Intraperitoneal Chemotherapy Guided by the Detection of DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer

• Status: Recruiting
• Trial end date: 2024-06-20
• Target enrollment: 0
• Participant gender: All

Summary

Peritoneal metastasis is a major pattern of gastric cancer recurrence and predicts poor prognosis. In our previous study, we developed a next-generation sequencing technology to detect minimal residual cancer cells in peritoneal lavage fluid with a personalized assay profiling tumor-specific mutations in patients with gastric cancer. With this technology, we predicted all the cases that developed peritoneal metastasis in patients with pT4 disease with 100% sensitivity and 91% specificity. Based on this result, a prospective phase 2 clinical trial is designed to evaluate the efficacy of adjuvant intraperitoneal chemotherapy in patients with positive cancer cell DNA detected in peritoneal lavage fluid by our personalized tumor-specific mutation profiling assay.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Criteria

Criteria:

1. Gastric adenocarcinoma confirmed by pathology (histology);

2. 18-75 years old;

3. Clinical T4 stage, no distant metastasis confirmed by CT and endoscopic ultrasonography (EUS), potentially curable by surgery;

4. Eastern Cooperative Oncology Group Performance Score 0 or 1;

5. Absolute neutrophil count at least 1.5×10^9/L; platelets count at least 80×10^9/L; hemoglobin at least 9 g/dL; serum creatinine or creatinine clearance no greater than 1.5 times upper normal limit (UNL); TSB no greater than 1.5 times ULN; AST (SGOT) and ALT (SGPT) no greater than 2.0 times ULN; albumin at least 3.0 mg/dL;

6. Provide tumor tissue, blood, and peritoneal lavage fluid samples;

7. Willing to accept long-term follow-up;

8. Ability to understand and sign a written informed consent before the trial procedure.

Exclusion Criteria

1. Currently participating in or receiving other clinical trial treatment;

2. Contraindications to investigational chemotherapy regimen including allergies to any of the chemotherapy medications;

3. Active infection requires systemic treatment;

4. Patients with poor compliance;

5. Patients who undergo non-curative surgery;

6. History of other malignant neoplasm within 5 years, except for early-stage skin cancer;

7. Pregnant or breast-feeding female;

8. Patients who have received neoadjuvant therapy.