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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chaoyang District, Panjiayuan Nanli NO.17
RECRUITING
Beijing
Contact Information
Primary
Dongbing Zhao
dbzhao@cicams.ac.cn
010-87787120
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 136
Treatments
Experimental: GC patients
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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