Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Keytruda shows promise for liver cancer in asian patients

NCT ID NCT03062358

Disease control Sponsor: Merck Sharp & Dohme LLC 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding the immunotherapy drug pembrolizumab (Keytruda) to best supportive care helps Asian patients with advanced liver cancer live longer. 453 patients who had already received one prior treatment were randomly assigned to get either pembrolizumab or a placebo, along with supportive care. The main goal was to see if pembrolizumab improved 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
pembrolizumab (Keytruda)
What this could lead to
If successful, this could provide a new second-line treatment option for Asian patients with advanced liver cancer, potentially extending survival.
What could go wrong
This trial is completed, but results may not apply to all populations. Pembrolizumab can cause immune-related side effects, and not all patients may benefit.

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

453 people

The number who actually took part.

Started

Apr 2017

Finished

Oct 2024

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: * Has a HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar, and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) * Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy and not amenable to a curative treatment approach. * Has a Child-Pugh A liver score within 7 days prior to first dose of study medication * Has a life expectancy of \>3 months * Has at least one measurable lesion based on RECIST version 1.1 as determined by investigator. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 7 days prior to receiving the first dose of study medication. * Has documented objective radiographic progression during or after treatment with sorafenib or oxaliplatin-based chemotherapy, or else intolerance to sorafenib or oxaliplatin-based chemotherapy * Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy * Female and male participants of reproductive potential must agree to use adequate contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication Exclusion Criteria: * Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study medication * Has received sorafenib or oxaliplatin-based chemotherapy within 14 days of first dose of study medication * Has had esophageal or gastric variceal bleeding within the last 6 months * Has clinically apparent ascites on physical examination * Has portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging * Has had clinically diagnosed hepatic encephalopathy in the last 6 months * Has had a solid organ or hematologic transplant * Has had prior systemic therapy for HCC in the advanced (incurable) setting other than sorafenib or oxaliplatin-based chemotherapy, prior to start of study medication * Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication * Has received locoregional therapy to liver (transcatheter chemoembolization \[TACE\], transcatheter embolization \[TAE\], hepatic arterial infusion \[HAI\], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study medication * Has had major surgery to liver or other site within 4 weeks prior to the first dose of study medication * Has had a minor surgery ≤7 days prior to the first dose of study medication * Has not recovered adequately (i.e., Grade ≤1 or baseline) from the toxicity and/or complications from any intervention prior to study start * Has a diagnosed additional malignancy within 3 years prior to first dose of study medication with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers * Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis * Has an active infection requiring systemic therapy * Is pregnant or breast feeding or expecting to conceive or father starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication * Has received prior immunotherapy with an anti-Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) or has previously participated in clinical studies with pembrolizumab * Has a known history of human immunodeficiency virus (HIV) * Has untreated active Hepatitis B * Has Hepatitis C in which participants received therapy for HCV \<4 weeks prior to receiving pembrolizumab * Has received a live vaccine within 30 days prior to the first dose of study therapy

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Carcinoma, hepatocellular are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 hepatocellular carcinoma

As listed by the trial registrant

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

Carcinoma, hepatocellular

Contacts and locations

Locations

  • Anhui Provincial Hospital ( Site 0032)

    Hefei, Anhui, 230001, China

  • Asan Medical Center ( Site 0072)

    Seoul, 05505, South Korea

  • Beacon Hospital Sdn Bhd ( Site 0092)

    Petaling Jaya, Selangor, 46050, Malaysia

  • Beijing Cancer Hospital ( Site 0010)

    Beijing, 100142, China

  • Bengbu Medical College First Affiliated Hospital ( Site 0020)

    Bengbu, 233030, China

  • Chia-Yi Chang Gung Memorial Hospital ( Site 0133)

    Chiayi City, 613, Taiwan

  • China Medical University Hospital ( Site 0131)

    Taichung, 40447, Taiwan

  • Fudan University Shanghai Cancer Center ( Site 0024)

    Shanghai, Shanghai Municipality, 200032, China

  • Fuzhou General Hospital of Nanjing Military Command ( Site 0019)

    Fuzhou, Fujian, 350025, China

  • Guangdong General Hospital ( Site 0015)

    Guangzhou, Guangdong, 510080, China

  • Harbin Medical University Cancer Hospital ( Site 0007)

    Harbin, Heilongjiang, 610000, China

  • Hong Kong Sanatorium Hospital ( Site 0053)

    Hong Kong, Hong Kong

  • Hospital Universiti Kebangsaan Malaysia ( Site 0093)

    Cheras, 56000, Malaysia

  • Hubei Cancer Hospital ( Site 0035)

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital ( Site 0027)

    Changsha, Hunan, 410006, China

  • Jiangsu Cancer Hospital ( Site 0003)

    Nanjing, Jiangsu, 210009, China

  • Jilin Province Cancer Hospital, Department of Chemotherapy ( Site 0002)

    Changchun, Jilin, 130012, China

  • Nantong Tumor Hospital ( Site 0028)

    Nantong, Jiangsu, 226361, China

  • National Cheng Kung University Hospital ( Site 0132)

    Tainan, 70403, Taiwan

  • Pamela Youde Nethersole Eastern Hospital ( Site 0052)

    Hong Kong, Hong Kong

  • Princess Margaret Hospital. ( Site 0051)

    Hong Kong, Hong Kong

  • Renji Hosp,Shanghai Jiao Tong University School of Medicine ( Site 0017)

    Shanghai, 200127, China

  • Samsung Medical Center ( Site 0071)

    Seoul, 06351, South Korea

  • Seoul National University Hospital ( Site 0074)

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 0073)

    Seoul, 03722, South Korea

  • The 81st Hospital of PLA ( Site 0016)

    Nanjing, Jiangsu, 210031, China

  • The First Affiliated Hospital of Anhui Medical University ( Site 0005)

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Dalian Medical University ( Site 0022)

    Dalian, Liaoning, 116011, China

  • The First Affiliated Hospital of Soochow University ( Site 0025)

    Suzhou, Jiangsu, 215006, China

  • The First Hospital Of Jilin University ( Site 0001)

    Changchun, Jilin, 130021, China

  • The First People s Hospital of Foshan ( Site 0033)

    Foshan, Guangdong, 528000, China

  • The First affiliated Hospital Zhejing University ( Site 0034)

    Hangzhou, Zhejiang, 310003, China

  • The Second Affiliated Hospital of Anhui Medical University ( Site 0008)

    Hefei, 230601, China

  • The Third Xiangya Hospital of Central South University ( Site 0026)

    Changsha, Hunan, 410013, China

  • The first affiliated Hospital of Xi an Jiaotong University ( Site 0014)

    Xi’an, Shanxi, 710061, China

  • University Malaya Medical Centre ( Site 0091)

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

  • West China Hospital of Sichuan University ( Site 0030)

    Chengdu, Sichuan, 610000, China

  • Wuhan Tongji Hospital ( Site 0021)

    Wuhan, Hubei, 430030, China

  • Yangzhou No.1 People's Hospital ( Site 0023)

    Yangzhou, Jiangsu, 225012, China

  • Zhejiang Cancer Hospital ( Site 0011)

    Hangzhou, Zhejiang, 310022, China

  • Zhongshan Hospital Fudan University ( Site 0012)

    Shanghai, 200032, China

More trials for these conditions

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