Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT05498766
Eligibility Criteria:
Inclusion Criteria:
* 18-75 years
* Pathologically diagnosed as stage II or III gastric adenocarcinoma (including gastroesophageal junction).
* Receiving radical surgery (R0, D2 resection, more than 16 lymph nodes should be detected) for gastric adenocarcinoma within 2 months prior to enrollment, and not receiving adjuvant treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
* Patients are volunteers, have signed informed consent, and agree to cooperate with investigators in data collection.
Exclusion Criteria:
* Patients had received neoadjuvant therapy.
* Patients who have received or plan to receive targeted therapy and/or immunotherapy。
* Patients allergic to the components of Huaier granules, or avoid to use Huaier granules or use with caution.
* More than two active primary tumors at the same time.
* Patients have not recovered from surgical complications after radical surgery.
* Patients received other Chinese patent medicine with anti-tumor effects.(including but not limited to Huaier Granule, Fufangbanmao Capsule, Huachansu Capsule, Kangai Injection, Pingxiao Table) in the past 1 month.
* Not able to take medication orally cause by difficulty in swallowing, complete or incomplete gastrointestinal obstruction, active bleeding from the gastrointestinal tract, perforation, etc.
* Pregnant or lactating women or women prepare for pregnancy.
* Serious concomitant infection disease.
* Patients with severe psychiatric illness or otherwise diseases are unsuitable for this study according to the judgment by investigators.
* Patients with combined immune disease and receiving immunosuppressive therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05498766
Study Brief:
Protocol Section:
NCT05498766