Chemotherapy Alone Versus Surgery Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Our study aims to compare the efficacy and safety of Chemotherapy Alone Versus D2 distal gastrectomy and metastasectomy plus Chemotherapy for gastric cancer (GC) with one non-curable Factor

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

1. Lower age limit of research subjects 18 years old and upper age limit of 75 years old.

2. PS (ECOG) of 0 or 1.

3. Without any other malignancies.

4. Written informed consent from the patient.

5. Standard gastrectomy with D2 lymphadenectomy for primary cancer

6. A single non-curable factor was defined by preoperative CT :

hepatic metastasis (H1 or H2; maximum diameter ≤4 cm, number ≤4); peritoneal metastasis (R0 or R1 resection) para-aortic lymph node metastasis （number ≤4) ovarian metastasis adrenal metastasis renal metastasis

7. No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L)

Exclusion Criteria:

1. Female in pregnancy or lactation.

2. Supraclavicular lymph nodes metastases，lung and bone metastases.

3. Massive ascites or cachexia.

4. Extensive cancer metastases of liver, peritoneal metastasis,para-aortic lymph node

5. Patients participating in any other clinical trails currently，or participated in other trails within 1 months.

6. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.

7. Poor treatment compliance of patients

8. The group of chemotherapy alone accepts gastrectomy for bleeding or obstruction

9. Failure of R0 or R1 metastasectomy and gastrectomy with D2 lymphadenectomy