NCT07366528RecruitingPhase 3
Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer
Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer After D2 Gastrectomy (DRAGON-Adjuvant): a Multicenter, Open-label, Phase 3, Randomized, Non-inferiority Study
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 387 (estimated)
- First submitted
- 16 Jan 2026
- Start date
- 15 Dec 2025
- Primary completion date
- 30 Oct 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07366528
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 387
- From 15 Dec 2025 to the primary completion date, 30 Oct 2028
- 5 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.
Other illness
- other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
- uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.
- allergic to study medication
- bowel obstruction or other conditions affecting oral administration
- other conditions that patients are unsuitable for this study assessed by the investigators
Other
- severe complications that may lead to an expected survival time less than 5 years
- organ functions that cannot tolerate study treatment
Who the study is looking for
- age 18 to 80 years old, male and female
- histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
- American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification
- with no evidence of metastatic disease
- ECOG 0 to 1
- Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
- Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends.
- Signed informed consent and willing to follow the study protocol
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| RenJi Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Yuebei People's Hospital Coordinator of this site? Confirm its status | Shaoguan | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.