Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06914674

Acronym

SPTP

Enrollment

Registered

2025-04-06

Start date

2025-03-20

Completion date

2028-02-28

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Keywords

Solid Pseudopapillary Tumor of the Pancreas, Malignant, Advanced, Recurrence, Metastasis

Brief summary

Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

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.

Interventions

DRUGTamoxifen 20 mg

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

• Tamoxifen: 10 mg orally twice daily.

Eligibility

Sex/Gender

ALL

Age

14 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactHuanyu Xia MD

xiahuanyu@fudanpci.org86 21 64031446

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026