Gastric / Gastroesophageal Junction AdenocarcinomaPhase 2MRD-ATLASNCT07257380
Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric Cancer With Neoadjuvant Treatment: An Adaptive Trial (MRD-ATLAS)
A Phase 2 study testing Standard neoadjuvant therapy, Radical gastrectomy and Standard adjuvant therapy in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Standard treatment for locally advanced gastric cancer currently involves surgery combined with chemotherapy administered both before and after the operation. However, post-surgery (adjuvant) chemotherapy often causes severe side effects, and it is unclear if all patients truly benefit from it. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Gastric / Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Standard neoadjuvant therapy, Radical gastrectomy and Standard adjuvant therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 30 Dec 2029
- Phase
- Phase 2
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to provide a written informed consent form (ICF), and understand, agree to, and comply with the study requirements and assessment schedule.
- Male or female aged 18 to 79 years.
- Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ), with clinical TNM staging (per the 8th edition of the AJCC/UICC Clinical TNM Staging for Gastric Cancer) as clinical Stage cIII to cIVa, and the primary gastric cancer lesion assessed to be amenable to curative resection.
- ECOG PS ≤ 2, tolerable to surgical treatment, no surgical contraindications.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to initiating neoadjuvant treatment. Males of reproductive potential and females of childbearing potential must agree to use adequate contraceptive measures during the study and for 24 months after the last dose of study medication.
- Prior to neoadjuvant treatment, complete blood count (CBC) and biochemical tests must meet the following criteria: a) Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; b) Platelet Count (PLT) ≥ 75 × 10⁹/L; c) Hemoglobin (Hb) ≥ 80 g/L; d) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN); e) Serum Creatinine (Cr) ≤ 1.5 × ULN, or Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m²; f) Serum Albumin (ALB) ≥ 30 g/L; g) For subjects not receiving anticoagulant therapy: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; for subjects receiving anticoagulant therapy: PT value must be within the expected therapeutic range for the anticoagulant used.
- No antitumor treatment for the tumor involved in the current study has been administered prior to the initiation of neoadjuvant treatment.
Who cannot join
- Subjects for whom investigators consider that there are obvious contraindications to (neo)adjuvant treatment or who cannot tolerate (neo)adjuvant treatment.
- Females of childbearing potential who have not undergone surgical sterilization or do not use adequate contraceptive measures, pregnant or lactating females, and males who plan to impregnate their partners in the near term.
- Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active bleeding, diabetes mellitus, and others.
- Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral therapy, including but not limited to tuberculosis (TB), human immunodeficiency virus (HIV) infection, and others.
- History of previous malignant tumors or other malignant tumors currently present, except for basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic/cervical/breast carcinoma in situ, and other such tumors that have been completely resected with no recurrence for at least 5 years.
- Other circumstances that investigators deem inappropriate for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xuefei Wang, MD, PhD, +86 21 64041990, wang.xuefei@zs-hospital.sh.cn
Xuefei Wang, MD, PhD
About this study
Standard treatment for locally advanced gastric cancer currently involves surgery combined with chemotherapy administered both before and after the operation. However, post-surgery (adjuvant) chemotherapy often causes severe side effects, and it is unclear if all patients truly benefit from it. Recent research, such as the SPACE-FLOT study, suggests that patients who respond well to pre-surgery treatment might not actually benefit from further aggressive treatment after surgery; in these cases, additional therapy may only increase the risk of side effects without improving survival.
To address this, researchers are investigating circulating tumor DNA (ctDNA) testing, which detects microscopic traces of cancer (Molecular Residual Disease, or MRD) in the blood. The utility of ctDNA is supported by extensive research:
Read more
In Colorectal Cancer: The GALAXY study demonstrated that ctDNA status accurately predicts patient survival and identifies who benefits from chemotherapy. Furthermore, the DYNAMIC study showed that using ctDNA to guide treatment decisions significantly reduced the use of unnecessary chemotherapy without compromising patient survival.
In Gastric Cancer: Studies such as MENCA-GC, CRITICS, and PLAGAST have confirmed that post-surgery ctDNA is a strong predictor of patient prognosis. Additionally, the MRD-GATE study provided preliminary evidence that ctDNA-guided strategies can reduce unnecessary chemotherapy in the adjuvant setting.
Building on this evidence, this study applies ctDNA testing to the standard perioperative treatment model for gastric cancer. The primary objective is to determine if a ctDNA-guided strategy can identify patients who can safely forgo post-surgery chemotherapy, thereby reducing treatment toxicity and unnecessary usage, without sacrificing long-term survival outcomes.
- Being tested
- Standard neoadjuvant therapy, Radical gastrectomy, Standard adjuvant therapy, ctDNA-MRD-guided adjuvant therapy
- Keywords
- Gastric / Gastroesophageal Junction Adenocarcinoma, Circulating Tumor DNA, Minimal Residual Disease, Perioperative treatment
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard neoadjuvant therapyDrug
Participants will receive 4 cycles of neoadjuvant therapy based on CSCO/NCCN guidelines. The specific regimen is determined by molecular characteristics and clinical practice:
- Chemotherapy: Options include SOX, DOS, FLOT, XELOX (CapeOx), or FOLFOX.
- HER2-Positive: Trastuzumab combined with chemotherapy, with or without immunotherapy.
- Immunotherapy: PD-(L)1 inhibitors may be administered as monotherapy or in combination with chemotherapy.
Dosages and administration follow standard pharmaceutical labeling and institutional protocols.
Radical gastrectomyProcedure or surgery
Radical gastrectomy with standard D2 lymphadenectomy will be performed.
Standard adjuvant therapyDrug
Postoperative adjuvant therapy for the control group is determined by an experienced clinician based on standard clinical guidelines (e.g., CSCO, NCCN) and the patient's clinical status.
The decision to administer adjuvant therapy, along with the specific regimen, is made at the discretion of experienced clinicians. If indicated, therapy typically begins 4-6 weeks post-surgery and consists of 4 cycles. The regimen generally mirrors the neoadjuvant therapy received and may include:
- Chemotherapy: Options include SOX, DOS, FLOT, XELOX (CapeOx), or FOLFOX.
- HER2-Positive: Trastuzumab combined with chemotherapy, with or without immunotherapy.
- Immunotherapy: PD-(L)1 inhibitors may be administered as monotherapy or in combination with chemotherapy.
Dosages and administration follow standard pharmaceutical labeling and institutional protocols.
Patients deemed unsuitable for adjuvant therapy by experienced clinicians will undergo observation.
ctDNA-MRD-guided adjuvant therapyDrug
Participants in the Experimental Arm will initially receive 4 cycles of neoadjuvant therapy followed by D2 radical gastrectomy. Postoperative management is strictly guided by ctDNA MRD status assessed at 4 weeks post-surgery:
- ctDNA MRD-Negative Subgroup: Participants will not receive adjuvant therapy and will undergo active surveillance (observation).
- ctDNA MRD-Positive Subgroup: Participants will receive 4 cycles of adjuvant therapy, initiating 4-6 weeks after surgery. The regimen generally mirrors the neoadjuvant therapy and is selected based on clinical guidelines (e.g., CSCO/NCCN). Options include: Chemotherapy: SOX, XELOX (CapeOx), FLOT, DOS, or FOLFOX . Targeted/Immunotherapy: Agents such as Trastuzumab (for HER2+) or PD-(L)1 inhibitors may be included if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants in this group will receive four cycles of neoadjuvant therapy followed by radical gastrectomy. Postoperatively, patients will be stratified based on their ctDNA MRD status at the post-surgical timepoint:
1. ctDNA MRD-Negative Subgroup (estimated n=30): Patients will not receive adjuvant therapy (observation only).
