Unresectable Hepatocellular CarcinomaPhase 1NCT04605185
Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
A Phase 1 study testing Donafenib Tosilate Tablets and Toripalimab Injection in people with Unresectable Hepatocellular Carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable 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
- 18 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2021to Dec 2024
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diffuse liver cancer；
- Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；
- Pregnancy or lactation；
- Patients with extrahepatic diffusion；
- Spontaneous tumor rupture；
- Expected non-compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
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.
Read the 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).
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Donafenib Tosilate Tablets, Toripalimab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donafenib Tosilate TabletsDrug
100mg Qd/150mg Qd/100mg Bid, po
Toripalimab InjectionBiological
Also called JS001
240 mg, iv drip,q3w
| Study group | Role | What they receive |
|---|---|---|
| Donafenib/JS001/TACE | Experimental | Donafenib and JS001 Combined With TACE Receives: Drug: Donafenib Tosilate Tablets; Biological: Toripalimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity(DLT)
Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.
Measured: 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years
Secondary outcomes (3)
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 date of randomization until death due to any cause, assessed up to 2 years.
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 date of randomization until the date of objective disease progression or death, assessed up to 2 years.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start8 Jan 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shanzhi Gu, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605185
- Sponsor's protocol ID
- JS001D-C-103
- Status last verified
- Mar 2024
- First submitted
- 21 Oct 2020
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04605185
- Acronym / sponsor ID
- JS001D-C-103
- Conditions
- Unresectable Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Oct 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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donafenib/JS001/TACE | Experimental | Drug: Donafenib Tosilate Tablets, Biological: Toripalimab InjectionDonafenib and JS001 Combined With TACE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- Diffuse liver cancer；
- Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；
- Pregnancy or lactation；
- Patients with extrahepatic diffusion；
- Spontaneous tumor rupture；
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 Tablets100mg Qd/150mg Qd/100mg Bid, po | Drug | Donafenib/JS001/TACE |
| Toripalimab InjectionAlso: JS001240 mg, iv drip,q3w | Biological | Donafenib/JS001/TACE |
Primary outcome
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.
3 secondary outcomes
Overall survival (OS)
Time frame: From the date of randomization until death due to any cause, assessed up to 2 years.
Progression free survival (PFS)
Time frame: From date of randomization until the date of objective disease progression or death, assessed up to 2 years.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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.
Shanzhi Gu, MD principal investigator
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donafenib Tosilate Tablets and Toripalimab Injection in people with Unresectable 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 6 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 6 Mar 2024. 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity(DLT) (time frame: 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years). 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 6 Mar 2024.