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Trial Title:
Canagliflozin With Gemcitabine in Pancreatic Carcinoma
NCT ID:
NCT05903703
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Canagliflozin
Gemcitabine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Canagliflozin and Gemcitabine
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
Arm group label:
Canagliflozin and Gemcitabine
Intervention type:
Drug
Intervention name:
Gemcitabine
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.
Arm group label:
standard cisplatin
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hangzhou first people's Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Start date:
October 1, 2023
Completion date:
March 31, 2027
Lead sponsor:
Agency:
Zhang Xiaofeng,MD
Agency class:
Other
Collaborator:
Agency:
College of Pharmaceutical Sciences at Zhejiang University
Agency class:
Other
Collaborator:
Agency:
The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University
Agency class:
Other
Source:
First People's Hospital of Hangzhou
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05903703
