Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer : A Multicenter, Randomized, Controlled and Prospective Trial

Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.

This is a prospective, randomized, multi-center, controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide and CPT-11 in advanced gastric cancer. A total of 900 patients are planned to be enrolled into the study. Patients with diagnosis of advanced gastric cancer will be randomized into two groups, and be treated with thalidomide+ CPT-11 or CPT-11, respectively. The primary end point is time to progression (TTP), and the secondary end points include efficacy, overall survival (OS) and the occurrence of delayed diarrhea.

Inclusion Criteria:

• 18y <Age<75y
• Patients with histologically proven tumor focus will be eligible for this protocol
• Measurable or assessable disease
• At least 4 weeks since last chemotherapy ;chemotherapy regimens without Irinotecan
• No hepatic, renal and hematopoietic dysfunction; no hemorrhage of digestive tract,obstructive jaundice, gastrointestinal perforation or obstruction
• ECOG PS:0-2
• Expected OS ≥ 3 months

Exclusion Criteria:

• obstruction of digestive tract, thrombosis or other intolerant side effects during treatment