Status:
UNKNOWN
Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Gastric Cancer
Chemotherapy Effect
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
Hyperthermic intraperitoneal chemotherapy (HIPEC) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (CRS). Further, there have been lots of randomized clinical trial...
Eligibility Criteria
Inclusion
- No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;
- Aged 18-75 years;
- Male or non-pregnant or lactating women;
- Pathological diagnosis of gastric adenocarcinoma;
- Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2 radical resection (AJCC Version 8, 2018);
- Normal function of major organs;
- 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;
- 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);
- ECOG score 0-1;
Exclusion
- A history of other malignant tumors within 5 years;
- Distant metastasis found during surgery;
- Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;
- Suffering from epilepsy or other mental illness, unable to control behavior;
- Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;
- Pregnant or lactating women.
- Receiving anti-cancer drug therapy from other clinical trials.
Key Trial Info
Start Date :
September 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04808466
Start Date
September 18 2021
End Date
September 1 2025
Last Update
February 21 2022
Active Locations (1)
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1
Wuhan Union Hospital
Wuhan, Hubei, China, 430000