NCT05466799进行中（未招募）2 期
An Open-label, Multi-centre, Randomized Study of TaRgeted Intratumoural Placement of P-32 (OncoSil™) in Addition to FOLFIRINOX Chemotherapy vs FOLFIRINOX Alone in Patients With Unresectable Locally Advanced Pancreatic Adenocarcinoma.
OncoSil Medical Limited14 个研究点 分布在 5 个国家目标入组 88 人开始时间: 2023年4月26日最近更新:
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）
- 发起方
- 入组人数
- 88
- 试验地点
- 14
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer
详细描述
Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will be informed about the study and the potential risks and benefits. After providing informed consent patients will undergo a 3 week screening period to confirm eligibility for the study. Patients who meet all eligibility criteria will be randomised 1:1 to either the control arm of up to 12 cycles of standard of care FOLFIRINOX chemotherapy or implantation of OncoSil™ in addition to the same FOLFIRINOX chemotherapy regimen. Patients will be followed for side side effects and palliative benefits during 4-8 weekly study visits and the objective efficacy of the treatment will be assessed by CT scans every 8 weeks. Quality of Life will be measured on various time-points using questionnaires.
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
- •Histologically or cytologically proven adenocarcinoma of the pancreas.
- •Unresectable locally advanced pancreatic adenocarcinoma according to NCCN 2021 guidelines.Staging and unresectability must be confirmed by central review of the baseline CT scan.
- •Pancreatic target tumour diameter of < 7.0 cm (longest axis), as qualified by the central reading centre.
- •Karnofsky Performance Status ≥ 70
- •≥ 18 years of age at screening.
- •Considered fit to commence first-line standard FOLFIRINOX chemotherapy:
- •i) Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).
- •ii) Adequate liver function: serum liver transaminases ≤ 3 x ULN and serum bilirubin ≤ 1.5 x ULN*.
- •*For study participants with recent biliary obstruction treated by drainage (e.g. stent), serum bilirubin of > 1.5 x ULN will be accepted for study entry provided that serial levels demonstrate clear improvement. In addition, chemotherapy should not be commenced until serum bilirubin is ≤ 1.5 x ULN.
- •iii) Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, haemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3 iv) UGT1A1 polymorphism and DPD deficiency test performed and dose reductions applied as per local institutional practice.
- •Provide signed Informed Consent.
- •Willing and able to complete study procedures within the study timelines.
- •Life expectancy of at least 3 months at the time of screening as judged by the investigator.
- •Treated with or eligible to commence prophylactic treatment with a proton-pump inhibitor prior to implantation, and to continue to receive treatment for at least 6 months post implantation.
- •Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device.
排除标准
- •Evidence of distant metastases, based on review of baseline CT scan.
- •More than one pancreatic tumour lesion.
- •Any prior radiotherapy or chemotherapy for pancreatic cancer.
- •Pregnant or lactating.
- •In the opinion of the investigator, EUS-directed implantation posing undue study subject risk. This includes:
- •i) where previous EUS-FNA was considered technically too difficult to perform; ii) imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas; iii) presence (or significant risk) of varices near to the target tumour. Note: The feasibility of implantation of the target tumour and assessment of risk can be repeated at any time between Screening Visit 1 and the implantation date. If any of the above risk features becomes apparent following subject screening and/or enrolment prior to and including at the time of OncoSil™ treatment, the patient should remain in the study but the implantation should be deferred or cancelled.
- •History of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
- •Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
- •A known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components.
- •Any other health condition that would preclude participation in the study in the judgment of the investigator.
研究组 & 干预措施
FOLFIRINOX Chemotherapy
Active Comparator
Subjects in Arm A will receive up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy
干预措施: FOLFIRINOX chemotherapy (Drug)
OncoSil™ in addition to FOLFIRINOX Chemotherapy
Experimental
Subjects in Arm B will be implanted with the OncoSil™ device in addition to up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy
干预措施: FOLFIRINOX chemotherapy (Drug)
OncoSil™ in addition to FOLFIRINOX Chemotherapy
Experimental
Subjects in Arm B will be implanted with the OncoSil™ device in addition to up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy
干预措施: OncoSil™ (Device)
结局指标
主要结局
Safety and Tolerability
时间窗: Through study completion, an average of 18 months
The primary analysis for safety of OncoSil™ is defined by the Adverse Event profile
Local Disease Control Rate (LDCR) at 16 Weeks
时间窗: 16 weeks after initiation of FOLFOX chemotherapy
The LDCR at Week 16 will be summarised as a count and proportion of subjects with Local Disease Control at 16 Weeks
次要结局
- Local Progression Free Survival (LPFS), within the pancreas(From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
- Progression Free Survival(From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
- Time to symptomatic progression(From date of enrolment until the date of symptomatic progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
- Overall Survival(Through study completion, an average of 18 months)
- Patient Reported Outcomes(Through study completion, an average of 18 months)
- Pain Scores(From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
- Weight loss(From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
- Tumour response(From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
- Surgical resection rate(Through study completion, an average of 18 months)
- Target Tumour Volumetric Change(From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
- Clinical Benefit Response(From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
- CA 19-9 response(From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient)
研究者
研究点 (14)
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