Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Phase 2

Recruiting

• Conditions: Pancreatic Neoplasms
• Interventions: Drug: Tamoxifen 20 mg

• Registration Number: NCT06914674
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2027-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tamoxifen	Tamoxifen 20 mg	Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFSn)	1 month	Time from enrollment to disease progression

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Shanghai Cancer Center; 🇨🇳 Shanghai, China