- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06378580
The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic PDAC (mPDAC). Surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGFR) 1, 2, 3, fibroblast growth factor receptor 1 (FGFR1), and colony stimulating factor 1 receptor (CSF-1R), and ex vivo experiments have demonstrated its effect on PC models.
A retrospective analysis of patients with PDAC who underwent surufatinib at Zhejiang Cancer Hospital (Hangzhou,China) from July 2022 to July 2023.The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Zhejiang Province Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
(i) were over 18 years old; (ii) had a histological diagnosis of pancreatic adenocarcinoma; (iii) had at least one measurable lesion; (iv) had undergone at least two cycles of surufatinib treatment.
Exclusion Criteria:
(i)non-R0 resection; (ii) Combined with other malignant tumors.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Surufatinib combine immune checkpoint inhibitor
|
Before drug use demographics, blood markers, pathology information# and enhanced CT features. Chemotherapy regimens that were combined with surufatinib included AG or FOLFIRINOX regimens. The AG regimen consisted of nab-paclitaxel (125 mg/m2) followed by gemcitabine (1000 mg/m2) on days 1 and 8 every 3 weeks. The FOLFIRINOX regimen included oxalip |
|
Chemotherapy
|
Before drug use demographics, blood markers, pathology information# and enhanced CT features. The AG regimen consisted of nab-paclitaxel (125 mg/m2) followed by gemcitabine (1000 mg/m2) on days 1 and 8 every 3 weeks. The FOLFIRINOX regimen included oxaliplatin (85 mg/m2), irinotecan (180 mg/m2), leucovorin (400 mg/m2), and 5-fluorouracil (400 mg/m2 bolus, 2400 mg/m2 continuous intravenous infusion for 46 hours) every 14 days. Both the AG and FOLFIRINOX regimens required completion of 6 cycles or until disease progression or unacceptable toxicity. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Median progression-free survival
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LGF22H160084 (Other Grant/Funding Number: Zhejiang Provincial Basic Public Welfare Research Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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