Paricalcitol Versus Pirfenidone for Improving Surgical Resectability in Patients With Peritoneal Cancer (RANDY 1A)
A Randomized Phase II Bayesian Pick-the-Winner Clinical Trial Investigating the Efficacy of Fibrosis-Modulating Agents (Paricalcitol and Pirfenidone) in Improving Surgical Resectability in Patients With Peritoneal Carcinomatosis Ineligible for Definitive Cytoreduction (Randy 1A)
The goal of this clinical trial is to learn if paricalcitol or pirfenidone can help make tumors removable by surgery in adults with peritoneal cancer who are currently unable to have their tumor removed.
The study aims to answer are whether paricalcitol or pirfenidone improve tumor response and tissue healing after 12 weeks of treatment, and which of these two drugs is more effective at helping participants become eligible for surgery. Researchers will compare paricalcitol to pirfenidone to see which drug works better and has a manageable safety profile.
Participants will take either paricalcitol or pirfenidone by mouth every day for 12 weeks while continuing their standard chemotherapy, visit the clinic regularly for checkups and lab tests, keep a daily diary to track their study medication, and undergo a surgical re-evaluation after treatment to see if their tumor can be removed.
研究概览
详细说明
This is a single-center, randomized Phase II clinical trial designed to investigate the efficacy of repurposing fibrosis-modulating agents to improve surgical resectability in patients with peritoneal carcinomatosis. Peritoneal carcinomatosis is characterized by a challenging tumor microenvironment (TME) featuring extensive fibrosis and a high density of cancer-associated fibroblasts (CAFs). These elements create a dense desmoplastic barrier that impedes drug penetration, limits therapeutic efficacy, and frequently renders patients ineligible for definitive surgical cytoreduction.
To overcome these barriers, the trial evaluates two distinct anti-fibrotic agents: paricalcitol, a synthetic Vitamin D receptor agonist that promotes CAF quiescence and stromal remodeling, and pirfenidone, an oral anti-fibrotic agent that inhibits fibrosis by downregulating the TGF-β signaling pathway and collagen synthesis. Eligible participants are randomized in a 1:1 ratio to receive a 12-week course of either oral paricalcitol (2 mcg daily, titratable) or oral pirfenidone (titrated to 801 mg three times daily with food), administered concurrently with their ongoing standard systemic chemotherapy.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Patrick Wagner, MD
- 电话号码：412-359-3731
- 邮箱：patrick.wagner@ahn.org
研究联系人备份
- 姓名：AHN Clinical Trial Contact
- 电话号码：412-359-3731
- 邮箱：clinicaltrials@ahn.org
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Males or females, age 18 to <81 years at the time of consent
- Biopsy-proven peritoneal carcinomatosis
- Documented receipt of at least three months of standard systemic chemotherapy prior to initiation, with persistent disease
- ECOG Performance Status of 0 or 1
- Adequate organ function within 14 days prior to anti-fibrotic initiation
- Negative serum pregnancy test for women of childbearing potential (WOCBP) within 7 days prior to initiation
- Able to understand and provide written informed consent
- Willingness and ability to comply with all study procedures
Exclusion Criteria:
-
Patients deemed eligible for definitive cytoreductive surgery
- Current or recent (within 30 days) use of paricalcitol, pirfenidone, or Vitamin D supplementation above USDA-recommended daily dosage
- Known allergy or medical contraindication to study drugs
- Hypersensitivity to any of the study drugs or to any ingredient in the formulation
- Receipt of any investigational drug within 30 days prior to initiation
- Active pregnancy or lactation
- Active smoking
- Active brain metastases
- Elevated Vitamin D level (>2x upper limit of normal)
- Significant comorbidities including abnormal calcium/phosphate, history of serious drug-induced liver injury, severe cardiac conditions, patients with or predisposed to cardiac arrhythmias, or uncontrolled hypertension
- Concomitant medications that, after review by the study pharmacist(s) and potential dose modification in accordance with prescribing guidelines, still pose an unmanageable drug-drug interaction or unacceptable safety risk with either study drug
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Paricalcitol Arm
Participants receive oral paricalcitol once daily for 12 weeks concurrently with standard systemic chemotherapy. |
Oral, 2 mcg once daily for 12 weeks |
|
实验性的：Pirfenidone Arm
Participants receive oral pirfenidone three times daily for 12 weeks (with initial dose titration) concurrently with standard systemic chemotherapy. |
Oral, titrated up to 801 mg three times daily (total daily dose: 2403 mg/day) with food for 12 weeks. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Paricalcitol Efficacy
大体时间：12 weeks from treatment initiation
|
Proportion of patients achieving a clinicopathologic response (CPR) |
12 weeks from treatment initiation
|
|
Pirfenidone Efficacy
大体时间：12 weeks from treatment initiation
|
