NBTXR3 Crystalline Nanoparticles and Stereotactic Body Radiation Therapy in the Treatment of Liver Cancers

Phase 1

Terminated

• Conditions: Liver Cancer

• 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.

Study Timeline

• Study First Submitted: 2015-12-24
• Study Start: 2016-01-28
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-28
• Primary Completion: 2020-05-06
• Study Completion: 2020-05-06
• Status Verified: 2020-10
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

CHU La Croix Rousse; 🇫🇷 Lyon, France

Institut de Cancérologie de Loraine; 🇫🇷 Nancy, France

CHU de NANCY; 🇫🇷 Nancy, France

Centre René Gauducheau; 🇫🇷 Nantes, France

Hôpital Haut-Lévêque; 🇫🇷 Pessac, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France