K-001 Treatment of Advanced Pancreatic Cancer: Clinical Trial of Monotherapy's Tolerability

Exclusion Criteria

• •Disease-related criteria for exclusion:
• •1. Patients of pancreatic tumor but not adenocarcinoma;
• •2. Having received radiotherapy for his/her target lesions prior to this study, with no progress;
• •3. Known presence of brain metastases or leptomeningeal metastases;
• •4. With Vater's ampulla cancer or bile duct cancer;
• •5. Partial or complete intestinal obstruction;
• •6. History of other malignancies in past five years, except for:
• •* A consecutive 5-year disease-free survival from single surgery of other malignancies;
• •* Cured basal cell carcinoma and cured cervical carcinoma in situ.
• •General criteria for exclusion:
• •7. Pregnant or breast-feeding women;
• •8. Any unstable systemic disease, including: active infection; hypertension uncontrollable by medication (≥160/100mmHg); unstable angina, or angina with the onset from within the last three months; congestive heart failure (≥level II according to New York Heart Association \[NYHA\], see Annex 4); myocardial infarction occurred within 1 year before the enrollment; severe arrhythmias requiring medical treatment; and mental disorders, etc.;
• •9. Presence of active hepatitis B (history of hepatitis B infection, whether with or without medication, HBV DNA≥104 copy number or ≥2000u/ml) or HCV-Ab positive; known HIV-positive patients (no clinical signs or symptoms suggesting exemption of HIV test for HIV-infected individuals);
• •10. Having received any of the following treatment within specific time period before inclusion:
• •* Having had a major surgery within 4 weeks before inclusion;
• •* Having received expanded scope of radiotherapy within 4 weeks, or having received limited scope of radiotherapy within 2 weeks before inclusion;
• •* Having participated in any other therapeutic/interventive clinical trials within 4 weeks before inclusion, or taking part in an ongoing trial.
• •11. With CTCAE toxicity at level II or above (excluding hair loss or skin pigmentation), uncured and caused by any previous treatment;
• •12. Not fitting in the study, as conceived by the researcher.