L1 testing during the screening period.\n\nAccording to RECIST V1.1, there is at least one measurable lesion. 10. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1.\n\n11\\. Have not received any systemic anti-tumor therapy or local radiotherapy for NSCLC in the past.\n\n12\\. Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous drugs for correcting hematological or liver and kidney dysfunction are allowed within 14 days prior to obtaining laboratory tests), as follows: Hematological function is sufficient, defined as absolute neutrophil count ≥ 1.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 100g\u002FL;\n\n* Adequate liver function, defined as total bilirubin levels ≤ 1.5 × upper limit of normal (ULN) and levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN, albumin (ALB) ≥ 35g\u002FL;\n* Adequate renal function, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL\u002Fmin (calculated using the Cockcroft\u002FGault formula), and urine routine test results showing urinary protein (UPRO)\\\u003C2+or 24-hour urine protein dose\\\u003C1g; Within 7 days prior to treatment, the international normalized ratio (INR) is ≤ 1.5 × ULN, and the prothrombin time (PT) or activated partial thromboplastin time (APTT) is ≤ 1.5 × ULN.\n\n  13\\. For female subjects of childbearing age, urine or serum pregnancy tests were negative within 7 days prior to receiving the first study drug administration. 14.If the urine pregnancy test result is positive, a blood pregnancy test is required.\n\n  15.If there is a risk of conception, male and female patients should use highly effective contraception (i.e. methods with an annual failure rate of less than 1%) and continue for at least 180 days after stopping the trial treatment. Note: If abstinence is the subject's usual lifestyle and preferred contraceptive method, then abstinence is acceptable as a contraceptive method.\n\nExclusion Criteria:\n\n* 1\\. Histological and pathological examinations show the presence of coexisting small cell carcinoma, large cell neuroendocrine tumor, and sarcomatoid tumor components.\n\n  2\\. Tumors invade the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), trachea, recurrent laryngeal nerve, esophagus, vertebral body, and protuberance.\n\n  3\\. Tumor of the superior sulcus of the lung. 4. There are tumor nodules in the contralateral lung lobe; If there is clinical suspicion of tumor nodules in the contralateral lung lobe, biopsy is required for clarification.\n\n  5\\. Confirm or suspect patients with brain metastases. 6. Currently participating in interventional clinical research treatment, or having received other investigational drugs or devices within the first 4 weeks of randomization.\n\n  7\\. Previous use of anti-PD-1, anti-PD-L1, anti programmed death receptor ligand 2 (PD-L2), or anti cytotoxic T lymphocyte associated antigen 4 (CTLA-4) drugs or any other drugs that act on T cell co stimulatory or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cell immunotherapy.\n\n  8\\. Have received Chinese herbal medicine, traditional Chinese patent medicines and simple preparations with anti-tumor indications, or drugs with immunomodulatory effects (including thymic peptides, interferon, interleukin) within the first two weeks of randomization.\n\n  9\\. Have undergone major surgery within the first 4 weeks of randomization. 10. There are unhealed surgical incisions, ulcers, or fractures present. 11. Received attenuated live vaccine within the first 4 weeks of randomization (or planned to receive attenuated live vaccine during the study period). Note: Accepting inactivated virus vaccines for injection against seasonal influenza is allowed; However, receiving attenuated live influenza vaccines is not allowed.\n\n  12\\. Patients who require long-term systemic use of corticosteroids; Received any other form of immunosuppressive therapy within the first 7 days of randomization. Note: Local corticosteroids administered via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses (≤ 10mg\u002Fday of prednisone or equivalent), or for pre-treatment purposes (such as preventing contrast agent allergies), are allowed.\n\n  13\\. There is a history of non infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease within the previous year of randomization.\n\n  14\\. Within the first 2 years of randomization, there have been active autoimmune diseases that require systemic treatment (such as the use of disease improving drugs, corticosteroids, or immunosuppressants), including but not limited to inflammatory bowel disease, such as ulcerative colitis or Crohn's disease; Diverticulitis; Celiac disease; Systemic lupus erythematosus; Sarcoidosis syndrome or Wegener syndrome (granulomas with polyangitis); Graves' disease; Rheumatoid arthritis; Multiple sclerosis; Vasculitis; Glomerulonephritis; Antiphospholipid syndrome; Pituitary inflammation; Uveitis, etc. Alternative therapies such as thyroid hormone, insulin, or physiological dose corticosteroids used for adrenal or pituitary insufficiency are not considered systemic treatments. Patients with positive autoimmune antibodies need to be evaluated and confirmed by the researcher that there are no autoimmune diseases that require systemic treatment before they can be enrolled.