The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients

Pancreatic Cancer Clinical Trial

Official title: An Open Single-center Phase II Clinical Study of Fruquintinib Combined With Chemotherapy in Patients With Liver Metastases From Pancreatic Cancer

Status Recruiting

Clinical Trial Summary

The aim of this study is to evaluate the safety and effectiveness of Fruquintinib combined with Albumin Paclitaxel and Gemcitabine on pancreatic cancer patients with liver metastases. Plan to enrollment 30 patients.

Clinical Trial Description

Pancreatic cancer is the most deadly malignant tumor commonly found in the digestive system and is known as the king of cancer. According to the global cancer statistics released in 2018, there are about 458,900 new cases of pancreatic cancer worldwide each year, and the number of deaths due to pancreatic cancer each year is about 432,200. The data of pancreatic cancer collected by the National Cancer Center of China in 2019 showed that the incidence rate was 6.92 per 100,000, and new cases accounted for about 4.31% of all malignant tumors, ranking 10th; the case fatality rate was 6.16 per 100,000, with deaths every year It accounts for about 3.78% of all malignant tumors, ranking 7th. Compared with urban areas and rural areas, the morbidity and mortality have increased compared with previous years. The incidence of pancreatic cancer has been increasing year by year worldwide, and it is expected that by 2030, it will surpass colorectal cancer and breast cancer to become the second cancer-fatal tumor. Pancreatic cancer is extremely malignant, with a 5-year survival rate of only 9%, and its case fatality rate is basically equal to the incidence rate. The case fatality rate of pancreatic cancer may continue to rise, which will seriously threaten and affect human health.

The specific etiology and pathogenesis of pancreatic cancer are currently unclear, the early clinical manifestations are not obvious, the rapid development, the extremely high degree of malignancy, and the poor prognosis, all of which lead to the refractory and high mortality of pancreatic cancer. It is precisely because the early symptoms are not typical and the clinical signs are not obvious, most patients are already in the locally advanced stage or have distant metastases when they are diagnosed.In this case, the chance of surgical treatment is low and the effect is not ideal. 80% of pancreatic cancer patients are already in the inoperable advanced stage at the time of diagnosis, and more than 50% of them have found metastases at the time of diagnosis, and have lost the chance of radical surgery. The most common distant metastasis site is the liver. At present, for patients with liver metastases from pancreatic cancer, the standard treatment regimen in domestic and foreign guidelines is palliative treatment based on chemotherapy.

According to the latest updated treatment guidelines for metastatic pancreatic cancer by the American Society of Clinical Oncology (ASCO), the first-line chemotherapy regimen should be selected based on the patient's physical status. For patients with good physical status, a combination regimen may be considered, and patients with poor physical status should choose single-agent chemotherapy. Or the best supportive treatment. For those with good physical status, FOLFIRINOX, gemcitabine and paclitaxel are recommended; for patients with poor physical status, single-agent gemcitabine can be used. If tolerable, they can be combined with albumin paclitaxel or calciner under the guidance of an experienced oncologist. Petabine or erlotinib. Overall, the median OS of first-line chemotherapy did not exceed 12 months, and the median OS of second-line chemotherapy ranged from 3.3 to 9.9 months. Therefore, the overall treatment effect of pancreatic cancer was poor, and the median survival was only 6 months. For 8 months, the effect was not good. All major guidelines recommend the development of multi-center clinical studies to prolong patient survival and discover new effective drugs. In summary, actively exploring new comprehensive treatment strategies, breaking through treatment options for advanced pancreatic cancer, improving the survival time of patients with liver metastases of pancreatic cancer, and exploring the biological characteristics of liver metastases of pancreatic cancer are important clinical issues that urgently need to be resolved. ;

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT05168527
• Study type: Interventional
• Source: Fudan University
• Contact: Xianjun MD Yu, PhD
• Phone: +86-18017317266
• Email: yuxianjun@fudanpci.org
• Status: Recruiting
• Phase: Phase 2
• Start date: September 3, 2021
• Completion date: May 31, 2024