Intraperitoneal Chemotherapy Guided by the Detection of DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- Drug: Intraperitoneal chemotherapyDrug: Adjuvant systemic chemotherapy
- Registration Number
- NCT05497739
- Brief 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.
- Detailed Description
Introduction:
Peritoneal metastasis is the most common pattern of gastric cancer recurrence and leads to rapid death. In a previous study, our team established a personalized method which could detect minimal cancer cell DNA in peritoneal lavage fluid with high sensitivity and specificity. We intend to perform a clinical trial to explore the efficacy of intraperitoneal chemotherapy on reducing the incidence of peritoneal metastases in patients with high risk defined by our personalized mutation detection method.
Methods and analysis:
This is a single-arm and single-center clinical trial. Sixty-eight patients with clinical T4 stage gastric cancers will be expected to be enrolled. During surgery, surgeons will wash upper abdominal cavity with 300-400 mL of normal saline before any manipulation of the tumor and collect about 200 mL peritoneal lavage fluid. Cancer cell DNA in peritoneal lavage fluid will be detected by next-generation sequencing using a personalized tumor-specific mutation profiling assay. Patients with positive peritoneal lavage fluid cancer cell DNA will receive adjuvant intraperitoneal chemotherapy in the second month since surgery, then followed by standard adjuvant systemic chemotherapy.
The primary endpoint is the incidence of peritoneal metastasis, and the secondary endpoints include peritoneal metastasis-free survival, disease-free survival (DFS), overall survival (OS), and the safety of intraperitoneal chemotherapy.
Ethics
This trial has been approved by the Ethics Committee of the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intraperitoneal chemotherapy group Intraperitoneal chemotherapy In this study, patients with positive peritoneal lavage fluid cancer cell DNA will be given intraperitoneal chemotherapy followed by adjuvant systemic chemotherapy. Intraperitoneal chemotherapy group Adjuvant systemic chemotherapy In this study, patients with positive peritoneal lavage fluid cancer cell DNA will be given intraperitoneal chemotherapy followed by adjuvant systemic chemotherapy.
- Primary Outcome Measures
Name Time Method The incidence of peritoneal metastasis Two years after surgery. The incidence of peritoneal metastasis.
- Secondary Outcome Measures
Name Time Method Overall survival Three years after surgery. The time from surgery to death or the last follow-up date.
The safety Ninety days after surgery. Adverse event and complications related to intraperitoneal chemotherapy. Adverse event is defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Complications will be recorded and graded according to the modified Clavien-Dindo classification.
Peritoneal metastasis-free survival Two years after surgery. The time from surgery to peritoneal metastasis.
Disease-free survival Three years after surgery. The time from surgery to either recurrence or relapse of cancer, or death.
Trial Locations
- Locations (1)
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
🇨🇳Beijing, Beijing, China