Phase I Study of Combination Therapy with OBP-301, Atezolizumab and Bevacizumab in Patients with Hepatocellular Carcinoma

Phase 1

• Conditions: Hepatocellular carcinoma

• Registration Number: JPRN-jRCT2033200223
• Lead Sponsor: Doi Toshihiko

Brief Summary

OBP-301, atezolizumab, and bevacizumab were administered to 4 subjects, and none of the subjects, including 1 subject included in the initial safety evaluation, experienced adverse events that were of questionable tolerability, but the results of this study were inconclusive for initial safety evaluation.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-01
• Study Completion: 2022-03-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology
Patients with cirrhosis require clinical confirmation of diagnosis based on the Clinical Practice Guidelines for Hepatocellular Carcinoma.
- Disease that is not amenable to curative surgical and/or locoregional therapies
- No prior systemic therapy (including non-approved and investigational agents) for HCC
- ECOG Performance Status of 0 or 1
- Child-Pugh class A

Exclusion Criteria

- Fibrolamellar HCC, sarcomatoid HCC, or a mixed type of cholangiocellular carcinoma and HCC have been confirmed.
- The patients who have history of hepatic encephalopathy
- The patients with symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified