Clinical trial · Interventional
Oxaliplatin-induced Portal Hypertension
Construction and Evaluation of the Early Identification and Individualized Treatment for Oxaliplatin-induced Portal Hypertension
- 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)
Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Varices Hemorrhage | — | UNRESOLVED | — |
| Received Oxaliplatin-based Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized Treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Individualized Treatment Group
- interventionNames
- Procedure: Individualized Treatment
Primary outcomes (1)
- measure
- 1-year rebleeding rate
- timeFrame
- 1 year
- description
- 1-year rebleeding rate
Secondary outcomes (2)
- measure
- 1-year death rate
- timeFrame
- 1 year
- description
- 1-year death rate
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Sign written informed consent * Male or female patients aged 18-75 * diagnosed as portal hypertension by contrast-enhanced computed tomography * and confirmed gastroesophageal varices by upper digestive endoscopy; * had a history of oxaliplatin-based chemotherapy after colorectal cancer surgery; Exclusion Criteria: * combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease. * with colorectal cancer required further anti-tumor treatment * Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.
References
Publications (4)
- RESULTHuang X, Li F, Wang L, Xiao M, Ni L, Jiang S, Ji Y, Zhang C, Zhang W, Wang J, Chen S. Endoscopic treatment of gastroesophageal variceal bleeding after oxaliplatin-based chemotherapy in patients with colorectal cancer. Endoscopy. 2020 Sep;52(9):727-735. doi: 10.1055/a-1157-8611. Epub 2020 May 7. PMID 32380558
- RESULTAloia T, Sebagh M, Plasse M, Karam V, Levi F, Giacchetti S, Azoulay D, Bismuth H, Castaing D, Adam R. Liver histology and surgical outcomes after preoperative chemotherapy with fluorouracil plus oxaliplatin in colorectal cancer liver metastases. J Clin Oncol. 2006 Nov 1;24(31):4983-90. doi: 10.1200/JCO.2006.05.8156. PMID 17075116
- RESULTIwai T, Yamada T, Koizumi M, Shinji S, Yokoyama Y, Takahashi G, Takeda K, Hara K, Ohta K, Uchida E. Oxaliplatin-induced increase in splenic volume; irreversible change after adjuvant FOLFOX. J Surg Oncol. 2017 Dec;116(7):947-953. doi: 10.1002/jso.24756. Epub 2017 Sep 6. PMID 28876454
- RESULTWard J, Guthrie JA, Sheridan MB, Boyes S, Smith JT, Wilson D, Wyatt JI, Treanor D, Robinson PJ. Sinusoidal obstructive syndrome diagnosed with superparamagnetic iron oxide-enhanced magnetic resonance imaging in patients with chemotherapy-treated colorectal liver metastases. J Clin Oncol. 2008 Sep 10;26(26):4304-10. doi: 10.1200/JCO.2008.16.1893. PMID 18779617