Comparing two chemotherapy methods for treating unresectable intrahepatic cholangiocarcinoma
Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma
PHASE3 · Sun Yat-sen University · NCT04961970
This study is testing whether a new way of giving chemotherapy directly to the liver works better than the standard treatment for patients with a type of liver cancer that can't be surgically removed.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04961970 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of hepatic arterial infusion chemotherapy (HAIC) using oxaliplatin, 5-fluorouracil, and leucovorin against systemic chemotherapy with gemcitabine and cisplatin in patients diagnosed with unresectable intrahepatic cholangiocarcinoma. Participants must have measurable tumor lesions and no prior treatment, while also meeting specific laboratory criteria. The study aims to determine which chemotherapy approach yields better outcomes for patients who cannot undergo surgery.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with unresectable intrahepatic cholangiocarcinoma who have not received prior treatment.
Not a fit: Patients with hepatic decompensation, distant metastasis, or those with a history of organ allograft may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with unresectable intrahepatic cholangiocarcinoma.
How similar studies have performed: Other studies have shown promise in using hepatic arterial infusion chemotherapy for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The diagnosis of ICC * Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria. * With no previous treatment * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * Without distant metastasis, but intrahepatic lymph node metastasis is allowed * The following laboratory parameters: Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 Exclusion Criteria: * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
Where this trial is running
Guangzhou, Guangdong
- Cancer Center Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intrahepatic Cholangiocarcinoma, intrahepatic cholangiocarcinoma, systemic chemotherapy, hepatic artery infusion chemotherapy