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Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Primary Purpose

Advanced Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Donafenib Tosilate Tablets
Toripalimab Injection
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring HCC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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；
  • Fully understand this research and voluntarily sign the ICF。

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.

Sites / Locations

  • No.81 Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JS001+Donafenib

Arm Description

Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv

Outcomes

Primary Outcome Measures

Dose limiting toxicity (DLT)
Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial
Objective response rate（ORR） as determined by the Invertigator using RECIST V1.1
The ratio of patients who are evaluated as CR or PR

Secondary Outcome Measures

Anti-JS001 antibody
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

Full Information

First Posted
August 3, 2020
Last Updated
November 28, 2022
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04503902
Brief Title
Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma
Acronym
HCC
Official Title
A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Clinical Study of Toripalimab（JS001） Combined With Donafenib in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is an open, multi-center phase I/II clinical study.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
Keywords
HCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JS001+Donafenib
Arm Type
Experimental
Arm Description
Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv
Intervention Type
Drug
Intervention Name(s)
Donafenib Tosilate Tablets
Other Intervention Name(s)
Donafenib
Intervention Description
In the dose exploration phase (phase I)，three doses of Donafenib tosylate tablets [100 mg once a day (QD); 100 mg twice a day (BID); 200 mg, BID] will be explored. In the dose expansion phase (phase II), patients will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study.
Intervention Type
Drug
Intervention Name(s)
Toripalimab Injection
Other Intervention Name(s)
JS001
Intervention Description
JS001 will be administrated by intravenous (i.v.) infusion once every 21 days
Primary Outcome Measure Information:
Title
Dose limiting toxicity (DLT)
Description
Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial
Time Frame
28 days after the first dose of JS001 and Donafenib
Title
Objective response rate（ORR） as determined by the Invertigator using RECIST V1.1
Description
The ratio of patients who are evaluated as CR or PR
Time Frame
From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months
Secondary Outcome Measure Information:
Title
Anti-JS001 antibody
Time Frame
From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months
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 time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months
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 the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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； Fully understand this research and voluntarily sign the ICF。 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shukui Qin, PhD
Phone
+86-025-80864541
Email
qinsk@csco.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shukui Qin, PhD
Organizational Affiliation
No.81 Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
No.81 Hospital of PLA
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shukui Qin
Phone
+86-025-80864541
Email
qinsk@csco.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

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