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Recruiting

NCT Number: NCT06914674

Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

Recruiting

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Cancer Center

Shanghai, 200032, China

Location status: Recruiting

Location contact

Guopei Luo Prof, MD

PRINCIPAL_INVESTIGATOR

Xia Huanyu MD

CONTACT

[email protected]

86 21 64031446

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 14-80 years.
  • Histologically confirmed advanced SPTP with ER/PR+.
  • Advanced disease:
  • Unresectable primary tumor or distant metastasis (liver, lung, peritoneum, etc.).
  • Recurrent or refractory after prior surgery/systemic therapy.
  • ≥1 measurable lesion.
  • ECOG performance status 0-2.
  • Life expectancy ≥1 month.
  • Able to comply with study visits and oral medication.

Exclusion criteria

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

Treatment and study plan

Tamoxifen 20 mg

Drug

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

Primary outcomes

  1. Progression-free survival (PFSn)

    Time frame: 1 month

    Time from enrollment to disease progression

Secondary outcomes

  1. Overall survival （OS）

    Time frame: 1 month

    OS of subjects from recruiting to the time of death from any cause

  2. disease control rate (DCR)

    Time frame: 1 month

    disease control rate (DCR = CR + PR + SD)

Study contacts

Contact information is provided by the study sponsor or research team.

Huanyu Xia MD

CONTACT

[email protected]

86 21 64031446

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Acronym: SPTP

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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