MRD-guided postoperative treatment for locally advanced gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use next-generation sequencing to detect molecular residual disease (MRD) in peritoneal lavage fluid and blood collected at the time of surgery from patients with cT4NanyM0 gastric or gastroesophageal junction adenocarcinoma. All participants will undergo radical resection followed by systemic chemotherapy, and patients with positive peritoneal lavage MRD will receive additional intraperitoneal chemotherapy. The study will track rates of peritoneal metastasis, recurrence-free survival, overall survival, and treatment safety with long-term follow-up. The aim is to determine whether MRD-guided use of intraperitoneal chemotherapy can personalize postoperative care and reduce peritoneal relapse.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma of the stomach or gastroesophageal junction (GEJ).
* Clinical stage cT4NanyM0, deemed suitable for radical resection.
* Age between 18 and 75 years.
* ECOG performance status of 0 or 1.
* No prior neoadjuvant therapy and strong patient/family preference for primary surgery.
* Adequate organ function defined as:

Absolute neutrophil count (ANC) \> 1.5 x 10⁹/L (or \> 1500/µL)；Hemoglobin (Hb) \> 90 g/L；Platelet count (PLT) \> 100 x 10⁹/L (or \> 100,000/µL)；Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \< 2.5 x Upper Limit of Normal (ULN)；Total bilirubin (TBIL) \< 1.5 x ULN；Serum creatinine (Cr) \< 1.0 x ULN

* Good compliance and willingness to undergo long-term follow-up.
* Provision of signed written informed consent.

Exclusion Criteria:

* Pathological specimens containing \>10% of other histological components (e.g., squamous cell carcinoma, neuroendocrine carcinoma, etc.).
* Uncontrolled gastrointestinal obstruction or recurrent bleeding.
* Inability to swallow oral medications.
* Active infection requiring systemic therapy.
* Moderate to severe cirrhosis due to any cause.
* Cardiac function classified as NYHA class \> I.
* History of myocardial infarction, unstable angina, stroke, or uncontrolled arrhythmia.
* Anticipated inability to tolerate postoperative adjuvant chemotherapy.
* Concurrent medical conditions that contraindicate chemotherapy.
* Pregnancy or lactation; history of psychiatric illness; poor compliance.

Where it's running

• Chaoyang District, Panjiayuan Nanli NO.17
  Beijing, China Recruiting

Study contacts

• Study coordinator: Dongbing Zhao
• Email: dbzhao@cicams.ac.cn
• Phone: 010-87787120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.