Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU

Официальное название

A Study to Evaluate the Efficacy and Safety of a First-line Treatment for Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU

Обзор

Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer

Подробное описание

To observe and evaluate the efficacy and safety of simultaneous infusion of levofolinate for injection and 5-FU in the first-line treatment of advanced colorectal cancer

Вмешательства

• Препарат mFOLFOX/FOLFIRI ( Standard Chemotherapy)
  mFOLFOX6: Oxaliplatin 85mg/m², intravenous infusion for 2 hours, day 1; 5-FU 400mg/m² injection, d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs. FOLFIRI: Irinotecan 180mg/m², intravenous infusion for 30 to 90 minutes on day 1; 5-FU 400mg/m² injection d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused s

Первичные конечные точки

• PFS [Срок оценки: up to 3 years]

Вторичные конечные точки (5)

• ORR [Срок оценки: up to 3 years]
• DCR [Срок оценки: up to 3 years]
• DoR [Срок оценки: up to 3 years]
• OS [Срок оценки: up to 3 years]
• Adverse Event [Срок оценки: Thirty days after the last treatment]

Критерии участия

Критерии включения

• The subjects voluntarily joined this study and signed the informed consent form.
• Age: 18 to 75 years old, gender not limited;
• ECOG PS score: 0-2 points
• Patients with unresectable or metastatic colorectal cancer confirmed by histology or cytology, where the primary tumor location and the status of RAS and BRAF are known;
• No previous treatment for unresectable or metastatic lesions has been received;
• There is at least one measurable lesion in accordance with the RECIST 1.1 standard;
• In the pre-treatment examination indicators, there was no serious hematopoietic function abnormality, and the functions of the heart, lungs, liver and kidneys were basically normal.

• Hemoglobin (Hb) ≥70 g/L;
• White blood cell count (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥1.5×109/L;
• Platelet count (PLT) ≥100×109/L;
• Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level ≤2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level ≤1.5 times the upper limit of the normal value (ULN). Total bilirubin (TBIL) ≤1.5 times the upper limit of the normal value (ULN).
• The expected survival period is more than three months.

Критерии исключения

• Those who have been confirmed to be allergic to the test drug and/or its excipients;
• Those with contraindications to chemotherapy;
• Colorectal cancer patients with MSI-H or dMMR;
• Pregnant or lactating women;
• There is a history of other malignant tumors in the past;
• Those with systemic internal diseases and mental disorders who are not suitable for chemotherapy;
• Patients who were determined by the researchers to be unsuitable for inclusion in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital, Beijing — Пекин

Идентификаторы

NCT: NCT07391618 · HL-ZY-058

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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