Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

• Status: Completed
• Trial end date: 2018-02-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;

2. male or female age >18 years old;

3. diagnosis GI cancer with histology;

4. Chronic neurotoxicity grade is 2 or more

5. Karnofsky Performance scores should be 80 or more

6. patients are in oxaliplatin-based chemotherapy courses or no more than 21 days after last oxaliplatin usage for patients who will discontinue oxaliplatin usage.

7. without uncured tumor except GI cancer,

8. Patients should be expected to live no shorter than 3 months

Exclusion Criteria:

1. patients who is receiving anti-neurotoxicity treatment;

2. WBC<4.0×109/L，ANC<1.5×109/L,PLT<100×109/L，Hb<90g/L,TBIL>1.5Limitation;BUN）>1.5Limitati on；Cr）>1.5Limitation；ALT or AST>2.5Limitation（without liver metastasis）；ALT or AST）>5Limitation（with liver metastasis）;

3. heart dysfunction;

4. brain metastasis with symptoms;

5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;

6. in situation of oxaliplatin-based chemotherapy progressed, the next chemotherapy regime should not contain agents which will cause neurotoxicity (such as paclitaxel and cisplatin)