Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

Last updated: March 4, 2024
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Overall Status: Active - Not Recruiting

Phase

1

Condition

Carcinoma

Treatment

Donafenib Tosilate Tablets

Toripalimab Injection

Clinical Study ID

NCT04605185
JS001D-C-103
  • Ages 18-75
  • All Genders

Study Summary

This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-75 (inclusive), male or female;
  • Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically orhistologically or cytologically according to the "Guidelines for diagnosis andtreatment of primary liver cancer" (2019 Edition);
  • At least one measurable lesion (according to RECIST v1.1)
  • ECOG performance status score of 0 -1;
  • Life expectancy ≥ 12 weeks;
  • Fully understand this research and voluntarily sign the ICF.

Exclusion

Exclusion Criteria:

  • Diffuse liver cancer；
  • Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；
  • Pregnancy or lactation；
  • Patients with extrahepatic diffusion；
  • Spontaneous tumor rupture；
  • Expected non-compliance.

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: Donafenib Tosilate Tablets
Phase: 1
Study Start date:
January 08, 2021
Estimated Completion Date:
December 31, 2024

Study Description

The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).

Connect with a study center

  • Hunan Cancer Hospital

    Changsha, Hunan 410006
    China

    Site Not Available

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