Canagliflozin With Gemcitabine in Pancreatic Carcinoma

NCT ID: NCT05903703

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2027-03-31

Brief Summary

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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

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canagliflozin and Gemcitabine

Group Type EXPERIMENTAL

Canagliflozin and Gemcitabine

Intervention Type 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

standard cisplatin

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type 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.

Interventions

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Canagliflozin and Gemcitabine

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

Gemcitabine

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.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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College of Pharmaceutical Sciences at Zhejiang University

UNKNOWN

Sponsor Role collaborator

The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University

UNKNOWN

Sponsor Role collaborator

Zhang Xiaofeng,MD

OTHER

Sponsor Role lead

Responsible Party

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Zhang Xiaofeng,MD

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hangzhou first people's Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Hongzhang Shen

Role: CONTACT

057156005600

Xiaofeng Zhang

Role: CONTACT

057156005600

Other Identifiers

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20230519

Identifier Type: -

Identifier Source: org_study_id

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