Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

About this trial

This is a prospective, open-label therapeutic interventional investigation designed to interrogate the efficacy and safety of individualized matched therapies in patients with pancreatic cancer at high risk of disease recurrence post-surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).

Pancreatic tumor is surgically removed and

patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or

Disqualifiers

CA 19-9 non-producers, unless high-risk pathological features present.

Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).

Radiographic evidence of metastatic disease.

Inability to ingest study drugs by mouth.

Trial design

Design model

Single group

Treatments tested in this trial

  • Treatment Plan

    Other intervention

    A matched treatment regimen will be administered for approximately 12 weeks based on recommendations made by the MTB.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Molecular Tumor Board (MTB)-recommended matched therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free Survival

The number of subjects exhibiting disease-free survival at six months. Disease-free survival is defined as the time from study therapy initiation until disease recurrence or death from any cause.

Time frame
Six months
2

Adverse Events

The number of clinically relevant Grade 3 to 4 adverse events and serious adverse events that are at least possibly related to the study therapy per investigator assessment.

Time frame
Up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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