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Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Experimental | Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen 20 mg | Drug | Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFSn) | Time from enrollment to disease progression | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS of subjects from recruiting to the time of death from any cause | 1 month |
| disease control rate (DCR) | disease control rate (DCR = CR + PR + SD) |
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Inclusion Criteria:
Age 14-80 years.
Histologically confirmed advanced SPTP with ER/PR+.
Advanced disease:
≥1 measurable lesion.
ECOG performance status 0-2.
Life expectancy ≥1 month.
Able to comply with study visits and oral medication.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huanyu Xia MD | Contact | 86 21 64031446 | xiahuanyu@fudanpci.org |
| Name | Affiliation | Role |
|---|---|---|
| Guopei Luo Prof, MD | Shanghai Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Cancer Center | Recruiting | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36176411 | Background | 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. | |
| 28054945 | Background |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D012008 | Recurrence |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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• Tamoxifen: 10 mg orally twice daily.
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| 1 month |
| 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. |
| 8378176 | Background | 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. |
| 25010708 | Background | 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. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |