gastric cancer
Conditions
Interventions
experimental group:Compound Realgar NaturalIndigo Tablet combined with irinotecan
control group: placebo combined with irinotecan
Sponsors
Xinhua Hospital, Affiliated to School of Medicine, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged 18 to 75 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2,or the score of Karnofsky(KPS)>= 60; 3. Diagnosis of late-stage gastric cancer (including adenocarcinoma occur at the integrant of gastric and esophageal tuberculosis); 4. First-line treatment using platinum,fluorouracil, paclitaxel have been defeated,and the patients intend to treat with irinotecan; 5. Expected lifetime above 3 months; 6. Adequate end organ function as defined by: (1) Alanine transaminase (ALT), Aspartate transaminase (AST) <=1.5 x upper limit of normal (ULN); (2) Total bilirubin <= 1.5 x ULN; (3) Cr <= 1.5 x ULN; (4) Serum amylase and lipase <= 1.5 x ULN; 7. The patients are voluntary to participant in this trail and signed informed consent; 8. The compliance is expected well and the efficacy and adverse reaction could evaluated.
Exclusion criteria
Exclusion criteria: 1. Previously received treatment with irinotecan prior to study entry and progressed withen one year after the end of treatment, or others who are considered unsuitable to receive treatment with irinotecan; 2. Treatment with any arsenic reagent prior to study entry; 3. Patients who are: (1) pregnant; (2) breast feeding; (3) female or male of childbearing potential unwilling to use contraceptive precautions throughout the trial; 4. Major surgery within 4 weeks prior to randomization or who have not recovered from prior surgery; 5. Patients who have not recovered from toxic reaction of prior similar treatment evaluated by investigators; 6. Impaired cardiac function including any one of the following: LVEF 450 msec for male or 470 msec for female: (1) History of clinically documented myocardial infarction or unstable angina (during the last 12 month); (2) Any other severe heart disease; 7. Patients with active, uncontrolled psychiatric disorders, without insight and the ability of exact expression; 8. Uncontrolled medical conditions: Uncontrolled diabetes with fasting blood-glucose >200mg/dl (11.1mmol/L), or with combined symptoms (nephropathy, peripheral neuropathy). Uncontrolled hypertension. Active or uncontrolled infection (persistent fever and worsening of the clinical symptoms); 9. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the tested drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery); 10. History of chronic pancreatitis or history of acute pancreatitis within 1 year of study entry; 11. Acute or chronic uncontrolled liver disease or severe renal disease considered unrelated to gastric cancer; 12. Patients actively receiving therapy with strong CYP3A4 inhibitors, strong CYP3A4 inducers or any medications being potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug; 13. Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks prior to randomization; 14. Known to be allergic to the study drugs, including crude drug or adjuvant; 15. As investigators evaluate, the patients do not fit to join the study (such as with severe complications).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate (ORR);disease control rate(DCR);Quality of life;overall survival (OS); | — |
Countries
China
Contacts
Public ContactSiyu Chen
Xinhua Hospital, Affiliated to School of Medicine, Shanghai Jiaotong University
Outcome results
None listed