Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT07034742

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-06-24

136

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gastric cancer is one of the most prevalent and lethal malignancies in China. The majority of patients are diagnosed at the locally advanced stage. Despite standard treatment involving radical resection combined with adjuvant chemotherapy, approximately 40% of patients experience recurrence and metastasis, with peritoneal metastasis accounting for nearly half of these cases. Building upon our team's previous establishment of next-generation sequencing (NGS) technology for detecting molecular residual disease (MRD) in peritoneal lavage fluid and blood, this project aims to guide systemic chemotherapy with or without intraperitoneal chemotherapy for locally advanced gastric cancer patients based on the results of peritoneal lavage fluid MRD testing. We will investigate whether intraperitoneal chemotherapy can reduce the peritoneal metastasis rate in patients testing positive for MRD in peritoneal lavage fluid. The ultimate goal is to propose a novel diagnostic and therapeutic strategy for post-operative adjuvant treatment of gastric cancer, addressing this critical clinical challenge. Patients testing negative for MRD in peritoneal lavage fluid will be enrolled in an observational cohort study. This cohort will explore the concordance between blood-based MRD positivity and actual clinical recurrence and metastasis. The objectives are to determine whether blood-based MRD can predict the occurrence of non-peritoneal metastasis after surgery and whether it can be used to evaluate the efficacy of post-operative systemic chemotherapy.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma of the stomach or gastroesophageal junction (GEJ).
  • Clinical stage cT4NanyM0, suitable for radical resection.
  • Age between 18 and 75 years.
  • ECOG performance status of 0 or 1.
  • No prior neoadjuvant therapy and strong preference for primary surgery.
  • Adequate organ function: ANC > 1.5 x 10^9/L; Hemoglobin > 90 g/L; Platelet count > 100 x 10^9/L; ALT and AST < 2.5 x ULN; Total bilirubin < 1.5 x ULN; Serum creatinine < 1.0 x ULN.
  • Good compliance and willingness for long-term follow-up.
  • Signed written informed consent.
Not Eligible

You will not qualify if you...

  • Pathological specimens containing >10% other histological components (e.g., squamous cell carcinoma, neuroendocrine carcinoma).
  • Uncontrolled gastrointestinal obstruction or recurrent bleeding.
  • Inability to swallow oral medications.
  • Active infection requiring systemic therapy.
  • Moderate to severe cirrhosis.
  • Cardiac function classified as NYHA class > I.
  • History of myocardial infarction, unstable angina, stroke, or uncontrolled arrhythmia.
  • Anticipated inability to tolerate postoperative adjuvant chemotherapy.
  • Medical conditions contraindicating chemotherapy.
  • Pregnancy or lactation.
  • History of psychiatric illness.
  • Poor compliance.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chaoyang District, Panjiayuan Nanli NO.17

Beijing, China

Actively Recruiting

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Research Team

D

Dongbing Zhao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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