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Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction

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

NCT04840264•Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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;
+4 more criteria

Locations (1)

The Sixth Affiliated hosipital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

January 7, 2022

Primary Completion Date

December 31, 2026

Completion Date

June 30, 2027

Last Updated

March 18, 2024

Enrollment

ESTIMATED participants

Conditions

Metastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaPeritoneal Carcinomatosis

Interventions

Docetaxel

DRUG

Oxaliplatin

DRUG

Fluorouracil

DRUG

Contacts

Jian Xiao, MD

CONTACT

86-20-38250745 xiao_jian@139.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction

Inclusion Criteria

Exclusion Criteria

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