Clinical trial · Interventional
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant 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
NCT04840264CI-TRIAL-00117805recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Gastric Adenocarcinoma | Gastric Adenocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | CURATED_BROADER | 0.78 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A (First-Line Therapy)
- description
- 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.
- interventionNames
- Drug: Docetaxel
- Drug: Oxaliplatin
- Drug: Fluorouracil
- type
- EXPERIMENTAL
- label
- B (Second-Line Therapy)
- description
- 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.
- interventionNames
- Drug: Docetaxel
- Drug: Oxaliplatin
- Drug: Fluorouracil
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDAnthony T, Baron T, Mercadante S, Green S, Chi D, Cunningham J, Herbst A, Smart E, Krouse RS. Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction. J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S49-59. doi: 10.1016/j.jpainsymman.2007.04.011. Epub 2007 Jun 4. PMID 17544243
- BACKGROUNDMadariaga A, Lau J, Ghoshal A, Dzierzanowski T, Larkin P, Sobocki J, Dickman A, Furness K, Fazelzad R, Crawford GB, Lheureux S. MASCC multidisciplinary evidence-based recommendations for the management of malignant bowel obstruction in advanced cancer. Support Care Cancer. 2022 Jun;30(6):4711-4728. doi: 10.1007/s00520-022-06889-8. Epub 2022 Mar 10. PMID 35274188