Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
NCT ID: NCT04605185
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2021-01-08
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Donafenib/JS001/TACE
Donafenib and JS001 Combined With TACE
Donafenib Tosilate Tablets
100mg Qd/150mg Qd/100mg Bid, po
Toripalimab Injection
240 mg, iv drip,q3w
Interventions
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Donafenib Tosilate Tablets
100mg Qd/150mg Qd/100mg Bid, po
Toripalimab Injection
240 mg, iv drip,q3w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；
* Pregnancy or lactation；
* Patients with extrahepatic diffusion；
* Spontaneous tumor rupture；
* Expected non-compliance.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Shanzhi Gu, MD
Role: PRINCIPAL_INVESTIGATOR
Hunan Cancer Hospital
Locations
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Hunan Cancer Hospital
Changsha, Hunan, China
Countries
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Other Identifiers
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JS001D-C-103
Identifier Type: -
Identifier Source: org_study_id
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