Tamoxifen treatment for advanced pancreatic tumors
Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas
This study is testing if tamoxifen can help people with advanced pancreatic tumors that can't be removed or have spread, especially for those with hormone receptor-positive tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06914674 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of tamoxifen, a selective estrogen receptor modulator, in patients with advanced solid pseudopapillary tumors of the pancreas. The study focuses on individuals with unresectable or metastatic disease, where standard treatment options are limited. Participants will receive tamoxifen at a dosage of 20 mg, and the trial aims to determine its impact on tumor progression and patient outcomes. The study is particularly relevant for those with hormone receptor-positive tumors, as previous case reports suggest potential benefits.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14-80 with histologically confirmed advanced solid pseudopapillary tumors that express estrogen and progesterone receptors.
Not a fit: Patients with non-solid pseudopapillary tumor pathology or those with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid pseudopapillary tumors of the pancreas.
How similar studies have performed: While there are limited studies on tamoxifen for this specific tumor type, case reports suggest it may improve outcomes, indicating a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Guopei Luo Prof, MD — Shanghai Cancer Center
- Study coordinator: Huanyu Xia MD
- Email: xiahuanyu@fudanpci.org
- Phone: 86 21 64031446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.