Clinical trial · Interventional
Intraperitoneal Chemotherapy Guided by the Detection of DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer
Adjuvant Intraperitoneal Chemotherapy Guided by the Detection of Cancer Cell DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer: an Open-label, Phase 2 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant systemic chemotherapy | Drug | — | UNRESOLVED |
| Intraperitoneal chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraperitoneal chemotherapy group
- description
- In this study, patients with positive peritoneal lavage fluid cancer cell DNA will be given intraperitoneal chemotherapy followed by adjuvant systemic chemotherapy.
- interventionNames
- Drug: Intraperitoneal chemotherapy
- Drug: Adjuvant systemic chemotherapy
Primary outcomes (1)
- measure
- The incidence of peritoneal metastasis
- timeFrame
- Two years after surgery.
- description
- The incidence of peritoneal metastasis.
Secondary outcomes (4)
- measure
- Peritoneal metastasis-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available