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RECRUITING
NCT03364530
PHASE2

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2018-06-11

Completion Date

2026-10-21

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

DRUG

Gemcitabine-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.

PROCEDURE

Hepatic 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.

Locations (7)

Amiens University Hospital

Amiens, France

Angers University Hospital

Angers, France

Bordeaux University Hospital

Bordeaux, France

Centre Georges François Leclerc

Dijon, France

Uhmontpellier

Montpellier, France

Hôpital Européen Georges Pompidou

Paris, France

Institut Gustave Roussy

Villejuif, France