Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the … (NCT05908747) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Pancreatic Cancer
China29 participantsStarted 2023-05-31
Plain-language summary
This study is designed to explore the efficacy and safety of surufatinib combined with gemcitabine and nab-paclitaxel as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed high-risk resectable or borderline resectable pancreatic cancer;
* 18-75 years old (including 18 and 75 years old);
* No BRCA1/2 or PALB2 mutation;
* No previous systematic treatment or radiotherapy;
* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
* Life expectancy ≥ 6 months;
* At least one measurable lesion according to RECIST version 1.1;
* Adequate organ and bone marrow functions: -Absolute neutrophil count≥1.5x10\^9/L; -Platelet count≥100x10\^9/L; -Hemoglobin≥9g/dL; -Serum bilirubin≤1.5x the upper limit of normal (ULN); -Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5x ULN; -Serum creatinine≤1.5x ULN or endogenous creatinine clearance rate ≥ 60ml / min; -INR≤1.5×ULN, PT and APTT≤1.5×ULN;
* Women of childbearing age need to take effective contraceptive measures.
Exclusion Criteria:
* With distant metastasis;
* Have received blood transfusion treatment, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
* Have received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.);
* Allergic to the study drug or any of its adjuvants;
* researchers judged clinically significant electrolyte abnormalities;
* History of serious cardiovascular and cerebrovascular diseases: -Cerebrovascular accident …
What they're measuring
1
Surgical complete resection rate (R0)
Timeframe: about 2 years
Trial details
NCT IDNCT05908747
SponsorTianjin Medical University Cancer Institute and Hospital