Pancreatic NeoplasmsPhase 2SPTPNCT06914674
Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas
A Phase 2 study testing Tamoxifen 20 mg in people with Pancreatic Neoplasms, run by Fudan University at 1 site in China.
Trial summary
Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Tamoxifen 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2025to 28 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- ECOG performance status 0-2.
- Life expectancy ≥1 month.
- Able to comply with study visits and oral medication.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Cancer Center
Shanghai, 200032
Xia Huanyu MD, 86 21 64031446, xiahuanyu@fudanpci.org
Guopei Luo Prof, MD
About this study
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.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Tamoxifen 20 mg
- Keywords
- Solid Pseudopapillary Tumor of the Pancreas, Malignant, Advanced, Recurrence, Metastasis
- Medical subject headings
- Pancreatic Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen 20 mgDrug
Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Experimental | Tamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition. Receives: Drug: Tamoxifen 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFSn)
Time from enrollment to disease progression
Measured: 1 month
Secondary outcomes (2)
Overall survival （OS）
OS of subjects from recruiting to the time of death from any cause
Measured: 1 month
disease control rate (DCR)
disease control rate (DCR = CR + PR + SD)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- • Tamoxifen: 10 mg orally twice daily.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Luo, Fudan University
- Investigators
- Guopei Luo Prof, MD, Principal investigator, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914674
- Sponsor's protocol ID
- PTCA199-14
- Acronym
- SPTP
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 36176411Guo 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 28054945Nishihara 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 8378176Dominguez-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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas
- ClinicalTrials.gov ID
- NCT06914674
- Acronym / sponsor ID
- SPTP / PTCA199-14
- Conditions
- Pancreatic Neoplasms
- Keywords
- Solid Pseudopapillary Tumor of the Pancreas, Malignant, Advanced, Recurrence, Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- • Tamoxifen: 10 mg orally twice daily.
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | Experimental | Drug: Tamoxifen 20 mgTamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age 14-80 years.
- Histologically confirmed advanced SPTP with ER/PR+.
- Advanced disease:
- ≥1 measurable lesion.
- ECOG performance status 0-2.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamoxifen 20 mgTamoxifen: 10 mg orally twice daily. Combination therapy: Chemotherapy, radiotherapy, surgery, or other treatments per NCCN guidelines and patient condition. | Drug | Tamoxifen |
Primary outcome
Progression-free survival (PFSn)
Time frame: 1 month
Time from enrollment to disease progression
2 secondary outcomes
Overall survival （OS）
Time frame: 1 month
disease control rate (DCR)
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 36176411Kornietskaya 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.
- Background: PubMed 28054945Guo 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.
- Background: PubMed 8378176Nishihara 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.
- Background: PubMed 25010708Dominguez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guopei Luo Prof, MD principal investigator
Shanghai Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen 20 mg in people with Pancreatic Neoplasms, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huanyu Xia MD (86 21 64031446, xiahuanyu@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFSn) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06914674, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.