A Phase 1 interventional study of Donafenib Tosilate Tablets and Toripalimab Injection in Unresectable Hepatocellular Carcinoma, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 1, Interventional, and Treatment
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.
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).
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's planned enrollment of 18 is below the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Donafenib and JS001 Combined With TACE
Drug: Donafenib Tosilate Tablets · Biological: Toripalimab Injection
100mg Qd/150mg Qd/100mg Bid, po
240 mg, iv drip,q3w
Also known as: JS001
Dose limiting toxicity(DLT)
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
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.
Time frame: 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
Time frame: 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
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.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd