Study on the effect of 2 immunotherapy drugs in combination with radioactive glass spheres on the survival in liver cancer

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Neoplasms [C04]; hepatocellular carcinoma; MedDRA version: 21.0Level: LLTClassification code: 10019828Term: Hepatocellular carcinoma non-resectable Class: 10029104

• Registration Number: CTIS2024-515127-11-00
• Lead Sponsor: Klinikum der Universitaet Muenchen AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Histological diagnosis of HCC, Life expectancy of at least 12 weeks, Disease which is not amenable to curative surgical or ablation treatment but eligible for TACE with tumor burden < 50% of liver volume, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Preserved liver function, as defined by a Child-Pugh score A and serum Bilirubin <1.5 x institutional upper limit of normal (ULN)

Exclusion Criteria

Diffuse HCC or presence of vascular invasion or extrahepatic spread (including extrahepatic lymph node affection or metastasis) or more than 7 lesions or at least one lesion = 7 cm, Major gastrointestinal bleeding within 4 weeks prior to inclusion, Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC, Decompensated liver function as defined by any of the following: Clinically meaningful ascites, hepatic encephalopathy or history of hepatic encephalopathy, Child Pugh =7 points. The presence of clinically meaningful ascites is defined as any ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for =2 months are eligible., Uncontrolled pleural effusion or pericardial effusion, Co-infection of HBV and HCV. Patients with a history of HCV infection but who are negative for HCV RNA by polymerase chain reaction (PCR) will be considered non-infected with HCV., Patients on a liver transplantation list, Prior systemic therapy for HCC (including previous CPI or VEGFi treatment), Prior treatment with TACE or SIRT, Ineligibility for locoregional treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified