- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04503902
Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
November 28, 2022 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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
This study is an open, multi-center phase I/II clinical study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
46
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shukui Qin, PhD
- Phone Number: +86-025-80864541
- Email: qinsk@csco.org.cn
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 215006
- Recruiting
- No.81 Hospital of PLA
-
Contact:
- Shukui Qin
- Phone Number: +86-025-80864541
- Email: qinsk@csco.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: JS001+Donafenib
Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv
|
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.
Other Names:
JS001 will be administrated by intravenous (i.v.) infusion once every 21 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicity (DLT)
Time Frame: 28 days after the first dose of JS001 and Donafenib
|
Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial
|
28 days after the first dose of JS001 and Donafenib
|
Objective response rate(ORR) as determined by the Invertigator using RECIST V1.1
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
|
The ratio of patients who are evaluated as CR or PR
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
|
Overall survival (OS)
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
|
The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.
|
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
|
Progression free survival (PFS)
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
|
The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shukui Qin, PhD, No.81 Hospital of PLA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 15, 2020
Primary Completion (ANTICIPATED)
December 1, 2023
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
August 3, 2020
First Submitted That Met QC Criteria
August 6, 2020
First Posted (ACTUAL)
August 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 29, 2022
Last Update Submitted That Met QC Criteria
November 28, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS001D-C-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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