Canagliflozin With Gemcitabine in Pancreatic Carcinoma

Not Applicable

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: Canagliflozin and Gemcitabine; Drug: Gemcitabine

• Registration Number: NCT05903703
• Lead Sponsor: Zhang Xiaofeng,MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-11
• Last Update Submitted: 2023-06-11
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Study Start: 2023-10-01
• Primary Completion: 2026-09-30
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canagliflozin and Gemcitabine	Canagliflozin and Gemcitabine	-
standard cisplatin	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Evaluation the clinical partial response (PR) at 6 weeks intervals	18 weeks	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	18 weeks	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	18 weeks	the combined increase in the longest diameter of the tumor lesion is ≥25%, or a new lesion appears
Evaluation the clinical complete response (CR) at 6 weeks intervals	18 weeks	The tumor lesion in our patient completely resolved and lasted for ≥4 weeks, and no new lesion appeared

Trial Locations

Locations (1)

Hangzhou first people's Hospital; 🇨🇳 Hangzhou, Zhejiang, China