Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • days left to enroll
    10
  • participants needed
    46
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Updated on 14 May 2021

Summary

This study is an open, multi-center phase I/II clinical study.

Description

It will explore the tolerability (phase I) and effectiveness (phase II) of the Donafenib tosilate tablets combined with Toripalimab injection in patients with advanced HCC. The study is conducted in two phases, the first phase is the dose exploration phase (phase I), and the second phase is the dose expansion phase (phase II).

Details
Condition Advanced Hepatocellular Carcinoma
Treatment donafenib tosilate tablets, Toripalimab Injection
Clinical Study IdentifierNCT04503902
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with locally advanced or metastatic HCC who are not suitable for surgical resection, who are clinically diagnosed or confirmed by histopathology and/or cytology according to the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (2017)
At least one measurable lesion (according to RECIST v1.1)
ECOG performance status score of 0 or 1
Life expectancy 12 weeks
Have not received systemic therapy (systemic chemotherapy and/or molecular targeted therapy).If the patient has received adjuvant chemotherapy after local treatment, the chemotherapy needs to be over for more than 12 months, and disease progression or metastasis occurs
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Exclusion Criteria

Patients with diffuse liver cancer, hepatic encephalopathy that is difficult to control, and liver cancer patients whose lesion size accounts for 70% or more of the entire liver
Patients with intrahepatic cholangiocarcinoma (ICC) or HCC-ICC mixed type
Tumor invades inferior vena cava VP4
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