A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction

Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点分布在 1 个国家目标入组 79 人开始时间: 2022年1月7日最近更新: 2026年7月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 79
试验地点: 1
主要终点: 60-day Obstruction Clearance Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.

详细描述

The primary study hypothesis is that the regimen will provide a clinically meaningful bowel obstruction clearance. This trial has 3 paralleled cohorts with the same experimental regimen: Cohort A (first-line therapy) will include 35 participants who have not received any palliative chemotherapy; Cohort B (second-line therapy) will include 22 participants who progress after the first-line therapy; Cohort C (third- or later-line therapy) plans to include 22 cases who have received two or more prior therapies for their metastatic disease.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18-75 years of age;
•ECOG PS ≤3;
•pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;
•peritoneal carcinomatosis established by imaging data or pathological evidence;
•MBO below the Treitz ligament based on clinical grounds or radiological findings;
•considered as inoperable MBO by two independent surgical consultants;
•Hb≥60g/L, WBC ≥4×10E9/L, ANC≥2×10E9/L，PLT≥100×10E9/L;
•Cr≤ Upper Normal Limit(UNL);
•Tbil≤1.5 UNL,AST≤1.5 UNL, ALT≤1.5 UNL, ALP≤1.5 UNL;
•Written informed consent form paticipants.

排除标准

•treated by a combination regimen containing all the study drugs;
•allergy to any of the study drugs;
•HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
•strangulated intestinal obstruction;
•active gastrointestinal bleeding;
•uncontrolled active infection;
•unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);
•severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc);
•mental disorders that affect clinical treatment or central nervous system diseases;
•concomitant cerebral parenchymal or meningeal metastasis;
•HIV infection or untreated active hepatitis;
•bowel surgery or stenting required due to obstruction;
•pregnant or lactating women;
•other conditions that are not suitable for participation in the study.