Gastric Cancer (GC)Phase 3NCT07366528
Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer
A Phase 3 study testing Oxaliplatin plus S-1 and Docetaxel plus S-1 in people with Gastric Cancer (GC) and Adjuvant Chemotherapy, run by Ruijin Hospital at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer (GC), Adjuvant Chemotherapy, Stage 3 Cancer
- What is being tested?
- Oxaliplatin plus S-1 and Docetaxel plus S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 5 sitesChina
- Study dates
- 15 Dec 2025to 31 Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
- severe complications that may lead to an expected survival time less than 5 years
- 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
- organ functions that cannot tolerate study treatment
- other conditions that patients are unsuitable for this study assessed by the investigators
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai
Jianpeng Gao, +86-021-64175590, jianpeng.gao@shca.org.cn
- Not yet recruiting
Renji Hospital
Shanghai
Xiang Xia, +86-021-58752345, xiangmoumou@163.com
- Recruiting
Ruijin Hospital
Shanghai
Chenfei Zhou, +86-21-64370045, zcf12085@rjh.com.cn
- Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai
Huiyuan Zhu, +86-021-66300588, zhy_pfmy@163.com
- Not yet recruiting
Yuebei People's Hospital
Shaoguan, Guandong
Guoxiong Zhang, +86-0751-6913346, 13411129137@163.com
About this study
Official title: 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
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.
Read the detailed description
In gastric cancer, adjuvant chemotherapy that can reduce the risk of recurrence and improve patient survival has been a standard of care for gastric cancer patients with pathological stage II-III after D2 gastrectomy and R0 resection. Currently, oxaliplatin plus S-1 (SOX) or docetaxel plus S-1 (DS) have been recommended as adjuvant therapy for stage III gastric cancer patients, based on the results of RESOLVE trial and JACCRO GC-07 trial, respectively. However, due to the different study design and patient enrollment, the efficacy of these two regimens can hardly be compared directly. The safety profiles and treatment period of the two regimens can be factors to guide regimen selection. For SOX regimen, oxaliplatin-related peripheral neuropathy and allergy are clinical concerned issues. Although frequency of similar toxicities of docetaxel is lower, S-1 should be administrated for 12 months after surgery in the DS regimen. Prolonged treatment period also increases the risk of treatment-related toxicities and impairs patients' adherence. There is necessary to compare these two regimens directly. In this study, gastric cancer patients who undergo D2 gastrectomy and achieve R0 resection with pathological stage III (IIIA, IIIB, IIIC) will be randomized and treated with SOX or DS regimen. In SOX group, eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; >1.5m2 60mg twice a day, days 1 to 14 of each cycle). In DS group, S-1 dose is also determined by body surface area. Patients are treated with S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year. Patients will be followed up for 5 years after surgery.
- Being tested
- Oxaliplatin plus S-1, Docetaxel plus S-1
- Medical subject headings
- Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin plus S-1Drug
SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; >1.5m2 60mg twice a day, days 1 to 14 of each cycle).
Docetaxel plus S-1Drug
DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin plus S-1 | Experimental | Patients will be treated with oxaliplatin plus S-1 as adjuvant therapy Receives: Drug: Oxaliplatin plus S-1 |
| Docetaxel plus S-1 | Active comparator | Patients will be treated with docetaxel plus S-1 as adjuvant therapy Receives: Drug: Docetaxel plus S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival rate
Defined as the proportion of patients who remain free from recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause at 3 years after randomization.
Measured: From randomization to 3 years after randomization
Secondary outcomes (3)
5-year overall survival rate
Defined as the proportion of patients who remain survival at 5 years after randomization.
Measured: From randomization to 5 years after randomization
Safety profiles
Adverse events during treatment
Measured: through treatment completion, an average of 6 months
Recurrence sites
Organs involved in tumor metastasis and recurrence
Measured: From randomization to 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Dec 2025
- Primary completion30 Oct 2028 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (\<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; \>1.5m2 60mg twice a day, days 1 to 14 of each cycle). DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.
- Masking
- None (open label)
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366528
- Sponsor's protocol ID
- DRAGON-Adjuvant/2025-No.675
- Status last verified
- Oct 2025
- First submitted
- 16 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07366528
- Acronym / sponsor ID
- DRAGON-Adjuvant/2025-No.675
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In gastric cancer, adjuvant chemotherapy that can reduce the risk of recurrence and improve patient survival has been a standard of care for gastric cancer patients with pathological stage II-III after D2 gastrectomy and R0 resection. Currently, oxaliplatin plus S-1 (SOX) or docetaxel plus S-1 (DS) have been recommended as adjuvant therapy for stage III gastric cancer patients, based on the results of RESOLVE trial and JACCRO GC-07 trial, respectively. However, due to the different study design and patient enrollment, the efficacy of these two regimens can hardly be compared directly. The safety profiles and treatment period of the two regimens can be factors to guide regimen selection. For SOX regimen, oxaliplatin-related peripheral neuropathy and allergy are clinical concerned issues. Although frequency of similar toxicities of docetaxel is lower, S-1 should be administrated for 12 months after surgery in the DS regimen. Prolonged treatment period also increases the risk of treatment-related toxicities and impairs patients' adherence. There is necessary to compare these two regimens directly. In this study, gastric cancer patients who undergo D2 gastrectomy and achieve R0 resection with pathological stage III (IIIA, IIIB, IIIC) will be randomized and treated with SOX or DS regimen. In SOX group, eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; >1.5m2 60mg twice a day, days 1 to 14 of each cycle). In DS group, S-1 dose is also determined by body surface area. Patients are treated with S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year. Patients will be followed up for 5 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; >1.5m2 60mg twice a day, days 1 to 14 of each cycle). DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin plus S-1 | Experimental | Drug: Oxaliplatin plus S-1Patients will be treated with oxaliplatin plus S-1 as adjuvant therapy |
| Docetaxel plus S-1 | Active comparator | Drug: Docetaxel plus S-1Patients will be treated with docetaxel plus S-1 as adjuvant therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
- severe complications that may lead to an expected survival time less than 5 years
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxaliplatin plus S-1SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; >1.5m2 60mg twice a day, days 1 to 14 of each cycle). | Drug | Oxaliplatin plus S-1 |
| Docetaxel plus S-1DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year. | Drug | Docetaxel plus S-1 |
Primary outcome
3-year disease-free survival rate
Time frame: From randomization to 3 years after randomization
Defined as the proportion of patients who remain free from recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause at 3 years after randomization.
3 secondary outcomes
5-year overall survival rate
Time frame: From randomization to 5 years after randomization
Safety profiles
Time frame: through treatment completion, an average of 6 months
Recurrence sites
Time frame: From randomization to 3 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxaliplatin plus S-1 and Docetaxel plus S-1 in people with Gastric Cancer (GC) and Adjuvant Chemotherapy, run by Ruijin Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenfei Zhou, MD, Ph.D (+86-21-64370045, zcf12085@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival rate (time frame: From randomization to 3 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.