NCT06783140进行中（未招募）2 期
Comparing Second-Line NABPLAGEM vs. Nab-paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This study will compare two different regimens for patients with BRCA1/2 or PALB2 mutated metastatic pancreatic cancer after progression on first-line FOLFIRINOX.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Metastatic pancreatic adenocarcinoma. Adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, and carcinoma not otherwise specified are also acceptable.
- •BRCA1/2 or PALB2 mutation (somatic or germline).
- •Measurable disease.
- •Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
- •Clinical or radiographic progression on first-line FOLFIRINOX (or NALIRIFOX) for metastatic disease.
- •Patients whose front-line chemotherapy was required to be simplified due to toxicity associated with any of the constituent components of FOLFIRINOX/NALIRIFOX (e.g. simplified to FOLFOX, FOLFIRI, 5-FU (including capecitabine)) will be eligible.
- •Patients with progressive disease while on maintenance PARP inhibitor treatment after FOLFIRINOX (or NALIRIFOX), irrespective of how long ago they received FOLFIRINOX/NALIRIFOX, will also be eligible.
- •Patients who develop metastatic disease during or within 6 months after completing FOLFIRINOX/NALIRIFOX in either the locally advanced or adjuvant/neoadjuvant settings will be eligible.
- •Age 18 years or older.
- •Ability to understand and willing to sign a written informed consent document.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Karnofsky Performance Status ≥60).
- •Required Initial Laboratory Values
- •Not pregnant and not nursing.
排除标准
- •Patients may not have received prior cisplatin for their pancreatic cancer in any setting.
- •Patients with > grade 2 peripheral sensory neuropathy are not eligible.
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 8-weeks. Patients with known, new or progressive brain metastases (active brain metastases) or leptomeningeal disease are ineligible.
- •HIV-infected patients on effective anti-retroviral therapy with undetectable viral load anytime within 6 months prior to registration are eligible for this trial.
- •For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- •Concomitant Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.
研究组 & 干预措施
Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine)
Experimental
Nab-paclitaxel 100 mg/m2 + cisplatin 25 mg/m2 + gemcitabine 800 mg/m2 on days 1 and 15 of every cycle.
干预措施: Gemcitabine (Drug)
Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine)
Experimental
Nab-paclitaxel 100 mg/m2 + cisplatin 25 mg/m2 + gemcitabine 800 mg/m2 on days 1 and 15 of every cycle.
干预措施: Nab paclitaxel (Drug)
Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine)
Experimental
Nab-paclitaxel 100 mg/m2 + cisplatin 25 mg/m2 + gemcitabine 800 mg/m2 on days 1 and 15 of every cycle.
干预措施: Cisplatin (Drug)
Arm 2 - Nab-paclitaxel+gemcitabine
Active Comparator
Nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 on days 1 and 15 of every cycle.
干预措施: Nab paclitaxel (Drug)
Arm 2 - Nab-paclitaxel+gemcitabine
Active Comparator
Nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 on days 1 and 15 of every cycle.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 12 months
The proportion of patients who achieve complete response (CR) or partial response (PR)
Overall Survival (OS) Time
时间窗: 6 years
The time form the date of randomization to the date of death
次要结局
- Progression-free Survival (PFS)(6 years)
- Duration of Response (DoR)(6 years)
- CA19-9 Response(6 years)
- Number of Adverse Events(6 years)
研究者
研究点 (1)
Loading locations...
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