Clinical trial · Interventional
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
NCT05498766CI-TRIAL-00078178not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Huaier granule | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Tegafur, Gimeracil and Oteracil Potassium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Huaier group
- description
- The participants volunteering to take Huaier granule will be assigned to the Huaier group.
- interventionNames
- Drug: Huaier granule
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- The participants volunteering to take SOX will be assigned to the control group.
- interventionNames
- Drug: Oxaliplatin
- Drug: Tegafur, Gimeracil and Oteracil Potassium
Primary outcomes (1)
- measure
- 3-year DFS rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.