A Phase II, Plateform Study, Open-label, Evaluating the Efficacy and Safety of Neoadjuvant Treatment in Patients With Surgically Resecable Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Major pathological response rate (mPR) on surgical resection specimen
研究概览
简要总结
This is an open master platform trial, which includes multi neo-adjuvant treatment trials, multi-center, national. This platform trial evaluates the major pathological response rate (mPR) after surgery.
Intervention: The procedure consists of administering a neoadjuvant treatment and then performing pancreatic surgery. The POWER platform trial aims to study several neoadjuvant treatments prior to surgery. They will be described in each sub-study, in appendix. The surgery will be performed on one day and the end of the treatment is the safety visit post-surgery (90 days after surgery).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, age ≥ 18 years old at the time of signing the informed consent form.
- •Documented informed consent.
- •Histologically or cytologically confirmed pancreatic adenocarcinoma.
- •Tumor deemed resectable based on local assessment.
- •No evidence of distant metastases on CT scan or PET scan, as well as liver MRI prior to registration.
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0 or
- •Adequate hematologic and organ function, defined by the following laboratory results obtained within 7 days prior to initiation of study treatment:
- •Neutrophils ≥ 1.5 × 10⁹/L (≥ 1500/µL) without granulocyte colony-stimulating factor support.
- •Platelet count ≥ 100 × 10⁹/L (≥ 100,000/µL) without transfusion.
- •Hemoglobin ≥ 90 g/L (≥ 9 g/dL). Patients may be transfused to meet this criterion.
- •AST, ALT, and ALP ≤ 3 × upper limit of normal (ULN).
- •Total bilirubin ≤ 1.5 × ULN.Creatinine clearance ≥ 50 mL/min (calculated using the MDRD formula).
- •Albumin ≥ 30 g/L (≥ 2.5 g/dL).
- •For patients not receiving anticoagulant therapy: INR and aPTT ≤ 1.5 × ULN.
- •Women of childbearing potential (WOCBP) must have a negative urine or serum β-HCG pregnancy test within 7 days prior to the registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required at 72-24 hours before starting the neo-adjuvant treatment. Sexually active female patients must agree to use two methods of effective contraception (cf. paragraph 7.10, one of them being a barrier method, or to abstain from sexual activity during the clinical investigation and for at least 6 months after last dose neoadjuvant treatment.
- •Sexually active males patients must agree to use condom during the clinical investigation and for at least 6 months after the neo-adjuvant treatment. Also, it is recommended the childbearing potential female partner uses a highly effective method of contraception for the same duration (see paragraph 6.12 " Pregnancy and contraception ").
- •Patients shall be eligible to undergo neo adjuvant treatment, surgery and tumor biopsies.
- •Patients must be affiliated to a social security system or beneficiary of the same.
- •Additional specific sub-study inclusion criteria: Patient should also meet the potential specific eligibility criteria of the sub-study for which they are screened.
排除标准
- •Ongoing participation in clinical sub-study involving the use of an investigational product prior to registration in the sub-study.
- •During participation in this study, patients will not receive any other clinical investigational drugs or any other anti-tumor drugs as describes on sub-study.
- •Previous neoadjuvant or induction treatment for pancreatic cancer, including cytotoxic chemotherapy, immunotherapy, experimental therapy, or radiotherapy.
- •Uncontrolled tumor-related pain.
- •Pregnancy or breastfeeding Pregnant or breastfeeding women or intending to become pregnant during the study.
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- •No prior treatment including surgery, radiation therapy or systemic therapy for pancreatic adenocarcinoma.
- •Patients with a history of another primary malignancy diagnosed or requiring treatment within the 2 years prior to the first administration of the study drug. The following prior malignancies are not considered exclusion criteria, provided they have been treated with curative intent: completely resected basal cell carcinoma or squamous cell carcinoma of the skin; localized prostate cancer; superficial or non-invasive bladder cancer; or carcinoma in situ of any site.
- •This should be discussed with the oncologist if necessary.
- •Additional specific sub-study exclusion criteria: Patient should also meet the specific eligibility criteria of the sub-study for which they are screened.
研究组 & 干预措施
POWER A - Folfirinox
POWER A is an open label phase II, national multicenter, sub-study. POWER A evaluates the major pathological response rate (mPR) after surgery.
The procedure consists of administering the neoadjuvant treatment: Folfirinox. Eligible patients will be registrated in POWER A assigned to receive neo adjuvant treatment for 28 days, with 2 infusions of Folfirinox administered every 14 days. The pancreatic surgery will be performed at the end of the neo adjuvant treatment.
干预措施: FOLFIRINOX (Drug)
POWER B - GnP
POWER B is an open label phase II, national multicenter, sub-study. POWER B evaluates the major pathological response rate (mPR) after surgery.
Intervention: The procedure consists of administering the neoadjuvant treatment: Gemcitabine & Nab-Paclitaxel. Eligible patients will be registrated in POWER B assigned to receive neo adjuvant treatment for 28 days, with one cycle of 28 days of Gemcitabine & Nab-Paclitaxel (GnP) administered. The pancreatic surgery will be performed at the end of the neo adjuvant treatment.
干预措施: GnP (Drug)
结局指标
主要结局
Major pathological response rate (mPR) on surgical resection specimen
时间窗: After pancreatic surgical resection, after 28 days of treatment
The efficacy of various experimental drugs, based on pathological response, when administered in a preoperative setting will be analyzed. The major pathological response rate (mPR) will be evaluated on the surgical resection specimen
次要结局
未报告次要终点