[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657107":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":46,"studyPopulation":46,"armGroups":53,"interventions":62,"overallOfficials":46,"centralContacts":76,"locations":85,"responsibleParty":102,"collaborators":46,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":46,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":132,"whyStopped":46,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"12-month Event Free Survival (EFS) rate","The starting point is the day of the first dose of neoadjuvant therapy, and observation continues until any of the following events occur (whichever comes first): 1. Disease progression (RECIST 1.1; re-evaluation is allowed if immune-related pseudoprogression is suspected); 2. Failure to complete the planned neoadjuvant therapy; 3. Inability to undergo surgery (including for non-disease reasons) or positive surgical margins; 4. Found to be unresectable during surgery; 5. Death for any reason.","From the first dose through 12 months",[14,18,21,25,28,31,35,38,42],{"measure":15,"description":16,"timeFrame":17},"Pathological complete remission rate (pCR)","In patients who underwent surgery after receiving neoadjuvant therapy, no remaining living tumor cells were found in the original tumor site or any regional lymph nodes in the surgical specimens (that is, ypT0N0).","At postoperative pathological assessment, approximately 4 months after the first dose",{"measure":19,"description":20,"timeFrame":17},"Major pathological remission rate (MPR)","This study defines patients who had surgery after receiving neoadjuvant therapy as having a proportion of remaining viable tumor cells in the resected tumor bed of ≤50% of the tumor bed area.",{"measure":22,"description":23,"timeFrame":24},"Objective Response Rate (ORR)","Refers to the proportion of patients whose tumors shrink by a certain amount and maintain that reduction for a certain period, including cases of CR and PR. Tumor objective response is assessed using the solid tumor response evaluation criteria (RECIST 1.1). Subjects must have measurable tumor lesions at baseline, and efficacy evaluation standards according to RECIST 1.1 are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).","Every 6 weeks (±7 days) from the first dose until disease progression or completion of neoadjuvant study treatment, assessed up to approximately 12 weeks.",{"measure":26,"description":27,"timeFrame":24},"Disease Control Rate (DCR)","The percentage of cases with complete response, partial response, or stable disease lasting more than 4 weeks among patients whose efficacy can be evaluated.",{"measure":29,"description":11,"timeFrame":30},"Event Free Survival (EFS)","From the date of the first dose of neoadjuvant therapy to the first documented EFS event, assessed up to 36 months.",{"measure":32,"description":33,"timeFrame":34},"Overall Survival","Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive at the last follow-up will be censored on the date they were last known to be alive.","From the date of enrollment until death from any cause, assessed up to 36 months.",{"measure":36,"description":37,"timeFrame":17},"R0 resection rate","The R0 resection rate refers to the proportion of surgery patients whose removed tissue shows no remaining tumor cells at any of the margins (both lateral and vertical) during postoperative pathology checks. Specifically, this means the margins are negative (margin ≥1mm, with no tumor invasion).",{"measure":39,"description":40,"timeFrame":41},"Conversion surgery success rate","Among patients who received neoadjuvant therapy and completed surgical evaluation, the proportion of patients who ultimately successfully converted to feasible radical surgery. Radical surgery refers to surgery where the tumor can be completely removed and meets the R0 resection criteria.","At the time of surgery following completion of neoadjuvant treatment, approximately 4 months after the first dose",{"measure":43,"description":44,"timeFrame":45},"Incidence and Severity of Adverse Events","Adverse events will be graded according to NCI CTCAE version 6.0. Treatment-related adverse events will be followed until resolution, stabilization, or initiation of new anticancer therapy.","From signing informed consent through 30 days after the last study treatment or initiation of new anticancer therapy, whichever occurs first",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"NA","SINGLE_GROUP","TREATMENT",{"masking":52,"maskingDescription":46,"whoMasked":46},"NONE",[54],{"label":55,"type":56,"description":57,"interventionNames":58},"Experimental Group","EXPERIMENTAL","All participants will receive up to four cycles of neoadjuvant surufatinib plus iparomlimab and tuvonralimab injection and AG chemotherapy. Eligible participants will undergo surgery approximately 4 weeks after neoadjuvant treatment. After