The combination of gemcitabine and oxaliplatin intra-arterial as second-line therapy can greatly improve the Objective Response Disorder (ORT) at 4 months MedDRA version: 20.0 Level: LLT Classification code 10036706 Term: Primary liver cancer non-resectable System Organ Class: 100000004864
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Current Sponsor code: gemcitabine
Other descriptive name: gemcitabine
Concentration unit: mg/m2 mill
Sponsors
University hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to meet all the following criteria: • Histologically-proven intrahepatic cholangiocarcinoma previously treated by first-line systemic therapy • Absence of extra-hepatic metastasis or peritoneal carcinomatosis (as demonstrated by CT-scan) • Age ? 18 years • General health status PS 0, 1 • Estimated life expectancy > 3 months • Disease that is not suitable for resection with a curative intent, as validated by a multidisciplinary committee with at least one senior hepatic surgeon • At least one measurable lesion according to RECIST 1.1 criteria • Platelets =100,000/mm3, polynuclear neutrophils =1000/mm3 , hemoglobin ? 9g/dL (even transfused patients can be included) • Creatininemia =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Patients eligible for this study must not meet any of the following criteria: • Patients with cholangiocarcinoma of the gallbladder or common bile duct or those with hepatocholangiocarcinoma or a Klatskin tumor • Patients who are eligible for surgical resection or liver transplantation • Extra-hepatic metastases [Pulmonary micronodules <7mm without uptake on PET are not a contra-indication] • Presence of clinical ascites • History of intra-arterial therapy or more than one line of systemic treatment • Contra-indication or grade 3-4 allergy to any of the treatment drugs • Grade ? 2 peripheral neuropathy • Ongoing participation or participation within the 21 days prior to inclusion in the study in another therapeutic trial with an experimental drug • Concomitant systemic treatment with immunotherapy, chemotherapy or hormone therapy • Serious non-stabilized disease, active uncontrolled infection or other serious underlying disorder likely to prevent the patient from receiving the treatment • Pregnancy, breast-feeding or the absence of effective contraception for women of child-bearing age • Another cancer in the 5 years preceding or at the time of inclusion in the trial (except for in situ cervical cancer or basal cell carcinoma of the skin) • Allergy to iodine contrast agents • Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 12 hours • Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or Plavix. • Contra-indication for use of an intra-arterial approach (severe arteriopathy) • Legal incapacity (persons in custody or under guardianship) • Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the objective response rate (complete or partial response) 4 months after inclusion using RECIST 1.1 evaluation;Secondary Objective: The secondary objectives are: •Safety (NCI-CTCAE version 4.0) •Quality of life (QLQ-C30) •Secondary resectability rate •Overall survival •Progression-free survival ;Primary end point(s): The primary endpoint is the percentage of patients with an objective response (defined as partial or complete response) 4 months after inclusion (using RECIST v1.1 criteria) ;Timepoint(s) of evaluation of this end point: 4 months after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be: • Safety (NCI-CTCAE version 4.0) • Quality of life (QLQ-C30 questionnaire). The time to a final deterioration in the global health score (decrease of 5 points or more with no further improvement before death). The delay will be calculated from date of the first cycle to QoL evaluation or date of death or date of last news if the patient has no deterioration • Secondary resectability rate (as evaluated by an experienced hepatic surgeon) • Overall survival (estimated by the time between the date of inclusion and the date of death or date of last news for alive patients) • Progression-free survival by CT-scan/MRI according to the investigator's opinion (defined as the time between the date of inclusion and the date of first progression or death [whichever occurs first] or date of last news for patients alive without any progression) ;Timepoint(s) of evaluation of this end point: 4 months after inclusion | — |
Countries
France
Contacts
Public ContactCADENE Anne
University Hospital of Montpellier
Outcome results
None listed