2. ctDNA MRD-Positive Subgroup (estimated n=30): Patients will receive adjuvant therapy. Receives: Drug: Standard neoadjuvant therapy; Procedure: Radical gastrectomy; Drug: ctDNA-MRD-guided adjuvant therapy |
| Control Arm | Active comparator | This group serves as a standard-of-care comparison. Participants will receive four cycles of neoadjuvant therapy followed by radical gastrectomy. The decision to administer postoperative adjuvant therapy will be made by experienced clinicians based on standard treatment guidelines and the patient's individual condition.
This group will include participants who meet any of the following criteria:
1. Patients who decline ctDNA-guided postoperative adjuvant therapy strategies.
2. Patients for whom insufficient tumor tissue was collected during screening to complete Whole Exome Sequencing (WES).
3. Patients who are unwilling or unable to provide sufficient peripheral blood samples for ctDNA MRD testing.
4. Any other conditions deemed unsuitable for inclusion in the Experimental Arm by the investigator. Receives: Drug: Standard neoadjuvant therapy; Procedure: Radical gastrectomy; Drug: Standard adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
RFS is defined as the time from the date of radical gastrectomy to the date of the first documented disease recurrence or death from any cause.
Measured: From completion of adjuvant therapy (or radical gastrectomy for patients not receiving adjuvant therapy) up to 2 years, assessed every 3 months.
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as the time from the date of radical gastrectomy to the date of death from any cause.
Measured: From completion of adjuvant therapy (or radical gastrectomy for patients not receiving adjuvant therapy) up to 2 years, assessed every 3 months.
ctDNA Clearance Rate
Defined as the proportion of patients whose ctDNA status converts from positive to negative.
Measured: Within 7 days prior to the initiation of neoadjuvant therapy. Within 7 days prior to radical gastrectomy. 3 to 5 weeks post-surgery. 4 weeks after completion of adjuvant therapy, or 5 months post-surgery.
The time point of ctDNA conversion from negative to positive and the time difference from the time point of radiological diagnosis of tumor recurrence
After peripheral blood collection, ctDNA detection is performed using a tumor-informed strategy based on NGS (Next-Generation Sequencing) and WES (Whole-Exome Sequencing) technologies.
Measured: Within 7 days prior to radical gastrectomy. 3 to 5 weeks post-surgery. 4 weeks after completion of adjuvant therapy, or 5 months post-surgery.
Pathological Complete Response (pCR) Rate
Pathological examination performed on gastric cancer surgical specimens
Measured: Within 1 week after radical gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric / Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuefei.Wang, Shanghai Zhongshan Hospital
- Investigators
- Xuefei Wang, MD, PhD, Principal investigator, Zhongshan Hospital, Fudan University, Shanghai, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257380
- Sponsor's protocol ID
- B2025-604R
- Acronym
- MRD-ATLAS
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric Cancer With Neoadjuvant Treatment: An Adaptive Trial (MRD-ATLAS)
- ClinicalTrials.gov ID
- NCT07257380
- Acronym / sponsor ID
- MRD-ATLAS / B2025-604R
- Keywords
- Gastric / Gastroesophageal Junction Adenocarcinoma, Circulating Tumor DNA, Minimal Residual Disease, Perioperative treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 2 Dec 2025 (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.
Standard treatment for locally advanced gastric cancer currently involves surgery combined with chemotherapy administered both before and after the operation. However, post-surgery (adjuvant) chemotherapy often causes severe side effects, and it is unclear if all patients truly benefit from it. Recent research, such as the SPACE-FLOT study, suggests that patients who respond well to pre-surgery treatment might not actually benefit from further aggressive treatment after surgery; in these cases, additional therapy may only increase the risk of side effects without improving survival.
To address this, researchers are investigating circulating tumor DNA (ctDNA) testing, which detects microscopic traces of cancer (Molecular Residual Disease, or MRD) in the blood. The utility of ctDNA is supported by extensive research:
In Colorectal Cancer: The GALAXY study demonstrated that ctDNA status accurately predicts patient survival and identifies who benefits from chemotherapy. Furthermore, the DYNAMIC study showed that using ctDNA to guide treatment decisions significantly reduced the use of unnecessary chemotherapy without compromising patient survival.
