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Clinical Trials in China / NCT04840264
Recruiting Phase 2

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

NCT04840264 · tracked via the Priya Life Science China tracker
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Phase
Phase 2
Started
2022-01-07
Last updated
2026-07-13

Condition(s) studied

Metastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaPeritoneal Carcinomatosis

Investigational drug(s) / intervention(s)

DocetaxelOxaliplatinFluorouracil

Docetaxel: 25 mg/square metre, D1, D8, D15, repeat every 4 weeks.

Oxaliplatin: 85 mg/msquare metre, D1, D15, repeat every 4 weeks.

Fluorouracil: 1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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; * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Guangdong Provincial People's Hospital Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04840264 on ClinicalTrials.gov ↗ ← All trials in China