Proportion of patients achieving a clinicopathologic response (CPR) |
12 weeks from treatment initiation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Severity of Treatment-Emergent Adverse Events for Paricalcitol [Safety]
大体时间：16 weeks from treatment initiation
|
Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome. |
16 weeks from treatment initiation
|
|
Severity of Treatment-Emergent Adverse Events for Pirfenidone [Safety]
大体时间：16 weeks from treatment initiation
|
Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome |
16 weeks from treatment initiation
|
|
Incidence of Treatment-Emergent Adverse Events for Paricalcitol [Safety
大体时间：16 weeks from treatment initiation
|
Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
16 weeks from treatment initiation
|
|
Incidence of Treatment-Emergent Adverse Events for Pirfenidone [Safety]
大体时间：16 weeks from treatment initiation
|
Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
16 weeks from treatment initiation
|
|
Patient-Reported Quality of Life Outcomes Using the Medical Outcomes Study 20-Item Short-Form Health Survey (SF-20) for Paricalcitol [Tolerability]
大体时间：12 weeks
|
Assessment of patient-reported quality of life outcomes using the SF-20 questionnaire. Each subscale ranges from a minimum score of 0 to a maximum score of 100, where higher scores indicate a better health-related quality of life outcome. |
12 weeks
|
|
Patient-Reported Quality of Life Outcomes Using the Medical Outcomes Study 20-Item Short-Form Health Survey (SF-20) for Pirfenidone [Tolerability]
大体时间：12 weeks
|
Assessment of patient-reported quality of life outcomes using the SF-20 questionnaire. Each subscale ranges from a minimum score of 0 to a maximum score of 100, where higher scores indicate a better health-related quality of life outcome. |
12 weeks
|
|
Treatment Adherence Evaluated via Study Drug Diaries for Paricalcitol [Feasibility]
大体时间：12 weeks
|
Percentage of total prescribed doses taken based on study drug diaries (number of doses taken divided by total expected doses over 12 weeks). |
12 weeks
|
|
Treatment Adherence Evaluated via Study Drug Diaries for Pirfenidone [Feasibility]
大体时间：12 weeks
|
Percentage of total prescribed doses taken based on study drug diaries (number of doses taken divided by total expected doses over 12 weeks). |
12 weeks
|
|
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Paricalcitol [Efficacy]
大体时间：12 weeks
|
Evaluation of molecular correlates of treatment response using research blood samples collected at baseline and post-treatment. |
12 weeks
|
|
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Pirfenidone [Efficacy]
大体时间：12 weeks
|
Evaluation of molecular correlates of treatment response using research blood samples collected at baseline and post-treatment. |
12 weeks
|
|
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Paricalcitol [Efficacy]
大体时间：12 weeks
|
Evaluation of circulating biomarkers of treatment response using research blood samples collected at baseline and post-treatment. |
12 weeks
|
|
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Pirfenidone [Efficacy]
大体时间：12 weeks
|
Evaluation of circulating biomarkers of treatment response using research blood samples collected at baseline and post-treatment. |
12 weeks
|
|
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
大体时间：12 weeks
|
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in Ki-67 positive tumor cells |
12 weeks
|
|
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
大体时间：12 weeks
|
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in Ki-67 positive tumor cells |
12 weeks
|
|
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
大体时间：12 weeks from treatment initiation
|
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in density of Fibroblast Activation Protein-positive (FAP+) |
12 weeks from treatment initiation
|
|
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
大体时间：12 weeks from treatment initiation
|
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in density of Fibroblast Activation Protein-positive (FAP+) |
12 weeks from treatment initiation
|
|
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
大体时间：12 weeks from treatment initiation
|
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples measuring changes in collagen density (quantified via Sirius Red or Masson's Trichrome staining). |
12 weeks from treatment initiation
|
|
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
大体时间：12 weeks from treatment initiation
|
Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples measuring changes in collagen density (quantified via Sirius Red or Masson's Trichrome staining). |
12 weeks from treatment initiation
|
合作者和调查者
调查人员
- 首席研究员：Patrick Wagner、AHN Health Network
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2026-077
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Sharing of data or bio-specimens is not currently planned and will require a separate IRB application and a Material Transfer Agreement (MTA) or Data Use Agreement (DUA), as applicable, in the event that such plans arise in the future
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