Toripalimab Plus Sorafenib in Patients With Advanced-Stage Hepatocellular Carcinoma

NCT04926532 | Unknown Phase 1

• 1 other identifier: ZSGW-PD1-sora
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Toripalimab is a programmed cell death protein 1 antibody.This is an open-label, single arm, multi-center exploratory study.The objective of this study is to evaluate the efficacy and safety of therapy with toripalimab and sorafenib in patients with advanced stage hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Toripalimab

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The proportion of patients in this trial whose tumor is destroyed or significantly reduced by the treatment. The extent of the reduction is assessed by researchers based on the RECIST 1.1 standard.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Progression free survival (PFS)

  through study completion, an average of 1 year

• Disease Control Rate (DCR)

  through study completion, an average of 1 year

• Duration of relief (DOR)

  through study completion, an average of 1 year

• Overall survival

  10 year

Study Arms (1)

Toripalimab + Sorafenib

EXPERIMENTAL

Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Sorafenib was taken orally after meals, twice a day.

Drug: Toripalimab; Drug: Sorafenib

Interventions

Toripalimab DRUG

Toripalimab is a humanized anti-PD-1 monoclonal antibody

Toripalimab + Sorafenib

Sorafenib DRUG

Sorafenib is a multi-kinase inhibitor

Toripalimab + Sorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age: 18-75 years old, male or female;
• According to the clinical stage of Chinese liver cancer (2017 edition), the stage is stage II b or III, and one of the following conditions is met: (1) patients with hepatocellular carcinoma who cannot undergo surgical resection; (2) are unwilling to undergo surgical resection or arterial Patients with hepatocellular carcinoma treated with chemoembolization (TACE).
• Child-Pugh liver function scores were grade A or B within 7 days prior to the first dose of study drug.
• Laboratory tests must meet the following criteria within 7 days of starting treatment:
• Neutrophils ≥1.5 × 109/L;
• platelets ≥ 50 × 109 / L;
• hemoglobin ≥ 90g / L (not infused with concentrated red blood cells within 2 weeks);
• serum creatinine ≤ 1.5 upper limit of normal (ULN) and creatinine clearance ≥ 50ml / min;
• aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN;
• serum albumin ≥ 30g / L;
• Patients who did not receive anticoagulant therapy: INR ≤ 1.5 × ULN. If the patient receives prophylactic anticoagulant therapy, the INR ≤ 2 × ULN within 14 days before the start of the study treatment and the activated partial thromboplastin time is within the normal range, acceptable for enrollment;
• serum bilirubin ≤ 1.25 × ULN;
• Life expectancy is \>3 months.
• Confirm that there is at least one measurable lesion based on the RECIST 1.1 standard.
• The Physical Status (PS) score of the Eastern Cooperative Oncology Group (ECOG) was 0-1 within 7 days prior to the first dose of study drug.

You may not qualify if:

• Esophageal or gastric varices bleeding occurred in the past 6 months.
• There is a bleeding or thrombotic disease or use an X-factor inhibitor or anticoagulant, such as warfarin or similar, that requires monitoring of the International Normalized Ratio (INR). Treatment with low molecular weight heparin is permitted. Antiplatelet drugs were banned throughout the study.
• Clinically significant ascites that was not controlled by drugs when examined. (Note: Ascites found only through imaging examinations is allowed to participate in the study)
• According to imaging examination, there is a tumor thrombus invasion, inferior vena cava or cardiac involvement at the portal vein (Vp4).
• It has been clinically diagnosed as hepatic encephalopathy in the past 6 months. Subjects with hepatic encephalopathy controlled with rifaximin or lactulose are not allowed to participate in the study.
• There are medical contraindications that do not accept any contrast-enhanced imaging (CT or MRI).
• Existing ≥ 3 gastrointestinal or non-gastrointestinal fistulas.
• Clinically significant hemoptysis or tumor hemorrhage for any cause within 2 weeks prior to the first dose of study drug.
• Major cardiovascular damage within 12 months prior to the first dose of study drug: a history of congestive heart failure, grade II or older, unstable angina, myocardial infarction, or cerebrovascular accident, or with the New York Heart Association (NYHA) Arrhythmias associated with hemodynamic instability.
• Suffering from severe unhealed wounds, ulcers or fractures.
• Previously received any surgery, intervention, radiotherapy, systemic chemotherapy, targeted therapy, anti-PD-1 and anti-PD-L1 antibodies and Chimeric Antigen Receptor T-Cell Immunotherapy and other immunotherapy.
• Vaccines were administered within 30 days prior to the first dose of study drug. Live vaccines include, but are not limited to, measles, mumps, rubella, varicella/herpes (chickenpox), yellow fever, rabies, Bacillus Calmette Guerin, and typhoid vaccine. Since the seasonal influenza vaccine for injection is usually an inactivated virus vaccine, it is allowed to be used; however, an intranasal influenza vaccine (for example, FluMist) is a live attenuated vaccine and is therefore not allowed.
• Currently participating in or previously participating in a trial drug study, or using a test device within 4 weeks prior to the first dose of the study drug. Note: Subjects who have entered the clinical trial follow-up period may participate in this trial, provided that the last trial is administered 4 weeks after the last dose of the drug.
• Diagnosis of immunodeficiency or long-term systemic steroid therapy (daily dose over 10 mg prednisone equivalent) or any form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Another malignant tumor is known and is currently undergoing progress or has been actively treated in the past 3 years. Note: Subjects who have received skin basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ (eg, breast cancer, cervical cancer in situ) that may be curable may be treated.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

toripalimab; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jian Zhou, Professor

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Jian Zhou, Professor

CONTACT

021 64037181; zhou.jian@zs-hospital.sh.cn

Study Design

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

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: June 15, 2021
• Study Start: August 1, 2019
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-05

Locations

CN (1)