ADVANCED HEPATOCELLULAR CARCINOMA MedDRA version: 14.1 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Trade Name: PLAQUENIL*100CONF 200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 118-42-3
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Con
Sponsors
UNIVERSITA' CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must have histologically confirmed metastatic or unresectable Hepatocellular carcinoma. • Patients must have at least one measurable site of disease according to RECIST criteria that has not been previously irradiated. • If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since radiation. • Male or female patients =18 years old. • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. • Child-Pugh A • Baseline MUGA or ECHO must demonstrate LVEF = the lower limit of the institutional normal. • ECOG Performance Status of =2 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: • Prior treatment with a multi-kinase inhibitor or chemotherapy or antibody therapy. • Patients who have had major surgery or significant traumatic injury within 4 weeks of start of study drug patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study • Prior treatment with any investigational drug within the preceding 4 weeks • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed • Female patients who are pregnant or breast feeding or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days of the first administration of oral hydroxychloroquine and Sorafenib)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: efficacy;Secondary Objective: safety;Primary end point(s): • Evaluation of clinical benefit;Timepoint(s) of evaluation of this end point: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evaluation of shrinkage rate • Evaluation of Progression Free Survival • Evaluation of Tumor Response Rate according to RECIST criteria • Determine the toxicity of adding hydroxychloroquine to standard first line therapy for stage IV Hepatocellular carcinoma;Timepoint(s) of evaluation of this end point: 2 months | — |
Countries
Italy
Contacts
Public ContactONCOLOGIA MEDICA
UNIVERSITA' CAMPUS BIOMEDICO DI ROMA
Outcome results
None listed