Gastric / Gastroesophageal Junction AdenocarcinomaPhase 3MRD-ATLAS-IIINCT07508956
Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric Cancer With Neoadjuvant Treatment
A Phase 3 study testing Standard neoadjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy, Radical gastrectomy and Standard adjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
For locally advanced gastric adenocarcinoma/esophagogastric junction adenocarcinoma, the currently recommended treatment strategy per clinical guidelines is radical gastrectomy combined with perioperative therapy (including chemotherapy, immunotherapy, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric / Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Standard neoadjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy, Radical gastrectomy and Standard adjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Mar 2032
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent (ICF) and capable of understanding and agreeing to comply with the study requirements and assessment schedule;
- Male or female aged ≥ 18 years;
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, with clinical TNM stage (according to the 8th edition of the AJCC/UICC clinical TNM staging system for gastric cancer; see Appendix 1) of cIIB-IVA, and the primary gastric tumor assessed as amenable to radical resection;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2), fit to undergo surgical treatment with no contraindications to surgery;
- Capable of providing adequate tumor tissue obtained via gastroscopy (or other means) prior to neoadjuvant treatment for whole-exome sequencing;
- Females of childbearing potential must have a negative pregnancy test within 7 days before initiation of neoadjuvant treatment. Males and females of childbearing potential must agree to use adequate contraception during the study period and for 24 months after the last dose of study treatment (see Appendix 3);
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- Hematologic and biochemical parameters meeting the following criteria prior to neoadjuvant treatment:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelet count (PLT) ≥ 75 × 10⁹/L
- Hemoglobin (Hb) ≥ 80 g/L
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN)
- Serum creatinine (Cr) ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m²
- Serum albumin (ALB) ≥ 30 g/L
- 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 within the expected therapeutic range for the anticoagulant;
- No prior anticancer therapy for the current study-related tumor prior to initiation of neoadjuvant treatment.
Who cannot join
- Patients deemed by the investigator to have significant contraindications to or intolerance of neoadjuvant/adjuvant therapy;
- Female patients of childbearing potential who have not undergone surgical sterilization or are not using adequate contraceptive measures, pregnant or lactating women, or male patients planning to father a child within a short period;
- Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active hemorrhage, diabetes mellitus, etc.;
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis, human immunodeficiency virus (HIV) infection, etc.;
- Prior history of malignancy or current presence of another malignancy, except for completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast with at least 5 years without recurrence;
- Other conditions deemed by the investigator to render the patient unsuitable 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
About this study
Official title: Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric Cancer With Neoadjuvant Treatment: An Open-Label, Randomized, Multi-Centered Phase III Trial
For locally advanced gastric adenocarcinoma/esophagogastric junction adenocarcinoma, the currently recommended treatment strategy per clinical guidelines is radical gastrectomy combined with perioperative therapy (including chemotherapy, immunotherapy, etc.). This approach involves several cycles of neoadjuvant therapy prior to surgery, followed by the surgical procedure, and then several cycles of adjuvant therapy post-surgery. This regimen is generally considered to offer favorable efficacy, ultimately leading to improved survival outcomes for patients. However, some patients are unable to complete the prescribed postoperative adjuvant therapy due to factors such as poor physical condition after surgery or cumulative treatment toxicity. Findings from the retrospective SPACE-FLOT study preliminarily suggest that for patients with a favorable response to neoadjuvant therapy, postoperative adjuvant therapy may not confer additional survival benefit, while potentially increasing the risk of treatment-related adverse events. Therefore, the investigators aim to utilize the latest technological approaches to identify patients who could safely forgo adjuvant therapy, enabling personalized treatment decisions, reducing unnecessary treatment, and thereby maximizing patients' long-term survival benefits.
To achieve this objective, the investigators have identified circulating tumor DNA (ctDNA) testing as a potential solution. ctDNA refers to DNA fragments released by tumor cells into the extracellular space (e.g., into the bloodstream). By drawing a small amount of peripheral blood and analyzing the ctDNA within, it is possible to detect minimal residual disease (MRD) that is difficult to identify through conventional imaging methods (such as CT or MRI) after treatment. MRD is considered a critical factor that may lead to tumor recurrence. Utilizing ctDNA to detect MRD enables a convenient and accurate assessment of tumor status and treatment efficacy, thereby offering the potential for personalized treatment.
Read more
Colorectal cancer represents a cancer type where ctDNA testing has been applied early and is relatively mature. In the field of colorectal cancer, the GALAXY study confirmed that ctDNA positivity can effectively predict patient survival outcomes, with superior performance to other traditional indicators. The study also found that patients with postoperative ctDNA MRD positivity tended to benefit from postoperative adjuvant chemotherapy, whereas those with ctDNA MRD negativity often did not derive such benefit. Subsequently, another randomized controlled trial (the DYNAMIC study) revealed that using ctDNA MRD to guide postoperative adjuvant chemotherapy strategies could effectively reduce unnecessary chemotherapy without adversely impacting patient survival outcomes.
In the field of gastric cancer, studies such as MENCA-GC, CRITICS, and PLAGAST have all demonstrated that postoperative ctDNA can effectively predict patient prognosis in the treatment model of radical gastrectomy combined with perioperative therapy. Additionally, preliminary findings from the ongoing MRD-GATE study indicate that in treatment models without preoperative neoadjuvant therapy (i.e., surgery followed by adjuvant therapy), utilizing ctDNA MRD to guide postoperative adjuvant treatment can also reduce unnecessary chemotherapy without compromising patient survival outcomes.
This study focuses on patients with locally advanced gastric cancer, integrating the latest clinical research advancements, and aims to fill the research gap concerning the efficacy of using ctDNA MRD to guide adjuvant therapy within the context of radical gastrectomy combined with perioperative therapy. This holds significant importance for optimizing treatment strategies and maximizing patient benefits.
- Being tested
- Standard neoadjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy, Radical gastrectomy, Standard adjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy, ctDNA-MRD-guided adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard neoadjuvant therapy: Chemotherapy/Targeted Therapy/ImmunotherapyDrug
Participants 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.
Radical gastrectomyProcedure or surgery
Radical gastrectomy with standard D2 lymphadenectomy will be performed.
Standard adjuvant therapy: Chemotherapy/Targeted Therapy/ImmunotherapyDrug
For control arm, postoperative adjuvant therapy begins 4-6 weeks post-surgery and consists of 4 cycles. The regimen generally mirrors the neoadjuvant therapy received. 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: 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.
| 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: Chemotherapy/Targeted Therapy/Immunotherapy; 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. Receives: Drug: Standard neoadjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy; Procedure: Radical gastrectomy; Drug: Standard adjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Defined as the time from the date of radical surgery to the first occurrence of disease recurrence or death from any cause.
Measured: The time from radical gastrectomy to documented disease recurrence or death, whichever occurs first, assessed up to 3 years.
Secondary outcomes (6)
Quality of Life (QoL)-EORTC QLQ-C30
Assessed using the EORTC QLQ-C30.
Measured: From screening (within 21 days before randomization) to 15 months after surgery.
Quality of Life (QoL)-QLQ-STO-22
Assessed using the QLQ-STO-22 questionnaires.
Measured: From screening (within 21 days before randomization) to 15 months after surgery.
Overall Survival (OS)
Defined as the time from the date of radical surgery to death from any cause.
Measured: The time from radical gastrctomy to death from any cause, assessed up to 3 years.
Proportion of Adjuvant Therapy Implementation
The proportion of subjects in each group who actually receive postoperative adjuvant therapy.
Measured: From the date of radical surgery to the initiation of adjuvant therapy (or up to 16 weeks after surgery if no therapy is given).
Changes in ctDNA Levels During Treatment
Measured: From randomization to 5 months post surgery.
Correlation of Changes in ctDNA Levels with Pathological Tumor Regression Grade, Time to Recurrence (TTR), and DFS.
Measured: From randomization to 5 months post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2032 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yihong Sun, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508956
- Sponsor's protocol ID
- KY2026043
- Acronym
- MRD-ATLAS-III
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2026
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. 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 Open-Label, Randomized, Multi-Centered Phase III Trial
- ClinicalTrials.gov ID
- NCT07508956
- Acronym / sponsor ID
- MRD-ATLAS-III / KY2026043
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 2 Apr 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.
For locally advanced gastric adenocarcinoma/esophagogastric junction adenocarcinoma, the currently recommended treatment strategy per clinical guidelines is radical gastrectomy combined with perioperative therapy (including chemotherapy, immunotherapy, etc.). This approach involves several cycles of neoadjuvant therapy prior to surgery, followed by the surgical procedure, and then several cycles of adjuvant therapy post-surgery. This regimen is generally considered to offer favorable efficacy, ultimately leading to improved survival outcomes for patients. However, some patients are unable to complete the prescribed postoperative adjuvant therapy due to factors such as poor physical condition after surgery or cumulative treatment toxicity. Findings from the retrospective SPACE-FLOT study preliminarily suggest that for patients with a favorable response to neoadjuvant therapy, postoperative adjuvant therapy may not confer additional survival benefit, while potentially increasing the risk of treatment-related adverse events. Therefore, the investigators aim to utilize the latest technological approaches to identify patients who could safely forgo adjuvant therapy, enabling personalized treatment decisions, reducing unnecessary treatment, and thereby maximizing patients' long-term survival benefits.
To achieve this objective, the investigators have identified circulating tumor DNA (ctDNA) testing as a potential solution. ctDNA refers to DNA fragments released by tumor cells into the extracellular space (e.g., into the bloodstream). By drawing a small amount of peripheral blood and analyzing the ctDNA within, it is possible to detect minimal residual disease (MRD) that is difficult to identify through conventional imaging methods (such as CT or MRI) after treatment. MRD is considered a critical factor that may lead to tumor recurrence. Utilizing ctDNA to detect MRD enables a convenient and accurate assessment of tumor status and treatment efficacy, thereby offering the potential for personalized treatment.
Colorectal cancer represents a cancer type where ctDNA testing has been applied early and is relatively mature. In the field of colorectal cancer, the GALAXY study confirmed that ctDNA positivity can effectively predict patient survival outcomes, with superior performance to other traditional indicators. The study also found that patients with postoperative ctDNA MRD positivity tended to benefit from postoperative adjuvant chemotherapy, whereas those with ctDNA MRD negativity often did not derive such benefit. Subsequently, another randomized controlled trial (the DYNAMIC study) revealed that using ctDNA MRD to guide postoperative adjuvant chemotherapy strategies could effectively reduce unnecessary chemotherapy without adversely impacting patient survival outcomes.
In the field of gastric cancer, studies such as MENCA-GC, CRITICS, and PLAGAST have all demonstrated that postoperative ctDNA can effectively predict patient prognosis in the treatment model of radical gastrectomy combined with perioperative therapy. Additionally, preliminary findings from the ongoing MRD-GATE study indicate that in treatment models without preoperative neoadjuvant therapy (i.e., surgery followed by adjuvant therapy), utilizing ctDNA MRD to guide postoperative adjuvant treatment can also reduce unnecessary chemotherapy without compromising patient survival outcomes.
This study focuses on patients with locally advanced gastric cancer, integrating the latest clinical research advancements, and aims to fill the research gap concerning the efficacy of using ctDNA MRD to guide adjuvant therapy within the context of radical gastrectomy combined with perioperative therapy. This holds significant importance for optimizing treatment strategies and maximizing patient benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Standard neoadjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy, 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: Chemotherapy/Targeted Therapy/Immunotherapy, Procedure: Radical gastrectomy, Drug: Standard adjuvant therapy: Chemotherapy/Targeted Therapy/ImmunotherapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Able to provide written informed consent (ICF) and capable of understanding and agreeing to comply with the study requirements and assessment schedule;
- Male or female aged ≥ 18 years;
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, with clinical TNM stage (according to the 8th edition of the AJCC/UICC clinical TNM staging system for gastric cancer; see Appendix 1) of cIIB-IVA, and the primary gastric tumor assessed as amenable to radical resection;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2), fit to undergo surgical treatment with no contraindications to surgery;
- Capable of providing adequate tumor tissue obtained via gastroscopy (or other means) prior to neoadjuvant treatment for whole-exome sequencing;
Key exclusion criteria (6 listed)
- Patients deemed by the investigator to have significant contraindications to or intolerance of neoadjuvant/adjuvant therapy;
- Female patients of childbearing potential who have not undergone surgical sterilization or are not using adequate contraceptive measures, pregnant or lactating women, or male patients planning to father a child within a short period;
- Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active hemorrhage, diabetes mellitus, etc.;
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis, human immunodeficiency virus (HIV) infection, etc.;
- Prior history of malignancy or current presence of another malignancy, except for completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast with at least 5 years without recurrence;
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 therapy: Chemotherapy/Targeted Therapy/ImmunotherapyParticipants 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 therapy: Chemotherapy/Targeted Therapy/ImmunotherapyFor control arm, postoperative adjuvant therapy begins 4-6 weeks post-surgery and consists of 4 cycles. The regimen generally mirrors the neoadjuvant therapy received. 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. | Drug | Experimental Arm |
Primary outcome
Disease-Free Survival (DFS)
Time frame: The time from radical gastrectomy to documented disease recurrence or death, whichever occurs first, assessed up to 3 years.
Defined as the time from the date of radical surgery to the first occurrence of disease recurrence or death from any cause.
6 secondary outcomes
Quality of Life (QoL)-EORTC QLQ-C30
Time frame: From screening (within 21 days before randomization) to 15 months after surgery.
Quality of Life (QoL)-QLQ-STO-22
Time frame: From screening (within 21 days before randomization) to 15 months after surgery.
Overall Survival (OS)
Time frame: The time from radical gastrctomy to death from any cause, assessed up to 3 years.
Proportion of Adjuvant Therapy Implementation
Time frame: From the date of radical surgery to the initiation of adjuvant therapy (or up to 16 weeks after surgery if no therapy is given).
Changes in ctDNA Levels During Treatment
Time frame: From randomization to 5 months post surgery.
Correlation of Changes in ctDNA Levels with Pathological Tumor Regression Grade, Time to Recurrence (TTR), and DFS.
Time frame: From randomization to 5 months post surgery.
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 8 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard neoadjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy, Radical gastrectomy and Standard adjuvant therapy: Chemotherapy/Targeted Therapy/Immunotherapy 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 15 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 8 Jun 2026. 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 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 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?
Disease-Free Survival (DFS) (time frame: The time from radical gastrectomy to documented disease recurrence or death, whichever occurs first, assessed up to 3 years.). 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 8 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.