The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma

NCT ID: NCT06378580

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surufatinib combine immune checkpoint inhibitor

Surufatinib combine immune checkpoint inhibitor

Intervention Type DRUG

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

AG/FOLFIRINOX

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

AG/FOLFIRINOX

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Luo Cong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luo Cong

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhejiang Province Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40463875 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LGF22H160084

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LGF22H160084

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Metastatic Advanced Pancreas Sorafenib
NCT00758381 UNKNOWN PHASE2