Gastric AdenocarcinomaPhase 2/3NCT07603349
Adaptive Adjuvant Therapy After Neoadjuvant Therapy and Gastrectomy for Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2/3 study testing Alternative Postoperative Treatment Regimen, Original Treatment Regimen and Postoperative Observation in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate postoperative adaptive adjuvant therapy in patients with gastric or gastroesophageal junction adenocarcinoma after neoadjuvant chemotherapy plus immunotherapy and radical gastrectomy.The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Alternative Postoperative Treatment Regimen, Original Treatment Regimen and Postoperative Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Dec 2029
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed written informed consent.
- Aged 18 to 75 years, inclusive, regardless of sex.
- Underwent radical gastrectomy with D2 or more extended lymphadenectomy and achieved R0 resection. Surgical approaches may include open or laparoscopic surgery.
- Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma.
- Received preoperative neoadjuvant immunotherapy combined with chemotherapy, including oxaliplatin plus fluoropyrimidine-based chemotherapy. Immunotherapy may include anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, PD-1/CTLA-4 bispecific antibodies, and other immune checkpoint inhibitors.
- Eligible for one of the following predefined cohorts:
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- Cohort 1: TRG grade 3 and postoperative pathological stage ypT3-4N2-3M0.
- Cohort 2: TRG grade 0 and postoperative pathological stage ypT0N0M0.
- ECOG performance status of 0 or 1.
- No evidence of metastasis or recurrence on postoperative imaging before enrollment.
- Adequate organ function, defined as hematologic, hepatic, renal, and thyroid function meeting the protocol-specified criteria based on laboratory tests performed within 14 days before randomization.
- Willing and able to comply with the study treatment, scheduled visits, laboratory tests, and other study procedures.
- Female participants of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after the last dose of study treatment. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose of study treatment.
Who cannot join
- Presence of liver, peritoneal, or other distant metastases.
- Inability to take oral medications.
- Unresolved postoperative complications at the time of randomization, such as postoperative infection, anastomotic leakage or wound dehiscence, gastrointestinal bleeding, pancreatic fistula, or intestinal obstruction.
- Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites at screening, defined as any of the following: pleural effusion or ascites with clinical symptoms and detectable by physical examination; or pleural effusion or ascites requiring drainage and/or intracavitary treatment during screening.
- Underwent any surgery requiring general anesthesia that was not related to gastric cancer within 28 days before randomization.
- History of or current diagnosis of another malignancy within 5 years.
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- Active or prior autoimmune disease that may relapse or require immunosuppressive treatment within 2 weeks or during the study period; or a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disease; or a history of organ transplantation.
- Participation in another clinical study, or any condition that may interfere with the interpretation of the study results.
- Any other severe acute or chronic disease that, in the investigator's judgment, may increase the risk associated with study participation or study treatment.
- Active or uncontrolled infection requiring systemic antibiotic therapy within 2 weeks before randomization or at the time of randomization.
- Diagnosis of interstitial pneumonia, noninfectious pneumonitis, pulmonary fibrosis, or acute lung disease.
- Active tuberculosis within 1 year or previous anti-tuberculosis treatment.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after the end of treatment.
- History of psychotropic drug abuse with inability to discontinue, or presence of a psychiatric disorder.
- Patients considered unsuitable for participation in this study by the investigator.
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
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Liying Zhao, M.D., Ph.D, 13430396746, zlyblue11@163.com
About this study
Official title: Efficacy and Safety of Postoperative Adaptive Adjuvant Therapy After Neoadjuvant Therapy and Radical Gastrectomy for Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label Clinical Trial
The goal of this clinical trial is to evaluate postoperative adaptive adjuvant therapy in patients with gastric or gastroesophageal junction adenocarcinoma after neoadjuvant chemotherapy plus immunotherapy and radical gastrectomy.The main questions it aims to answer are:
- In patients with poor pathological response, does switching to a alternative postoperative treatment regimen improve survival?
- In patients with complete pathological response, can observation without routine postoperative treatment maintain favorable survival outcomes? Participants will be assigned to different cohorts according to their pathological response after surgery and will be followed regularly for recurrence, survival, and treatment-related side effects.
Read the detailed description
This prospective clinical trial will enroll patients with gastric or gastroesophageal junction adenocarcinoma who have received neoadjuvant chemotherapy plus immunotherapy followed by radical gastrectomy. Participants will be assigned to predefined cohorts according to postoperative pathological response and pathological stage.
Patients with poor pathological response, defined as TRG 3 and ypT3-4N2-3M0 disease, will be evaluated to determine whether switching to a alternative postoperative treatment regimen improves survival and remains safe compared with continuing the original treatment regimen. For patients with complete pathological response, defined as TRG 0 and ypT0N0M0 disease, will be evaluated to determine whether observation without routine postoperative treatment maintain favorable survival outcomes.
The study aims to assess whether postoperative treatment can be adapted according to pathological response after neoadjuvant therapy, rather than applying the same postoperative treatment strategy to all patients. The results may help develop more individualized postoperative management strategies for patients at very high or very low risk of recurrence after neoadjuvant therapy and radical surgery.
- Being tested
- Alternative Postoperative Treatment Regimen, Original Treatment Regimen, Postoperative Observation
- Keywords
- Gastric cancer, Gastroesophageal junction cancer, Neoadjuvant therapy, Adaptive adjuvant therapy, Pathological response, Prognosis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative Postoperative Treatment RegimenDrug
Participants in this arm will switch to an alternative postoperative treatment regimen selected by the investigator according to prior neoadjuvant therapy, postoperative molecular subtype, and the 2025 CSCO and NCCN guidelines. The regimen will include taxane-based or irinotecan-based treatment that was not used before surgery, with dosage and administration based on clinical practice standards and drug prescribing information.
Original Treatment RegimenDrug
The original preoperative treatment regimen will be continued postoperatively. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information.
Postoperative ObservationOther
Participants will undergo postoperative observation without further antitumor drug therapy. Routine follow-up monitoring will be conducted according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Experimental Arm | Experimental | Participants randomized to the cohort 1 experimental arm will switch to an alternative postoperative treatment regimen. The alternative regimen will be selected by the investigator based on the participant's preoperative treatment regimen, postoperative molecular subtype, and the 2025 CSCO and 2025 NCCN guidelines. The regimen should include taxane-based or irinotecan-based monotherapy or combination therapy that was not used before surgery. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information. Receives: Drug: Alternative Postoperative Treatment Regimen |
| Cohort 1 Control Arm | Active comparator | Participants randomized to the Cohort 1 control arm will continue treatment according to the preoperative treatment regimen. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information. Receives: Drug: Original Treatment Regimen |
| Cohort 2 | Experimental | Participants in Cohort 2 will undergo postoperative observation without routine antitumor drug therapy. They will receive regular follow-up monitoring according to the study protocol. Receives: Other: Postoperative Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Event-Free Survival in Cohort 1（mEFS）
defined as the time from randomization to the first documented local, regional, or distant recurrence, or death from any cause, whichever occurs first.
Measured: Up to approximately 13 months
2-year Event-Free Survival Rate in Cohort 2（2-y EFS）
defined as the proportion of participants in Cohort 2 who are alive without documented local, regional, or distant recurrence at 2 years after cohort assignment.
Measured: Up to 2 years
Secondary outcomes (7)
1-year Event-Free Survival Rate in Cohort 1（1-y EFS）
defined as the proportion of participants in Cohort 1 who are alive without documented local, regional, or distant recurrence at 1 year after randomization.
Measured: Up to 1 year
1-Year Overall Survival Rate in Cohort 1（1-y OS）
defined as the proportion of participants in Cohort 1 who are alive at 1 year after randomization.
Measured: Up to 1 year
Median Overall Survival in Cohort 1（mOS）
defined as the time from randomization to death from any cause. Median overall survival will be evaluated in participants in Cohort 1.
Measured: Up to approximately 3 years
2-Year Overall Survival Rate in Cohort 2（2-y OS）
defined as the proportion of participants in Cohort 2 who are alive at 2 years after cohort assignment.
Measured: Up to 2 years
3-year Event-Free Survival Rate in Cohort 2（3-y EFS）
defined as the proportion of participants in Cohort 2 who are alive without documented local, regional, or distant recurrence at 3 years after cohort assignment.
Measured: Up to 3 years
3-year Overall Survival Rate in Cohort 2（3-y OS）
defined as the proportion of participants in Cohort 2 who are alive at 3 years after cohort assignment.
Measured: Up to 3 years
Incidence and Severity of Adverse Events
The incidence and severity of adverse events will be assessed according to NCI CTCAE version 5.0. Safety assessments will include adverse events, serious adverse events, vital signs, ECOG performance status, physical examination, electrocardiogram, echocardiography, and clinically significant changes from baseline in laboratory test results.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603349
- Sponsor's protocol ID
- NFEC-2026-306
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Postoperative Adaptive Adjuvant Therapy After Neoadjuvant Therapy and Radical Gastrectomy for Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label Clinical Trial
- ClinicalTrials.gov ID
- NCT07603349
- Acronym / sponsor ID
- NFEC-2026-306
- Keywords
- Gastric cancer, Gastroesophageal junction cancer, Neoadjuvant therapy, Adaptive adjuvant therapy, Pathological response, Prognosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 May 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.
The goal of this clinical trial is to evaluate postoperative adaptive adjuvant therapy in patients with gastric or gastroesophageal junction adenocarcinoma after neoadjuvant chemotherapy plus immunotherapy and radical gastrectomy.The main questions it aims to answer are:
- In patients with poor pathological response, does switching to a alternative postoperative treatment regimen improve survival?
- In patients with complete pathological response, can observation without routine postoperative treatment maintain favorable survival outcomes? Participants will be assigned to different cohorts according to their pathological response after surgery and will be followed regularly for recurrence, survival, and treatment-related side effects.
Detailed description
This prospective clinical trial will enroll patients with gastric or gastroesophageal junction adenocarcinoma who have received neoadjuvant chemotherapy plus immunotherapy followed by radical gastrectomy. Participants will be assigned to predefined cohorts according to postoperative pathological response and pathological stage.
