Irradiating the spleen with nanoliposomal irinotecan and chemotherapy for metastatic pancreatic cancer
Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma: a Phase II Study (SINAI)
This study is testing if combining spleen radiation with chemotherapy can help people with advanced pancreatic cancer who have an enlarged spleen and haven’t responded to previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Tainan and 1 other locations) |
| Trial ID | NCT05363007 on ClinicalTrials.gov |
What this trial studies
This phase II study aims to evaluate the effects of spleen irradiation combined with standard chemotherapy in patients with metastatic pancreatic adenocarcinoma who have splenomegaly and have previously failed gemcitabine-based therapy. The hypothesis is that spleen irradiation will reduce the volume of the spleen and the number of immunosuppressive cells, potentially enhancing the efficacy of the chemotherapy. Participants will receive nanoliposomal irinotecan and leucovorin alongside spleen irradiation to improve treatment outcomes. The study will enroll patients aged 20 to 75 with specific eligibility criteria related to their cancer status and prior treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 75 with metastatic pancreatic adenocarcinoma who have splenomegaly and have failed prior gemcitabine-based therapy.
Not a fit: Patients who have previously received radiotherapy or other local therapies for pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment efficacy and outcomes for patients with advanced pancreatic cancer.
How similar studies have performed: While the combination of spleen irradiation with chemotherapy is a novel approach, similar studies have shown promise in enhancing treatment outcomes for other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Tainan and 1 other locations
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Shih-Hung Yang, MD., PhD. — National Taiwan University Hospital
- Study coordinator: Shih-Hung Yang, MD., PhD.
- Email: b4401064@gmail.com
- Phone: 886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.