Efficacy evaluation of 188Re-SSS lipiodol Selective Internal Radiation Therapy of non operable hepatocellular carcinoma patients, a phase II study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre De Lutte Contre Le Cancer Eugene Marquis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Feb 2024 → 24 Apr 2026

Decision date (initial)

2023-07-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Programme hospitalier de recherche Clinique en cancérologie - Institut National du Cancer

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy, Dose response

To evaluate the efficacy of 188Re-SSS lipiodol Selective Internal Radiation Therapy in non-operable hepatocellular carcinoma

Conditions and MedDRA coding

non-operable hepatocellular carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age ≥ 18 year
2. ECOG Performance Status 0-1
3. Hepatocellular Carcinoma with histological diagnosis or non-invasive diagnosis according to AASLD criteria
4. Non operable and not accessible to ablation therapy
5. At least one measurable lesion using mRECIST
6. Tumor involvement <50% of the liver
7. BCLC classification A to C
8. Compensated cirrhosis (Child Pugh A only), if cirrhosis present
9. Patient information and signature of informed consent or legal representative

Exclusion criteria 13

1. Inadequate haematological, hepatic, renal, thyroid and coagulation functions: Haemoglobin < 8,5 g/dl, Granulocytes < 1500/mm3, Platelets< 50 000 /mm3, Bilirubin level ≥ 35 µmol/l, Transaminases > 6 UNL, Creatinine > 1,5 UNL, TSH < 0.2 µUI/L
2. Previous systemic treatment for HCC within 4 weeks before radioembolization
3. More than 2 previous transcatheter arterial chemoembolization (TACE) (or embolization), in the area to be treated
4. Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 1 month after the end of the treatment
5. Other neoplasia except if complete remission from at least one year
6. Contraindication related to the technique, in particular severe arterial pathology of the lower limbs or the aorta contraindicating or making difficult an arteriography by femoral approach
7. Chronic respiratory insufficiency history
8. Know hemophilia with exophytic tumor > 1 cm
9. Extra-hepatic metastasis except hilum node < 2 cm
10. Lung shunt >20%
11. Poor tumor targeting
12. Previous SIRT
13. Ascites (even if only radiological)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. The objective response rate, defined as the best overall response occurring within 6 months’ post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma
2. The best overall responses at months 1, 3, and every 3 months until 24 months after radioembolization
3. Time to liver progression (TTLP), defined as the time from patient inclusion to progression according modified RECIST criteria
4. Progression-free survival (PFS), defined as the time from patient inclusion to progression according mRECIST criteria (whatever the location of the progressive lesion) including death from any cause and initiation of a new antineoplastic therapy
5. Overall survival (OS), defined as the time from patient inclusion to death from any cause
6. The biological response rate is defined as the proportion of patients with a complete or partial AFP response, as determined by the lowest serum alpha-fetoprotein (AFP) level observed during the first six months. A complete AFP response is defined as normalization of the AFP level at a minimum of one-point measurement. A partial AFP response is defined as no normalization of the AFP level, but a reduction of at least 20% from the baseline level. Point measurements are planned at M1, M3, and M6

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre De Lutte Contre Le Cancer Eugene Marquis

Sponsor organisation

Centre De Lutte Contre Le Cancer Eugene Marquis

Address

Avenue La Bataille Flandre Dunkerque, Cs 44229 Cs 44229

City

Rennes Cedex

Postcode

35042

Country

France

Scientific contact point

Organisation

Centre De Lutte Contre Le Cancer Eugene Marquis

Contact name

Pr Etienne GARIN

Public contact point

Organisation

Centre De Lutte Contre Le Cancer Eugene Marquis

Contact name

Pr Etienne GARIN

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 6 files

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

Application history

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