Overview

Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with hyperthermic intraperitoneal chemotherapy
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wuhan Union Hospital, China
Treatments:
Paclitaxel
Criteria
Inclusion Criteria:

1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;

2. Aged 18-75 years;

3. Male or non-pregnant or lactating women;

4. Pathological diagnosis of gastric adenocarcinoma;

5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2
radical resection (AJCC Version 8, 2018);

6. Normal function of major organs;

7. Routine blood examinations meeting the following criteria:

A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L;

8. Chemistry indexs meeting the following criteria:

A. TBIL < 1.5ULN; B. ALT and AST < 2.5ULN; ALB > 30 g/L C. serum Cr ≤ 1.25 ULN or
endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula);

9. ECOG score 0-1;

Exclusion Criteria:

1. A history of other malignant tumors within 5 years;

2. Distant metastasis found during surgery;

3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;

4. Suffering from epilepsy or other mental illness, unable to control behavior;

5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;

6. Pregnant or lactating women.

7. Receiving anti-cancer drug therapy from other clinical trials.