A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer
- Histologically/cytologically confirmed metastatic pancreatic adenocarcinoma.
- Patients have failed from the prior chemotherapy without Xeloda. Adjuvant
chemotherapy containing Xeloda and 6 months before recruitment is included.
- Patients haven't taken QYHJ Granules before. Prior exposure to Traditional Chinese
Medicine not based on QYHJ Formula is allowed provided that at least one week washout
time is given prior to initiation of experimental treatment.
- ECOG performance status 0, 1 or 2.
- Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone
will not be accepted as measurable disease. Lytic lesions seen on plain radiographs
will not be accepted as measurable disease but will be evaluated in conjunction with
bone scan abnormalities. Pure blastic bone metastases will not be accepted as
measurable disease. Pleural or peritoneal effusions will not be accepted as
measurable disease. Irradiated lesions are not considered measurable.
- Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal
- Patients must have adequate organ functions reflected by the laboratory criteria
below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85
g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin
- Age ≥ 18.
- Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4
weeks washout time is given.
- Concomitant bisphosphonates are allowed for patients with bone metastases. Patients
with jaundice must have a biliary drainage decompression operation before
- Ability to understand and the willingness to sign a written informed consent.
- Subjects who have a life expectancy of at least 3 months.
- ECOG performance status 3 or 4.
- Known central nervous system involvement and leptomeningeal disease.
- Previous Xeloda-based chemotherapy （except usage for Adjuvant chemotherapy and 6
months before recruitment）.
- Prior treatment with QYHJ Granules.
- Other serious illness or condition including cardiac disease including congestive
heart failure (New York Heart Association Classification III or IV),unstable angina,
myocardial infarction within the past six months, severe arrhythmia.
- Concurrent infection requiring intravenous antibiotics, active HIV infection/HIV
disease, psychiatric disorders, drug abuse.
- Known allergies to the QYHJ or Xeloda.
- Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days
prior to study treatment start, or within 14 days with a confirmatory urine pregnancy
test within 7 days prior to study treatment start. Men and women of childbearing
potential not using effective means of contraception.
- Known other non-adenocarcinoma pathological type.
- Other primary tumour (including primary brain tumours) within the last 5 years prior
to enrollment, except for adequately treated carcinoma in situ of the cervix or basal
cell skin cancer.
- Inability to take oral medication, prior surgical procedures affecting absorption or
unwilling to take the Traditional Chinese Medicine.
- Patiens who are suffering from diarrhea.
- Subjects with poor compliance.