Phase 2 N=220 Randomized Treatment

A Study to Evaluate SHR-1210 in Subjects With Advanced HCC

Hepatocellular Carcinoma Non-Resectable

Bottom Line

View on ClinicalTrials.gov: NCT02989922 ↗

Enrolled (actual)

220

Serious AEs

44.2%

Results posted

Mar 2024

Primary outcome: Primary: Objective Response Rate — 11.9; 16.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SHR-1210 (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate	11.9; 16.7	—
PRIMARY 6-month Overall Survival Rate	75.9; 73.0	—
SECONDARY Duration of Response	30.4; 30.5	—
SECONDARY Adverse Events	109; 108	—
SECONDARY Overall Survival	14.3; 13.2	—

Summary

This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210 in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and Overall Survival when compare with SOC.

Eligibility Criteria

Inclusion Criteria

Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
Failed or intolerable to at least one prior systemic treatment for advanced HCC
ECOG Performance Status of 0 or1
Child-Pugh Class A or B with 7 points
Life Expectancy of at least 12 weeks
HBV DNA<500 IU/ml
Adequate organ function
Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug

Exclusion Criteria

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Known liver transplant or plan to transplant
GI hemorrhage with 6 months
History or current brain metastases
Active known, or suspected autoimmune disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02989922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.