Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Montpellier

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Aug 2024 → ongoing

Decision date (initial)

2024-08-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GUERBET

External identifiers

EU CT number

2024-515456-20-00

EudraCT number

2017-004859-22

ClinicalTrials.gov

NCT03727633

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.

Secondary objectives 7

1. Treatment safety
2. Objective response rate according to mRECIST at 6 months after the first cycle
3. The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol
4. Overall survival at 12 months after the first cycle of chemo-lipiodol
5. Overall survival without progression of the deasese
6. Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol.
7. Arterial liver thrombosis/sténosis artérielle hépatique after each cycle of chemo-lipiodol

Conditions and MedDRA coding

Hepato carcinoma cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Histologically-proven HCC or according to EASL criteria
2. Child-Pugh A or B7
3. Disease that is not suitable for resection, ablation or radiofrequency
4. Performance Status ECOG 0 or 1
5. BCLC A/B or C if Performance Status ECOG = 1
6. Measurable lesions according to mRECIST criteria
7. No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
8. Age superior or equal to 18 years
9. Platelets > 50,000/mm3, Polynuclear neutrophils > 1000/mm3, Creatininemia < 150umol/L, Bilirubinemia < 5 mg/dL
10. Absence of heart failure (Ultrasound LVEF > 50%)
11. Women of child-bearing age using an adequate method of contraception throughout treatment and 6.5 months after treatment
12. Men using an adequate method of contraception throughout the treatment and at least 3,5 months after the end of treatment
13. Written informed consent
14. National health insurance cover (France)

Exclusion criteria 16

1. Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
2. Large HCC with liver invasion >50%
3. History of other cancer than HCC and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose
4. Advanced liver disease (Child B8, B9 or C)
5. Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)
6. Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).
7. Contra-indication to idarubicin (Hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis)
8. Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)
9. Concomitant disease or uncontrolled severe clinical situation
10. Uncontrolled severe infection
11. Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
12. Grade 2 or 3 oesograstric varices on the last endoscopy less than 3 months old.
13. Pregnancy (Beta HCG positive) or breastfeeding
14. Patient who for psychological, social, family or geographical reasons cannot be followed regularly
15. Vulnerable person
16. Concomitant participation of the patient in another research involving the human person

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease control rate (partial, complete or stable response) at 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.

Secondary endpoints 7

1. Time until treatment failure defined as the time interval between the inclusion date and the date of treatment failure. Patients alive without treatment failure will be censored on the latest news date. Treatment failure is defined as progression, the appearance of toxicities, or the inability to administer chemotherapy.
2. Progression-free survival: defined as the time interval between the date of inclusion and the date of first progression or death (whatever the cause). Patients living without progress will be censored on the date of the last news.
3. The rate of patients in objective response (complete response or partial response) at 6 months to from the date of the first course of chemo-lipiodol according to the mRECIST criteria evaluated according to the investigator and centralized proofreading
4. Tolérance defined by the NCI CTC AE v4.03 scale.
5. Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol at baseline, and 2, 4, 6, 12 months after the first cycle
6. The rate of thrombosis/hepatic arterial stenosis defined as the number of courses lasting which vascular thrombosis or stenosis is/are visible on arteriography initial hepatic artery(s), divided by the total number of cures.
7. Overall survival defined as the time interval between the date of inclusion and the date of death (all causes). Patients alive without progression will be censored on the date of latest news.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Montpellier

Sponsor organisation

Centre Hospitalier Universitaire De Montpellier

Address

39 Avenue Charles Flahault, Pavillon 32 Pavillon 32

City

Montpellier Cedex 5

Postcode

34295

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Montpellier

Contact name

Pr Boris GUIU

Public contact point

Organisation

Centre Hospitalier Universitaire De Montpellier

Contact name

Anne Cadene

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications