esophageal squamous cell carcinoma
Conditions
Interventions
Metformin treatment group:Metformin hydrochloride
Dextromethorphan treatment group:Dextromethorphan hydrobromide
Metformin and dextromethorphan treatment group:Metformin hydrochloride and Dextromethorphan hydrobromide
Placebo group:Placebo
Sponsors
Jinan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the study and sign the informed consent form; 2. Age older than 18 years old, no gender limitation; 3. Metastatic/locally advanced ESCC(non-resectable)/recurrence, progression after at least 5-FU-, platinum- or paclitaxel- based regimen of chemotherapy or radiotherapy; 4. Subjects had at least one measurable lesion that met the following criteria: spiral CT (MRI, PET-CT): maximum diameter of 10mm; esophageal X-Ray imaging: maximum diameter of 20mm; lymph nodes: maximum diameter of 20mm; 5. Blood pressure less than 160/100 mmHg; 6. Less than 8 mmol/L blood triglyceride; 7. At least receiving liquid diet or nasal feeding.
Exclusion criteria
Exclusion criteria: 1. Patients with hepatic and renal insufficiency: AST and ALT exceeding 3 times of the normal upper limit and CCR 170/110mmHg). 7. Infectious diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis or desmosis are in active stage. 8. Severe infections, especially those in the lungs. 9. Patients concurrent with severe oral disease (severe periodontitis and oral tumors, etc.). 10. Didnt have the ability of being informed the consent. 11. Patients who have participated in other clinical trials within one year prior or are participating in other clinical trials. 12. Known to be allergic or intolerant to metformin or dextromethorphan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival;Overall survival;CD44;SOX2;OCT4;a7nAchR;Inflammation marker;Immune cell marker;PD-L1;PD-1; | — |
Countries
China
Contacts
Public ContactHao Zhang
Jinan University Medical College
Outcome results
None listed