Early Gastrointestinal Cancer
Conditions
Interventions
Blank Control Group:Routine Follow-up
Huaier Granule Group:Huaier Granules
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate and sign the informed consent form; 2.Patients with non-curative resection after endoscopic submucosal dissection (ESD) for early gastrointestinal cancer are defined as follows: for gastric lesions, non-piecemeal resection or positive resection margin; differentiated-type intramucosal cancer with an ulcerative lesion >3 cm in size; undifferentiated-type intramucosal cancer without ulceration >2 cm in size; undifferentiated-type intramucosal cancer with ulceration; or presence of submucosal invasion; and for colorectal lesions, positive horizontal margin; or negative vertical margin accompanied by any of the following: poorly differentiated adenocarcinoma, signet-ring cell carcinoma, mucinous adenocarcinoma, depth of submucosal invasion >=1000 µm, positive lymphovascular invasion, or tumor budding grade 2/3. 3.Age >=18 years and <=80 years;
Exclusion criteria
Exclusion criteria: 1.Concomitant severe cardiac, cerebral, pulmonary, hepatic, or renal diseases; 2.Currently receiving immunosuppressive agents or hormone therapy; 3.Women planning pregnancy, pregnant, or breastfeeding; 4.Patients planning to undergo surgery, radiotherapy, or chemotherapy; 5.Other conditions deemed unsuitable for participation by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Recurrence-Free Survival (RFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Adverse Event Rate;Time to Recurrence (TTR); | — |
Countries
China
Contacts
Public ContactLiansong Ye
West China Hospital of Sichuan University
Outcome results
None listed