Back to resultsCanagliflozin With Gemcitabine in Pancreatic Carcinoma
Primary Purpose
Pancreatic Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Canagliflozin and Gemcitabine
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
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; 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. 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.
Sites / Locations
- Hangzhou first people's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Canagliflozin and Gemcitabine
standard cisplatin
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05903703
First Posted
May 19, 2023
Last Updated
June 11, 2023
Sponsor
Zhang Xiaofeng,MD
Collaborators
College of Pharmaceutical Sciences at Zhejiang University, The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05903703
Brief Title
Canagliflozin With Gemcitabine in Pancreatic Carcinoma
Official Title
Clinical Study of Capeline Combined With Gemcitabine in the Treatment of Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhang Xiaofeng,MD
Collaborators
College of Pharmaceutical Sciences at Zhejiang University, The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Canagliflozin and Gemcitabine
Arm Type
Experimental
Arm Title
standard cisplatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Canagliflozin and Gemcitabine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation the clinical complete response (CR) at 6 weeks intervals
Description
The tumor lesion in our patient completely resolved and lasted for ≥4 weeks, and no new lesion appeared
Time Frame
18 weeks
Title
Evaluation the clinical partial response (PR) at 6 weeks intervals
Description
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
Time Frame
18 weeks
Title
Evaluation the clinical stable disease (SD) at 6 weeks intervals
Description
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
Time Frame
18 weeks
Title
Evaluation the clinical disease progression (PD) at 6 weeks intervals
Description
the combined increase in the longest diameter of the tumor lesion is ≥25%, or a new lesion appears
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongzhang Shen
Phone
057156005600
Email
sakshen@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofeng Zhang
Phone
057156005600
Facility Information:
Facility Name
Hangzhou first people's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Canagliflozin With Gemcitabine in Pancreatic Carcinoma
We'll reach out to this number within 24 hrs