The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC)

The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03851939

Enrollment

Registered

2019-02-22

Start date

2019-02-26

Completion date

2021-03-01

Last updated

2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

To evaluate the efficacy of TAI combine toripalimab in advanced HCC.

Interventions

COMBINATION_PRODUCTTransarterial Chemoinfusion (TAI) Combine Toripalimab

Transarterial Chemoinfusion (TAI) Combine Toripalimab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* older than 18 years old and younger than 75 years; * ECOG PS≤1; * proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; * not previous treated for tumor; * cannot accepted hepatectomy; * the lab test could meet: * neutrophil count≥2.0×109/L; * hemoglobin≥100g/L; * platelet count≥75×109/L; * serum albumin≥35g/L; * total bilirubin\<2-times upper limit of normal; * ALT\<3-times upper limit of normal; * AST\<3-times upper limit of normal; * serum creatine\<1.5-times upper limit of normal; * PT≤upper limit of normal plus 4 seconds; * INR≤2.2; * sign up consent;

Exclusion criteria

* cannot tolerate TAI or toripalimab; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of HIV infection; * known history of drug or alcohol abuse; * have GI hemorrhage or cardiac/brain vascular events within 30 days; * pregnancy;

Design outcomes

Primary

Measure	Time frame	Description
PFS	From date of randomization until the date of progression, assessed up to 36 months	progression-free survival
ORR	From date of randomization until the date of death, assessed up to 36 months	objective response rate

Secondary

Measure	Time frame	Description
OS	From date of randomization until the date of death from any cause, assessed up to 36 months	overall survival
DCR	From date of randomization until the date of death, assessed up to 36 months	disease control rate

Countries

China

Contacts

Primary ContactShaohua Li, MD

lishaoh@sysucc.org.cn+8615088064187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026