esophageal cancer
Conditions
Interventions
control group:none
experimental group:Sanjie Dihuang Decoction
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed with esophageal squamous carcinoma by pathology or cytology and clinically staged as T3-T4 or TxN+M0; (2) Age 45-75 years old male or female; (3) Good general condition ECOG score 0-2 and expected survival greater than 3 months; (4) No previous systemic treatment including surgery radiotherapy targeted and immunotherapy; (5) Those who have undergone standardized tongue image collection; (6) Normal function of major organs without serious blood heart lung liver kidney bone marrow and other functional abnormalities and immunodeficiency diseases; (7) At least one measurable lesion (according to RECIST 1.1 criteria) or evaluable non-measurable lesion with upcoming preoperative neoadjuvant immunotherapy; (8) Expected to be well adherent and able to follow up on efficacy and adverse events/responses as required by the protocol. (9) Understand and agree to receive information and specimen collection related to the program and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant or nursing patients; (2) With any active autoimmune disease or history of autoimmune disease (e.g. interstitial pneumonia enteritis hepatitis myocarditis nephritis hyperthyroidism vasculitis pituitary gland inflammation); (3) Suffering from congenital or acquired immune function defects such as human immunodeficiency virus (HIV) infection active Hepatitis B Hepatitis C (Hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method) or co-infection of hepatitis B and hepatitis C; (4) Concurrent malignant tumors in other parts of the body acute oral infections; (5) History of diarrhea or infectious disease within 4 weeks prior to collection of oral flora; (6) Use of antibiotics PPI or other acid-suppressing drugs hormones drugs related to the regulation of intestinal flora etc. within 4 weeks before the collection of oral flora. (6) Use of antibiotics PPI or other acid-suppressing drugs hormones or drugs related to the regulation of intestinal flora within 4 weeks before the collection of oral flora (7) Consumption of food or medication that affects the color of the tongue prior to the collection of the tongue image; (8) Mental illness or other conditions that the researcher considers unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response rate;1-year disease free survival rate;Radical Resection Removal rate; | — |
Countries
China
Contacts
Public Contactliqun jia
China-Japan Friendship Hospital
Outcome results
None listed