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A Prospective Study of Concurrent Hyperthermia, Chemotherapy and Radiotherapy in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT) (PANHEAT)

2026年9月23日 更新者：Pedro C Lara、Fernando Pessoa Canarias University

A Prospective Study of Concurrent Hyperthermia Plus Standard of Care in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)

The project proposes a prospective multicenter study to evaluate the incorporation of deep regional hyperthermia into the standard of care neoadjuvant chemotherapy (mFOLFIRINOX/NABPACLITAXEL) followed by radiotherapy in borderline and locally advanced ductal adenocarcinoma pancreatic cancer. Although current treatments, based on induction chemotherapy followed by surgery or radiotherapy in selected patients, have improved survival and resection rates, overall survival remains poor.

Hyperthermia is a therapeutic intensification strategy with a solid biological basis. By controlling tumor heating (39-43°C), it enhances the efficacy of chemotherapy and radiation therapy by improving tumor oxygenation, increasing perfusion, and inhibiting DNA damage repair, without adding significant systemic toxicity. The available clinical evidence, although based mainly on retrospective and small studies, suggests that the combination of HRP with multimodal treatments improves local control, favors conversion to surgery, and may prolong survival while maintaining a favorable safety profile.

The protocol contemplates the initial administration of induction chemotherapy (preferably mFOLFIRINOX or, alternatively, gemcitabine with nab-paclitaxel)plus hyperthermia followed by multidisciplinary reevaluation. Patients who deemed resectable will undergo surgery and adjuvant chemoradiotherapy and hyperthermia. Patients without metastatic progression who remain unresectable will receive SBRT in five fractions along with sessions of deep regional hyperthermia. Subsequently, the possibility of surgery will be assessed again and a standardized follow-up will be carried out with clinical, radiological, biochemical and pathological evaluation when appropriate.

The main objective of the study is to determine the impact of this strategy on overall survival. Secondary objectives will be to evaluate progression-free survival, local control, conversion rate to surgery, proportion of R0 resections, tumor response, safety, tolerability, and feasibility of treatment. With this, the study aims to provide prospective evidence on the role of hyperthermia as a therapeutic intensification strategy in localized pancreatic cancer.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 西班牙
    • Las Palmas
      • Las Palmas de Gran Canaria、Las Palmas、西班牙、35010
        • Hospital Universitario de Gran Canaria Dr Negrín
        • 接触：
    • Malaga
      • Málaga、Malaga、西班牙

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Patients of borderline or Locally advanced pancreatic cancer

Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy/cytology).

ECOG performance scale 0 and 1.

Age between 18 and 80 years.

Adequate kidney functionality defined as creatinine clearance >50 ml/min.

Adequate liver functionality defined as total bilirubin ≤2 times of the upper limit of normal.

Adequate bone marrow reserves: WBC count ≥2.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin ≥8.0 g/L.

Women of child-bearing age must secure sufficient contraception control (dual protection with condoms and pills) during the clinical trial and 6 months after the clinical trial is completed.

For females of child bearing potential, pregnancy test within 2 week prior to randomization should be negative.

Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule.

Exclusion criteria

Absence of distant metastasis or gross peritoneal carcinomatosis.

Prior or concurrent malignancies.

Patients having metal implants, pacemakers or clustered markers.

Patients with metallic endobiliary stent would need to be replaced with plastic stents.

Any history of myocardial infarction within the past 12 months.

Any connective tissue disorder that contraindicate RT, e.g., scleroderma.

Pre-existing grade 2 peripheral neuropathy.

Any known contraindication or hypersensitivity to the chemotherapeutic agents used in the study as decided by the medical oncologists.

Pregnancy, lactation period or lack of reliable contraception.

Any other disease or therapy, which, according to the investigator, present a risk to the patient or which are not compatible with the aims of the clinical trial.

Indications that the person concerned will possibly not keep to the clinical trial plan because of unwillingness to cooperate or difficulties in keeping the check-up appointments.

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学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 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：Hyperthermia plus neoadjuvant chemotherapy/radiotherapy

Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyperthermia plus adjuvant chenmotherapy+/-radiotherapy b) surgically non-resectable: hyperthermia plus SBRT
设备：Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp

Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyperthermia plus adjuvant chenmotherapy+/-radiotherapy b) surgically non-resectable: hyperthermia plus SBRT

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
overall survival
大体时间：one year

Time from included in the study to death for any cause
one year

次要结果测量

结果测量
措施说明
大体时间
Progression Free Survival
大体时间：one year

Time from included in the study to disease progression
one year
Objective response rate (ORR)
大体时间：6 months

according to RECIST 1.1.
6 months
disease control rate (DCR),
大体时间：6 months

according to RECIST 1.1.
6 months
Biochemical response using CEA and CA 19-9.
大体时间：6 months

Modifications CEA and CA19.9 values
6 months
Conversion rate to surgery.
大体时间：6 months

Resectabiity after neoadjuvant treatment
6 months
R0 resection rate
大体时间：7 months

Rate of complete resection in surgically treated patients
7 months
Pathological response, including ypTNM and GRT.
大体时间：7 months

Pathological confirmed response after neoadjuvant treatment
7 months
Local progression-free survival as first cause of failure
大体时间：one year

Time from included in the study to local progression after treatment as first site of failure
one year
Acute and late toxicity chemotherapy and radiotherapy
大体时间：Acute: one month. Late: 12 months

Acute and late toxicity of treatment according to CTCAE v5.0.
Acute: one month. Late: 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fernando Pessoa Canarias University

调查人员

  • 首席研究员：Pedro C Lara, Md, PhD、Universidad Fernando Pessoa Canarias

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年3月31日

初级完成 (估计的)

2032年3月31日

研究完成 (估计的)

2032年3月31日

研究注册日期

首次提交

2026年9月13日

首先提交符合 QC 标准的

2026年9月23日

首次发布 (实际的)

2026年9月24日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UFPC-26-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Data will be sharing under request due to ethic limitations

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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