Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Oral prescription granules of traditional Chinese medicine, once a day in the morning and evening.
Control group:Oral control placebo granule (95% dextrin and 5% real drug)
Sponsors
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Postoperative pathological staging II-III stage II-III lymph node positive esophageal squamous cell carcinoma patients; diagnostic criteria refer to the criteria for diagnosis and treatment of esophageal cancer (2018 version); staging criteria: using UICC/AJCCTNM esophageal squamous cell carcinoma staging system (8th edition 2017); (2) Postoperative chemotherapy or radiotherapy within 2 months, or do not accept or do not tolerate radiotherapy and chemotherapy; confirmed by examination that there is no recurrence and metastasis; (3) ECOG score = 2, and expected survival time > 3 months; (4) 18-75 years old, no serious diseases of heart, brain, kidney, liver, blood and other systems; no other tumors; (5) Agreed to participate in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women; (2) Patients who are known to be allergic to research drugs; (3) Patients who are conducting other drug trials; (4) Severe non-neoplastic diseases and dysfunction in major organs such as heart, liver, kidney and heart, active cerebrovascular disease, uncontrolled infection and metabolic diseases; (5) The researchers determined that it was not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year OS rate;Quality of life (supplemented by QLQ-C30 and QLQ-OES 18);TCM syndrome score of esophageal cancer;Safety indicators (blood, urine, stool routine, liver and kidney function, ECG, etc.); | — |
Countries
China
Contacts
Public ContactLiu Huaimin
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Outcome results
None listed