NBTXR3 Crystalline Nanoparticles and Stereotactic Body Radiation Therapy in the Treatment of Liver Cancers
- Conditions
- Liver Cancer
- Interventions
- Radiation: NBTXR3, IL or IA injection + SBRT
- Registration Number
- NCT02721056
- Lead Sponsor
- Nanobiotix
- Brief Summary
The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.
- Detailed Description
PHASE I PART: Dose escalation and Recommended Dose (Volume) The purpose of the Phase I part of the study is to determine the Recommended Dose (volume), the safety profile and the feasibility of the treatment of NBTXR3 administered either by intrahepatic lesion injection or super selective transcatheter arterial injection and activated by stereotactic body radiation therapy (SBRT), in patients with liver cancers. Primary objective
- To determine the Recommended Dose(s) (volume(s)) and the early Dose Limiting Toxicity (DLT) of NBTXR3 administered either by intralesional injection or by super selective transcatheter arterial injection and activated by stereotactic body radiation therapy (SBRT) in patients with liver cancers
PHASE II PART: Safety and Efficacy evaluation Primary objectives
The primary objectives of the Phase II part are:
* To assess and characterize the safety profile, including liver function evaluation using MELD/MELD-Na and Child-Pugh scores, of NBTXR3 activated by SBRT, at the Recommended Dose(s)(Volume(s)) as determined previously in the Phase I part, in patients with liver cancers Clinical Investigation Plan - NBTXR3/103
* To evaluate the antitumor activity in terms of Complete Response Rate (CRR) of target lesions, as per mRECIST for HCC and RECIST version 1.1 for liver metastases at 12 weeks' post radiotherapy, of NBTXR3 activated by SBRT, at the Recommended Dose(s) (Volume(s)) as determined previously in the Phase I part, in patients with liver cancer.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NBTXR3, IL or IA injection +SBRT NBTXR3, IL or IA injection + SBRT * Patients will receive a single intralesional (IL) injection of NBTXR3 at four increasing dose levels (Volume levels) equivalent to: 10%, 15%, 22%, 33% and 42% of the baseline tumor volume, activated by SBRT. * Patients with primary and secondary nodular intra hepatic cancers only will receive a single superselective transcatheter arterial (IA) injection of NBTXR3 at five increasing dose levels (Volume levels) equivalent to: 10%, 15%, 22%, 33% and 45% of the baseline tumor volume, activated by SBRT.
- Primary Outcome Measures
Name Time Method Determination of the Recommended Doses Toxicities (DLT) 50 Months To determine the Recommended Doses (DLT) of NBTXR3 administered as two different schedules (intra-lesional or intra-arterial injection), activated by Stereotactic Body Radiation Therapy (SBRT)
Determination of the early Dose Limiting Toxicities 50 Months To determine the early Dose Limiting Toxicities
- Secondary Outcome Measures
Name Time Method Response Rate 50 Months To evaluate the antitumor activity in terms of Response Rate (RR) of target lesions/s, as per mRECIST and RECIST 1.1 criteria
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 50 Months Local Progression Free Survival 50 Months To evaluate the local control in terms of local Progression Free Survival
Trial Locations
- Locations (7)
Centre René Gauducheau
🇫🇷Nantes, France
Institut de Cancérologie de Loraine
🇫🇷Nancy, France
Hôpital Haut-Lévêque
🇫🇷Pessac, France
CHU La Croix Rousse
🇫🇷Lyon, France
Centre Eugène Marquis
🇫🇷Rennes, France
CHU de NANCY
🇫🇷Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France