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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03092895
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Primary Liver Cancer Advanced Biliary Tract Carcinoma Biological: SHR-1210 Drug: Apatinib Drug: FOLFOX4 Drug: GEMOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer（PLC）or Biliary Tract Carcinoma (BTC)
Actual Study Start Date : April 27, 2017
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: SHR-1210+Apatinib(Arm A） Biological: SHR-1210
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Drug: Apatinib
Subjects receive Apatinib orally every day with a dose escalation
Experimental: SHR-1210+FOLFOX4 or GEMOX regimen(Arm B） Biological: SHR-1210
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Drug: FOLFOX4
Subjects receive FOLFOX4 treatment every 2 weeks

Drug: GEMOX
Subjects receive GEMOX treatment every 2 weeks


Outcome Measures
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Primary Outcome Measures :
  1. The safety and tolerability [ Time Frame: 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 :
  1. Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]
    Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  2. Duration of Response (DoR) [ Time Frame: Up to approximately 2 years ]
    Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  3. Disease Control Rate (DCR) [ Time Frame: Up to approximately 6 months2 years ]
    Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  4. Time to Progression (TTP) [ Time Frame: Up to approximately 2 years ]
    Time to Progression (TTP) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  5. Overall Survival [ Time Frame: Up to approximately 2 years ]
    Overal Survial will be calculated based on Kaplan-Meier estimates


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092895


Locations
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China, Anhui
The Second Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China, 230000
China, Changsha
Hunan Cancer Hospital
Hunan, Changsha, China, 410000
China, Henan
Cancer Hospital of Henan province
Zhengzhou, Henan, China, 450008
China, Jiangsu
81 Hospital Nanjing
Nanjing, Jiangsu, China, 210002
China, Nanchang
The First Affiliated Hospital of Nanchang University
Jiangxi, Nanchang, China, 330006
China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 200003
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03092895    
Other Study ID Numbers: SHR-1210-APTN-II-203-PLC
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Liver Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action