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Hepatocellular CarcinomaPhase 3NCT04194775

A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma

A Phase 3 study testing Nofazinlimab (CS1003)+Lenvatinib in people with Hepatocellular Carcinoma, run by CStone Pharmaceuticals at 74 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Nofazinlimab (CS1003)+Lenvatinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
534 participants
Where
74 sitesin 6 countries
Study dates
13 Dec 2019to 30 Sep 2026
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

  • Age ≥18 years on the day of signing informed consent-(For Taiwan, the lower limit of age is 20 years).
  • Subjects with unresectable advanced HCC, that is not eligible for surgery and/or locoregional therapy (Stage B or C based on Barcelona Clinic Liver Cancer [BCLC] staging system, and meets either one of the following criteria: 1) histologically or cytologically confirmed diagnosis of HCC, 2) clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria. Patients without cirrhosis require histological confirmation of diagnosis.
  • With at least one measurable lesion can be assessed
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
  • Life expectancy ≥ 3 months.
  • Child-Pugh A
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  • No prior systemic treatment for advanced HCC
  • Subjects with hepatitis B virus (HBV) infection, are willing to continue receiving antiviral treatment while on study.
  • Subjects have adequate organ and marrow function. Female subjects with childbearing potential must have negative serum pregnancy test result at screening. Female subjects with childbearing potential, and male subjects and their female partners with childbearing potential must agree to use an contraceptive method(s) from the day of signing informed consent form (ICF), during the study and till at least 6 months after the last dose of study treatment.

Who cannot join

  • Fibrolamellar-HCC, sarcomatoid, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC.
  • A prior bleeding event due to esophageal within 6 months or other gastrointestinal bleeding events within 28 days prior to screening.
  • Malabsorption syndrome or inability to take oral medication due to other causes.
  • HBV and HCV co-infection.
  • Investigator evaluates to increase the drug related risk caused by enrolling subjects in trial and taking study drug, or any serious or uncontrolled systematic disease that confound the drug absorption or the study outcome, e,g diabetes mellitus, hypertension, rheumatoid arthritis, major cardiovascular disease and so on.
  • Surgery or locoregional therapy for palliative purpose within 4 weeks prior to study treatment.
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  • History of other malignancy(ies) in the past 5 years, except for malignant disease treated with curative intent and without active disease.
  • Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • Current or prior use of systemic corticosteroid (> 10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study treatment.
  • History of bone marrow transplantation or organ transplantation.
  • History of anaphylaxis or hypersensitivity to any ingredient of the investigational product.
  • Any contraindication of lenvatinib.
  • Known history of drugs abuse that would interfere with cooperation with the requirements of the trial.
  • Pregnant or lactating female subjects.
  • History of psychiatric disease that would interfere with cooperation with the requirements of the trial; lack of or with restricted physical capability.
  • QTc interval > 470 msec (as calculated with Fridericia's formula) at screening electrocardiogram (ECG);
  • Any condition that would in the investigator's judgment, prevent the subject from participating in this study.

Trial locations and contacts

74 sites in 6 countries.

74 sites in 6 countries

China40 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • Beijing You'an Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • Hunan Cancer Hospital - Radiology

    Changsha, Hunan

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Sichuan University - West China Hospital

    Chengdu, Sichuan

  • Foshan First People's Hospital

    Foshan, Guangdong

  • The 900th Hospital of Joint Logistic Support Force of PLA

    Fuzhou, Fujian

  • Nanfang Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou, Guangdong

  • Hainan General Hospital - Hepatology

    Haikou, Hainan

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The First People's Hospital of Huai'an

    Huai'an, Jiangsu

  • Jinan Military Region General Hospital of the People's Liber

    Jinan, Shandong

  • Shangdong Provicial Qianfoshan Hospital

    Jinan, Shandong

  • Affiliated Hospital Of Jining Medical University

    Jining, Shandong

  • Linyi Cancer Hospital

    Linyi, Shandong

  • Luoyang Central Hospital

    Luoyang, Henan

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi

  • Nantong Tumor Hospital

    Nantong, Jiangsu

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 201203

  • Shanghai Cancer Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Eastern Hepatobiliary Surgery Hospital - Hepatology

    Shanghai, Shanghai Municipality

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Tianjin Medical University - Cancer Institute & Hospital - Oncology

    Tianjin, Tianjin Municipality

  • hubei Cancer Hospital

    Wuhan, Hubei

  • Tongji Hospital - Medical Oncology

    Wuhan, Hubei

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • Yanbian University Hospital

    Yanbian, Jilin

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • Zhengzhou University - First Affiliated Hospital

    Zhengzhou, Henan

Other trials in China

Spain14 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia

  • Hospital Ntra. Sra. de Sonsoles

    Ávila

  • Hospital Del Mar

    Barcelona

  • H.U. de Burgos

    Burgos

  • ICO-Hospital Universitari de Girona Dr. Josep Trueta

    Girona

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta De Hierro De Majadahonda

    Majadahonda, Madrid

  • H.U.V.Arrixaca

    Murcia

  • Complejo Hospitalario Universitario de Orense

    Ourense, Galicia

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias

  • Hospital Universitario Virgen De La Macarena

    Seville

  • Consorcio Hospital General Universitario de Valencia

    Valencia

  • Hospital Unviersitario Miguel Servet

    Zaragoza

Other trials in Spain

Taiwan6 sites

  • China Medical University Hospital - Internal Medicine - Taichung

    Taichung

  • Taichung Veterans General Hospital - Gastroenterology

    Taichung

  • Chi Mei Hospital, Liouying - Department of Oncology

    Tainan

  • Chi Mei Medical Center - YongKang - Gastroenterology - Gastroenterology

    Tainan

  • National Cheng Kung University Hospital - Internal Medicine

    Tainan

  • Tri-Service General Hospital - Neihu Branch - Pulmonary

    Taipei

Other trials in Taiwan

United States5 sites

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Southern California Research Center

    Coronado, California, 92118

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Stony Brook University Cancer Clinical Trials

    Stony Brook, New York, 11794

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Italy5 sites

  • PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology

    Cremona

  • Azienda Unità Locale Socio Sanitaria n. 1 Dolomiti, Distretto di Feltre, Ospedale di Feltre

    Feltre, Belluno

  • Istituto Oncologico Veneto IOV IRCCS - Medical Oncology Unit 1

    Padova, Veneto

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

  • Casa di Cura Dott. Pederzoli S.p.A (Ospedale Pederzoli)

    Peschiera del Garda, Verona

Other trials in Italy

Poland4 sites

  • Centrum Onkologii im. prof. F. Lukaszczyka

    Bydgoszcz

  • MED-POLONIA Sp.z o.o.

    Poznan, Greater Poland Voivodeship

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

    Warsaw

  • Centrum Badan Klinicznych

    Wroclaw, Lower Silesian Voivodeship

Other trials in Poland

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of Nofazinlimab (CS1003) in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)

This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC). Subjects cannot be eligible for locoregional therapy. In this study, Nofazinlimab (CS1003) (or placebo) and lenvatinib are both considered as the study treatment while Nofazinlimab (CS1003) (or placebo) is the investigational product and lenvatinib is selected as the basic treatment for HCC.

Being tested
Nofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Nofazinlimab (CS1003)+LenvatinibDrug

    Nofazinlimab (CS1003), intravenous (i.v.) administration every 21 days; Lenvatinib oral administration, once daily

  • Nofazinlimab (CS1003) Placebo+LenvatinibDrug

    Nofazinlimab (CS1003) Placebo, i.v. administration every 21 days ; Lenvatinib oral administration, once daily

Study groups in NCT04194775
Study groupRoleWhat they receive
Nofazinlimab (CS1003)ExperimentalNot described
Receives: Drug: Nofazinlimab (CS1003)+Lenvatinib
Nofazinlimab (CS1003) placeboPlacebo comparatorNot described
Receives: Drug: Nofazinlimab (CS1003) Placebo+Lenvatinib

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 interval between the date of randomization to the date of death from any cause.

    Measured: From enrollment to end of follow-up, a median of 42.5 months

Secondary outcomes (12)

  1. Objective Response Rate (ORR) Assessed by Blinded Independent Central Review Committee(BICR)

    ORR assessed by BICR was defined as the proportion of participants who achieve objective response (complete response [CR] or partial response [PR]) assessed by BICR based on RECIST v1.1.

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  2. Progression-free Survival(PFS) Assessed by Blinded Independent Central Review Committee(BICR) Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

    PFS assessed by BICR was defined as the time from the date of randomization to disease progression assessed by BICR or death, whichever occurs first.

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  3. Progression-free Survival(PFS) Evaluated by Investigator Based on RECIST v1.1

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  4. Objective Response Rate (ORR) Evaluated by Investigators Based on RECIST v1.1

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  5. Duration of Response (DoR) Evaluated by Blinded Independent Central Review Committee(BICR) Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  6. Duration of Response (DoR) Evaluated by Investigators Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  7. Disease Control Rate (DCR) Evaluated by Blinded Independent Central Review Committee(BICR) Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  8. Disease Control Rate (DCR) Evaluated by Investigators Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  9. Percentage of Participants With Adverse Events

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  10. Peak and Trough Serum Concentrations of CS1003

    Measured: Peak: assessed post-dose (within 30 minutes after the end of infusion) on Cycle 4 Day 1; Trough: assessed pre-dose (within 60 minutes prior to infusion) on Cycle 4 Day 1 (cycle length = 21 days).

  11. Number and Percentage of Subjects Who Develop Anti-CS1003 Antibody (ADA)

    Measured: From enrollment to end of follow-up, a median of 42.5 months

  12. Time to Deterioration (TTD), Defined as the Time From Randomization to the First Deterioration of European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Scale

    Measured: From enrollment to end of follow-up, a median of 42.5 months

Timeline

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

  1. First posted11 Dec 2019
  2. Study start13 Dec 2019
  3. Primary completion18 Jun 2025
  4. Study completion30 Sep 2026 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04194775
Sponsor's protocol ID
CS1003-305
Status last verified
Jun 2026
First submitted
10 Dec 2019
Last updated
30 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nofazinlimab (CS1003)+Lenvatinib in people with Hepatocellular Carcinoma, run by CStone Pharmaceuticals at 74 sites in 6 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 9 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in China, Spain, Taiwan, United States, Italy and 1 more country. 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. Some participants in this study may receive a placebo. 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 30 Jul 2026). 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: From enrollment to end of follow-up, a median of 42.5 months). 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 NCT04194775.

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 30 Jul 2026.

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