Combination therapy for gastric cancer with inoperable bowel obstruction

A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction

This study is testing a combination of three cancer drugs to see if it can help people with gastric cancer and a blocked bowel feel better and improve their condition.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 79 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04840264 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma and inoperable malignant bowel obstruction.

Not a fit: Patients with HER-2 amplification, active gastrointestinal bleeding, or those who have previously received a combination of the study drugs may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could significantly improve bowel function and quality of life for patients with advanced gastric cancer.

How similar studies have performed: While similar approaches have been explored, this specific combination for this patient population is relatively novel.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• The Sixth Affiliated hosipital, Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Jian Xiao, MD

Conditions: Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis, Malignant Bowel Obstruction, Docetaxel, Oxaliplatin, Fluorouracil