Postoperative recurrence and metastasis of squamous esophageal cancer
Conditions
Interventions
Control group:Placebo
Trial Group:Huage granules
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients with positive lymph nodes in ypTNM stage III-IVa after radical esophageal cancer surgery who had completed neoadjuvant therapy for squamous esophageal cancer before surgery; Diagnostic criteria refer to the Diagnosis and Treatment Guidelines for Esophageal Cancer (2018 edition); Staging criteria: Using the UICC/AJCC TNM esophageal squamous cell carcinoma staging system (8th edition 2017); 2.Within 2 months of completion of postoperative chemotherapy or radiotherapy, or not receiving/intolerant of radiotherapy; Confirmed no recurrence or metastasis upon examination; 3.Consistent with the Chinese medicine diagnosis of qi deficiency and blood stasis patterns, refer to the national standard GB/T16751.2-1997. Qi deficiency syndrome has 2 main symptoms and 1 secondary symptom; Blood stasis syndrome has 2 main symptoms, or 1 main symptom+2 secondary symptoms; 4.KPS >= 70 points; 5.Age 18-80 years; agreed to participate in this study and signed an informed consent form;
Exclusion criteria
Exclusion criteria: 1.Pregnant or nursing mothers; 2.Patients with known allergies to study medications; 3.Patients undergoing trials of other drugs; 4.Combined presence of serious non-neoplastic diseases and dysfunctions of the heart, liver, kidneys, cardiac and other major organs, active cerebrovascular lesions, uncontrolled infections and metabolic diseases; presence of other primary tumors; 5.The investigator determined that the patient was not suitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| QLQ-C30;Esophageal Cancer Chinese Medicine Symptoms Score;Tests for blood, urine, stool routine, liver and kidney function, electrocardiogram, etc. Adverse reactions are classified according to NCI toxicity classification standards; | — |
Countries
China
Contacts
Public ContactLiu Huaimin
Henan Cancer Hospital
Outcome results
None listed