In Gastric Cancer: Studies such as MENCA-GC, CRITICS, and PLAGAST have confirmed that post-surgery ctDNA is a strong predictor of patient prognosis. Additionally, the MRD-GATE study provided preliminary evidence that ctDNA-guided strategies can reduce unnecessary chemotherapy in the adjuvant setting.
Building on this evidence, this study applies ctDNA testing to the standard perioperative treatment model for gastric cancer. The primary objective is to determine if a ctDNA-guided strategy can identify patients who can safely forgo post-surgery chemotherapy, thereby reducing treatment toxicity and unnecessary usage, without sacrificing long-term survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Standard neoadjuvant therapy, Procedure: Radical gastrectomy, Drug: ctDNA-MRD-guided adjuvant therapyParticipants in this group will receive four cycles of neoadjuvant therapy followed by radical gastrectomy. Postoperatively, patients will be stratified based on their ctDNA MRD status at the post-surgical timepoint: 1. ctDNA MRD-Negative Subgroup (estimated n=30): Patients will not receive adjuvant therapy (observation only). 2. ctDNA MRD-Positive Subgroup (estimated n=30): Patients will receive adjuvant therapy. |
| Control Arm | Active comparator | Drug: Standard neoadjuvant therapy, Procedure: Radical gastrectomy, Drug: Standard adjuvant therapyThis group serves as a standard-of-care comparison. Participants will receive four cycles of neoadjuvant therapy followed by radical gastrectomy. The decision to administer postoperative adjuvant therapy will be made by experienced clinicians based on standard treatment guidelines and the patient's individual condition. This group will include participants who meet any of the following criteria: 1. Patients who decline ctDNA-guided postoperative adjuvant therapy strategies. 2. Patients for whom insufficient tumor tissue was collected during screening to complete Whole Exome Sequencing (WES). 3. Patients who are unwilling or unable to provide sufficient peripheral blood samples for ctDNA MRD testing. 4. Any other conditions deemed unsuitable for inclusion in the Experimental Arm by the investigator. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be able to provide a written informed consent form (ICF), and understand, agree to, and comply with the study requirements and assessment schedule.
- Male or female aged 18 to 79 years.
- Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ), with clinical TNM staging (per the 8th edition of the AJCC/UICC Clinical TNM Staging for Gastric Cancer) as clinical Stage cIII to cIVa, and the primary gastric cancer lesion assessed to be amenable to curative resection.
- ECOG PS ≤ 2, tolerable to surgical treatment, no surgical contraindications.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to initiating neoadjuvant treatment. Males of reproductive potential and females of childbearing potential must agree to use adequate contraceptive measures during the study and for 24 months after the last dose of study medication.
Key exclusion criteria (6 listed)
- Subjects for whom investigators consider that there are obvious contraindications to (neo)adjuvant treatment or who cannot tolerate (neo)adjuvant treatment.
- Females of childbearing potential who have not undergone surgical sterilization or do not use adequate contraceptive measures, pregnant or lactating females, and males who plan to impregnate their partners in the near term.
- Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active bleeding, diabetes mellitus, and others.
- Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral therapy, including but not limited to tuberculosis (TB), human immunodeficiency virus (HIV) infection, and others.
- History of previous malignant tumors or other malignant tumors currently present, except for basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic/cervical/breast carcinoma in situ, and other such tumors that have been completely resected with no recurrence for at least 5 years.
