Advanced Hepatocellular CarcinomaPhase 1/2HCCNCT04503902
Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing Donafenib Tosilate Tablets and Toripalimab Injection in people with Advanced Hepatocellular Carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study is an open, multi-center phase I/II clinical study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Donafenib Tosilate Tablets and Toripalimab Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2020to Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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。
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
No.81 Hospital of PLA
Nanjing, Jiangsu, 215006
Shukui Qin, +86-025-80864541, qinsk@csco.org.cn
About this study
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
This study is an open, multi-center phase I/II clinical study.
Read the 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).
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- Donafenib Tosilate Tablets, Toripalimab Injection
- Keywords
- HCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donafenib Tosilate TabletsDrug
Also called Donafenib
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.
Toripalimab InjectionDrug
Also called JS001
JS001 will be administrated by intravenous (i.v.) infusion once every 21 days
| Study group | Role | What they receive |
|---|---|---|
| JS001+Donafenib | Experimental | Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv Receives: Drug: Donafenib Tosilate Tablets; Drug: Toripalimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial
Measured: 28 days after the first dose of JS001 and Donafenib
Objective response rate（ORR） as determined by the Invertigator using RECIST V1.1
The ratio of patients who are evaluated as CR or PR
Measured: 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 outcomes (3)
Anti-JS001 antibody
Measured: 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)
The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.
Measured: 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)
The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start15 Oct 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shukui Qin, PhD, Principal investigator, No.81 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503902
- Sponsor's protocol ID
- JS001D-C-102
- Acronym
- HCC
- Status last verified
- Nov 2022
- First submitted
- 3 Aug 2020
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04503902
- Acronym / sponsor ID
- HCC / JS001D-C-102
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- HCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JS001+Donafenib | Experimental | Drug: Donafenib Tosilate Tablets, Drug: Toripalimab InjectionDonafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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；
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donafenib Tosilate TabletsAlso: DonafenibIn 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. | Drug | JS001+Donafenib |
| Toripalimab InjectionAlso: JS001JS001 will be administrated by intravenous (i.v.) infusion once every 21 days | Drug | JS001+Donafenib |
Primary outcome
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
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shukui Qin, PhD principal investigator
No.81 Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Donafenib Tosilate Tablets and Toripalimab Injection in people with Advanced Hepatocellular Carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shukui Qin, PhD (+86-025-80864541, qinsk@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 28 days after the first dose of JS001 and Donafenib). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.