Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer

• Status: Recruiting
• Trial end date: 2024-05-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Affiliated Hospital of Qinghai University

Criteria

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.