Combination therapy for gastric cancer with inoperable bowel obstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, non-randomized phase II trial evaluates a combination of docetaxel, oxaliplatin, and fluorouracil in patients with gastric cancer who have inoperable malignant bowel obstruction and peritoneal carcinomatosis. The study consists of three cohorts: first-line therapy for patients who have not received prior chemotherapy, second-line therapy for those who have progressed after initial treatment, and third-line therapy for patients with two or more previous treatments. The primary goal is to achieve clinically meaningful bowel obstruction clearance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jian Xiao, MD
• Email: xiao_jian@139.com
• Phone: 86-20-81884713

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.