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A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma

NCT04635527 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-16

No results posted yet for this study

Summary

The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.

Conditions

Interventions

DRUG

IBI318

before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W

PROCEDURE

cTACE

conventional transarterial chemoembolization

DRUG

placebo

before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-24
Primary Completion
2021-08-27
Completion
2023-03-07

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635527 on ClinicalTrials.gov