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Predictive value of circulating tumor cells and circulating tumor DNA in abdominal lavage fluid for peritoneal metastasis after radical surgery for gastric cancer (cT4NxM0/cT1-3N+M0) and its application to guide therapeutic interventions: an open, prospective, multicenter randomized controlled study

Predictive value of circulating tumor cells and circulating tumor DNA in abdominal lavage fluid for peritoneal metastasis after radical surgery for gastric cancer (cT4NxM0/cT1-3N+M0) and its application to guide therapeutic interventions: an open, prospective, multicenter randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108191
Enrollment
Unknown
Registered
2025-08-26
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

A:HIPEC + chemotherapy group (clinically treated with standard chemotherapy + HIPEC):Hyperthermic intraperitoneal chemotherapy
A::Chemotherapy (The treatment is carried out using standard chemotherapy methods):None

Sponsors

Renji Hospital ,Shanghai Jiaotong University School Of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. patients voluntarily enrolled in this study by signing an informed consent form; 2. >=18 years old, both sexes; 3. presence of histologically confirmed, untreated gastric or gastroesophageal junction (GEJ) cancer with histologically confirmed predominantly adenocarcinoma cT4NxM0/cT1-3N+M0 gastric cancer; 4. ECOG score: 0 to 1; 5. no preoperative antitumor therapy against gastric cancer, including chemotherapy, radiotherapy, targeted and immunotherapy; 6. surgical specimens or tumor-containing tissue specimens by puncture can be obtained; 7. sufficient peripheral blood is available; 8. have access to at least 2 years of follow-up information.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women; 2. diagnosis of distant metastases by CT /MR/ EUS; 3. has received prior antitumor therapy, including chemotherapy, radiotherapy, or immunotherapy; 4. other malignant tumor within the last 5 years; 5. uncontrolled pleural effusion; 5. uncontrolled pleural effusion, pericardial effusion, or ascites; 6. does not have adequate organ function, such as severe abnormalities in blood, heart, lung, liver, or kidney function; 7. inability to obtain surgical tissue specimens; 8. those with extensive abdominal adhesions, high risk of fistula from gastrointestinal anastomosis, complete intestinal obstruction as well as bone marrow suppression, and severe abdominal infection; 9. other factors that, in the judgment of the investigator, may affect subject safety or compliance with the trial. For example, serious medical conditions (including psychiatric disorders) requiring comorbid treatment, serious laboratory test abnormalities, or other family or social factors.

Design outcomes

Primary

MeasureTime frame
circulating tumor cells;Circulating tumor DNA;

Countries

China

Contacts

Public ContactZizhen Zhang

Renji Hospital , Shanghai Jiao Tong University School of Medicine

zzzhang16@hotmail.com+86 139 1787 9569

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026