K-001 Treatment of Advanced Pancreatic Cancer: Clinical Trial of Monotherapy's Tolerability
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
Disease-related criteria for inclusion:
- Based on histodiagnosis or cytodiagnosis;
- Locally advanced or metastatic pancreatic adenocarcinoma;
- Failure of standard treatment, >28 days after the last chemotherapy;
- Patients not suitable for or having given up standard treatment;
- At least one lesion measurable according to RECIST V 1.0 criteria;
- ECOG score: 0~1;
Expected survival: ≥3 months;
Haematological, biochemical and organ functions:
Hematological indices:
- Absolute neutrophil count: ≥1.5×109/L;
- Platelet count: ≥80×109/L;
- Hemoglobin: ≥9.0 g/dL.
- Total bilirubin: ≤1.5 x ULN, albumin: ≥3.0g/dL;
- Patients without liver metastasis: ALT (SGPT) & AST (SGOT) ≤3.0 x ULN Patients with liver metastasis: ALT (SGPT) & AST (SGOT)≤5.0 x ULN;
Renal functions: serum creatinine ≤ 1.5xULN, Ccr ≥ 60ml/min (Cockcroft-Gault);
General criteria for inclusion:
- Age: 18~70;
- Letter of Consent signed by the patient or his/her legal representative:
- Women of childbearing age must have a urine pregnancy test within 7 days before starting treatment, only negative results shall be included in the group. Male and female patients of childbearing age have agreed to use a reliable method of contraception before and during participating the study as well as 90 days (at least) after withdrawal.
Exclusion Criteria:
Disease-related criteria for exclusion:
- Patients of pancreatic tumor but not adenocarcinoma;
- Having received radiotherapy for his/her target lesions prior to this study, with no progress;
- Known presence of brain metastases or leptomeningeal metastases;
- With Vater's ampulla cancer or bile duct cancer;
- Partial or complete intestinal obstruction;
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:
- Pregnant or breast-feeding women;
- 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.;
- 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);
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.
- With CTCAE toxicity at level II or above (excluding hair loss or skin pigmentation), uncured and caused by any previous treatment;
- Not fitting in the study, as conceived by the researcher.
Sites / Locations
- Shanghai General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Group A:K-001 2700mg/d (1350mg BID)
Group B: K-001 3240mg/d (1620mg BID)
Group C: K-001 3780mg/d (1890mg BID)
Group D: K-001 4320mg/d (2160mg BID)
K-001 1350mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.
K-001 1620mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.
K-001 1890mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.
K-001 2160mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.