\n\n  15\\. Suffering from primary immunodeficiency disease. 16. Past or current presence of myocarditis. 17. Prior to randomization, there was insufficient recovery from toxicity and\u002For complications caused by any intervention measures (i.e.,\\>grade 1 or not recovered to baseline levels).\n\n  18\\. ≥ Grade 2 peripheral neuropathy. 19. Genetic bleeding tendency or coagulation dysfunction, or history of thrombosis: Any arterial thrombosis, embolism, or ischemia occurred within the first 6 months of randomization, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism. A history of deep vein thrombosis or any other severe thromboembolism within the first 3 months of randomization (implantable venous infusion port or catheter-related thrombosis, or superficial vein thrombosis is not considered a \"severe\" thromboembolism).\n\n  20\\. Uncontrolled hypertension (systolic blood pressure greater than 160mmHg and\u002For diastolic blood pressure greater than 100mmHg); History of hypertensive crisis or hypertensive encephalopathy; Uncontrolled hyperglycemia (fasting blood glucose\\>8.9 mmol\u002FL).\n\n  21\\. Any unstable systemic disease or concurrent disease, including but not limited to:\n  * Active infection (requiring treatment with anti infective drugs or having used systemic anti infective drugs within the week prior to randomization);\n  * Congestive heart failure \\[New York Heart Association (NYHA) classification ≥ II\\]; Serious arrhythmias, liver, kidney or metabolic diseases that require medication treatment;\n  * Untreated coronary atherosclerotic heart disease; Type I or II respiratory failure; History of gastrointestinal perforation and\u002For fistula, intestinal obstruction, extensive intestinal resection, or long-term chronic diarrhea within the past 6 months.\n\n    22\\. Received solid organ or blood system transplantation. 23. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1\u002F2 antibody positive), known active syphilis.\n\n    24\\. Active or tuberculosis requiring medical intervention at this stage, including but not limited to tuberculosis.\n\n    25\\. Active hepatitis B.\n  * Subjects with hepatitis B who meet the following criteria meet the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load before randomization\\\u003C1000 copies\u002Fml or\\\u003C200IU\u002Fml or lower than the detection limit.\n\nHBsAg (+) subjects should receive anti HBV therapy throughout the entire study drug treatment period to avoid viral activation.\n\nFor subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of virus reactivation is necessary.\n\n26\\. Active hepatitis C (HCV antibody positive and HCV-RNA level above the detection limit).\n\n27\\. Malignant tumors other than diagnosed NSCLC within the first 5 years of randomization, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid carcinoma after radical surgery.\n\n28\\. It is known that there is an allergic reaction to the active ingredients and\u002For any excipients of the selected chemotherapy regimen (non squamous NSCLC: pemetrexed plus cisplatin or carboplatin; squamous NSCLC: gemcitabine, docetaxel, paclitaxel or albumin paclitaxel plus cisplatin or carboplatin).\n\n29\\. Pregnant or lactating women or women preparing to become pregnant or breastfeed during the study period.\n\n30\\. It is known that there are mental illnesses or drug abuse situations that may affect compliance with experimental requirements, and there is a history of alcohol abuse.\n\n31\\. There may be medical history, diseases, treatments, or laboratory abnormalities that could interfere with the trial results, hinder the full participation of the subjects in the study, or the researcher believes that participating in the study is not in the best interests of the subjects. Local or systemic diseases caused by non malignant tumors, or secondary reactions to cancer, can lead to higher medical risks and\u002For uncertainty in survival evaluation.",{"count":242,"type":21},86,[24],"To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer",[171,29,246,247],"Low Dose Radiotherapy","Sintilimab",[171,29,246,247],"2025-02-06",{"date":251,"type":41},"2025-02-10",{"date":253,"type":41},"2024-11-20",{"date":255,"type":21},"2027-06-01",{"name":257,"class":48},"Anhui Provincial Cancer Hospital",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":265,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":158},"100564001","the-application-value-of-68ga-grazytracer-pet-in-immunotherapy-for-stage-iii-non-small-cell-lung-cancer-100564001","NCT06623487","The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer","The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer: a Prospective, Observationa Trial","Inclusion Criteria:\n\n1. Patients with stage III NSCLC, after assessment according to clinical guidelines, require neoadjuvant immunotherapy;\n2. Fully-informed written consent obtained from patients;\n3. Patient ability to comply with protocol requirements;\n4. Age 18-75 years;\n5. Life expectancy of at least 6 months.\n\nExclusion Criteria:\n\n1. Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;\n2. Intestinal perforation, complete intestinal obstruction;\n3. Patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol\u002FL on the day of the test;\n4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;\n5. Patients with poor compliance.",{"count":92,"type":21},"Neoadjuvant immunotherapy can significantly improve the pathological complete response (pCR) and major pathological response (MPR) rates in resectable stage III non-small cell lung cancer (NSCLC), and extend the event-free survival (EFS). However, the current means for evaluating its efficacy are limited. This study aims to utilize the convenient and non-invasive 68Ga-grazytracer PET imaging to detect the aggregation of CD8+ T cells in target lesions after neoadjuvant immunotherapy for stage III NSCLC, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions.",[120,268,29],"PET \u002F CT","2024-09-29",{"date":271,"type":41},"2024-10-02",{"date":273,"type":41},"2024-07-19",{"date":275,"type":21},"2027-07-31",{"name":277,"class":48},"Ruijin Hospital",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":285,"minAge":18,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":22,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":158},"100532168","phase-2-phase-ii-study-on-neoadjuvant-therapy-of-ak104-combined-with-nab-paclitaxelcarboplatin-in-fertility-preserving-surgery-100532168","NCT06209294","Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel\u002FCarboplatin in Fertility Preserving Surgery","Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel\u002FCarboplatin in Fertility Preserving Surgery for Stage IB2-IB3 Cervical Cancer (FIGO 2018)","Inclusion Criteria:\n\n* Voluntarily sign a written ICF.\n* Age ≥ 18 years old and ≤ 45 years old at the time of enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Patients with histologically confirmed (2018 FIGO) stage IB2-IB3 cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma.\n* Imaging evaluation showed no distant metastasis or regional lymph node metastasis, and the tumor was limited to the cervix.\n* Have not received any systemic or local anti-tumor treatment for cervical cancer before the first medication, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc.\n* Patients who require preservation of reproductive function and who are judged by the researcher to have no contraindications to childbirth surgery.\n* At least 1 untreated measurable lesion according to RECIST v1.1.\n* Subjects agree to collect tumor tissue and peripheral blood samples required during the screening period and research process and use them in related research.\n* With good organ function:\n\n  a) Hematology (no blood components and cell growth factor support therapy were used within 7 days before starting study treatment): i. Absolute neutrophil count ANC ≥ 1.5 × 109\u002FL (1,500\u002Fmm3); ii. Platelet count ≥ 100 × 109\u002FL (100,000\u002Fmm3); iii. Hemoglobin ≥ 90 g\u002FL. b) Kidney: i. Calculated creatinine clearance\\* (CrCl) ≥ 50 mL\u002Fmin\n\n  \\* CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft-Gault formula) CrCl (mL\u002Fmin) = {(140 - age) × weight (kg) × 0.85}\u002F (serum creatinine. (mg\u002FdL) × 72) ii .Urine protein \\\u003C 2+ or 24-hour (h) urine protein quantification \\\u003C 1.0 g.\n\n  c) Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN ii. AST and ALT ≤ 2.5× ULN iii. Serum albumin (ALB) ≥ 28 g\u002FL d) Coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (e.g.\n\nIf the subject is receiving anticoagulant therapy, the subject must receive a stable dose of anticoagulant and have coagulation during screening.\n\nParameters (PT\u002FINR and APTT) were within the expected range for anticoagulant therapy).\n\ne) Heart function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n* Female subjects with childbearing potential must undergo a urine or serum pregnancy test within 3 days before taking the drug for the first time (if the urine pregnancy test result cannot be confirmed to be negative, a serum pregnancy test must be performed, and the serum pregnancy result shall prevail). and the result was negative. If a female subject of childbearing potential has sexual intercourse with a non-sterilized male partner, the subject must use an acceptable method of contraception since screening and must agree to continue using contraception methods for 120 days after the last dose of the study drug. Whether to discontinue contraception after this time point should be discussed with the investigator. Cyclic abstinence and safe period contraception are unacceptable methods of contraception.\n\n  1. Women of childbearing potential are those who have not been surgically sterilized (i.e., bilateral fallopian tube ligation, bilateral oophorectomy, or total hysterectomy) or who have not undergone menopause (menopause is defined as at least one without alternative medical reasons). 12 consecutive months of amenorrhea and serum follicle-stimulating hormone levels within the laboratory reference range for postmenopausal women);\n  2. Highly effective contraceptive methods refer to contraceptive methods that have a very low contraceptive failure rate (e.g. less than 1% per year) when used correctly and consistently. Not all birth control methods are highly effective. In addition to barrier contraceptive methods, female subjects of childbearing potential must also use hormonal contraceptive methods (such as birth control pills) alone to ensure that pregnancy does not occur.\n* Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other requirements of the study.\n\nExclusion Criteria:\n\n* The histopathological types are small cell carcinoma, gastric adenocarcinoma, etc.\n* In addition to cervical cancer, subjects suffered from other malignant tumors within 3 years before enrollment. Subjects with other malignant tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, breast cancer, etc., are not excluded.\n* Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.\n* Patients with distant tumor metastasis or local and regional lymph node metastasis.\n* Patients who received non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, tumor necrosis factor, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first medication; Received non-specific immunomodulatory therapy within 1 week before the first medication Chinese herbal medicine or Chinese patent medicine with anti-tumor indications.\n* Suffering from active autoimmune diseases that require systemic treatment (such as disease-modifying drugs, corticosteroids, immunosuppressive treatment), Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic therapy.\n* Patients have a history of non-infectious pneumonia or pneumonia requiring systemic glucocorticoid treatment or a current history of interstitial lung disease.\n* With a history of severe bleeding tendency or coagulation disorder.\n* Patients with currently uncontrolled comorbid diseases, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or a mental illness\u002Fsocial condition that would limit the subject's ability to comply with research requirements or affect the subject's ability to provide written informed consent.\n* Patients with history of myocarditis, cardiomyopathy, and malignant arrhythmia. Patients suffered unstable angina, congestive heart failure or vascular disease requiring hospitalization (such as aortic aneurysm or peripheral venous thrombosis requiring surgical repair) within 12 months before the first dose, or other heart damages (such as poorly controlled arrhythmia, myocardial infarction or ischemia) that may affect the safety evaluation of the study.\n\nPatients with a history of esophageal and gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months before the first administration; Patients suffered any arterial thromboembolic event, NCI CTCAE version 5.0 grade 3 or above, venous thromboembolism, transient ischemic attack, cerebrovascular accident, hypertensive crisis or hypertensive encephalopathy within 6 months before the first dose; Patients with acute exacerbation of COPD within 1 month before first dose; Current hypertension with systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg after treatment with oral antihypertensive drugs.\n\n* Patients with active or clear history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis or chronic diarrhea).\n* Patients with serious infection occurring within 4 weeks before the first dose, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia; Patients with active infection (excluding antiviral therapy for hepatitis B or hepatitis C) that has been treated with systemic anti-infectious therapy within 10 days before the first dose.\n* Patients suffered major surgery or serious trauma within 30 days before the first medication; or minor local surgery within 3 days before the first medication (excluding central venous catheterization via peripheral venipuncture).\n* Patients with a history of immunodeficiency; those with positive HIV antibody test; Patients who are taking long-term systemic corticosteroids or other immunosuppressants.\n* Subjects who are known to have active pulmonary tuberculosis (TB) and are suspected of having active TB need to undergo clinical examination to exclude (such as sputum tuberculosis bacilli examination, chest X-ray, etc.); known active syphilis infection.\n* Patients with history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies\u002Fml (200 IU\u002Fml) or higher than the lower limit of detection).Subjects with hepatitis B are required to receive anti-hepatitis B virus treatment during the study treatment period; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection).\n* Patients who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study.\n* Patients who are hypersensitive to any component of any study drug; with history of severe hypersensitivity reactions to other monoclonal antibodies.\n* Patients with history of mental illness, substance abuse, alcoholism, or drug abuse.\n* Pregnant or lactating women.