NCT06914674

Brief Summary

Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
22mo left

Started Mar 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Mar 2025Feb 2028

Study Start

First participant enrolled

March 20, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

March 31, 2025

Last Update Submit

March 31, 2025

Conditions

Pancreatic Neoplasms

Keywords

Solid Pseudopapillary Tumor of the PancreasMalignantAdvancedRecurrenceMetastasis

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFSn)

    Time from enrollment to disease progression

    1 month

Secondary Outcomes (2)

  • Overall survival （OS）

    1 month

  • disease control rate (DCR)

    1 month

Study Arms (1)

Tamoxifen

EXPERIMENTAL

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

Tamoxifen 20 mgDRUG

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

Tamoxifen

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

Related Publications (4)

  • 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: 36176411BACKGROUND

  • 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: 28054945BACKGROUND

  • 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: 8378176BACKGROUND

  • 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: 25010708BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsRecurrenceNeoplasm Metastasis

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Guopei Luo Prof, MD

    Shanghai Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huanyu Xia MD

CONTACT

86 21 64031446xiahuanyu@fudanpci.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: • Tamoxifen: 10 mg orally twice daily.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

April 6, 2025

Record last verified: 2025-03

Locations

CN(1)