esophageal carcinoma
Conditions
Interventions
experimental group:Huaier granules were given orally, 20g/ time, 3 times/day, for 6 months.
Sponsors
First Affiliated Hospital of Xi’an Jiaotong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =3cm, poorly differentiated)/cT1b-2N+M0/cT3-4aN0-3M0, requiring neoadjuvant therapy before radical esophagectomy; 4. Can eat orally (at least liquid diet) 5. ECOG status score (PS) =18.5 kg/m^2; 7. The tumor did not invade the surrounding vital organs and distant metastasis; There was no obvious enlargement of supraclavicular and retroperitoneal lymph nodes and no evidence of distant metastasis (M0). 8. The main organ function is basically normal: the lung function can accept general anesthesia; NYHA grades of cardiac function were 0 ~ 1. 9. Before the study, the patient and/or his legal representative have the ability to fully understand the content, process and possible adverse reactions of the study, and can make the patient comply with the visit required by the protocol; 10. Women of childbearing age must have a negative pregnancy test and not be breastfeeding, confirm that both men and women are receiving a method of contraception approved by the investigator, and agree to maintain this contraceptive method from the signing of the informed consent until 3 months after the end of the study
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors; 2. Patients with a history of esophagectomy or gastrectomy; 3. Patients with a history of thoracic surgery or extensive abdominal adhesion; 4. Patients with heart thrombosis; 5. Suffering from mental, psychiatric or neurological diseases; 6. Patients with cachexia and severe malnutrition are expected to survive less than 6 months; 7. Recent recurrence of gastric ulcer, history of gastric bleeding and other serious underlying diseases; 8. Patients with contraindications such as coagulopathy, HIV-positive antibody, and serious infection with poor clinical control; 9. Patients with other co-existing diseases (such as obvious abnormalities of liver and kidney function, etc.) or co-medication, which the investigator judged may affect the results of this study. 10. Patients who are also participating in another clinical study; 11. Patients who are known to be allergic to the material of surgical instruments, or to allergies; 12. Other participants judged by the investigator to be unfit to participate in the clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neoadjuvant immunochemotherapy indexcompletion rate of neoadjuvant therapy, adverse events during the period, postoperative major pathological response rate (MPR), pathological complete response rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative complications;Survival and recurrence;quality of life; | — |
Countries
China
Contacts
Public ContactZhuoqi Jia
Department of Thoracic Surgery, First Affiliated Hospital of Xi’an Jiaotong University
Outcome results
None listed