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 |
|---|---|---|
| Standard neoadjuvant therapyParticipants will receive 4 cycles of neoadjuvant therapy based on CSCO/NCCN guidelines. The specific regimen is determined by molecular characteristics and clinical practice: 1. Chemotherapy: Options include SOX, DOS, FLOT, XELOX (CapeOx), or FOLFOX. 2. HER2-Positive: Trastuzumab combined with chemotherapy, with or without immunotherapy. 3. Immunotherapy: PD-(L)1 inhibitors may be administered as monotherapy or in combination with chemotherapy. Dosages and administration follow standard pharmaceutical labeling and institutional protocols. | Drug | Control Arm, Experimental Arm |
| Radical gastrectomyRadical gastrectomy with standard D2 lymphadenectomy will be performed. | Procedure or surgery | Control Arm, Experimental Arm |
| Standard adjuvant therapyPostoperative adjuvant therapy for the control group is determined by an experienced clinician based on standard clinical guidelines (e.g., CSCO, NCCN) and the patient's clinical status. The decision to administer adjuvant therapy, along with the specific regimen, is made at the discretion of experienced clinicians. If indicated, therapy typically begins 4-6 weeks post-surgery and consists of 4 cycles. The regimen generally mirrors the neoadjuvant therapy received and may include: 1. Chemotherapy: Options include SOX, DOS, FLOT, XELOX (CapeOx), or FOLFOX. 2. HER2-Positive: Trastuzumab combined with chemotherapy, with or without immunotherapy. 3. Immunotherapy: PD-(L)1 inhibitors may be administered as monotherapy or in combination with chemotherapy. Dosages and administration follow standard pharmaceutical labeling and institutional protocols. Patients deemed unsuitable for adjuvant therapy by experienced clinicians will undergo observation. | Drug | Control Arm |
| ctDNA-MRD-guided adjuvant therapyParticipants in the Experimental Arm will initially receive 4 cycles of neoadjuvant therapy followed by D2 radical gastrectomy. Postoperative management is strictly guided by ctDNA MRD status assessed at 4 weeks post-surgery: 1. ctDNA MRD-Negative Subgroup: Participants will not receive adjuvant therapy and will undergo active surveillance (observation). 2. ctDNA MRD-Positive Subgroup: Participants will receive 4 cycles of adjuvant therapy, initiating 4-6 weeks after surgery. The regimen generally mirrors the neoadjuvant therapy and is selected based on clinical guidelines (e.g., CSCO/NCCN). Options include: Chemotherapy: SOX, XELOX (CapeOx), FLOT, DOS, or FOLFOX . Targeted/Immunotherapy: Agents such as Trastuzumab (for HER2+) or PD-(L)1 inhibitors may be included if clinically indicated. | Drug | Experimental Arm |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: From completion of adjuvant therapy (or radical gastrectomy for patients not receiving adjuvant therapy) up to 2 years, assessed every 3 months.
RFS is defined as the time from the date of radical gastrectomy to the date of the first documented disease recurrence or death from any cause.
4 secondary outcomes
Overall Survival (OS)
Time frame: From completion of adjuvant therapy (or radical gastrectomy for patients not receiving adjuvant therapy) up to 2 years, assessed every 3 months.
ctDNA Clearance Rate
Time frame: Within 7 days prior to the initiation of neoadjuvant therapy. Within 7 days prior to radical gastrectomy. 3 to 5 weeks post-surgery. 4 weeks after completion of adjuvant therapy, or 5 months post-surgery.
The time point of ctDNA conversion from negative to positive and the time difference from the time point of radiological diagnosis of tumor recurrence
Time frame: Within 7 days prior to radical gastrectomy. 3 to 5 weeks post-surgery. 4 weeks after completion of adjuvant therapy, or 5 months post-surgery.
Pathological Complete Response (pCR) Rate
Time frame: Within 1 week after radical gastrectomy
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 2 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Xuefei Wang, MD, PhD principal investigator
Zhongshan Hospital, Fudan University, Shanghai, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard neoadjuvant therapy, Radical gastrectomy and Standard adjuvant therapy in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site 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 6 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: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xuefei Wang, MD, PhD (+86 21 64041990, wang.xuefei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: From completion of adjuvant therapy (or radical gastrectomy for patients not receiving adjuvant therapy) up to 2 years, assessed every 3 months.). 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 2 Dec 2025.