Canagliflozin With Gemcitabine in Pancreatic Carcinoma

Pancreatic Cancer Clinical Trial

Official title:

Clinical Study of Capeline Combined With Gemcitabine in the Treatment of Pancreatic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05903703
• Other study ID #: 20230519
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: June 2023
• Source: First People's Hospital of Hangzhou
• Contact: Hongzhang Shen
• Phone: 057156005600
• Email: sakshen[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 31, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

1. Inclusion criteria: # Age =18 years old; #Metastatic or unresectable pancreatic cancer is confirmed through histology or cytology; # Estimated survival time > 3 months; # Without any chemotherapy treatment or more than one month from the end of the last chemotherapy course; #ECOG physical status score 0-2;

2. Exclusion criteria: # patients who had allergic reaction to therapeutic drugs; # patients with other types of cancer; # Patients with severe diseases of heart, liver, kidney, etc.; (4) gastrointestinal dysfunction or unable to oral medication.

3. Shedding/eliminating criteria: exiting in the midway; Lost to follow-up during the follow-up period; Treatment was not continued according to the treatment protocol.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Canagliflozin and Gemcitabine
on the first, 8th and 15th day of treatment, patients were given intravenous drip of 1000mg/m2 gemcitabine, and 21 days was a course of treatment, lasting for 6 courses. Take 400mg canagliflozin orally every day, and continue to use it until the end of chemotherapy. According to the patient's tolerance to disulfiram, the dose of canagliflozin can be re-evaluated during the treatment, and the highest dose is 125mg per day. The clinical symptoms, signs and adverse reactions of patients were observed, and the treatment effect of patients was evaluated after two consecutive cycles with 4 weeks as a cycle
• Gemcitabine
on the first, 8th and 15th day of treatment, patients were given 1000mg/m2 gemcitabine intravenously, and 21 days was a course of treatment, lasting for 6 courses.

Locations

Country	Name	City	State
China	Hangzhou first people's Hospital	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Zhang Xiaofeng,MD	College of Pharmaceutical Sciences at Zhejiang University, The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation the clinical complete response (CR) at 6 weeks intervals	The tumor lesion in our patient completely resolved and lasted for =4 weeks, and no new lesion appeared	18 weeks
Primary	Evaluation the clinical partial response (PR) at 6 weeks intervals	the overall reduction in the longest diameter of the tumor focus is > 50% and it can be maintained for at least 4 weeks, with no new focus emerging	18 weeks
Primary	Evaluation the clinical stable disease (SD) at 6 weeks intervals	the overall reduction or increase of the longest diameter of the tumor lesion is < 50% or < 25%, and the duration is > 4 weeks; no new lesion appears	18 weeks
Primary	Evaluation the clinical disease progression (PD) at 6 weeks intervals	the combined increase in the longest diameter of the tumor lesion is =25%, or a new lesion appears	18 weeks