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

NCT04605185 | Active Not Recruiting Phase 1

• 1 other identifier: JS001D-C-103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity(DLT)

  Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.

  21 days after the first dose of JS001 and Donafenib, assessed up to 2 years

Secondary Outcomes (3)

• Overall survival (OS)

  From the date of randomization until death due to any cause, assessed up to 2 years.

• Progression free survival (PFS)

  From date of randomization until the date of objective disease progression or death, assessed up to 2 years.

• Duration of response (DOR)

  From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.

Study Arms (1)

Donafenib/JS001/TACE

EXPERIMENTAL

Donafenib and JS001 Combined With TACE

Drug: Donafenib Tosilate Tablets; Biological: Toripalimab Injection

Interventions

Donafenib Tosilate Tablets DRUG

100mg Qd/150mg Qd/100mg Bid, po

Donafenib/JS001/TACE

Toripalimab Injection BIOLOGICAL

240 mg, iv drip,q3w

Also known as: JS001

Donafenib/JS001/TACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 (inclusive), male or female;
• Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically or histologically or cytologically according to the "Guidelines for diagnosis and treatment 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.

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

Location

MeSH Terms

Interventions

toripalimab

Study Officials

• Shanzhi Gu, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: January 8, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)