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Clinical Trials/NCT05048017
NCT05048017RecruitingPhase 2

Regorafenib Combined With PD-1 Inhibitor Therapy for Second-line Treatment of Hepatocellular Carcinoma: A Single Arm, Nonrandomized, Single Center Clinical Study

Peking Union Medical College Hospital1 site in 1 country20 target enrollmentStarted: October 1, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Progression Free Survival (PFS)

Study Overview

Brief Summary

This is a single arm, nonrandomized, single center clinical study to investigate the safety and efficacy of regorafenib combined with PD-1 inhibitor therapy for second-line treatment of hepatocellular carcinoma

Detailed Description

To observe and evaluate the efficacy, safety and biomarker analysis of regorafenib combined with PD-1 inhibitor for the second-line treatment of hepatocellular carcinoma.In this study, 20 patients with hepatocellular carcinoma will be enrolled for regorafenib combined with PD-1 inhibitor therapy.In the absence of any of the following conditions, such as withdrawal of informed consent by subjects, intolerable drug side effects, or the investigator's determination that further study is not appropriate, the expected study treatment for each subject will continue until radiologically confirmed tumor progression. Efficacy indicators and safety indicators will be observed during the trial.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Regorafenib plus PD-1 inhibitor

Experimental

Regorafenib (BAY 73-4506, Stivarga®) is an oral diphenylurea multi-kinase inhibitor that targets angiogenic (VEGFR1-3, TIE2), stromal (PDGFR-β, FGFR), and oncogenic receptor tyrosine kinases (KIT, RET, and RAF).

Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd, recently received conditional approval in China for the treatment of relapsed or refractory classical Hodgkin lymphoma.

Toripalimab, a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2), is being developed by Shanghai Junshi Bioscience Co., Ltd in China for the treatment of various cancers.

Pembrolizumab (Keytruda) the programmed cell death protein 1 (PD1) is one of the checkpoints that regulates the immune response. Ligation of PD1 with its ligands PDL1 and PDL2 results in transduction of negative signals to T-cells.

Intervention: Regorafenib (Drug)

Regorafenib plus PD-1 inhibitor

Experimental

Regorafenib (BAY 73-4506, Stivarga®) is an oral diphenylurea multi-kinase inhibitor that targets angiogenic (VEGFR1-3, TIE2), stromal (PDGFR-β, FGFR), and oncogenic receptor tyrosine kinases (KIT, RET, and RAF).

Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd, recently received conditional approval in China for the treatment of relapsed or refractory classical Hodgkin lymphoma.

Toripalimab, a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2), is being developed by Shanghai Junshi Bioscience Co., Ltd in China for the treatment of various cancers.

Pembrolizumab (Keytruda) the programmed cell death protein 1 (PD1) is one of the checkpoints that regulates the immune response. Ligation of PD1 with its ligands PDL1 and PDL2 results in transduction of negative signals to T-cells.

Intervention: PD-1 inhibitor (Drug)

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: one year

A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause

Secondary Outcomes

  • Percentage of patients with stable disease (SD) ≥ 4 weeks(one year)
  • Progression-free survival rate at 3 months(6 months)
  • Mortality at 12 months(one year and a half)
  • Objective Response Rate (ORR)(one year)
  • Partial response (PR)(one year)
  • Complete response (CR)(one year)
  • Overall survival (OS)(one year)
  • Duration of response (DOR)(one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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