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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 : Active, not recruiting
First Posted : March 28, 2017
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date April 27, 2022
Actual Study Start Date  ICMJE April 27, 2017
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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)
  • 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)
  • 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)
  • 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)
  • Overall Survival [ Time Frame: Up to approximately 2 years ]
    Overal Survial will be calculated based on Kaplan-Meier estimates
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Primary Liver Cancer
  • Advanced Biliary Tract Carcinoma
Intervention  ICMJE
  • 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
  • Drug: FOLFOX4
    Subjects receive FOLFOX4 treatment every 2 weeks
  • Drug: GEMOX
    Subjects receive GEMOX treatment every 2 weeks
Study Arms  ICMJE
  • Experimental: SHR-1210+Apatinib(Arm A)
    Interventions:
    • Biological: SHR-1210
    • Drug: Apatinib
  • Experimental: SHR-1210+FOLFOX4 or GEMOX regimen(Arm B)
    Interventions:
    • Biological: SHR-1210
    • Drug: FOLFOX4
    • Drug: GEMOX
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 26, 2022)
157
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
36
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03092895
Other Study ID Numbers  ICMJE SHR-1210-APTN-II-203-PLC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP