Gastric / Gastroesophageal Junction AdenocarcinomaPhase 4NCT07161453
Comparing the Efficacy and Safety of Different Postoperative Adjuvant Regimens in Patients With Resectable Adenocarcinoma of the Esophagogastric Junction Who Underwent Radical Surgery After Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR in Postoperative Pathology
A Phase 4 study testing SOX plus PD-1 inhibitor, PD-1 / PD-L1 monoclonal antibody and SOX Chemotherapy in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Liaoning Cancer Hospital & Institute.
Trial summary
This study is to evaluate the efficacy and safety of different postoperative adjuvant regimens in patients with resectable adenocarcinoma of the esophagogastric junction who underwent radical surgery after neoadjuvant chemotherapy combined with immunotherapy and achieved pCR in postoperative pathology 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?
- SOX plus PD-1 inhibitor, PD-1 / PD-L1 monoclonal antibody and SOX Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 31 Dec 2027
- Phase
- Phase 4
- 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
- Age ≥ 18 years old, gender not restricted;
- Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;
- HER2 overexpression or amplification results are negative;
- Subjects who have received neoadjuvant chemotherapy for GC/GEJC before, and have undergone at least 3-4 cycles;
- Having undergone radical surgical treatment and with postoperative pathological result reaching pCR
- After radical surgery treatment, the investigator assesses that further adjuvant treatment is necessary, and the adjuvant treatment plan must be the one specified in this protocol.
Who cannot join
- 1) Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types; 2) Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency; 3) Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and/or had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; 4) Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated); 5) Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;
About this study
Official title: A Multicenter, Prospective, Real-world Study Comparing the Efficacy and Safety of Different Postoperative Adjuvant Regimens in Patients With Resectable Adenocarcinoma of the Esophagogastric Junction Who Underwent Radical Surgery After Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR in Postoperative Pathology
This study is to evaluate the efficacy and safety of different postoperative adjuvant regimens in patients with resectable adenocarcinoma of the esophagogastric junction who underwent radical surgery after neoadjuvant chemotherapy combined with immunotherapy and achieved pCR in postoperative pathology
- Being tested
- SOX plus PD-1 inhibitor, PD-1 / PD-L1 monoclonal antibody, SOX Chemotherapy, Tegafur-Ugotex or Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOX plus PD-1 inhibitorDrug
SOX or XELOX plus PD-1 inhibitor
PD-1 / PD-L1 monoclonal antibodyDrug
PD-1/PD-L1 monoclonal antibody
SOX ChemotherapyDrug
SOX or XELOX
Tegafur-Ugotex or CapecitabineDrug
Tegafur-Ugotex or Capecitabine
| Study group | Role | What they receive |
|---|---|---|
| SOX or XELOX with immunotherapy | Experimental | Not described Receives: Drug: SOX plus PD-1 inhibitor |
| Immunotherapy | Experimental | Not described Receives: Drug: PD-1 / PD-L1 monoclonal antibody |
| SOX or XELOX | Active comparator | Not described Receives: Drug: SOX Chemotherapy |
| Tegafur-Ugotex or Capecitabine | Active comparator | Not described Receives: Drug: Tegafur-Ugotex or Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the differences in the DFS rates between the two groups of subjects, DFS (Disease-Free Survival, which is the time from the start of postoperative adjuvant therapy until the first occurrence of recurrent disease
Measured: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years
Secondary outcomes (2)
Compare the differences in the OS rates between the two groups of subjects, OS (Overall Survival, which refers to the time from the start of postoperative adjuvant therapy until death due to any cause)
Measured: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years
The Adverse Events of anti-PD1/PDL1 monoclonal antibody combined with chemotherapy versus chemotherapy in postoperative adjuvant treatment for gastric cancer/adenocarcinoma of the esophagogastric junction
Measured: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Yan, Liaoning Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161453
- Sponsor's protocol ID
- NeoGC-04
- Other IDs
- KY20250312
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Real-world Study Comparing the Efficacy and Safety of Different Postoperative Adjuvant Regimens in Patients With Resectable Adenocarcinoma of the Esophagogastric Junction Who Underwent Radical Surgery After Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR in Postoperative Pathology
- ClinicalTrials.gov ID
- NCT07161453
- Acronym / sponsor ID
- NeoGC-04
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Sep 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.
This study is to evaluate the efficacy and safety of different postoperative adjuvant regimens in patients with resectable adenocarcinoma of the esophagogastric junction who underwent radical surgery after neoadjuvant chemotherapy combined with immunotherapy and achieved pCR in postoperative pathology
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SOX or XELOX with immunotherapy | Experimental | Drug: SOX plus PD-1 inhibitor |
| Immunotherapy | Experimental | Drug: PD-1 / PD-L1 monoclonal antibody |
| SOX or XELOX | Active comparator | Drug: SOX Chemotherapy |
| Tegafur-Ugotex or Capecitabine | Active comparator | Drug: Tegafur-Ugotex or Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, gender not restricted;
- Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;
- HER2 overexpression or amplification results are negative;
- Subjects who have received neoadjuvant chemotherapy for GC/GEJC before, and have undergone at least 3-4 cycles;
- Having undergone radical surgical treatment and with postoperative pathological result reaching pCR
Key exclusion criteria (1 listed)
- 1) Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types; 2) Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency; 3) Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and/or had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; 4) Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated); 5) Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;
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 |
|---|---|---|
| SOX plus PD-1 inhibitorSOX or XELOX plus PD-1 inhibitor | Drug | SOX or XELOX with immunotherapy |
| PD-1 / PD-L1 monoclonal antibodyPD-1/PD-L1 monoclonal antibody | Drug | Immunotherapy |
| SOX ChemotherapySOX or XELOX | Drug | SOX or XELOX |
| Tegafur-Ugotex or CapecitabineTegafur-Ugotex or Capecitabine | Drug | Tegafur-Ugotex or Capecitabine |
Primary outcome
Compare the differences in the DFS rates between the two groups of subjects, DFS (Disease-Free Survival, which is the time from the start of postoperative adjuvant therapy until the first occurrence of recurrent disease
Time frame: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years
2 secondary outcomes
Compare the differences in the OS rates between the two groups of subjects, OS (Overall Survival, which refers to the time from the start of postoperative adjuvant therapy until death due to any cause)
Time frame: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years
The Adverse Events of anti-PD1/PDL1 monoclonal antibody combined with chemotherapy versus chemotherapy in postoperative adjuvant treatment for gastric cancer/adenocarcinoma of the esophagogastric junction
Time frame: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 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 8 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SOX plus PD-1 inhibitor, PD-1 / PD-L1 monoclonal antibody and SOX Chemotherapy in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Liaoning Cancer Hospital & Institute.
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 6 inclusion and 1 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Compare the differences in the DFS rates between the two groups of subjects, DFS (Disease-Free Survival, which is the time from the start of postoperative adjuvant therapy until the first occurrence of recurrent disease (time frame: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 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 Sep 2025.