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

Phase 2

Completed

• Conditions: Advanced Primary Liver Cancer; Advanced Biliary Tract Carcinoma
• Interventions: Biological: SHR-1210; Drug: FOLFOX4; Drug: Apatinib; Drug: GEMOX

• Registration Number: NCT03092895
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Study Start: 2017-04-27
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）	SHR-1210	-
SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）	FOLFOX4	-
SHR-1210+Apatinib(Arm A）	SHR-1210	-
SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）	GEMOX	-
SHR-1210+Apatinib(Arm A）	Apatinib	-

Primary Outcome Measures

Name	Time	Method
The safety and tolerability	Up to approximately 2years	The incidence and grade of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	Up to approximately 2 years	Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Disease Control Rate (DCR)	Up to approximately 6 months2 years	Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Objective Response Rate (ORR)	Up to approximately 2 years	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time to Progression (TTP)	Up to approximately 2 years	Time to Progression (TTP) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Overall Survival	Up to approximately 2 years	Overal Survial will be calculated based on Kaplan-Meier estimates

Trial Locations

Locations (7)

Cancer Hospital of Henan province; 🇨🇳 Zhengzhou, Henan, China

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Hunan Cancer Hospital; 🇨🇳 Hunan, Changsha, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Jiangxi, Nanchang, China

The Second Affiliated Hospital Of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

81 Hospital Nanjing; 🇨🇳 Nanjing, Jiangsu, China