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Trial Title:
Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Pancreatic Cancer
NCT ID:
NCT05908747
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
surufatinib + gemcitabine + nab-paclitaxel
Description:
surufatinib: 250mg, QD po; nab-paclitaxel: 125mg/m2, I.V., D1/8/15, Q4W; gemcitabine:
1000/m2, ivgtt for more than 30min, D1/8/15, Q4W
Arm group label:
surufatinib + gemcitabine + nab-paclitaxel
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.
Detailed description:
This is a phase II, multi-centered, open-label study, aims to explore the efficacy and
safety of surufatinib (250mg, qd po) combined with gemcitabine (1000mg/m2, I.V, d1/8/15,
Q4W) and nab-paclitaxel (125mg/m2, I.V, d1/8/15, Q4W) as peri-operative treatment in
locally advanced or borderline resectable pancreatic cancer. Potential therapeutic
biomarkers will also be explored.
Criteria for eligibility:
Criteria:
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 (excluding lacunar cerebral infarction, minor cerebral ischemia or
transient ischemic attack), myocardial infarction, unstable angina pectoris, and
poorly controlled arrhythmia (including QTc interval ≥ 450ms for male and ≥ 470ms
for female) occurred within 6 months before the first administration of the study
drug (QTc interval was calculated by fridericia formula); -New York Heart
Association (NYHA) cardiac function classification > grade II or left ventricular
ejection fraction (LVEF) < 50%;
- With active ulcer, intestinal perforation and intestinal obstruction;
- Uncontrollable malignant ascites (defined as ascites that cannot be controlled by
diuretics or puncture according to the judgment of the investigator);
- Clinically significant electrolyte abnormalities judged by researchers;
- With active bleeding or obvious evidence of bleeding tendency;
- Hypertension that cannot be controlled by drugs: systolic blood pressure ≥ 150 mmHg
and / or diastolic blood pressure ≥ 100 mmHg;
- Women who are pregnant or lactating;
- Urinary protein ≥ ++, or the 24-hour urine protein quantification is greater than
1.0g;
- Concurrent tumors within 5 years (except treated cervical carcinoma in situ, basal
cell carcinoma);
- Any disease or state that affects the absorption of drugs, or the subject cannot
take oral drugs;
- Known human immunodeficiency virus (HIV) infection;
- History of clinically significant hepatic disease, including, but not limited to,
known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10^4/ml or
>2000 IU/ml); known hepatitis C virus infection with HCV RNA positive (copies
≥1×10^3/m); hepatitis and cirrhosis;
- Have any other disease, metabolic disorder, physical examination anomaly, abnormal
laboratory result, or any other conditions that makes the subject not suitable for
enrolling according to the judgment of the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
jihui Hao, MD
Phone:
022-23524155
Email:
ec_tjcih@126.com
Contact backup:
Last name:
Song Gao, MD
Start date:
May 31, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05908747
