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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Primary Liver Cancer Advanced Biliary Tract Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-1210+Apatinib(Arm A）

Group Type EXPERIMENTAL

SHR-1210

Intervention Type BIOLOGICAL

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Apatinib

Intervention Type DRUG

Subjects receive Apatinib orally every day with a dose escalation

SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）

Group Type EXPERIMENTAL

SHR-1210

Intervention Type BIOLOGICAL

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

FOLFOX4

Intervention Type DRUG

Subjects receive FOLFOX4 treatment every 2 weeks

GEMOX

Intervention Type DRUG

Subjects receive GEMOX treatment every 2 weeks

Interventions

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SHR-1210

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Intervention Type BIOLOGICAL

Apatinib

Subjects receive Apatinib orally every day with a dose escalation

Intervention Type DRUG

FOLFOX4

Subjects receive FOLFOX4 treatment every 2 weeks

Intervention Type DRUG

GEMOX

Subjects receive GEMOX treatment every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No