Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Last updated: March 31, 2025
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Treatment

Tamoxifen 20 mg

Clinical Study ID

NCT06914674
PTCA199-14
  • Ages 14-80
  • All Genders

Study Summary

Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

Eligibility Criteria

Inclusion

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.

  1. ≥1 measurable lesion.

  2. ECOG performance status 0-2.

  3. Life expectancy ≥1 month.

  4. Able to comply with study visits and oral medication.

Exclusion

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 Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Tamoxifen 20 mg
Phase: 2
Study Start date:
March 20, 2025
Estimated Completion Date:
February 28, 2028

Study 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.

Connect with a study center

  • Shanghai Cancer Center

    Shanghai, 200032
    China

    Active - Recruiting

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