A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or… (NCT03092895) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 2 study combining SHR-1210 (an immunotherapy) with either apatinib or chemotherapy for advanced liver or biliary tract cancer — since the trial is now completed, can you tell me what the safety results showed and whether any of these combinations are considered appropriate options for my specific situation?
2The primary goal of this trial was measuring safety and tolerability, which means it wasn't designed to prove the treatment works — how does that affect how we should interpret any results that came out of it when thinking about my treatment plan?
3Since this trial combined an immunotherapy with a targeted drug or chemotherapy, what are the main side effects or risks my doctor would want me to watch for if a similar combination were ever considered for me?
4Are there currently any follow-up Phase 3 trials or approved treatments that came out of research like this one that might be more relevant for me to explore now that this study is completed?
5Given that this trial enrolled people with advanced primary liver cancer or biliary tract carcinoma, how does my specific diagnosis and overall health compare to the kinds of patients who participated, and would a combination approach like this even make sense for where I am in my treatment journey?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.