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

Primary Purpose

Unresectable Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Donafenib Tosilate Tablets

Toripalimab Injection

About this trial

This is an interventional treatment trial for Unresectable Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hunan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Donafenib/JS001/TACE

Arm Description

Donafenib and JS001 Combined With TACE

Outcomes

Primary Outcome Measures

Dose limiting toxicity(DLT)

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

Secondary Outcome Measures

Overall survival (OS)

The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.

Progression free survival (PFS)

The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death

Duration of response (DOR)

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

Full Information

NCT ID

NCT04605185

First Posted

October 21, 2020

Last Updated

November 28, 2022

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04605185

Brief Title

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

Official Title

Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 8, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unresectable Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Donafenib/JS001/TACE

Arm Type

Experimental

Arm Description

Donafenib and JS001 Combined With TACE

Intervention Type

Drug

Intervention Name(s)

Donafenib Tosilate Tablets

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Toripalimab Injection

Other Intervention Name(s)

JS001

Intervention Description

240 mg, iv drip,q3w

Primary Outcome Measure Information:

Title

Dose limiting toxicity(DLT)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.

Time Frame

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

Title

Progression free survival (PFS)

Description

The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death

Time Frame

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

Title

Duration of response (DOR)

Description

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

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shanzhi Gu, MD

Phone

+86-0731-89762041

105575191@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shanzhi Gu, MD

Organizational Affiliation

Hunan Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hunan Cancer Hospital

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shanzhi Gu, MD

Phone

+8673189762041

105575191@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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