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Phase I: Patients will be allocated to sequential cohorts of progressively higher dose levels of NMS-01940153E based on the presence of Dose Limiting Toxicities (DLT).

Phase II: Patients will be treated at the recommended Phase II dose (RP2D) defined in the Phase I portion.

Route of administration: intravenous (IV) solution

NMS-01940153E

This is a Phase I/II, open-label, non-randomized, multicenter study to explore safety, tolerability and antitumor activity of NMS-01940153E as single agent in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy.

The Phase I portion is designed as a dose-escalation study in sequential cohorts of patients aimed to obtain the maximum tolerated dose (MTD) that is defined based on the dose limiting toxicities (DLTs) observed in the first cycle of treatment.

The Phase II portion is designed as a two-stage study with an interim analysis for futility and stopping criteria for unacceptable toxicity to assess the antitumor activity of NMS-01940153E in adult patients with unresectable HCC previously treated with systemic therapy measured as objective response rate.

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy

Phase I/II Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy

Overall safety profile of NMS-01940153E characterized by type, severity (graded using National Cancer Institute Common Terminology Criteria for Adverse Events ((NCI CTCAE) Version 5.0), duration of the adverse events (AEs) and laboratory and electrocardiogram (ECGs) abnormalities, and relationship of the AEs to study treatment in the first and subsequent cycles of therapy.

Nerviano Medical Sciences

Antineoplastic Agents

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants weighing ≥ 60 kg will be enrolled in this arm.

Participants weighing \< 60 kg will be enrolled in this arm.

Lenvatinib 4 mg capsules will be administered orally, once daily continuously 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.

The primary purpose of this study is to assess the single- and multiple-dose pharmacokinetic (PK) profile of lenvatinib in Chinese participants with unresectable Hepatocellular Carcinoma (HCC).

Pharmacokinetic Study of E7080/Lenvatinib in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)

Eisai Co., Ltd.

Symptoms and General Pathology

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Hematinics

Liver Extracts

This cohort will include patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, who have been prescribed selective internal radiation therapy (SIRT) with SIR-Spheres per medical decision.

Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.

SIRT

Janet Bell

Mohamed Bouattour

Hélène Regnault

Nicolas Jacquet-Francillon

Lourdes Gutierrez

Pilar Garcia Alfonso

Paloma Lluch

Saifee Mullamitha

Paul Ross

Rohini Sharma

This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres

This is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with SIR-Spheres per medical decision.

The study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.

Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)

Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)

The (EurolQol) EQ-5D-5L is comprised of five questions on mobility, self-care, pain, usual activities, and psychological status with 5 level answers, 5 being extreme and 1 minimum.

The 30 EORTC QLQ-C30 items constitute consist of 9 domains: physical function, role function, cognitive function, emotional function, social function, fatigue, pain, nausea and vomiting, and global health status. Items are answered on a scale of 1 to 4 or 1 to 7.

The EORTC QLQ-HCC18 instrument consists of 6 symptom scales and 2 single items: that measures fatigue, body image, jaundice, nutrition, pain, fever, sexual interest and abdominal swelling. Scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much').

Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates

Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints

The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy	NCT05630937	Unresectable He...	NMS-01940153E	18 Years -	Nerviano Medical Sciences
Pharmacokinetic Study of E7080/Lenvatinib in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)	NCT02953743	Unresectable He...	Lenvatinib	18 Years -	Eisai Inc.
Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy	NCT05630937	Unresectable He...	NMS-01940153E	18 Years -	Nerviano Medical Sciences
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)	NCT05967143	Unresectable He... Liver Metastase...	SIRT	18 Years -	Sirtex Medical

Spots Global Cancer Trial Database for unresectable hepatocellular carcinoma (hcc)