Canagliflozin With Gemcitabine in Pancreatic Carcinoma

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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 obser
• Препарат 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.

Первичные конечные точки

• Evaluation the clinical complete response (CR) at 6 weeks intervals [Срок оценки: 18 weeks]
• Evaluation the clinical partial response (PR) at 6 weeks intervals [Срок оценки: 18 weeks]
• Evaluation the clinical stable disease (SD) at 6 weeks intervals [Срок оценки: 18 weeks]
• Evaluation the clinical disease progression (PD) at 6 weeks intervals [Срок оценки: 18 weeks]

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Hangzhou first people's Hospital — Ханчжоу

Идентификаторы

NCT: NCT05903703 · 20230519

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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