2024-512176-35-00招募中2 期
The role of sonoporation-enhanced treatment with Gemcitabine, Nab-Paclitaxel and FOLFIRINOX in patients with inoperable pancreatic cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression free survival based on the RECIST-criteria
研究概览
简要总结
To evaluate the safety and efficacy of the combined Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX, and Sonazoid under ultrasound treatment, compared to Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX treatment alone.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •A new diagnosis of metastatic or locally advanced pancreatic ductal adenocarcinoma
- •Must be ambulatory with an ECOG performance status between 0 and 2
- •Female patients of child-bearing potential must have a negative urine pregnancy test and use (and agree to continue to use) an effective or highly effective birth control method
- •Male patients with a female partner who is considered of childbearing potential, must agree to use a condom throughout the study and for 6 months after last exposure to the IMPs.
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.
- •Patient must be ≥18 years old.
排除标准
- •Operable pancreatic cancer
- •Patients that are allergic to any other component of Sonazoid.
- •Patient is allergic to or intolerant of any IMPs included in the chemotherapy regimen that the patient is scheduled for (Gemcitabine/Nab-Paclitaxel or FOLFIRINOX).
- •Patient has any known contraindications to any of the IMPs that the patient is scheduled for. Contraindications are described in the SmPCs.
- •Any reason why, in the opinion of the investigator, the patient should not participate.
- •Patient is pregnant or is breast-feeding.
- •Patient participated in an investigational study within 7 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).
- •Patient has severe chronic obstructive pulmonary disease,or pulmonary hypertension or unstable cardiopulmonary conditions.
- •Patients who are medically unstable
- •Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
- •Patient has a known history of HIV infection or active Hepatitis B or Hepatitis C infection.
- •Patient requires dialysis or has severely impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) < 30 at the Screening Visit.
- •Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the ULN) or Child Pugh Score C, at the Screening Visit
- •Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of Sonazoid).
结局指标
主要结局
Progression free survival based on the RECIST-criteria
Progression free survival based on the RECIST-criteria
次要结局
- Key secondary efficacy endpoint: Overall survival.
- Time to treatment failure, defined as time from study day 1 to disease progression (RECIST-criteria from CT) and/or rapidly deteriorating ECOG performance status.
- Number of completed chemotherapy cycles before treatment failure
- Changes in local disease progression using RECIST-criteria (CT)
- Changes in maximum tumour diameter (CT and ultrasound)
- Changes in disease progression using primary tumour volume (CT and ultrasound)
研究者
Odd Helge Gilja
Scientific
Helse Bergen HF
研究点 (1)
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