[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656703":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":55,"overallOfficials":39,"centralContacts":39,"locations":39,"responsibleParty":72,"collaborators":39,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":39,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":39,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":39,"overallStatus":94,"whyStopped":39,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":39},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"surgical conversion rate","The proportion of patients who become eligible for surgery after treatment, relative to the total number of patients.","3 years",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"R0\u002FR1 Resection Rate","The proportion of patients who achieve R0 (microscopically margin-negative) or R1 (microscopically margin-positive) resection among all patients who undergo surgery. R0 is defined as no residual tumor at the resection margin; R1 is defined as microscopic residual tumor at the resection margin.","in 3 years",{"measure":19,"description":20,"timeFrame":17},"pCR","Pathological Complete Response: The absence of residual invasive tumor cells in the resected primary tumor specimen and\u002For lymph nodes upon pathological evaluation.",{"measure":22,"description":23,"timeFrame":17},"MPR","Major Pathological Response: The presence of ≤10% viable residual tumor cells in the resected primary tumor specimen upon pathological evaluation.",{"measure":25,"description":26,"timeFrame":17},"ORR","The proportion of patients who achieve a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST v1.1 (or other specified criteria) from the start of treatment until disease progression or initiation of subsequent anticancer therapy.",{"measure":28,"description":29,"timeFrame":17},"EFS","The time from the date of treatment initiation to the date of first occurrence of any of the following events: disease progression that precludes surgery, local or distant recurrence, or death from any cause. Patients who are event-free at the time of data cutoff are censored at the date of their last disease assessmen",{"measure":31,"description":32,"timeFrame":17},"OS","The time from the date of treatment initiation to the date of death from any cause. Patients who are alive at the time of data cutoff are censored at the date of last known follow-up.",{"measure":34,"description":35,"timeFrame":17},"the incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs)","Safety endpoints include the incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.",{"measure":37,"description":38,"timeFrame":17},"Immune Age Rejuvenation","Defined as a reduction in immune age of ≥3 years compared to the baseline measurement, as calculated by the immune age estimation model based on the data generated from the specified assay kit.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"NA","SINGLE_GROUP","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"LPAC+NALIRIFOX+Adebrelimab","EXPERIMENTAL","The intervention starts with modified stereotactic body radiation therapy (3-day regimen), followed by systemic therapy within 1-2 weeks after irradiation. Subsequently, the investigator will evaluate the resectability of the lesion.\n\nFor subjects converted to resectable status, surgical resection will be performed, followed by postoperative adjuvant therapy.\n\nFor subjects who remain unresectable but maintain stable disease, a second cycle of conversion therapy will be continued. If the lesion is converted to resectable, surgical resection will be performed followed by adjuvant therapy. If disease progression occurs, subsequent treatment will be carried out in accordance with the first-line treatment for advanced pancreatic cancer.\n\nFor subjects who experience disease progression or distant metastasis, subsequent treatment will be administered by adjusting the chemotherapy regimen in accordance with the first-line standard regimen for advanced pancreatic cancer.",[52,53,54],"Drug: Adebrelimab (PD-L1 inhibitor)","Drug: NALIRIFOX","Radiation: SBRT",[56,63,67],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"DRUG","Adebrelimab (PD-L1 inhibitor)","20 mg\u002Fkg, intravenous infusion, administered on Day 1, every 3 weeks as one cycle (Q3W)",[48],[62],"Adebrelimab",{"type":57,"name":64,"description":65,"armGroupLabels":66,"otherNames":39},"NALIRIFOX","Oxaliplatin: 60 mg\u002Fm², intravenous infusion over 2 hours, administered on Day 1 Irinotecan Liposome: 50 mg\u002Fm², intravenous infusion for more than 90 minutes, administered on Day 1 LV (Leucovorin): 400 mg\u002Fm², intravenous infusion over 2 hours, administered on Day 1 5-FU (5-Fluorouracil): 2400 mg\u002Fm², continuous intravenous infusion for 46 hours Every 3 weeks is defined as one treatment cycle (Q3W)",[48],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":39},"RADIATION","SBRT","Target Volume Delineation: The gross tumor volume GTV1 is delineated on CT images. A 1 cm inward contraction from GTV1 is performed to generate GTV-lattice, within which small spherical volumes GTV-sbrt with a diameter of 1-1.5 cm are created, and the spacing between adjacent spheres is 3 times the sphere diameter.\n\nPrescription Fractionation: Simultaneous integrated boost radiotherapy is adopted, with the prescription dose: GTV-sbrt: 24 Gy in 3 fractions; GTV1: 9 Gy in 3 fractions.",[48],{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Jiang Long","Chief Physician","100656703","phase-2-clinical-study-of-radiotherapy-combined-with-adebrelimab-and-nalirifox-for-conversion-therapy-in-locally-advanced-pancreatic-cancer-100656703",false,"NCT07827053","Clinical Study of Radiotherapy Combined With Adebrelimab and NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Signed informed consent form\n\nAge 18-75 years\n\nHistologically or cytologically confirmed pancreatic ductal adenocarcinoma\n\nLocally advanced disease as determined by the investigator (with reference to the CSCO Clinical Practice Guidelines for Pancreatic Cancer)\n\nNo prior treatment for pancreatic cancer, including radiotherapy, chemotherapy, or surgery\n\nAt least one measurable lesion according to RECIST v1.1 criteria\n\nECOG performance status score of 0-1\n\nAdequate organ function based on laboratory tests performed within 28 days prior to the first dose:\n\n1. Complete blood count:\n\n   Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 75 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL\n2. Blood biochemistry:\n\n   Serum albumin ≥ 30 g\u002FL Serum total bilirubin ≤ 1.5 × ULN ALT and AST ≤ 3 × ULN Serum creatinine (Cr) ≤ 1.5 × ULN; or creatinine clearance calculated by the Cockcroft-Gault formula \\> 50 mL\u002Fmin\n3. International normalized ratio (INR) ≤ 1.2, or prothrombin time (PT) exceeding the normal range by ≤ 2 seconds\n4. Urine protein \\\u003C 2+ (if urine protein ≥ 2+, 24-hour urine protein quantification is required; patients with 24-hour urine protein \\\u003C 1.0 g are eligible) Male subjects and female subjects of childbearing potential must use contraceptive measures from the first dose until 6 months after the last dose of the study drug\n\nExclusion Criteria:\n\n* Presence of distant metastasis\n\nContraindications to surgical resection of pancreatic cancer\n\nHistory of another malignancy other than pancreatic cancer within 5 years prior to enrollment, or concurrent malignancy at the time of enrollment\n\nPrior allogeneic stem cell transplantation or solid organ transplantation\n\nSymptomatic active central nervous system (CNS) metastases and\u002For carcinomatous meningitis, or uncontrolled major seizure disorder, unless ruled out by CT or MRI\n\nHistory of uncorrectable electrolyte disturbances, including serum potassium, calcium, or magnesium abnormalities\n\nCurrent interstitial pneumonia or interstitial lung disease, history of interstitial pneumonia or interstitial lung disease requiring corticosteroid therapy, or any other condition that may interfere with the assessment and management of immune-related pulmonary toxicity; active pulmonary tuberculosis\n\nActive autoimmune disease or history of autoimmune disease with potential for recurrence\n\nUse of immunosuppressive agents or systemic corticosteroids for the purpose of immunosuppression within 2 weeks prior to enrollment\n\nActive infection, unexplained fever ≥ 38.5°C within 1 week prior to enrollment, or baseline white blood cell count \\> 15 × 10⁹\u002FL; use of oral or intravenous therapeutic antibiotics within 2 weeks prior to enrollment\n\nCongenital or acquired immunodeficiency (e.g., HIV infection)\n\nReceipt of a live attenuated vaccine within 4 weeks prior to enrollment, or anticipated need for such vaccination during adebrelimab treatment or within 60 days after the last dose\n\nClinically significant bleeding symptoms or evident bleeding tendency within 6 months prior to enrollment; known hereditary or acquired bleeding tendency or thrombotic tendency\n\nMajor vascular disease, arterial thromboembolism\n\nUncontrolled or poorly controlled cardiac clinical symptoms or disease, such as:\n\n1. New York Heart Association (NYHA) Class \\> II heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 50% as assessed by color Doppler echocardiography\n2. Unstable angina pectoris\n3. Myocardial infarction within 1 year prior to initiation of study treatment\n4. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention\n5. QTc interval \\> 450 ms (males) or \\> 470 ms (females) (QTc calculated using Fridericia's formula; if the QTc value is abnormal, measurements should be repeated three times at 2-minute intervals and the average value taken) Uncontrolled pleural effusion, pericardial effusion, or moderate or greater ascites\n\nHypertension not adequately controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); history of hypertensive crisis or hypertensive encephalopathy\n\nPresence of severe, non-healing or dehisced wounds, active ulcers, or untreated fractures\n\nMajor surgery (excluding diagnostic surgery) within 4 weeks prior to enrollment, or planned major surgery during the study period\n\nHistory of intestinal obstruction and\u002For clinical symptoms or signs of gastrointestinal obstruction within 6 months prior to enrollment\n\nKnown allergy or hypersensitivity to any study drug or excipient\n\nParticipation in another clinical study of an investigational drug within 4 weeks prior to enrollment\n\nPregnant or breastfeeding women\n\nOther factors that, in the opinion of the investigator, render the subject unsuitable for study participation","ALL","18 Years","85 Years",{"count":86,"type":87},36,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","This study intends to explore conversion therapy for locally advanced pancreatic cancer (LAPC). The intervention starts with modified stereotactic body radiation therapy (3-day regimen), followed by systemic therapy within 1-2 weeks after irradiation. Subsequently, the investigator will evaluate the resectability of the lesion.\n\nFor subjects converted to resectable status, surgical resection will be performed, followed by postoperative adjuvant therapy.\n\nFor subjects who remain unresectable but maintain stable disease, a second cycle of conversion therapy will be continued. If the lesion is converted to resectable, surgical resection will be performed followed by adjuvant therapy. If disease progression occurs, subsequent treatment will be carried out in accordance with the first-line treatment for advanced pancreatic cancer.\n\nFor subjects who experience disease progression or distant metastasis, subsequent treatment will be administered by adjusting the chemotherapy regimen in accordance with the first-line standard regimen for advanced pancreatic cancer.",[93],"Pancreatic Ductal Adenocarcinoma (PDAC)","NOT_YET_RECRUITING","2026-09-17",{"date":97,"type":98},"2026-09-18","ACTUAL",{"date":100,"type":87},"2026-09-01",{"date":102,"type":87},"2030-09-01",{"name":5,"class":6}]