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Canagliflozin With Gemcitabine in Pancreatic Carcinoma

Z

Zhang Xiaofeng,MD

Status

Not yet enrolling

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine
Drug: Canagliflozin and Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT05903703
20230519

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Canagliflozin and Gemcitabine
Experimental group
Treatment:
Drug: Canagliflozin and Gemcitabine
standard cisplatin
Active Comparator group
Treatment:
Drug: Gemcitabine

Trial contacts and locations

1

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Central trial contact

Hongzhang Shen; Xiaofeng Zhang

Data sourced from clinicaltrials.gov

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