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

Summary

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.

Eligibility

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.

Conditions4

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