---
title: Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC
nct_id: NCT04547153
overall_status: COMPLETED
phase: PHASE2
sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
study_type: INTERVENTIONAL
primary_condition: Gastric Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04547153.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04547153"
ct_last_update_post_date: 2024-03-25
last_seen_at: "2026-05-12T06:25:33.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC

**Official Title:** Infusional Fluorouracil and Weekly Docetaxel as First-line Therapy for Gastric Cancer With Bone Marrow Metastasis and Disseminated Intravascular Coagulation: a Multi-center, Phase II Trail

**NCT ID:** [NCT04547153](https://clinicaltrials.gov/study/NCT04547153)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Sixth Affiliated Hospital, Sun Yat-sen University
- **Conditions:** Gastric Cancer, Bone Marrow Metastasis, Disseminated Intravascular Coagulation
- **Start Date:** 2021-01-15
- **Completion Date:** 2024-03-22
- **CT.gov Last Update:** 2024-03-25

## Brief Summary

A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC has been described. Few patients have been treated properly due to the lack of standard care. We designed this phase II study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (HAGC).

## Detailed Description

5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* ECOG PS 0-3;
* Pathologically confirmed adenocarcinoma in stomach or esophagogastric junction;
* Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan;
* overt DIC according to the International Society on Thrombosis and Haemostasis (ISTH) criteria;
* Treatment-naive after the diagnosis of metastasis;
* Platelet ≤ 50 \* 10E9/L;
* ALT≤5×ULN, AST≤5×ULN, Bilirubin≤5×ULN, Creatinine≤3×ULN;
* Written informed consent.

Exclusion Criteria:

* Concurrent aggressive malignancy;
* Docetaxel containing perioperative treatment within 6 months;
* Allergic to the study drugs;
* Serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc.
* HIV positive;
* MSI-H;
* Her-2 gene overexpression;
* Inadequate contraceptive measures.
```

## Arms

- **LD-FUD (Zhen Long)** (EXPERIMENTAL) — 5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.

## Interventions

- **5-fluorouracil** (DRUG) — 200mg/square metre/day civ D1-D21
- **Docetaxel** (DRUG) — 25mg/square metre ivdrip D1, D8, D15

## Primary Outcomes

- **hematological response rate (HeRR)** _(time frame: 2 months)_ — percentage of participants whose platelet restored to normal range

## Secondary Outcomes

- **time to hematological response (TTHeR)** _(time frame: 2 months)_
- **one-month mortality (OMM)** _(time frame: 30 days)_
- **overall survival (OS)** _(time frame: 2 years)_
- **toxicities** _(time frame: 2 months)_
- **quality of life assessed by EORTC QOL C-30 and STO-22 (QoL)** _(time frame: 3 months)_

## Locations (1)

- Jian Xiao, Guangzhou, Guangdong, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.jian xiao|guangzhou|guangdong|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04547153.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04547153*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*