NCT06571461Not yet recruitingPhase 3
Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 27 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 408 (estimated)
- First submitted
- 22 Aug 2024
- Start date
- Sept 2024
- Primary completion date
- Jan 2028
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Diseases
- Pancreatic cancer
- NCT number
- NCT06571461
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 408
- From Sept 2024 to the primary completion date, Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Macroscopic incomplete tumor removal (R2 resection).
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
- CA 19-9\> 180 U / ml within 21 days before randomization.
- The toxicity of previous therapy has not recovered to Grade 1 or below.
Other illness
- Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
- Subjects with a confirmed diagnosis of Gilbert's syndrome
Other
- Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
- Known peripheral neuropathy (CTCAE ≥ Grade 2).
- Known deficiency of dihydropyrimidine dehydrogenase (DPD)
Who the study is looking for
- Patients able and willing to provide a written informed consent aged 18-75 years.
- Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
- Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
- Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- The main organs function well.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.