Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas (SPTP)

March 31, 2025 updated by: Guopei Luo, Fudan University
Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Solid pseudopapillary tumor of the pancreas (SPTP) is a rare neoplasm, predominantly affecting young females, with unclear pathogenesis and hormonal receptor (estrogen/progesterone receptor) expression potentially influencing tumor behavior. While surgical resection is the standard treatment, patients with advanced, metastatic, or recurrent disease lack effective therapies. Case reports suggest tamoxifen, a selective estrogen receptor modulator, may improve outcomes in hormone receptor-positive SPTP. This trial aims to evaluate tamoxifen's efficacy and safety in advanced SPTP.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Shanghai Cancer center
        • Contact:
        • Contact:
          • Guopei Luo Prof, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 14-80 years.
  2. Histologically confirmed advanced SPTP with ER/PR+.

  3. Advanced disease:

    • Unresectable primary tumor or distant metastasis (liver, lung, peritoneum, etc.).
    • Recurrent or refractory after prior surgery/systemic therapy.
  4. ≥1 measurable lesion.
  5. ECOG performance status 0-2.
  6. Life expectancy ≥1 month.
  7. Able to comply with study visits and oral medication.

Exclusion Criteria:

  1. Non-SPTP pathology.
  2. Active gastrointestinal inflammation/infection (e.g., pancreatitis).
  3. Pregnancy/lactation.
  4. Severe organ dysfunction (renal, cardiac, hepatic, or pulmonary).
  5. Uncontrolled comorbidities (e.g., CNS disorders, unstable angina).
  6. Conditions compromising patient safety or data integrity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamoxifen
Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition.
Drug: Tamoxifen 20 mg
Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFSn)
Time Frame: 1 month
Time from enrollment to disease progression
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival （OS）
Time Frame: 1 month
OS of subjects from recruiting to the time of death from any cause
1 month
disease control rate (DCR)
Time Frame: 1 month
disease control rate (DCR = CR + PR + SD)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Guopei Luo Prof, MD, Shanghai Cancer center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTCA199-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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