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RecruitingNCT06914674SPTPUpdated Apr 6, 2025

Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

A Phase 2 interventional study of Tamoxifen 20 mg in Pancreatic Neoplasms, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
14 Years to 80 Years
Sex
All
01

Study summary

Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

Read the 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.

02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • Solid Pseudopapillary Tumor of the Pancreas
  • Malignant
  • Advanced
  • Recurrence
  • Metastasis
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's planned enrollment of 30 is below the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Browse Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Tamoxifen

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

    Drug: Tamoxifen 20 mg

Interventions

  • DrugTamoxifen 20 mg

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

06

What researchers measure

Primary outcomes

  1. Progression-free survival (PFSn)

    Time from enrollment to disease progression

    Time frame: 1 month

Secondary outcomes

  1. Overall survival （OS）

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

    Time frame: 1 month

  2. disease control rate (DCR)

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

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Shanghai Cancer Center
    Shanghai, 200032, China
    • Xia Huanyu MD · Contact · xiahuanyu@fudanpci.org · 86 21 64031446
    • Guopei Luo Prof, MD · Principal investigator
    Recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 25010708 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06914674
Lead sponsor
Fudan University
Responsible party
Guopei Luo (Prof., Fudan University) — Principal investigator
First posted
Apr 6, 2025
Start date
Mar 20, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Apr 6, 2025

Study contacts

Huanyu Xia MD
Contact
xiahuanyu@fudanpci.org
86 21 64031446
Guopei Luo Prof, MD
principal investigator · Shanghai Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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