Clinical trial · Interventional
Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer
The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for chemotherapy. Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse effects which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity(OIN). But it did not certificated by phase III trial. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monosialotetrahexosylganglioside Sodium | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- placebo
- description
- arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant
- interventionNames
- Other: placebo
- type
- EXPERIMENTAL
- label
- monosialotetrahexosylganglioside Sodium
- description
- arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant
- interventionNames
- Drug: monosialotetrahexosylganglioside Sodium
Primary outcomes (1)
- measure
- The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients shall have normal organic function such as liver function, Cardiac function and renal function; 2. age \>18 years old; 3. diagnosis metastatic colorectal cancer with histology; 4. Did not received first-line chemotherapy 5. Karnofsky Performance scores should be 60,70,or80 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 Exclusion Criteria: 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
References
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