Clinical trial NCT02461836 (phase 2, status: unknown status)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: gemcitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          1. Male/Female subjects, age ≥ 18 years and ≤ 75 years old at the time informed consent
             is signed

          2. Pathologically confirmed pancreatic adenocarcinoma or mixed-type pancreatic carcinoma
             (adenocarcinoma predominantly)

          3. The operation must be radical resection (R0), with all margins negative.

          4. Eastern Cooperative Oncology Group (ECOG) score: 0-2

          5. Without large volume ascites or pleural effusion

          6. Lab tests:

             a Complete blood cell count: HGB≥100g/L, WBC≥4×109/L, PLT≥100×109/L b Liver function:
             Total bilirubin≤3 x upper limit of normal range (ULN) with direct bilirubin within
             normal range, alanine aminotransferase (ALT) / aspartate aminotransferase (AST)≤3 c
             Renal function: Creatine≤1.5 x ULN or creatine clearance≥60 ml/min

          7. Heart and lung function well (Eject function>55%)

          8. Females of child-bearing potential must demonstrate a negative serum pregnancy test
             result at screening confirmed by local negative urine pregnancy dipstick within 72
             hours prior to the first dose of Gemcitabine.

          9. At least 30 days from major surgery before randomization, with full recovery

         10. Understand and voluntarily sign an informed consent document prior to any study
             related assessments/procedures are conducted

         11. Able to adhere to the study visit schedule and other protocol requirements

        Exclusion Criteria:

          1. Margin positive resections (R1 or R2)

          2. Resection of recurrence pancreatic cancer

          3. Other types of pancreatic cancer (non-adenocarcinoma)

          4. Subjects with severe complications, can't tolerate chemotherapy in 4-12 weeks after
             surgery

          5. Subjects with severe bone marrow suppression

          6. Subjects with a history of severe lung diseases (interstitial lung disease,
             sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity
             pneumonitis), severe liver diseases (active hepatitis, liver cirrhosis), renal
             dysfunction, uncontrolled diabetes and hypertension, or multiple and severe allergies
             which may lead to serious complications

          7. Subjects with severe heart diseases (congested heart failure, systematic coronary
             disease, uncontrolled arrhythmia, or myocardial infarction in 6 months)

          8. Under treatment with steroids for a long time

          9. Subjects with early recurrence of pancreatic cancer before initiation of chemotherapy

         10. Subjects with diarrhea and infection (body temperature >38.5℃)

         11. Subjects who was enrolled into another clinical study or finished another clinical
             study within the previous 4 weeks prior to randomization

         12. Pregnant or nursing women

         13. Subjects with other type of malignancies, except of curated basal cell carcinoma and
             carcinoma in situ of cervix which finished treatments more than half one year ago

         14. Subjects having any significant medical condition, laboratory abnormality, or
             psychiatric illness that would prevent them from participating in the study

         15. Any condition that confounds interpreting data from the study