A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Официальное название

A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer

Обзор

To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Подробное описание

This is a multicenter, randomized, open-label, active-controlled, phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Вмешательства

• Препарат Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
  Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Camrelizumab: 200mg, IV drip, Q3W, D1 3. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 4. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
• Препарат Nab-paclitaxel Plus Gemcitabine
  Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
• Препарат Surufatinib with Nab-paclitaxel, and Gemcitabine
  Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months)]

Вторичные конечные точки (6)

• Progression-free Survival (PFS) (RECIST1.1) [Срок оценки: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)]
• Objective response rate (ORR)(RECIST1.1) [Срок оценки: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)]
• Duration of response (DoR)(RECIST1.1) [Срок оценки: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)]
• Disease control rate (DCR)(RECIST1.1) [Срок оценки: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)]
• Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)（only for phase III） [Срок оценки: From the within 7 days prior to the initiation of treatment to 30 days after the last administration]
• Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)（only for phase III） [Срок оценки: From the within 7 days prior to the initiation of treatment to 30 days after the last administration]

Критерии участия

Критерии включения

• Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
• Age range is 18-75 years old (inclusive);
• Pancreatic cancer confirmed by histology or cytology;
• Stage IV metastasis Pancreatic cancer patients;
• Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;
• According to RECIST 1.1, there is at least one measurable lesion;
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
• Expected survival time ≥ 12 weeks;

Критерии исключения

• Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose；
• Presence of other malignancies in the past 5 years;
• Received major surgical surgery within 4 weeks before the first dose;
• Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
• Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
• Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
• Use of immunosuppressive drugs within 4 weeks before first dose;
• Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
• Patients who currently have hypertension that cannot be controlled by medication;

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 · 2 центра

• Nanjing Tianyinshan Hospital — Нанкин
• Tianjin Cancer Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06361888 · 2023-012-00CH1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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