Metastatic Pancreatic CancerPhase 2SINAINCT05363007
Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma
A Phase 2 study testing nanoliposomal irinotecan and spleen irradiation in people with Metastatic Pancreatic Cancer, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Splenomegaly is common in advanced pancreatic ductal adenocarcinoma (PDAC). The spleen is an important source of immune suppressive cells and phagocytic cells and may mediate the accumulation of liposomal drugs and immunosuppression. In this study, spleen irradiation (SI) will be added to standard chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- nanoliposomal irinotecan and spleen irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 May 2022to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arm A:
- histologically or cytologically proved PDAC
- metastatic PDAC
- failed frontline gemcitabine-based chemotherapy and preparing for application of NHI-reimbursed nal-IRI/FL
- splenomegaly: SV > 270 ml (estimated)
- lymphopenia: < 1200/mm3
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- no previous radiotherapy, local therapy (eg. radiofrequency ablation, irreversible electroporation, etc.), cell therapy (autologous or allogenic) used for pancreatic cancer
- presence of at least one measurable lesion outside spleen
- age between 20 and 75 years at registration
- ECOG performance status of 0 or 1
- adequate major organ functions
- Arm B:
- limited progressive disease after prior nal-IRI/FL
- prior treatment of nal-IRI/FL at least 4 doses
- histologically or cytologically proven PDAC
- metastatic PDAC before starting prior nal-IRI/FL
- failed frontline gemcitabine-based chemotherapy before prior nal-IRI/FL
- presence of at least one measurable lesion outside spleen
- age between 20 and 75 years at registration
- ECOG performance status of 0 or 1 or 2 after the chemotherapy phase
- adequate major organ functions
Who cannot join
- interstitial lung disease
- presence of diarrhea ≥ CTCAE v.5.0 grade 2
- concomitant systemic infection requiring treatment
- clinically significant co-morbid medical conditions
- prior organ allograft or allogeneic bone marrow transplantation
- received systemic corticosteroids or immunosuppressants within 28 days before registration
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- known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment
- central nervous system metastasis
- prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
- any major surgery within 4 weeks of study treatment. Participants must have recovered from the effects of major surgery or significant traumatic injury.
- pregnant women or nursing mothers, or positive pregnancy tests
- severe mental disorder
- spleen metastasis or direct invasion
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan
Yan-Shen Shan, ysshan@mail.ncku.edu.tw
- Recruiting
National Taiwan University Hospital
Taipei
Si-Chen Lin, 02-23123456, 123796susu@ntuh.gov.tw
About this study
Official title: Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma: a Phase II Study (SINAI)
Splenomegaly is common in advanced pancreatic ductal adenocarcinoma (PDAC). The spleen is an important source of immune suppressive cells and phagocytic cells and may mediate the accumulation of liposomal drugs and immunosuppression. In this study, spleen irradiation (SI) will be added to standard chemotherapy.
Read the detailed description
Splenomegaly is common in PDAC. Therefore, we design a phase II study to enroll metastatic PDAC patients who have failed prior gemcitabine-based therapy and have splenomegaly. With add-on SI to standard nal-IRI/FL therapy, we hypothesize that 1) splenic phagocytes and spleen volume will be reduced with attenuated entrapment of nal-IRI within spleen, 2) splenic source of immunosuppressive immune cells will be reduced with potential reconstitution of antitumor TME.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- nanoliposomal irinotecan, spleen irradiation
- Keywords
- pancreatic cancer, nanoliposomal irinotecan, spleen irradiation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoliposomal irinotecanDrug
Also called 5-FU/leucovorin
Upfront SI (Arm A): Upfront nanoliposomal irinotecan (80 mg/m2, day 1) + 5-FU/leucovorin (2400 mg/m2, 400 mg/m2) plus SI
Add-on SI (Arm B): Add-on SI following limited progression to prior nanoliposomal irinotecan (last dose used) + 5-FU/leucovorin (last dose used)
spleen irradiationRadiation
Upfront SI (Arm A): upfront spleen irradiation (1 Gy/fx, day 1-4) in cycle 2
Add-on SI (Arm B): add-on spleen irradiation (1 Gy/fx, day 1-4) in cycle 1 following limited progression to prior nanoliposomal irinotecan + 5-FU/leucovorin
| Study group | Role | What they receive |
|---|---|---|
| Upfront SI | Experimental | Upfront nanoliposomal irinotecan + 5-FU/leucovorin plus SI Receives: Drug: nanoliposomal irinotecan; Radiation: spleen irradiation |
| Add-on SI | Experimental | Add-on SI following limited progression to nanoliposomal irinotecan + 5-FU/leucovorin Receives: Drug: nanoliposomal irinotecan; Radiation: spleen irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
12W-PFS
12-week PFS rate (%)
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shih-Hung Yang, MD., PhD., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363007
- Sponsor's protocol ID
- 202110064MIPB
- Acronym
- SINAI
- Status last verified
- Jun 2023
- First submitted
- 2 May 2022
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma: a Phase II Study (SINAI)
- ClinicalTrials.gov ID
- NCT05363007
- Acronym / sponsor ID
- SINAI / 202110064MIPB
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- pancreatic cancer, nanoliposomal irinotecan, spleen irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 May 2022 (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.
