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New combo shows promise for tough liver and bile duct cancers

NCT ID NCT03092895

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new combination treatment for people with advanced liver cancer or bile duct cancer. The treatment combines an immunotherapy drug (SHR-1210) with either a targeted therapy (apatinib) or chemotherapy. The goal was to see if the combination is safe and can shrink tumors. The study included 157 adults who had either failed prior treatment or were starting treatment for the first time.

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

157 people

The number who actually took part.

Started

Apr 2017

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 to 70 years

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.

1. Histologically confirmed advanced PLC or advanced BTC (including bile duct carcinoma and gallbladder carcinoma) ; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1. 2. Arm A:Failed or intolerable to at least one prior systemic treatment for advanced PLC. Arm B:No previous systemic treatment for advanced PLC or BTC 3. ECOG Performance Status of 0 or1. 4. Child-Pugh Class A or B with 7 points . 5. Life Expectancy of at least 12 weeks. 6. Has controlled infection by Hepatitis B Virus (HBV DNA\<500 IU/ml) or Hepatitis C Virus. 7. Adequate organ function. 8. Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug. 9. Patient has given written informed consent. Exclusion Criteria: 1. Known fibrolamellar HCC; Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured. 2. Known or occurrence of central nervous system (CNS) metastases. 3. Ascites with clinical symptoms. 4. Known or evidence of GI hemorrhage within the past 6 months. 5. Known or occurrence of hemorrhage/ thrombus. 6. Known or evidence of abdomen fistula, gastrointestinal perforation, or abdominal abscess within the past 2 months. 7. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias. 8. Grade III\~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%. 9. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90 mmHg). 10. Factors to affect oral administration (such as patients unable to swallow oral medications, chronic diarrhea and ileus etc. situations evidently affect drug oral medication and absorption). 11. History of hepatic encephalopathy. 12. Known history of human immunodeficiency virus (HIV) infection. 13. Active infection or an unexplained fever \> 38.5°C during screening visits. 14. Has received a live vaccine within 30 days. 15. Prior or planning to organ transplantation including liver transplantation. 16. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity. 17. Proteinuria≥ 2+ or 24 hours total urine protein \> 1.0 g. 18. Active known, or suspected autoimmune disease. 19. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily. prednisone equivalent, are permitted in the absence of active autoimmune disease 20. Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study. 21. Prior therapy with anti-PD-1 or other anti-PD-1/anti-PD-L1 immunotherapy. 22. Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs. 23. Treatment with anti-coagulation therapy(Warfarin or heparin) or anti-platelet therapy(aspirin at dose≥300mg/day, clopidogrel at dose≥75mg/day). 24. Pregnant or breast-feeding women. 25. According to the investigator, other conditions that may lead to stop the research.

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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

  • 81 Hospital Nanjing

    Nanjing, Jiangsu, 210002, China

  • Cancer Hospital of Henan province

    Zhengzhou, Henan, 450008, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Hunan Cancer Hospital

    Hunan, Changsha, 410000, China

  • The First Affiliated Hospital of Nanchang University

    Jiangxi, Nanchang, 330006, China

  • The Second Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230000, China

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200003, China

More trials for these conditions

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