Clinical trial NCT04503902: Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Keywords: HCC
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: 28 days after the first dose of JS001 and Donafenib
measure: Objective response rate（ORR） as determined by the Invertigator using RECIST V1.1
timeFrame: 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:
measure: Anti-JS001 antibody
timeFrame: 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
measure: Overall survival (OS)
timeFrame: 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
measure: Progression free survival (PFS)
timeFrame: 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
Other outcomes:
Locations:
city: Nanjing
country: China
facility: No.81 Hospital of PLA
state: Jiangsu
Study officials:
affiliation: No.81 Hospital of PLA
name: Shukui Qin, PhD
role: PRINCIPAL_INVESTIGATOR
References: