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

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology231 enrolled

Overview

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

Hyperthermic intraperitoneal chemotherapy (HIPEC) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (CRS). Further, there have been lots of randomized clinical trials assessing the efficacy of surgery + HIPEC for the treatment of locally advanced gastric cancer conducted. Nonetheless, to date, the kinds, doses, combinations of HIPEC drugs are not clearly been evaluate a criterion. Thus, This study aim to compare the efficacy of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with HIPEC. We plan to recruit 231 patients and divide into 3 groups, 2 drug groups and 1 control groups, radomly. all patients with advanced gastric cancer receive D2 surgery + HIPEC + SOX/XELOX chemotherapy regimen. the mainly experimental variable is HIPEC drugs and three groups employ Lobaplatin, Paclitaxel and none respectively. the endpoints of study include peritoneal metastasis, overall survival, immune status and perioperative safety assessment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

231

Conditions

Gastric Cancer

Interventions

PaclitaxelDRUG

Paclitaxel is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Paclitaxel 75 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

LobaplatinDRUG

Lobaplatin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: lobaplatin 50 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

peritoneal metastasis

peritoneal metastasis-free survival (pRFS)

Time frame: 3-year

overall survival

overall survival (OS)

Time frame: 3-year

Secondary Outcomes

Number of participants with immunosuppression events as assessed by blood immunological indicators

Before and After Hyperthermic Intraperitoneal Chemotherapy, collect 5mL blood samples of patients for detecting immunological indicators such as CD3, CD4 and CD8 lymphocyte population; Interferon-γ; tumor necrosis factor (TNF)-α; interleukin-2, 4, 8, 10, etc

Time frame: up to 4 weeks

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

postoperative adverse events (referring to CTCAE 5.0 \[including blood routine, liver and kidney function, patient reaction to HIPEC, adverse events\]) was analyzed

Time frame: up to 4 weeks

The positive rate of cancer cells of participants by exfoliative cytology examination

According to the positive rate of cancer cells measured in exfoliative cytology before and after HIPEC, the difference between the groups is analyzed.

Time frame: 1 week