New combo shows promise for tough liver and bile duct cancers
NCT ID NCT03092895
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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157 people
The number who actually took part.
- Started
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Apr 2017
- Finished
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Mar 2021
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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81 Hospital Nanjing
Nanjing, Jiangsu, 210002, China
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Cancer Hospital of Henan province
Zhengzhou, Henan, 450008, China
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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Hunan Cancer Hospital
Hunan, Changsha, 410000, China
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The First Affiliated Hospital of Nanchang University
Jiangxi, Nanchang, 330006, China
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The Second Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, 230000, China
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Zhongshan Hospital
Shanghai, Shanghai Municipality, 200003, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New cocktail of drugs shows promise for tough bile duct cancer
- New hope for bile duct cancer? keytruda and lenvima combo tested
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- New hope for bile duct cancer: targeted combo trial launches