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

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Pancreatic Neoplasms

Treatments: Drug: Tamoxifen 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06914674

PTCA199-14

Details and patient eligibility

About

Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Tamoxifen

Experimental group

Description:

Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition.

Treatment:

Drug: Tamoxifen 20 mg