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Recruiting NCT06914674

Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Phase II Interventional Pancreatic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tamoxifen 20 mg.
Who it may be relevant to
Registry conditions: Pancreatic Neoplasms. Basic parameters: 14 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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

  • Progression-free survival (PFSn) [Time frame: 1 month]
Secondary outcome measures (2)
  • Overall survival （OS） [Time frame: 1 month]
  • disease control rate (DCR) [Time frame: 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Cancer Center — Shanghai

Publications

  • 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. PMID 36176411
  • 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. PMID 28054945
  • 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. PMID 8378176
  • 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. PMID 25010708

Identifiers

NCT: NCT06914674 · PTCA199-14

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