New drug combo shows promise for tough liver cancer

NCT ID NCT03463876

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs, SHR-1210 (an immunotherapy) and apatinib (a targeted therapy), in 190 adults with advanced liver cancer that did not respond to or could not tolerate prior treatment. The goal was to see if the combination could shrink tumors and control the disease. Results help doctors understand how well this approach works for advanced cases.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

190 people

The number who actually took part.

Started

Mar 2018

Finished

Mar 2021

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. Aged 18 years old, both genders. 2. Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1. 3. Liver function status Child-Pugh Class A. 4. Barcelona Clinic Liver Cancer stage Category B or C. 5. Failure or intolerance to prior treatment with targeted therapy. 6. Eastern Cooperative Oncology Group Performance Status of 0 or 1. 7. Life expectancy of at least 12 weeks. 8. Adequate bone marrow, liver and renal function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment). Exclusion Criteria: 1. Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. 2. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. 3. More than one regimen. 4. Known history of hypersensitivity to any components of the SHR-1210 formulation, or other antibody formulation. 5. Known or occurrence of central nervous system (CNS) metastases or hepatic encephalopathy. 6. Patients with tumor burden ≥50% of the liver volume or received liver transplantation. 7. Patients with clinical symptoms of ascites. 8. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg. 9. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class \> 2), ventricular arrhythmia which need medical intervention. 10. Coagulation abnormalities (INR\>2.0、PT\>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy. 11. Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency, such as: esophageal varices, local active ulcerative lesions, gastric ulcer and duodenal ulcer, the ulcerous colitis, gastrointestinal diseases such as portal hypertension or resection of tumor with bleeding risk, etc. 12. Previous Arterial/venous thrombosis events within 3 months. 13. Proteinuria ≥ (++) and 24 hours total urine protein \> 1.0 g. 14. Prior systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, surgery or target therapy within 4 weeks (Or 5 half-life of the drug, calculate the longer ) before the study drug administration, or any unresolved AEs \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 1. 15. Active infection or an unexplained fever \> 38.5°C during screening visits or on the first scheduled day of dosing. 16. History of immunodeficiency or human immunodeficiency virus (HIV) infection. 17. HBV DNA\>2000 IU/ml(or 104copies/ml),HCV RNA\>103copies/ml,HBsAg+ and anti-HCV+; 18. Patients with other malignant tumor (except cured skin basal cell carcinoma and cervical carcinoma). 19. Patients who has bone metastasis, has received Palliative radiotherapy (radiotherapy area \> 5% marrow area). 20. Patients must not have had prior treatment with SHR-1210 or any other PD-L1 or PD-1 antagonists or apatinib. 21. Patients who may receive live vaccine during the study, or previous had vaccination within 4 weeks. 22. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    Beijing, Beijing Municipality, 100071, China

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