Tianjin Medical University Cancer Institute and Hospital
it is a placebo controlled phase III trial. investigators plan to enroll 240 patients with 1:1 to A arm and B arm
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;
2. age \>18 years old;
3. diagnosis mCRC with histology;
4. Did not received first-line chemotherapy
5. Karnofsky Performance scores \>70 scores
6. should have target lesions or non-target lesions
7. For patients received oxaliplatin before, the residual neurotoxicity should less than grade 2
8. For diabetes without neuropathy, blood glucose before meal should less than 8mmol/L and HBA1C\<7.0%
9. Patients should be expected to live no shorter than 3 months
You may not be if
1. patients who is receiving chemotherapy;
2. WBC\<4.0×109/L，ANC\<1.5×109/L,PLT\<100×109/L，Hb\<90g/L,TBIL\>1.5Limitation;BUN）\>1.5Limitation；Cr）\>1.5Limitation；ALT or AST\>2.5Limitation（without liver metastasis）；ALT or AST）\>5Limitation（with liver metastasis）;
3. heart dysfunction;
4. brain metastasis;
5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
6. patients who received Glutathione, acetylcysteine, calcium / magnesium, amifostine, carbamazepine, B vitamins, vitamin E within 30 days
Clareo Health | Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC
