MRD-guided postoperative treatment for locally advanced gastric cancer

Exploratory Study on the Application of Molecular Residual Disease (MRD) in Postoperative Treatment of Gastric Cancer

This trial will test whether using MRD results from peritoneal lavage fluid to decide on adding intraperitoneal chemotherapy after surgery can lower peritoneal relapse in people with locally advanced gastric cancer.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT07034742 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with histologically confirmed gastric or gastroesophageal junction adenocarcinoma staged cT4NanyM0, ECOG 0–1, no prior neoadjuvant therapy, adequate organ function, and willingness to undergo surgery and long-term follow-up are ideal candidates.

Not a fit: Patients with early-stage or widely metastatic disease, poor performance status, significant non-adenocarcinoma histology (>10% other components), prior neoadjuvant therapy, or inadequate organ function are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, MRD-guided addition of intraperitoneal chemotherapy could reduce peritoneal metastasis and personalize postoperative treatment for high-risk gastric cancer patients.

How similar studies have performed: Intraperitoneal chemotherapy has shown modest benefits in some gastric cancer settings and MRD-guided therapy is promising in other cancers, but using peritoneal lavage NGS MRD to decide intraperitoneal chemotherapy is largely novel and unproven.

Eligibility criteria

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 this trial is running

Beijing

• Chaoyang District, Panjiayuan Nanli NO.17 — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Dongbing Zhao

Conditions: Gastric Adenocarcinoma