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New immunotherapy combo aims to fight advanced liver cancer

NCT ID NCT04194775

Disease control Sponsor: CStone Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This phase 3 study tests whether adding nofazinlimab (an immunotherapy) to lenvatinib (a standard targeted therapy) helps people with advanced liver cancer live longer. About 534 participants who have not had prior systemic treatment will receive either the combo or a placebo plus lenvatinib. The main goal is to see if the combo improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nofazinlimab (an immunotherapy drug) combined with lenvatinib (a targeted therapy drug)
What this could lead to
If successful, this combination could become a new first-line treatment option for people with advanced liver cancer, potentially extending survival.
What could go wrong
This is a phase 3 trial, but results are not yet available. The combination may not improve survival compared to lenvatinib alone, and immunotherapy can cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

534 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Age ≥18 years on the day of signing informed consent-(For Taiwan, the lower limit of age is 20 years). 2. 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. 3. With at least one measurable lesion can be assessed 4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. 5. Life expectancy ≥ 3 months. 6. Child-Pugh A 7. No prior systemic treatment for advanced HCC 8. Subjects with hepatitis B virus (HBV) infection, are willing to continue receiving antiviral treatment while on study. 9. 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. Exclusion criteria 10. Fibrolamellar-HCC, sarcomatoid, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC. 11. A prior bleeding event due to esophageal within 6 months or other gastrointestinal bleeding events within 28 days prior to screening. 12. Malabsorption syndrome or inability to take oral medication due to other causes. 13. HBV and HCV co-infection. 14. 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. 15. Surgery or locoregional therapy for palliative purpose within 4 weeks prior to study treatment. 16. History of other malignancy(ies) in the past 5 years, except for malignant disease treated with curative intent and without active disease. 17. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 18. 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. 19. History of bone marrow transplantation or organ transplantation. 20. History of anaphylaxis or hypersensitivity to any ingredient of the investigational product. 21. Any contraindication of lenvatinib. 22. Known history of drugs abuse that would interfere with cooperation with the requirements of the trial. 23. Pregnant or lactating female subjects. 24. History of psychiatric disease that would interfere with cooperation with the requirements of the trial; lack of or with restricted physical capability. 25. QTc interval \> 470 msec (as calculated with Fridericia's formula) at screening electrocardiogram (ECG); 26. Any condition that would in the investigator's judgment, prevent the subject from participating in this study.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma

Contacts and locations

Locations

  • Affiliated Hospital Of Jining Medical University

    Jining, Shandong, China

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

    Feltre, Belluno, Italy

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, China

  • Beijing You'an Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

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

    Peschiera del Garda, Verona, Italy

  • Centrum Badan Klinicznych

    Wroclaw, Lower Silesian Voivodeship, Poland

  • Centrum Onkologii im. prof. F. Lukaszczyka

    Bydgoszcz, Poland

  • Chi Mei Hospital, Liouying - Department of Oncology

    Tainan, Taiwan

  • Chi Mei Medical Center - YongKang - Gastroenterology - Gastroenterology

    Tainan, Taiwan

  • China Medical University Hospital - Internal Medicine - Taichung

    Taichung, Taiwan

  • Complejo Hospitalario Universitario de Orense

    Ourense, Galicia, Spain

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia, Spain

  • Consorcio Hospital General Universitario de Valencia

    Valencia, Spain

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Italy

  • Foshan First People's Hospital

    Foshan, Guangdong, China

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, China

  • H.U. de Burgos

    Burgos, Spain

  • H.U.V.Arrixaca

    Murcia, Spain

  • Hainan General Hospital - Hepatology

    Haikou, Hainan, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Hospital Del Mar

    Barcelona, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, Spain

  • Hospital Ntra. Sra. de Sonsoles

    Ávila, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Puerta De Hierro De Majadahonda

    Majadahonda, Madrid, Spain

  • Hospital Universitario Virgen De La Macarena

    Seville, Spain

  • Hospital Unviersitario Miguel Servet

    Zaragoza, Spain

  • Hunan Cancer Hospital - Radiology

    Changsha, Hunan, China

  • Hunan Provincial People's Hospital

    Changsha, Hunan, China

  • ICO-Hospital Universitari de Girona Dr. Josep Trueta

    Girona, Spain

  • Inland Empire Liver Foundation

    Rialto, California, 92377, United States

  • Istituto Oncologico Veneto IOV IRCCS - Medical Oncology Unit 1

    Padova, Veneto, Italy

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

    Jinan, Shandong, China

  • Linyi Cancer Hospital

    Linyi, Shandong, China

  • Luoyang Central Hospital

    Luoyang, Henan, China

  • MED-POLONIA Sp.z o.o.

    Poznan, Greater Poland Voivodeship, Poland

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • Nanfang Hospital

    Guangzhou, Guangdong, China

  • Nantong Tumor Hospital

    Nantong, Jiangsu, China

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

    Warsaw, Poland

  • National Cheng Kung University Hospital - Internal Medicine

    Tainan, Taiwan

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

    Cremona, Italy

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

  • Shangdong Provicial Qianfoshan Hospital

    Jinan, Shandong, China

  • Shanghai Cancer Hospital of Fudan University

    Shanghai, Shanghai Municipality, China

  • Shanghai Eastern Hepatobiliary Surgery Hospital - Hepatology

    Shanghai, Shanghai Municipality, China

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, China

  • Sichuan University - West China Hospital

    Chengdu, Sichuan, China

  • Southern California Research Center

    Coronado, California, 92118, United States

  • Stony Brook University Cancer Clinical Trials

    Stony Brook, New York, 11794, United States

  • Taichung Veterans General Hospital - Gastroenterology

    Taichung, Taiwan

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

    Fuzhou, Fujian, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, China

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

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • The First People's Hospital of Huai'an

    Huai'an, Jiangsu, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Tianjin Medical University - Cancer Institute & Hospital - Oncology

    Tianjin, Tianjin Municipality, China

  • Tongji Hospital - Medical Oncology

    Wuhan, Hubei, China

  • Tri-Service General Hospital - Neihu Branch - Pulmonary

    Taipei, Taiwan

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, China

  • Yanbian University Hospital

    Yanbian, Jilin, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

  • Zhengzhou University - First Affiliated Hospital

    Zhengzhou, Henan, China

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 201203, China

  • hubei Cancer Hospital

    Wuhan, Hubei, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.