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A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer

NCT07711067 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-07-17

No results posted yet for this study

Summary

Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis and limited treatment options following failure of first-line therapy. Whole-body hyperthermia (WBHT) is a non-invasive treatment approach that raises the body's core temperature under controlled conditions and may enhance the effects of anticancer therapies through multiple biological mechanisms, including improved drug delivery, modulation of the immune response, and increased sensitivity to treatment.

The MATTERS-2 study is a multicentre, randomized clinical trial designed to evaluate the efficacy and safety of WBHT in combination with standard systemic anticancer therapy in patients with metastatic PDAC after failure of first-line treatment. Participants will receive either standard systemic therapy alone or standard systemic therapy combined with WBHT.

The primary objective of the study is to determine whether the addition of WBHT improves clinical outcomes compared with standard therapy alone in terms of overall survival (OS) while maintaining safety. Secondary objectives include other clinical outcomes such as progression-free survival (PFS), disease control rate (DCR) and objective response rate (ORR). Further, quality of life assessments (QoL) and exploratory biomarker analyses will also be performed.

Conditions

  • Pancreatic Ductal Adenocarcinoma (mPDAC)
  • Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

DEVICE

Whole-body hyperthermia

Initially every 2 weeks, until a total of 3 treatments is reached. Thereafter every 4 weeks. The treatment will raise the body temperature to 41,50 °C for a total of 4 hours.

DRUG

Standard-of-Care Systemic therapy

Standard-of-care systemic therapy for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC, stage IV) after failure of first-line treatment.

Sponsors & Collaborators

  • Xper research

    collaborator UNKNOWN

  • ElmediX

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2030-03-31
Completion
2030-12-31

Countries

  • Belgium
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711067 on ClinicalTrials.gov