Clinical trial NCT06914674: Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas
Official title: Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Keywords: Solid Pseudopapillary Tumor of the Pancreas
Malignant
Advanced
Recurrence
Metastasis
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: • Tamoxifen: 10 mg orally twice daily.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Progression-free survival (PFSn)
timeFrame: 1 month
Secondary outcomes:
measure: Overall survival （OS）
timeFrame: 1 month
measure: disease control rate (DCR)
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center
Study officials:
affiliation: Shanghai Cancer Center
name: Guopei Luo Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kornietskaya A, Evdokimova S, Kachmazov A, Fedenko A, Bolotina L, Sidorov D, Volchenko N, Goeva N, Govaleshko A, Kaprin A. Endocrine therapy for metastatic solid pseudopapillary neoplasm of the pancreas: A case report. Front Oncol. 2022 Sep 13;12:970142. doi: 10.3389/fonc.2022.970142. eCollection 2022.
citation: Guo M, Luo G, Jin K, Long J, Cheng H, Lu Y, Wang Z, Yang C, Xu J, Ni Q, Yu X, Liu C. Somatic Genetic Variation in Solid Pseudopapillary Tumor of the Pancreas by Whole Exome Sequencing. Int J Mol Sci. 2017 Jan 3;18(1):81. doi: 10.3390/ijms18010081.
citation: Nishihara K, Tsuneyoshi M, Ohshima A, Yamaguchi K. Papillary cystic tumor of the pancreas. Is it a hormone-dependent neoplasm? Pathol Res Pract. 1993 Jun;189(5):521-6. doi: 10.1016/S0344-0338(11)80359-6.
citation: Dominguez-Rosado I, Chan C, Ortiz-Hidalgo C, Chable-Montero F, Uscanga LF, Campuzano M, Robles-Diaz G. Immunohistochemical expression of luteinizing hormone receptor in solid pseudopapillary tumor of the pancreas. Pancreas. 2014 Aug;43(6):971-2. doi: 10.1097/MPA.0000000000000134. No abstract available.