NCT05498766Not yet recruitingPhase 4
Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients
Effect and Safety of Huaier Granule Versus SOX Regimen for the Prevention of Recurrence/Metastasis After Radical Surgery for Stage II-III Gastric Cancer Patients: a Prospective, Multi-center, Open-label and Randomised Control Study
Source: ClinicalTrials.gov · Last updated 24 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, multi-center, open-label, randomised controlled study. The purpose of this study is to evaluate the efficacy and safety of Huaier Granule versus SOX regimen in the postoperative adjuvant treatment of resectable stage II-III gastric cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 702 (estimated)
- First submitted
- 7 Aug 2022
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05498766
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 702
- From 1 Jul 2024 to the primary completion date, 1 Jul 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients had received neoadjuvant therapy.
- Patients who have received or plan to receive targeted therapy and/or immunotherapy。
- 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.
- Serious concomitant infection disease.
- Patients with combined immune disease and receiving immunosuppressive therapy.
Other illness
- Patients allergic to the components of Huaier granules, or avoid to use Huaier granules or use with caution.
- Not able to take medication orally cause by difficulty in swallowing, complete or incomplete gastrointestinal obstruction, active bleeding from the gastrointestinal tract, perforation, etc.
- Patients with severe psychiatric illness or otherwise diseases are unsuitable for this study according to the judgment by investigators.
Other
- More than two active primary tumors at the same time.
- Pregnant or lactating women or women prepare for pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Wuhan Union Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.