Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas
NCT ID: NCT06914674
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-03-20
2028-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tamoxifen
Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition.
Tamoxifen 20 mg
Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition.
Interventions
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Tamoxifen 20 mg
Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition.
Eligibility Criteria
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Inclusion Criteria
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
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.
14 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Guopei Luo
Prof.
Principal Investigators
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Guopei Luo Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Cancer Center
Locations
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Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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PTCA199-14
Identifier Type: -
Identifier Source: org_study_id
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