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OpenTrials
Completed

NCT Number: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Province Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surufatinib combine immune checkpoint inhibitor

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

AG/FOLFIRINOX

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.

Primary outcomes

  1. Median progression-free survival

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Luo Cong

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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