drugset / Trial / NCT05497739

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

NCT05497739

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-06-28
Primary completion
2024-06-20
Completion
2024-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2
Subject Paclitaxel Small molecule 80 mg
Subject Paclitaxel Small molecule 100 mg
Subject aldesleukin Protein / enzyme biologic 2e+06 iu
Subject fluorouracil Small molecule 1000 mg/m2
Background Oxaliplatin Small molecule 85 mg/m2
Background S-1 Small molecule 40 mg
Background S-1 Small molecule 50 mg
Background S-1 Small molecule 60 mg

Indications