Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT04840264

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

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2024-03-18

79

Participants Needed

1

Research Sites

285 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years
  • ECOG performance status 0 to 3
  • Pathological diagnosis of gastric or gastroesophageal junction adenocarcinoma
  • Peritoneal carcinomatosis confirmed by imaging or pathology
  • Malignant bowel obstruction below the Treitz ligament by clinical or radiological findings
  • Inoperable malignant bowel obstruction confirmed by two independent surgeons
  • Hemoglobin 60 g/L or higher, white blood cell count 4x10^9/L or higher, absolute neutrophil count 2x10^9/L or higher, platelet count 100x10^9/L or higher
  • Serum creatinine at or below the upper normal limit
  • Total bilirubin, AST, ALT, and alkaline phosphatase all at or below 1.5 times the upper normal limit
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Prior treatment with a regimen containing all study drugs (docetaxel, oxaliplatin, fluorouracil)
  • Allergy to any of the study drugs
  • HER-2 amplification or overexpression, mismatch repair protein deficiency, or high microsatellite instability
  • Strangulated intestinal obstruction
  • Active gastrointestinal bleeding
  • Uncontrolled active infection
  • Severe heart disease with serious ECG abnormalities or conditions affecting treatment
  • Severe lung diseases such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema
  • Mental disorders affecting treatment or central nervous system diseases
  • Presence of brain or meningeal metastases
  • HIV infection or untreated active hepatitis
  • Requirement for bowel surgery or stenting due to obstruction
  • Pregnant or breastfeeding women
  • Other conditions deemed unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Sixth Affiliated hosipital, Sun Yat-Sen University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

J

Jian Xiao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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