NCT06378580

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 17, 2024

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Median progression-free survival

    5 months

Study Arms (2)

Surufatinib combine immune checkpoint inhibitor

Drug: Surufatinib combine immune checkpoint inhibitor

Chemotherapy

Drug: AG/FOLFIRINOX

Interventions

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

Surufatinib combine immune checkpoint inhibitor

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.

Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients with mPDAC who received the surufatinib regimen treatment between July 2022 and July 2023 at Zhejiang Cancer Hospital.

You may qualify if:

  • (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.

You may not qualify if:

  • (i)non-R0 resection; (ii) Combined with other malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Province Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

  • Yang Y, Xie Q, Shang C, Jiang L, Ding G, Long D, Luo C. The prognostic impact of surufatinib for the treatment of advanced pancreatic ductal adenocarcinoma: a single center real-world retrospective study. Front Oncol. 2025 May 20;15:1574934. doi: 10.3389/fonc.2025.1574934. eCollection 2025.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 22, 2024

Study Start

July 1, 2022

Primary Completion

July 1, 2023

Study Completion

April 1, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations