AzTrials
AzTrials

Locally Advanced or Metastatic and Unresectable HCCPhase 3NCT03764293

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

A Phase 3 study testing SHR-1210, Apatinib and Sorafenib in people with Locally Advanced or Metastatic and Unresectable HCC, run by Jiangsu HengRui Medicine Co., Ltd. at 121 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SHR-1210, Apatinib and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
543 participants
Where
121 sitesin 13 countries
Study dates
10 Jun 2019to 14 Jun 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

121 sites in 13 countries.

121 sites in 13 countries

China37 sites

  • Chinese Academy of Medical Sciences Cancer Hospital

    Beijing, Beijing Municipality, 100020

  • Beijing cancer Hospital

    Beijing, Beijing Municipality, 100089

  • Peking University International Hospital

    Beijing, Beijing Municipality, 102206

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Cancer Hospital&Institute

    Chengdu, Sichuan, 610054

  • The Second Hospital Affiliated To AMU

    Chongqing, Chongqing Municipality, 400037

  • The First Hospital Affiliated To AMU

    Chongqing, Chongqing Municipality, 400038

  • TheThird Affiliated Hospital ,Army Medical University

    Chongqing, Chongqing Municipality, 400042

  • The Second Affiliated Hospital of ChongQing Medical University

    Chongqing, Chongqing Municipality, 400060

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Sun Yat-sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510220

  • NanFang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • ZheJiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincal Cancer Hospital

    Hefei, Anhui, 230000

  • Anhui Provincal Hospital

    Hefei, Anhui, 230000

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230009

  • The Second Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230601

  • Shandong Cancer Hospital Affiliated to Shandong University

    Jinan, Shandong, 250000

  • The 940th Hospital of the joint logistic support force of People's Liberation Army

    Lanzhou, Gansu

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330006

  • Eastern Theater General Hospital, Qinhuai District Medical Area

    Nanjing, Jiangsu, 210002

  • The first affiliated hospital of guangxi medical university

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200043

  • The Sixth People's Hospital of Shengyang

    Shengyang, Liaoning, 110006

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Wuhan Union Hospital,Tongji Medical College,Huazhong University of Science&Technology

    Wuhan, Hubei, 430022

  • Tongji hospital,Tongji Medical College,Huazhong University of Science&Technology

    Wuhan, Hubei, 430030

Other trials in China

Russia13 sites

  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

    Arkhangelsk, 164045

  • SBHI Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

    Chelyabinsk, 454087

  • Irkutsk Regional Oncology Dispensary

    Irkutsk, 664035

  • SBIH " Clinical Oncological Dispensary # 1"

    Krasnodar, 350040

  • RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee

    Kursk, 305035

  • "VitaMed" LLC

    Moscow, 121309

  • SBIH of Moscow city "Moscow city oncology hospital №62" of Moscow Healthcare departement

    Moscow, 143423

  • CJSC Avicenna

    Novosibirsk, 630099

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk, 644013

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • SPb SBIH "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

    Saint Petersburg, 197758

  • SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

    Ufa, 450054

Other trials in Russia

United States8 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California San Diego (UCSD)-Moores Cancer Center

    La Jolla, California, 92037

  • Cornell University Weill Cornell Medical College

    New York, New York, 10065

  • University of California - Irvine

    Orange, California, 92868

  • Renovatio Clinical

    The Woodlands, Texas, 77380

Other trials in United States

Italy8 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, 40138

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

  • Azienda Ospedaliero-Universitaria

    Cagliari, 09124

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • A.S.L. Napoli 1 Centro Ospedale del Mare

    Ponticelli, Napoli, 80147

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    Verona, 37134

Other trials in Italy

Poland8 sites

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81338

  • Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

    Gliwice, 44101

  • Pratia MCM Krakow

    Krakow, 30510

  • Przychodnia Med-Polonia Sp. z o.o.

    Poznan, 60693

  • Wielkopolskie Centrum Onkologii

    Poznan, 61866

  • Centrum Zdrowia MDM

    Warsaw, 00635

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, 02034

  • NZOZ Centrum Badan Klinicznych

    Wroclaw, 51162

Other trials in Poland

South Korea8 sites

  • Dong-A University Hospital

    Busan, 602715

  • Seoul National University Bundang Hospital Gyeonggi-do

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02481

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Taiwan8 sites

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua, 500006

  • Chang Gung Memorial Hospital, Chiayi

    Chiayi City, 613

  • E-DA Cancer Hospital

    Kaohsiung City, 82445

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

Other trials in Taiwan

Ukraine8 sites

  • CNE"City Clin Hosp#4"of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipro, 49102

  • Communal Non-profit Enterprise Regional Center of Oncology

    Kharkiv, 61070

  • CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

    Kharkiv, 61166

  • Medical Center of Limited Liability Company Medical Center Concilium Medical

    Kyiv, 04050

  • Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council

    Lutsk, 43018

  • Communal Institution Odesa Regional Clinical Hospital

    Odesa, 65025

  • CNCE of SRC Sumy Reg Clinical Oncology Dispensary, SSU, Chair of Oncology and Radiology

    Sumy, 40022

  • Zaporizhzhya City Clinical Hospital #3

    Zaporizhzhya, 69032

Other trials in Ukraine

Spain7 sites

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, 28050

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Turkey (Türkiye)6 sites

  • Baskent University Adana Application and Research Center

    Adana, 01229

  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Ankara, 06105

  • Ankara City Hospital

    Ankara, 06800

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

    Istanbul, 34147

  • Inonu Uni. Med. Fac.

    Malatya, 44280

Other trials in Turkey (Türkiye)

Belgium5 sites

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZA

    Edegem, 2650

  • AZ Maria Middelares

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

Other trials in Belgium

Hong Kong4 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • The University of Hong Kong

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

  • The Chinese University of Hong Kong

    Shatin

Other trials in Hong Kong

Germany1 site

  • Charite Universitaetsmedizin Berlin - Campus Virchow-Klinikum Berlin

    Berlin, 13353

Other trials in Germany

About this study

Official title: A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy

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.

Being tested
SHR-1210, Apatinib, Sorafenib
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    Also called Camrelizumab

    Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial

  • ApatinibDrug

    Also called Rivoceranib

    Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet

  • SorafenibDrug

    Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet

Study groups in NCT03764293
Study groupRoleWhat they receive
SHR-1210ExperimentalSHR-1210+Apatinib
Receives: Drug: SHR-1210; Drug: Apatinib
ControlActive comparatorSorafenib
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause.

    Measured: Up to approximately 3 years

  2. Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1

    PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Up to approximately 3 years

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    ORR defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated by the BIRC or investigator based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.

    Measured: Up to approximately 3 years

  2. Disease Control Rate (DCR)

    DCR defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Up to approximately 3 years

  3. Duration of Response (DOR)

    DOR defined as time from the date of first record of objective response (CR or PR) to the first occurrence of radiological progression or death, whichever comes first, evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start10 Jun 2019
  3. Primary completion8 Feb 2022
  4. Study completion14 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03764293
Sponsor's protocol ID
SHR-1210-III-310
Status last verified
Feb 2023
First submitted
28 Nov 2018
Last updated
6 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qin S, Gu S, Chan SL, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Xu L, Yuan X, Li D, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Du J, Shi W, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): final analysis of a randomised, open-label, international, phase 3 study. Lancet Oncol. 2025 Dec;26(12):1598-1611. doi: 10.1016/S1470-2045(25)00543-1.

    PubMed 41308676

  • Qin S, Chan SL, Gu S, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Cheng Y, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Osypchuk Y, Sinielnikov I, Yang TS, Liang X, Chen C, Wang L, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023 Sep 30;402(10408):1133-1146. doi: 10.1016/S0140-6736(23)00961-3. Epub 2023 Jul 24.

    PubMed 37499670

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR-1210, Apatinib and Sorafenib in people with Locally Advanced or Metastatic and Unresectable HCC, run by Jiangsu HengRui Medicine Co., Ltd. at 121 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in China, Russia, United States, Italy, Poland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03764293, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in