RecruitingPhase 2NCT03364530

Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma

Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma: a Multicentric Single-arm Phase II Study

Sponsor

University Hospital, Montpellier

Enrollment

40 participants

Start Date

Jun 11, 2018

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma Non-resectable Non Metastatic

Summary

We hypothesized that intra-arterial gemcitabine/oxaliplatin administered as second-line treatment could strongly improve objective response rate at 4 months after inclusion in patient with non-metastatic unresectable intra-hepatic cholangiocarcinoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether delivering chemotherapy drugs directly into the liver's blood supply (called hepatic arterial infusion) can help patients with bile duct cancer inside the liver that has already been treated with standard chemotherapy but cannot be surgically removed. **You may be eligible if...** - You have bile duct cancer inside the liver (intrahepatic cholangiocarcinoma) confirmed by tissue biopsy - You have already received first-line standard chemotherapy - The cancer has not spread outside the liver - Your overall health is good (performance status 0 or 1) - Your expected survival is more than 3 months - The cancer cannot be surgically removed with curative intent - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if...** - Your cancer has spread beyond the liver to other organs - Your liver or kidney function is too poor - Your overall health is too poor to tolerate the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine-Oxaliplatin Regimen

Vascularisation of hepatic tumors is almost exclusively provided by the hepatic artery. Gemcitabine and oxaliplatin have a high rate of hepatic extraction during the first passage, thus allowing the drugs to reach high intra-tumoral concentrations with low systemic toxicity.

PROCEDUREHepatic intra arterial chemotherapy

The implantation of a hepatic arterial catheter has now been mastered by interventional radiologists and makes it possible to increase the intra-tumoral concentration of the drugs and probably to limit their systemic toxicity. Very recently, we have reported that this combination in progressive IHC following systemic gemcitabine/oxaliplatin has led to partial responses and allowed certain patients to benefit from curative treatment. This suggests that the intra-arterial approach increases the efficacy of these 2 drugs. For locally-advanced IHC, such a loco-regional approach is worth exploring in this poor-prognosis tumor.