Patients with poor pathological response, defined as TRG 3 and ypT3-4N2-3M0 disease, will be evaluated to determine whether switching to a alternative postoperative treatment regimen improves survival and remains safe compared with continuing the original treatment regimen. For patients with complete pathological response, defined as TRG 0 and ypT0N0M0 disease, will be evaluated to determine whether observation without routine postoperative treatment maintain favorable survival outcomes.
The study aims to assess whether postoperative treatment can be adapted according to pathological response after neoadjuvant therapy, rather than applying the same postoperative treatment strategy to all patients. The results may help develop more individualized postoperative management strategies for patients at very high or very low risk of recurrence after neoadjuvant therapy and radical surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Experimental Arm | Experimental | Drug: Alternative Postoperative Treatment RegimenParticipants randomized to the cohort 1 experimental arm will switch to an alternative postoperative treatment regimen. The alternative regimen will be selected by the investigator based on the participant's preoperative treatment regimen, postoperative molecular subtype, and the 2025 CSCO and 2025 NCCN guidelines. The regimen should include taxane-based or irinotecan-based monotherapy or combination therapy that was not used before surgery. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information. |
| Cohort 1 Control Arm | Active comparator | Drug: Original Treatment RegimenParticipants randomized to the Cohort 1 control arm will continue treatment according to the preoperative treatment regimen. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information. |
| Cohort 2 | Experimental | Other: Postoperative ObservationParticipants in Cohort 2 will undergo postoperative observation without routine antitumor drug therapy. They will receive regular follow-up monitoring according to the study protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily signed written informed consent.
- Aged 18 to 75 years, inclusive, regardless of sex.
- Underwent radical gastrectomy with D2 or more extended lymphadenectomy and achieved R0 resection. Surgical approaches may include open or laparoscopic surgery.
- Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma.
- Received preoperative neoadjuvant immunotherapy combined with chemotherapy, including oxaliplatin plus fluoropyrimidine-based chemotherapy. Immunotherapy may include anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, PD-1/CTLA-4 bispecific antibodies, and other immune checkpoint inhibitors.
Key exclusion criteria (15 listed)
- Presence of liver, peritoneal, or other distant metastases.
- Inability to take oral medications.
- Unresolved postoperative complications at the time of randomization, such as postoperative infection, anastomotic leakage or wound dehiscence, gastrointestinal bleeding, pancreatic fistula, or intestinal obstruction.
- Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites at screening, defined as any of the following: pleural effusion or ascites with clinical symptoms and detectable by physical examination; or pleural effusion or ascites requiring drainage and/or intracavitary treatment during screening.
- Underwent any surgery requiring general anesthesia that was not related to gastric cancer within 28 days before randomization.
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 |
|---|---|---|
| Alternative Postoperative Treatment RegimenParticipants in this arm will switch to an alternative postoperative treatment regimen selected by the investigator according to prior neoadjuvant therapy, postoperative molecular subtype, and the 2025 CSCO and NCCN guidelines. The regimen will include taxane-based or irinotecan-based treatment that was not used before surgery, with dosage and administration based on clinical practice standards and drug prescribing information. | Drug | Cohort 1 Experimental Arm |
| Original Treatment RegimenThe original preoperative treatment regimen will be continued postoperatively. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information. | Drug | Cohort 1 Control Arm |
| Postoperative ObservationParticipants will undergo postoperative observation without further antitumor drug therapy. Routine follow-up monitoring will be conducted according to the study protocol. | Other | Cohort 2 |
Primary outcome
Median Event-Free Survival in Cohort 1（mEFS）
Time frame: Up to approximately 13 months
defined as the time from randomization to the first documented local, regional, or distant recurrence, or death from any cause, whichever occurs first.
2-year Event-Free Survival Rate in Cohort 2（2-y EFS）
Time frame: Up to 2 years
defined as the proportion of participants in Cohort 2 who are alive without documented local, regional, or distant recurrence at 2 years after cohort assignment.
7 secondary outcomes
1-year Event-Free Survival Rate in Cohort 1（1-y EFS）
Time frame: Up to 1 year
1-Year Overall Survival Rate in Cohort 1（1-y OS）
Time frame: Up to 1 year
Median Overall Survival in Cohort 1（mOS）
Time frame: Up to approximately 3 years
2-Year Overall Survival Rate in Cohort 2（2-y OS）
Time frame: Up to 2 years
3-year Event-Free Survival Rate in Cohort 2（3-y EFS）
Time frame: Up to 3 years
3-year Overall Survival Rate in Cohort 2（3-y OS）
Time frame: Up to 3 years
Incidence and Severity of Adverse Events
Time frame: Up to approximately 3 years
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 22 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alternative Postoperative Treatment Regimen, Original Treatment Regimen and Postoperative Observation in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Nanfang Hospital, Southern Medical University 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 13 inclusion and 15 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 22 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 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 combined 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.
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 Liying Zhao, M.D., Ph.D (13430396746, zlyblue11@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Event-Free Survival in Cohort 1（mEFS） (time frame: Up to approximately 13 months). The study lists 2 primary outcomes in all. 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 22 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.