Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

NCT04503902 | Unknown Phase 1

• 1 other identifier: JS001D-C-102
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open, multi-center phase I/II clinical study.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

HCC

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT)

  Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial

  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

  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

  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)

  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)

  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

Study Arms (1)

JS001+Donafenib

EXPERIMENTAL

Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv

Drug: Donafenib Tosilate Tablets; Drug: Toripalimab Injection

Interventions

Donafenib Tosilate Tablets DRUG

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.

Also known as: Donafenib

JS001+Donafenib

Toripalimab Injection DRUG

JS001 will be administrated by intravenous (i.v.) infusion once every 21 days

Also known as: JS001

JS001+Donafenib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

No.81 Hospital of PLA

Nanjing, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Interventions

donafenib; toripalimab

Study Officials

• Shukui Qin, PhD

  No.81 Hospital of PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shukui Qin, PhD

CONTACT

+86-025-80864541; qinsk@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 7, 2020
• Study Start: October 15, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)