Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

NCT ID: NCT06914674

Last Updated: 2025-04-06

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2028-02-28

Brief Summary

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Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

Detailed Description

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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.

Conditions

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Pancreatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

• Tamoxifen: 10 mg orally twice daily.
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Tamoxifen 20 mg

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Guopei Luo

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Huanyu Xia MD

Role: CONTACT

86 21 64031446

Facility Contacts

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Xia Huanyu MD

Role: primary

86 21 64031446

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.

Reference Type BACKGROUND
PMID: 36176411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28054945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8378176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25010708 (View on PubMed)

Other Identifiers

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PTCA199-14

Identifier Type: -

Identifier Source: org_study_id

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