\n* Patients with any past or current disease, treatment, or laboratory test abnormality may confuse the research results and affect the subject's full participation in the research, or participation in the research may not be in the best interests of the subject.","FEMALE","45 Years",{"count":92,"type":21},[24],"This is a Phase II study of neoadjuvant therapy of AK104 combined with nab-paclitaxel\u002Fcarboplatin in fertility saving surgery for stage IB2-IB3 cervical cancer (FIGO 2018). The main questions it aims to answer are:\n\n* · Evaluate the safety of AK104 combined with nab-paclitaxel\u002Fcarboplatin in the neoadjuvant treatment of cervical cancer\n* · Evaluate the tumor regression and Major Pathological Response(MPR) of AK104 combined with nab-paclitaxel\u002Fcarboplatin as neoadjuvant therapy for cervical cancer.",[29,291,292],"Cervical Cancer","Fertility-sparing Surgery","2024-01-06",{"date":295,"type":41},"2024-01-17",{"date":297,"type":41},"2023-09-01",{"date":299,"type":21},"2028-12-30",{"name":301,"class":48},"Xiaohua Wu",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":4},"100460069","phase-3-study-evaluating-neoadjuvant-immunotherapy-increasing-cd8-cell-infiltration-in-advance-gastric-adenocarcinoma-100460069","NCT05270824","Study Evaluating Neoadjuvant Immunotherapy Increasing CD8+ Cell Infiltration in Advance Gastric Adenocarcinoma","Study Evaluating Neoadjuvant Immunotherapy Increasing CD8+ Cell Infiltration in Advance Gastric Adenocarcinoma : a Single Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age from 18 to 75 years\n2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically ；\n3. CT\u002FMRI, PET-CT, or laparoscopic exploration should be performed before surgery to confirm the diagnosis of stage ≥cT2 or N+；\n4. Patients who have not received other treatments such as surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy；\n5. Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)；\n6. Estimated survival time was over 3 months；\n7. No serious heart, lung and liver dysfunction; no jaundice and gastrointestinal obstruction; no acute infection;；\n8. The major organs are functioning normally and meet the following criteria:\n\n(1) Blood routine examination should meet the requirements (no blood transfusion within 14 days):\n\n1. HB≥100g\u002FL，\n2. WBC≥3×109\u002FL\n3. ANC≥1.5×109\u002FL，\n4. PLT≥100×109\u002FL； （2）Biochemical tests must meet the following criteria：\n\na. BIL \\\u003C1.5×upper limit of normal (ULN)， b. ALT and AST\\\u003C2.5ULN，GPT≤1.5×ULN； c. Cr≤1ULN，Ccr \\>60ml\u002Fmin 9. Fertile women must have taken a pregnancy test (serum) within 7 days prior to enrollment with negative results and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last trial drug; For men, they should be surgically sterilized or agree to use the appropriate method of contraception during the trial period and 8 weeks after the last administration of the trial drug 10. Did not participate in other clinical studies before and during treatment 11. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up\n\nExclusion Criteria:\n\n1. History of other malignant disease within past five years；\n2. History of immunodeficiency, including HIV positive, or other acquired congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation；\n3. Contraindications to surgery and chemotherapy, or whose physical condition and organ function do not allow for major abdominal surgery\n4. Distant metastases；\n5. Accompanied by severe heart, lung, liver and kidney diseases; neurological and mental diseases; jaundice and accompanied by severe infection；\n6. Women during pregnancy or breast-feeding；\n7. Patients with high blood pressure that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure\\>140 mmHg, diastolic blood pressure\\>90 mmHg);\n8. Suffering from coronary heart disease of grade I or above, arrhythmia (including QTc interval prolongation \\> 450 ms in men and \\> 470 ms in women), and cardiac insufficiency;\n9. Patients with a clear tendency to gastrointestinal bleeding, including the following conditions: patients with locally active ulcer lesions, fecal occult blood (++), and history of melena and hematemesis within 2 months; patients with abnormal coagulation function (INR\\> 1.5, APTT\\>1.5 ULN);\n10. Patients with a history of cardiovascular and cerebrovascular diseases who are still taking oral thrombolytics or anticoagulants;\n11. Patients with positive urine protein (urinary protein test 2+ or above, or 24-hour urine protein quantitative\\> 1.0g;\n12. Multiple factors affect oral drugs (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);\n13. Those who have allergic reactions to the drugs in this study;\n14. The researcher believes that it is not suitable for inclusion.",{"count":310,"type":21},120,[62],"Focusing on the clinical question of whether patients with advanced gastric cancer can benefit from immunotherapy, this project intends to detect the degree of CD8+ tumor-infiltrating lymphocyte infiltration in patients with advanced gastric cancer before and after receiving neoadjuvant combined immunotherapy and neoadjuvant therapy alone. To explore the evolving nature of tumor immune response before and after neoadjuvant therapy for gastric cancer, and quantitatively present it through chemical immunohistochemical techniques to achieve a more accurate diagnosis and treatment and improve the long-term efficacy of patients.",[314,315,29],"Advanced Gastric Carcinoma","CD8+ Tumor Infiltrating Lymphocytes","2022-02-26",{"date":318,"type":41},"2022-03-08",{"date":320,"type":21},"2022-03-01",{"date":322,"type":21},"2027-03-01",{"name":324,"class":48},"Fujian Medical University"]