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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer

NCT02289378

Docetaxel, Oxaliplatin and Fluorouracil

UNKNOWN PHASE2

Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer

NCT00446290

Stomach Cancer

COMPLETED PHASE1

Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer

NCT04483076

Gastric Cancer Chemotherapy Effect

RECRUITING PHASE3

Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer

NCT04358354

Metastatic Gastric Cancer

UNKNOWN PHASE3

Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

NCT00591045

Stomach Neoplasms Gastric Cancer

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Peritoneal Carcinomatosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A (First-Line Therapy)

Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

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

Oxaliplatin

Intervention Type DRUG

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

Fluorouracil

Intervention Type DRUG

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

B (Second-Line Therapy)

Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

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

Oxaliplatin

Intervention Type DRUG

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

Fluorouracil

Intervention Type DRUG

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

C (Third- or Later-Line Therapy)

Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

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

Oxaliplatin

Intervention Type DRUG

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

Fluorouracil

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel

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

Intervention Type DRUG

Oxaliplatin

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

Intervention Type DRUG

Fluorouracil

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

5-FU

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No