Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
About this trial
This is an interventional treatment trial for Metastatic Gastric Adenocarcinoma focused on measuring Malignant Bowel Obstruction, Docetaxel, Oxaliplatin, Fluorouracil
Eligibility Criteria
Inclusion Criteria:
- Age 18-75 years of age;
- ECOG PS 0-1, or ECOG PS 2-3 due to the tumor situation or obstruction;
- Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma
- Cohort 1 recruits patients with who have not received any previous therapy. Cohort 2 recruits patients who have received only one previous therapy for the metastatic disease. Cohort 3 recruits patients who have received two or more prior therapies for their metastatic disease.
- Diagnosis of bowel obstruction below the Treitz ligament by clinical symptoms (nausea, vomiting, and constipation ± abdominal pain) and radiology.
- Diagnosis of peritoneal metastasis by radiology or pathology.
- Patient must be 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:
- Patients who have previously been treated with the three experimental drugs together;
- Severe uncontrolled active infection;
- HIV infection or untreated active hepatitis;
- HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
- Patients with heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);
- Patients with severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
- Patients with mental disorders that affect clinical treatment or have a previous history of central nervous system diseases;
- Concomitant parenchymal or meningeal metastases;
- Patients with active gastrointestinal bleeding;
- Allergy to any of the study drugs;
- Strangulated intestinal obstruction;
- According to the judgment of the researchers, the patient needs to undergo bowel surgery or stenting due to obstruction;
- Pregnant or lactating women, or patients of childbearing age who refuse to use effective contraception during the study period;
- The researcher believes that the patient has any other conditions that are not suitable for participation in the study
Sites / Locations
- The Sixth Affiliated hosipital, Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
A (First-Line Therapy)
B (Second-Line Therapy)
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.
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.
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.