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

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ClinicalTrials.gov Identifier: NCT04605185
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Unresectable Hepatocellular Carcinoma Drug: Donafenib Tosilate Tablets Biological: Toripalimab Injection Phase 1

Detailed 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
Actual Study Start Date : January 8, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Donafenib/JS001/TACE
Donafenib and JS001 Combined With TACE
 Drug: Donafenib Tosilate Tablets
100mg Qd/150mg Qd/100mg Bid, po

Biological: Toripalimab Injection
240 mg, iv drip,q3w
Other Name: JS001


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicity(DLT) [ Time Frame: 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years ]
    Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From the date of randomization until death due to any cause, assessed up to 2 years. ]
    The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.

  2. Progression free survival (PFS) [ Time Frame: From date of randomization until the date of objective disease progression or death, assessed up to 2 years. ]
    The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death

  3. Duration of response (DOR) [ Time Frame: 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. ]
    defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605185


Contacts
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Contact: Shanzhi Gu, MD +86-0731-89762041 105575191@qq.com

Locations
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China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China, 410006
Contact: Shanzhi Gu, MD    +8673189762041    105575191@qq.com   
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
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Principal Investigator: Shanzhi Gu, MD Hunan Cancer Hospital
More Information
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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT04605185    
Other Study ID Numbers: JS001D-C-103
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases