Stage II-III Gastric CancerNCT06157216
Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer
A study testing MRD-guided therapy in people with Stage II-III Gastric Cancer, run by Qilu Hospital of Shandong University at 5 sites in China.
Trial summary
This is a single-arm, interventional study to explore the feasibility of circulating tumor DNA (ctDNA)-MRD testing to guide postoperative adjuvant treatment strategies in patients with stage II-III gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage II-III Gastric Cancer
- What is being tested?
- MRD-guided therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 5 sitesChina
- Study dates
- 1 Oct 2023to 1 Apr 2029
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
- No preoperative neoadjuvant or adjuvant therapy received.
- Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
- Age between 18-75 years, with no gender restrictions.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated survival of 6 months or more.
- Baseline hematological and biochemical parameters within specified limits: a. Hemoglobin ≥ 80g/L. b. Absolute neutrophil count ≥ 1.5×10^9/L. c. Platelet count ≥ 100×10^9/L. d. Aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal. e. Alkaline phosphatase ≤ 2.5 times the upper limit of normal. f. Thyroid-stimulating hormone (TSH) ≤ 1 times the upper limit of normal (if abnormal, T3 and T4 levels must be normal).
Who cannot join
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
- Evidence of postoperative recurrence or metastasis.
- Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
- Positive resection margins identified in postoperative pathology.
- History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
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- Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
- Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
- Allergic reactions to study drugs.
- Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
- Administration of live attenuated vaccines within 4 weeks prior to the first study treatment dose or plans to receive such vaccines during the study period.
- Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
- Positive for COVID-19 nucleic acid or antigen test.
- Other conditions deemed by the investigator to potentially affect patient safety or trial compliance, including serious illnesses requiring treatment, severe laboratory abnormalities, or other social or family reasons.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Qilu Hospital of Shandong Univertisy
Jinan, Shandong, 250012
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250012
Jinan Central Hospital
Jinan, Shandong
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
About this study
Official title: Circulating Tumor DNA Minimal Residual Disease-guided Adjuvant Chemotherapy in Patients With Stage II-III Gastric Cancer
This is a single-arm, interventional study to explore the feasibility of circulating tumor DNA (ctDNA)-MRD testing to guide postoperative adjuvant treatment strategies in patients with stage II-III gastric cancer.
- Conditions
- Stage II-III Gastric Cancer
- Being tested
- MRD-guided therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRD-guided therapyDrug
MRD negative stage II gastric cancer: Observation; MRD negative stage III gastric cancer: S1 (40-60 mg, PO, bid, d1-d14 q3w); MRD positive stage II/III gastric cancer: XELOX (Oxaliplatin 130mg/m2, d1 +Capecitabine 1000mg/m2，PO. bid, d1-14, q3w) or SOX (Oxaliplatin 130mg/m2, d1 +S-1 40-60 mg, PO. bid, d1-14, q3w); MRD-negative patients will receive XELOX or SOX if MRD becomes positive.
| Study group | Role | What they receive |
|---|---|---|
| MRD-guided treatment | Experimental | Patients post-surgery will receive MRD tests and receive MRD-guided adjuvant therapies. After that, MRD status will be continuously monitored for three years to guide the following therapies. Receives: Drug: MRD-guided therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Disease-Free Survival (DFS) rate
The 3-year DFS rate is defined as the percentage of patients who remain free of tumor recurrence or death within three years after surgery.
Measured: 3-year after the last subject participating in
Secondary outcomes (4)
Rate of De-escalation Treatment
The Rate of De-escalation Treatment is defined as the proportion of patients among a study population who receive a reduction in the intensity or scope of therapeutic interventions.
Measured: 3-year after the last subject participating in
Disease-Free Survival (DFS)
Disease-Free Survival (DFS) is defined as the duration of time from the initiation of surgery until the recurrence of the disease or death from any cause, whichever comes first.
Measured: 3-year after the last subject participating in
Cumulative Risk of Recurrence
The Cumulative Risk of Recurrence is defined as the cumulative probability or risk of disease recurrence over a specified period, considering the entire study population.
Measured: 3-year after the last subject participating in
3-year Overall Survival (OS) Rate
3-year Overall Survival (OS) Rate is defined as the percentage of patients who are still alive three years after the initiation of a specific treatment, regardless of disease recurrence or progression.
Measured: 3-year after the last subject participating in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Oct 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II-III Gastric CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Jinan Central Hospital, Yantai Yuhuangding Hospital, The Affiliated Hospital of Qingdao University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157216
- Sponsor's protocol ID
- MRD-GATE
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2023
- Last updated
- 18 May 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Minimal Residual Disease-guided Adjuvant Chemotherapy in Patients With Stage II-III Gastric Cancer
- ClinicalTrials.gov ID
- NCT06157216
- Acronym / sponsor ID
- MRD-GATE
- Conditions
- Stage II-III Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Jinan Central Hospital, Yantai Yuhuangding Hospital, The Affiliated Hospital of Qingdao University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 5 Dec 2023 (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 single-arm, interventional study to explore the feasibility of circulating tumor DNA (ctDNA)-MRD testing to guide postoperative adjuvant treatment strategies in patients with stage II-III gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRD-guided treatment | Experimental | Drug: MRD-guided therapyPatients post-surgery will receive MRD tests and receive MRD-guided adjuvant therapies. After that, MRD status will be continuously monitored for three years to guide the following therapies. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
- No preoperative neoadjuvant or adjuvant therapy received.
- Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
- Age between 18-75 years, with no gender restrictions.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (14 listed)
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
- Evidence of postoperative recurrence or metastasis.
- Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
- Positive resection margins identified in postoperative pathology.
- History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
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 |
|---|---|---|
| MRD-guided therapyMRD negative stage II gastric cancer: Observation; MRD negative stage III gastric cancer: S1 (40-60 mg, PO, bid, d1-d14 q3w); MRD positive stage II/III gastric cancer: XELOX (Oxaliplatin 130mg/m2, d1 +Capecitabine 1000mg/m2，PO. bid, d1-14, q3w) or SOX (Oxaliplatin 130mg/m2, d1 +S-1 40-60 mg, PO. bid, d1-14, q3w); MRD-negative patients will receive XELOX or SOX if MRD becomes positive. | Drug | MRD-guided treatment |
Primary outcome
3-year Disease-Free Survival (DFS) rate
Time frame: 3-year after the last subject participating in
The 3-year DFS rate is defined as the percentage of patients who remain free of tumor recurrence or death within three years after surgery.
4 secondary outcomes
Rate of De-escalation Treatment
Time frame: 3-year after the last subject participating in
Disease-Free Survival (DFS)
Time frame: 3-year after the last subject participating in
Cumulative Risk of Recurrence
Time frame: 3-year after the last subject participating in
3-year Overall Survival (OS) Rate
Time frame: 3-year after the last subject participating in
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 18 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRD-guided therapy in people with Stage II-III Gastric Cancer, run by Qilu Hospital of Shandong University 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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 18 May 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Disease-Free Survival (DFS) rate (time frame: 3-year after the last subject participating in). 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 18 May 2026.