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Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer

StatusRecruiting
PhasePhase 2
Started2024-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-07-01
minor
2 amendments v4-v5
2 re-verifications since 2025-06-25, no change to tracked fields
2025-03-10
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v3
Start dateestimated 2024-08→confirmed 2024-08-01
Enrollment target20→30
Eligibility criteria+72 characters
[...] ocarcinoma or acinar cell carcinoma; No distant metastasis; The pancreatic tumor is located more than 1cm away from the duodenum; Clinical assessment was locally advanced or critical for res [...] nteric artery ≤180°; Tumor contact with celiac artery ≤180°; 7.There was no history of immune system diseases, other malign [...]
Secondary endpoints7 to 8 entries
ConversionSurgical toconversion negativerate Tumor regression rate 3-year DiseaseEvent Free Survival (DFSEFS) Quality of life scores
Study title-84 characters
To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen +Chemotherapy Plus+ Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer
2024-08-13
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2024-06-17→2024-08
Study sitesdetails revised at 1 of 1 site
2024-06-22
minor
Study Status, Outcome Measures, Eligibility v1
Start date2024-06-01→2024-06-17
Eligibility criteria+1,058 characters
[...] istant metastasis; Clinical assessment was locally advanced (ator leastcritical qualifiedfor oneresectable. Locally ofadvanced thepancreatic followingcancer diagnostic criteria:①Lymph node(1) metastasisdue outsideto thetumor surgicalinvasion, area;②tumorvenous surroundedocclusion moreor thaninvolving halfa wide range of the superior mesenteric vein;③tumor wasbranch adjacentof tojejunum, cannot safely - superior mesenteric vein reconstruction. ② (pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or wrappedceliac moreartery than> half180°. Tumor contact with [...] [...]
Secondary endpointsdetails revised at 1 of 7 entries
2024-05-29
minor
Original filing
The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of Borderline Resectable/locally advanced pancreatic cancer.
Trial Details
NCT Number NCT06435260
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions Pancreatic Cancer
Enrollment 30 participants
Start Date 2024-08-01
Primary Completion 2025-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-06