Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderat… (NCT07474324) | Clinical Trial Compass
RecruitingPhase 2
Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial
China124 participantsStarted 2026-03-15
Plain-language summary
This is a prospective, multicenter, randomized, phase II clinical trial intended to enroll patients with HER2-moderate/high-expressing, pathologically staged stage III gastric cancer who have undergone D2 or more extensive surgery. The study aims to evaluate the preliminary efficacy and safety of disitamab vedotin combined with the SOX regimen versus SOX alone as post-operative adjuvant therapy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 18 and 75 years.
* Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status.
* No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery.
* Histopathologically confirmed gastric adenocarcinoma.
* Pathological stage III gastric and gastroesophageal junction adenocarcinoma patients (according to the 8th edition of the American Joint Committee on Cancer \[AJCC\] staging system).
* HER2 moderate-to-high expression (IHC 3+ or 2+).
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
* Expected survival time ≥ 3 months.
* Able to understand the study protocol, voluntarily participate in the study, and provide written informed consent;
* Good compliance and able to cooperate with the treatment regimen specified in this study;
* Possesses complete imaging and pathological clinical data;
* Adequate organ and bone-marrow function.
Exclusion Criteria:
* Primary stage III gastric or gastroesophageal-junction adenocarcinoma not histologically or cytologically confirmed;
* Unable to receive disitamab vedotin or SOX chemotherapy;
* Unable to comply with the required follow-up schedule;
* Unable to accept the treatment regimen specified in this protocol;
* Unable or unwilling to undergo mandated response assessments (e.g., CT imaging);
* Active autoimmune disease;
* History of psychoactive-substance abuse that cannot be discontinued, or any severe/uncontrolled…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
3-year-DFS rate
Timeframe: 3 years
Trial details
NCT IDNCT07474324
SponsorThe First Affiliated Hospital with Nanjing Medical University