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NCT Number: NCT05903703

Canagliflozin With Gemcitabine in Pancreatic Carcinoma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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;
  • 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.
  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Evaluation the clinical complete response (CR) at 6 weeks intervals

    Time frame: 18 weeks

    The tumor lesion in our patient completely resolved and lasted for ≥4 weeks, and no new lesion appeared

  2. Evaluation the clinical partial response (PR) at 6 weeks intervals

    Time frame: 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

  3. Evaluation the clinical stable disease (SD) at 6 weeks intervals

    Time frame: 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

  4. Evaluation the clinical disease progression (PD) at 6 weeks intervals

    Time frame: 18 weeks

    the combined increase in the longest diameter of the tumor lesion is ≥25%, or a new lesion appears

Study contacts

Contact information is provided by the study sponsor or research team.

Hongzhang Shen

CONTACT

[email protected]

057156005600

Xiaofeng Zhang

CONTACT

057156005600

Sponsors and collaborators

Lead sponsor

Zhang Xiaofeng,MD

Other

Collaborators

  • College of Pharmaceutical Sciences at Zhejiang University
  • The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University

Registry information

Official study title

Clinical Study of Capeline Combined With Gemcitabine in the Treatment of Pancreatic Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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