Recurrence of early gastric cancer after ESD
Conditions
Interventions
Treatment group:Weifuchun granule
Control group:No drug intervention is used
Sponsors
THE FIRST AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age= 18 years old; and signed informed consent; 2. Endoscopic resection of early gastric cancer for the first time, and the preoperative evaluation meets the absolute indications: (1) Differentiated intramucosal carcinoma (cT1a) without ulceration, regardless of the size of the lesion; (2) Differentiated intramucosal carcinoma with ulceration, lesion length and diameter = 3 cm; 3. Postoperative pathological results suggest early gastric cancer and meet the criteria for endoscopic curative resection (eCuraA/B), as well as block resection, negative horizontal margins (HM0), negative vertical margins (VM0), and no lymphovascular invasion (ly0, v0). Among them, eCuraA must meet one of the following conditions: (1) pT1a(M), UL0, and histological classification are mainly differentiated, regardless of lesion size; (2) pT1a(M), UL0, and histological classification were mainly undifferentiated, and the length and diameter of the lesion were = 2 cm; (3) pT1a(M), UL1, and histological classification were mainly differentiated, and the length and diameter of the lesion were = 3 cm. eCuraB should meet: pT1b (SM1), histological classification is mainly differentiated, and the length and diameter of the lesion are = 3 cm; 4. HP negative, or previous infection but successful completion of HP eradication therapy; 5. The patient's clinical data is complete.
Exclusion criteria
Exclusion criteria: 1. Postoperative pathological results indicate that curative resection cannot be completed, and there is a risk of tumor recurrence and lymph node metastasis (eCuraC): that is, the criteria of eCuraA/B are not met, or the lesion cannot be resected in a single piece, or the horizontal margin is positive (HM1), or the vertical margin is positive (VM1), or there is SM2 infiltration (>500µm), or there is lymphovascular invasion (ly1, v1), or the postoperative pathology cannot be evaluated. 2. Patients with a history of other malignant tumors, or severe hepatic and renal insufficiency (such as eGFR <30 mL/min/1.73m², decompensated liver disease), or patients who cannot tolerate endoscopic treatment due to other diseases, or who have contraindications to endoscopic treatment; 3. Patients with contraindications to the study drug or allergy to the study drug; 4. Pregnant and lactating women or women with a birth plan within 1 year; 5. History of drug abuse or alcohol abuse in the past 1 year; 6. Those with mental disorders; 7. Patients who plan to take tepredone during the trial; 8. Other situations judged by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of early cancer recurrence and metachronous cancer within 5 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early cancer recurrence rate and metachronous cancer incidence within 1 year, 2 years, 3 years and 4 years;Gastric mucosal atrophy reversal/progression rate;Endoscopic Kimura-Takeamoto grading evaluation;Traditional Chinese Medicine Syndrome Score;Gastric function (pepsinogen I (PGI), pepsinogen II (PGII), and gastrin-17 (G-17) ) carcinoembryonic antigen;Single-cell omics; | — |
Countries
China
Contacts
Public ContactChen Tanzhou
THE FIRST AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY
Outcome results
None listed