Advanced colorectal cancer
Conditions
Interventions
One:FOLFOX/FOLFORI(Every two weeks, 12 cycles)with cetuximab(250mg/m2),added by thalidomide(50mg/d by 7 days, then added to 100mg/d without obvious complications)
Two:FOLFOX/FOLFORI(Every two weeks, 12 cycles)with cetuximab(250mg/m2)
Sponsors
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with newly histologically confirmed advanced colorectal cancer,RAS wild type; 2. Male or female,between 18-70 years old; KPS=60 and expected survival time more than 3 mongths; 4. With normal liver and renal function,with normal hematopoietic function test and without severe important organs dysfunction such as heart, lung and so on; 5. Pregnancy test negative and no plan for having offspring in following 3 years; 6. Without usage of cetuximab or other drugs with similar mechanism; 7. Patients must give signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who must take drugs which could induce rashes; 2) Patients with bone metastases; 3) breast-feeding and pregnant women; 4) Blood routine (WBC, ANC, RBC, Hb, PLT), liver function (ALT, AST, ALP, LDH, TBil, DBil), renal function (Cr, BUN), electrolyte (K, Na, Cl, Ca, P, Mg), blood glucose, heart function and coagulation were abnormal and did not meet the indication of chemotherapy; 5) TNF-a less than 1/4 standard level. 6) History of thrombosis; 7) Allergy to cetuximab or thalidomide; 9) Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Leval III-IV erythra; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR;VEGF;TNF-a;IL-1; | — |
Countries
China
Contacts
Public ContactZan Shen
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Outcome results
None listed