Canagliflozin With Gemcitabine in Pancreatic Carcinoma

NCT05903703 | Not Yet Recruiting

• 1 other identifier: 20230519
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Canagliflozin and Gemcitabine

EXPERIMENTAL

Drug: Canagliflozin and Gemcitabine

standard cisplatin

ACTIVE COMPARATOR

Drug: Gemcitabine

Interventions

Canagliflozin and Gemcitabine DRUG

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

Canagliflozin and Gemcitabine

Gemcitabine DRUG

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.

standard cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Canagliflozin; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Central Study Contacts

Hongzhang Shen

CONTACT

057156005600; sakshen@126.com

Xiaofeng Zhang

CONTACT

057156005600

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 15, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)