NCT07034742RecruitingEarly phase 1
Exploratory Study on the Application of Molecular Residual Disease (MRD) in Postoperative Treatment of Gastric Cancer
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 14 Jun 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07034742
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 136
- From 1 Jun 2025 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to swallow oral medications.
- Anticipated inability to tolerate postoperative adjuvant chemotherapy.
- Concurrent medical conditions that contraindicate chemotherapy.
Other illness
- Uncontrolled gastrointestinal obstruction or recurrent bleeding.
- Active infection requiring systemic therapy.
- Cardiac function classified as NYHA class \> I.
- History of myocardial infarction, unstable angina, stroke, or uncontrolled arrhythmia.
- Pregnancy or lactation; history of psychiatric illness; poor compliance.
Other
- Pathological specimens containing \>10% of other histological components (e.g., squamous cell carcinoma, neuroendocrine carcinoma, etc.).
- Moderate to severe cirrhosis due to any cause.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chaoyang District, Panjiayuan Nanli NO.17 Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.