Phase
Condition
Pancreatitis
Digestive System Neoplasms
Pancreatic Cancer
Treatment
Gemcitabine
Liposomal Irinotecan
S-1
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients able and willing to provide a written informed consent aged 18-75 years.
Histologically confirmed resected ductal pancreatic adenocarcinoma (includingadenosquamous carcinoma).
Undergone radical resection and confirmed macroscopic complete resection (R0 andR1).
Full recovery after surgery; able to start adjuvant treatment within 12 weeks aftersurgery.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
The main organs function well.
Exclusion
Exclusion Criteria:
Patients with other types of non-ductal tumor of the pancreas, including endocrinetumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillarytumor.
Macroscopic incomplete tumor removal (R2 resection).
Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreaticadenocarcinoma.
Presence or history of metastatic or locally recurrent 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.
Known peripheral neuropathy (CTCAE ≥ Grade 2).
Known deficiency of dihydropyrimidine dehydrogenase (DPD)
Subjects with a confirmed diagnosis of Gilbert's syndrome