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History of Changes for Study: NCT03092895
A Study of SHR-1210 in Combination With Apatinib or FOLFOX4 Regimen in Subjects With Advanced Primary Liver Cancer(PLC)
Latest version (submitted April 26, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 22, 2017 None (earliest Version on record)
2 April 13, 2017 Study Status
3 April 19, 2017 Contacts/Locations and Study Status
4 May 15, 2017 Recruitment Status, Study Status and Contacts/Locations
5 July 24, 2018 Arms and Interventions, Study Status, Contacts/Locations, Study Identification, Eligibility, Study Design, Conditions and Study Description
6 April 26, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03092895
Submitted Date:  March 22, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: SHR-1210-APTN-II-203-PLC
Brief Title: A Study of SHR-1210 in Combination With Apatinib or FOLFOX4 Regimen in Subjects With Advanced Primary Liver Cancer(PLC)
Official Title: A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or FOLFOX4 Regimen in Subjects With Advanced Primary Liver Cancer(PLC)
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Not yet recruiting
Study Start: March 2017
Primary Completion: December 2017 [Anticipated]
Study Completion: December 2018 [Anticipated]
First Submitted: March 15, 2017
First Submitted that
Met QC Criteria:
March 22, 2017
First Posted: March 28, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
March 22, 2017
Last Update Posted: March 28, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 FOLFOX4 regimen in subjects with Advanced PLC.

Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 regimen.

Detailed Description:
Open or close this module Conditions
Conditions: Advanced Primary Liver Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Histologically confirmed PLC in advanced stage; 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.

  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.
Open or close this module Contacts/Locations
Central Contact Person: Jie Jiang, MD
Email: jiangjie@shhrp.com
Central Contact Backup: Shu Wang
Email: wangshu@hrs.com.cn
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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