Gastric Cancer
Conditions
Keywords
Thalidomide, Irinotecan, Second Line
Brief summary
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.
Detailed description
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.
Interventions
DRUGThalidomide
Given orally
DRUGCPT-11
Given Ivgtt
Sponsors
The First Affiliated Hospital of Zhengzhou University
Henan Provincial People's Hospital
Second Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Henan University of Science and Technology
Wang Jufeng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression(TTP) | up to 2 months |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate (CRR) for advanced gastric cancer | up to 2 months |
| overall survival (OS) | up to 2 months |
Countries
China
Contacts
Primary ContactWang Jufeng
Outcome results
None listed