Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Phase 2RecruitingNCT06914674

Fudan University30 enrolled

Overview

Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Neoplasms

Interventions

Tamoxifen 20 mgDRUG

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

Eligibility

Sex: ALLMin age: 14 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Cancer Center

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Progression-free survival (PFSn)

Time from enrollment to disease progression

Time frame: 1 month

Secondary Outcomes

Overall survival （OS）

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

Time frame: 1 month

disease control rate (DCR)

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

Time frame: 1 month

Central Contacts

Huanyu Xia MD

CONTACT

86 21 64031446 xiahuanyu@fudanpci.org

Data from ClinicalTrials.gov

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