Canagliflozin With Gemcitabine in Pancreatic Carcinoma

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Canagliflozin and Gemcitabine; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongzhang Shen; Phone Number: 057156005600; Email: sakshen@126.com
• Study Contact Backup: Name: Xiaofeng Zhang; Phone Number: 057156005600

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canagliflozin and Gemcitabine	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
Active Comparator: standard cisplatin	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Zhang Xiaofeng,MD
• Collaborators: College of Pharmaceutical Sciences at Zhejiang University; The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Sodium-Glucose Transporter 2 Inhibitors; Canagliflozin; Gemcitabine
• Other Study ID Numbers: 20230519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No