CompletedPhase 2

A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC

China157 participantsStarted 2017-04-24

Plain-language summary

This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects with Advanced PLC.or BTC Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC or BTC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 or GEMOX regimen.

Who can participate

Age range18 Years – 70 Years

SexALL

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Exclusion criteria

✕. Known fibrolamellar HCC; Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
✕. Known or occurrence of central nervous system (CNS) metastases.
✕. Ascites with clinical symptoms.
✕. Known or evidence of GI hemorrhage within the past 6 months.
✕. Known or occurrence of hemorrhage/ thrombus.
✕. Known or evidence of abdomen fistula, gastrointestinal perforation, or abdominal abscess within the past 2 months.
✕. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
✕. Grade III\~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%.

What they're measuring

The Safety and Tolerability

Timeframe: Up to approximately 4 years

Trial details

NCT IDNCT03092895

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-31

Results submitted2023-07-04

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