surgery, participants will receive either GemCap or modified FOLFIRINOX adjuvant chemotherapy, as selected by the investigators.",[59,60,61],"Drug: Surufatinib Plus Iparomlimab and Tuvonralimab and AG Chemotherapy","Drug: Gemcitabine plus Capecitabine","Drug: Modified FOLFIRINOX",[63,68,72],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":46},"DRUG","Surufatinib Plus Iparomlimab and Tuvonralimab and AG Chemotherapy","Surufatinib 200 mg orally once daily; iparomlimab and tuvonralimab injection 5 mg\u002Fkg intravenously every 21 days; nab-paclitaxel 125 mg\u002Fm² and gemcitabine 1000 mg\u002Fm² intravenously on Days 1 and 8 of each 21-day cycle, for up to four cycles.",[55],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":46},"Gemcitabine plus Capecitabine","After surgery, eligible participants may receive gemcitabine 1000 mg\u002Fm² intravenously on Days 1 and 8 plus capecitabine 1650-2000 mg\u002Fm²\u002Fday orally on Days 1-14 of each 21-day cycle.",[55],{"type":64,"name":73,"description":74,"armGroupLabels":75,"otherNames":46},"Modified FOLFIRINOX","After surgery, eligible participants may receive oxaliplatin 85 mg\u002Fm², irinotecan 150 mg\u002Fm², leucovorin 400 mg\u002Fm², and fluorouracil 2400 mg\u002Fm² every 14 days.",[55],[77,82],{"name":78,"role":79,"phone":80,"phoneExt":46,"email":81},"Liang Liu, M.D. Ph.D","CONTACT","021-64041990","liu.liang@zs-hospital.sh.cn",{"name":83,"role":79,"phone":80,"phoneExt":46,"email":84},"Xu Han, M.D. Ph.D","han.xu1@zs-hospital.sh.cn",[86],{"facility":5,"status":46,"city":87,"state":46,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Shanghai","200000","China","CN",{"type":92,"coordinates":93},"Point",[94,95],121.45806,31.22222,{"lat":95,"lon":94},[98,100],{"name":99,"role":79,"phone":80,"phoneExt":46,"email":81},"Liang Liu, MD PhD",{"name":101,"role":79,"phone":80,"phoneExt":46,"email":84},"Xu Han, MD PhD",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"PRINCIPAL_INVESTIGATOR","Liang Liu","Principal Investigator","100657107","phase-2-surufatinib-in-combination-with-iparomlimab-and-tuvonralimab-injection-and-ag-chemotherapy-for-neoadjuvant-therapy-of-hrpc-or-brpc-100657107",false,"NCT07833241","Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for Neoadjuvant Therapy of HRPC or BRPC","Neoadjuvant Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for High-risk Resectable or Borderline Resectable Pancreatic Cancer: a Single-arm, Single-center, Exploratory Clinical Study","ZSPAC-22","Inclusion Criteria:\n\n* Have fully understood this study and voluntarily signed the informed consent form.\n* Aged between 18 and 75 years inclusive, of any gender.\n* Patients with high-risk resectable or borderline resectable pancreatic adenocarcinoma confirmed by histopathology or cytology. (The definition of borderline resectable pancreatic pancreatic cancer refers to the NCCN Guidelines 2026 (Version 1). High-risk resectable disease is defined as meeting all three of the following criteria:\n\n  ① The tumor does not abut the portal vein-superior mesenteric vein (PV-SMV), or abuts the PV-SMV for \\\u003C180° with intact venous contour.\n\n  ② The tumor does not abut arteries (celiac trunk, superior mesenteric artery, or common hepatic artery).\n\n  ③ CA19-9 ≥ 500 U\u002FmL or maximum diameter of primary tumor \\> 3.0 cm.\n* Have at least one measurable lesion per RECIST 1.1.\n* No pathogenic BRCA1\u002F2 or PALB2 mutations, or unknown BRCA1\u002F2 and PALB2 mutation status.\n* No prior systemic anti-tumor therapy or locoregional radiotherapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Expected survival ≥ 24 weeks.\n* Absence of contraindications to surgery.\n* Laboratory hematology parameters (without blood transfusion within the preceding 14 days):\n\n  ① Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelets ≥ 100 × 10⁹\u002FL; hemoglobin ≥ 9 g\u002FdL.\n\n  ② Liver function: AST and ALT ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 1.5 × ULN. For patients with liver metastases, AST and ALT ≤ 5 × ULN.\n\n  ③ Renal function: serum creatinine ≤ 1.5 × ULN; creatinine clearance (CCr) ≥ 60 mL\u002Fmin.\n\n  ④ Coagulation parameters: international normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n* Male and female patients of reproductive potential agree to use effective contraceptive methods throughout the study period and for 6 months after the last study drug administration, such as dual-barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered of reproductive potential unless they have natural menopause, induced menopause, or sterilization procedures (e.g., hysterectomy, bilateral adnexectomy, ovarian radiation, etc.).\n\nExclusion Criteria:\n\n* Patients with distant metastasis.\n* Patients who have received blood transfusion, blood products or hematopoietic growth factors (such as albumin and granulocyte colony-stimulating factor \\[G-CSF\\]) within 14 days prior to enrollment.