Clinical trial · Interventional
Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer
Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Patients With Resectable or Locally Advanced Gastric or Gastro-oesophageal Junction Cancer
NCT03957564CI-TRIAL-00042932unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To explore the clinical value of dynamic detection of circulating tumor cells(CTCs), circulating tumor DNA(ctDNA) and cell-free DNA(cfDNA) in neoadjuvant chemotherapy and operation of resectable or locally advanced gastric or gastro-oesophageal junction cancer.
Conditions
Conditions (2)
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 |
| Gastro-oesophageal Junction Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma. | Other | — | UNRESOLVED |
| Detect the tumor related DNA in pathological tissues after operation. | Other | — | UNRESOLVED |
| Follow-up of DFS and OS in patients with gastric cancer after operation. | Other | — | UNRESOLVED |
| Neoadjuvant chemotherapy with PSOX regimen. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients receiving neoadjuvant chemotherapy.
- description
- 1. Compare the monitoring of CTC, ctDNA and cfDNA with the results of CT scan and the blood level of CEA ,CA19-9 and CA72-4 tumor markers to explore the clinical value of dynamic detection of CTC, ctDNA and cfDNA in neoadjuvant chemotherapy and operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. 2. Explore the clinical value of different types of CTC in neoadjuvant chemotherapy and Operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. CTC can be classified into three types: epithelial CTC, mesenchymal CTC, hybrids CTC. 3. Explore the consistency between plasma ctDNA and tumor related DNA in pathological tissues after operation. 4. To explore the relationship between the dynamic changes of plasma CTC, ctDNA and cfDNA levels and the prognosis of patients after operation.
- interventionNames
- Drug: Neoadjuvant chemotherapy with PSOX regimen.
- Other: Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma.
- Other: Detect the tumor related DNA in pathological tissues after operation.
- Other: Follow-up of DFS and OS in patients with gastric cancer after operation.
Primary outcomes (6)
- measure
- Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria： 1. Patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer(\>T1 and N+) without distant metastases (M0). 2. Pathological examination confirmed gastric or gastro-oesophageal junction cancer (adenocarcinoma, signet ring cell carcinoma, mucinous adenocarcinoma, squamous cell carcinoma, regardless of the degree of tissue differentiation). 3. Ambulatory males or females, age ≥ 18 years. 4. Karnofsky Performance Score (KPS) ≥70 or ECOG(Eastern Cooperative Oncology Group) performance status: 0 or 1. 5. Patients who can tolerate PSOX neoadjuvant chemotherapy. 6. Planning to undergo radical gastrectomy after neoadjuvant chemotherapy. 7. With cancer lesions that can be measured according to RECIST 1.1 criteria. 8. No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy. 9. Adequate organ function as defined below: Hemoglobin ≥ 9 g/dl, Absolute neutrophil count(ANC） ≥ 1.5×109/L, Platelets ≥ 100\*109/L, Alkaline phosphatase( ALP) ≤ 2.5×ULN,Total bilirubin（TBIL）≤ 1.5×ULN(upper limit of normal), Renal Serum Creatinine \< 1.5 ULN, Serum Albumin ≥ 30g/l. Exclusion criteria: 1. Female in pregnancy or lactation, or refuse to receive contraception measures during chemotherapy. 2. With distant metastasis or peritoneal dissemination diagnosed by CT/EUS(endoscopic ultrasonography). 3. Underwent prior antitumor treatment, including chemotherapy, radiotherapy, immune therapy or target therapy. 4. Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease or condition that would make the subject inappropriate for study participation. 5. Clinically serious cardiac disease or pulmonary dysfunction. 6. Refuse to provide blood/tissue sample. 7. Other situation to be judged not adaptive to the study by investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.