A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC

  • STATUS
    Recruiting
  • End date
    Jun 23, 2022
  • participants needed
    510
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 23 January 2021

Summary

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.

Details
Condition Locally Advanced or Metastatic and Unresectable HCC
Treatment Sorafenib, apatinib, SHR-1210
Clinical Study IdentifierNCT03764293
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histopathologically or cytologically confirmed advanced HCC
No previous systematic treatment for HCC
Have at least one measurable lesion (in accordance with RECIST v1.1)
BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
ECOG-PS score 0 or 1
Child-Pugh Class: Grade A
Life Expectancy of at least 12 weeks
Subjects with HBV infection: HBV DNA<500 IU/ml or < 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
Subjects with HCV-RNA(+) must receive antiviral therapy
Adequate organ function

Exclusion Criteria

Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
Moderate-to-severe ascites with clinical symptoms
History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
Known genetic or acquired hemorrhage or thrombotic tendency
Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
Cardiac clinical symptom or disease that is not well controlled
Hypertension that can not be well controlled through antihypertensive drugs
Factors to affect oral administration
History of hepatic encephalopathy
Previous or current presence of metastasis to central nervous system
HIV infection
Combined hepatitis B and hepatitis C co-infection
Be ready for or previously received organ or allogenic bone marrow transplantation
Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
Active known, or suspected autoimmune disease
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
Severe infection within 4 weeks prior to the start of study treatment
Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
Treatment of other investigational product(s) within 28 days prior to the start of study treatment
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note