\n* Patients who have undergone any surgery or invasive treatment\u002Fprocedure within 4 weeks prior to enrollment (except venous catheterization, puncture and drainage, etc.).\n* Known hypersensitivity to any study drug.\n* Uncontrolled hypertension defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg.\n* Patients with any disease or condition affecting drug absorption, or patients unable to receive oral surufatinib.\n* Patients with active gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions judged by the investigator to carry risks of gastrointestinal bleeding or perforation.\n* Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or paracentesis as assessed by the investigator).\n* Patients with evidence or history of obvious bleeding tendency within 3 months prior to enrollment (bleeding \\>30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood \\>5 mL within 4 weeks), or thromboembolic events within 10 months (including stroke and\u002For transient ischemic attack \\[TIA\\]).\n* Clinically significant electrolyte abnormalities as judged by the investigator.\n* Significant clinically relevant cardiovascular diseases, including but not limited to: acute myocardial infarction, severe\u002Funstable angina or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) class \\>2 congestive heart failure; ventricular arrhythmias requiring pharmacological treatment; left ventricular ejection fraction (LVEF) \\\u003C50%.\n* History of other malignancies within the past 5 years, except for radically resected basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Active or uncontrolled severe infections:\n\n  ①Known human immunodeficiency virus (HIV) infection;\n\n  ②Known history of clinically significant liver disease, including viral hepatitis. ③Known hepatitis B virus (HBV) carriers must be excluded if there is active HBV infection, i.e., positive HBV DNA (\\>1×10⁴ copies\u002FmL or \\>2000 IU\u002FmL); Known hepatitis C virus (HCV) infection with positive HCV RNA (\\>1×10³ copies\u002FmL), or other hepatitis, liver cirrhosis.\n* Pregnant females (positive pregnancy test prior to study drug administration) or lactating females.\n* The investigator judges that the subject has any clinical or laboratory abnormality or other conditions rendering the subject unsuitable for participation in this clinical study.\n* Urinalysis showing urine protein ≥2+, with 24-hour urinary protein quantification \\>1.0 g.\n* Patients with active autoimmune or inflammatory diseases requiring systemic therapy within the previous 2 years (i.e., disease-modifying agents, glucocorticoids or immunosuppressive agents); or diseases treated with long-term systemic hormones or any other immunosuppressive drugs (excluding inhaled corticosteroids).\n* Patients with hypothyroidism\u002Fadrenal or pituitary insufficiency who only require stable hormone replacement therapy, as well as patients with type 1 diabetes mellitus with stable disease managed solely by insulin replacement, are eligible for enrollment.\n* History of (non-infectious) pneumonia requiring steroid treatment; past or current history of interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, pulmonary fibrosis or other lung diseases resulting in severely impaired pulmonary function; or active pulmonary infection at present.\n* Receipt of any live or attenuated live vaccine within 4 weeks before the first study drug administration, or planned administration of such vaccines during the study period.","ALL","18 Years","75 Years",{"count":118,"type":119},56,"ESTIMATED","INTERVENTIONAL",[122],"PHASE2","This is a prospective, single-center, single-arm phase 2 study evaluating the efficacy and safety of neoadjuvant surufatinib plus iparomlimab and tuvonralimab injection and nab-paclitaxel\u002Fgemcitabine chemotherapy in patients with high-risk resectable or borderline resectable pancreatic cancer. Approximately 56 participants will be enrolled, including about 19 patients with high-risk resectable disease and 37 patients with borderline resectable disease. Participants will receive up to four 21-day cycles of neoadjuvant treatment. Participants considered eligible for surgery will undergo surgical resection approximately 4 weeks after neoadjuvant treatment. After surgery, adjuvant chemotherapy with either gemcitabine plus capecitabine or modified FOLFIRINOX will be selected by the investigators after multidisciplinary team review. The primary outcome is the 12-month event-free survival rate.",[125,126],"Borderline Resectable Pancreatic Cancer","High-Risk Resectable Pancreatic Cancer",[128,129,130,131],"Surufatinib","Iparomlimab and Tuvonralimab","Neoadjuvant","pancreatic cancer","NOT_YET_RECRUITING","2026-09-20",{"date":135,"type":136},"2026-09-22","ACTUAL",{"date":138,"type":119},"2026-09-01",{"date":140,"type":119},"2029-09-01",{"name":5,"class":6},1]