Splenomegaly is common in advanced pancreatic ductal adenocarcinoma (PDAC). The spleen is an important source of immune suppressive cells and phagocytic cells and may mediate the accumulation of liposomal drugs and immunosuppression. In this study, spleen irradiation (SI) will be added to standard chemotherapy.
Detailed description
Splenomegaly is common in PDAC. Therefore, we design a phase II study to enroll metastatic PDAC patients who have failed prior gemcitabine-based therapy and have splenomegaly. With add-on SI to standard nal-IRI/FL therapy, we hypothesize that 1) splenic phagocytes and spleen volume will be reduced with attenuated entrapment of nal-IRI within spleen, 2) splenic source of immunosuppressive immune cells will be reduced with potential reconstitution of antitumor TME.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront SI | Experimental | Drug: nanoliposomal irinotecan, Radiation: spleen irradiationUpfront nanoliposomal irinotecan + 5-FU/leucovorin plus SI |
| Add-on SI | Experimental | Drug: nanoliposomal irinotecan, Radiation: spleen irradiationAdd-on SI following limited progression to nanoliposomal irinotecan + 5-FU/leucovorin |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Arm A:
- histologically or cytologically proved PDAC
- metastatic PDAC
- failed frontline gemcitabine-based chemotherapy and preparing for application of NHI-reimbursed nal-IRI/FL
- splenomegaly: SV > 270 ml (estimated)
Key exclusion criteria (14 listed)
- interstitial lung disease
- presence of diarrhea ≥ CTCAE v.5.0 grade 2
- concomitant systemic infection requiring treatment
- clinically significant co-morbid medical conditions
- prior organ allograft or allogeneic bone marrow transplantation
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 |
|---|---|---|
| nanoliposomal irinotecanAlso: 5-FU/leucovorinUpfront SI (Arm A): Upfront nanoliposomal irinotecan (80 mg/m2, day 1) + 5-FU/leucovorin (2400 mg/m2, 400 mg/m2) plus SI Add-on SI (Arm B): Add-on SI following limited progression to prior nanoliposomal irinotecan (last dose used) + 5-FU/leucovorin (last dose used) | Drug | Add-on SI, Upfront SI |
| spleen irradiationUpfront SI (Arm A): upfront spleen irradiation (1 Gy/fx, day 1-4) in cycle 2 Add-on SI (Arm B): add-on spleen irradiation (1 Gy/fx, day 1-4) in cycle 1 following limited progression to prior nanoliposomal irinotecan + 5-FU/leucovorin | Radiation | Add-on SI, Upfront SI |
Primary outcome
12W-PFS
Time frame: 12 week
12-week PFS rate (%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shih-Hung Yang, MD., PhD. principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nanoliposomal irinotecan and spleen irradiation in people with Metastatic Pancreatic Cancer, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 21 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Hung Yang, MD., PhD. (886-2-23123456, b4401064@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12W-PFS (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2023.