Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
Recruiting now · Phase 2
Conditions studied: Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
In brief
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.
Key facts
- Study ID
- NCT04840264
- Run by
- Sixth Affiliated Hospital, Sun Yat-sen University
- People needed
- 79
- Starts
- 2022-01-07
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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