A Study to Evaluate SHR-1210 in Subjects With Advanced HCC

• ClinicalTrials.gov Identifier: NCT02989922
• Recruitment Status: Completed
• First Posted: December 12, 2016
• Results First Posted: March 15, 2024
• Last Update Posted: March 15, 2024
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Tracking Information

• First Submitted Date: November 22, 2016
• First Posted Date: December 12, 2016
• Results First Submitted Date: July 3, 2020
• Results First Posted Date: March 15, 2024
• Last Update Posted Date: March 15, 2024
• Actual Study Start Date: November 15, 2016
• Actual Primary Completion Date: March 3, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2024)

• Objective Response Rate [ Time Frame: approximate 3 years ]
  Tumour responses were evaluated by the independent review committee (IRC) according to RECIST 1.1.The primary endpoints were the proportion of patients with a IRC-assessed objective response (defined as the percentage of patients whose best overall response was confirmed complete or partial response).
• 6-month Overall Survival Rate [ Time Frame: from the date of the first dose to 6 months ]
  6-month overall survival rate (defined as cumulative overall survival rate from the date of the first dose to 6 months)

Original Primary Outcome Measures (submitted: December 8, 2016)

• Objective Response Rate per RECIST 1.1 [ Time Frame: Up to approximately 6 months ]
• Overall Survival Rate at 6-month [ Time Frame: Up to approximately 6 months ]

Current Secondary Outcome Measures (submitted: March 14, 2024)

• Duration of Response [ Time Frame: approximate 3 years ]
  time from first response to progression or death base on the IRC assessment
• Adverse Events [ Time Frame: approximate 3 years ]
  Number of Subjects with one or more adverse events as assessed by CTCAE 4.03
• Overall Survival [ Time Frame: approximate 3 years ]
  Time from first dose to death from any cause

Original Secondary Outcome Measures (submitted: December 8, 2016)

• Duration of Response Rate per RECIST 1.1 [ Time Frame: Up to approximately 2 years ]
• Number of Subjects with one or more adverse events as assessed by CTCAE 4.0 [ Time Frame: Up to approximately 2 years ]
• Overall Survival [ Time Frame: Up to approximately 2 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate SHR-1210 in Subjects With Advanced HCC
• Official Title: A Randomized Controlled Multicentered Phase 2/3 Study to Evaluate SHR-1210 (PD-1 Antibody) in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Failed or Intolerable to Prior Systemic Treatment
• Brief Summary: This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210 in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and Overall Survival when compare with SOC.
• Detailed Description: In June 2017, this study was revised to expand the Phase 2 part to enroll more subjects and remove the Phase 3 part under the same protocol. A Phase 3 study will be initiated separately.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatocellular Carcinoma Non-Resectable

Intervention

Biological: SHR-1210

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Study Arms

• Experimental: SHR-1210 Q2W
  Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
  Intervention: Biological: SHR-1210
• Experimental: SHR-1210 Q3W
  Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks
  Intervention: Biological: SHR-1210

Publications *

• Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1):e003133. doi: 10.1136/jitc-2021-003133.
• Qin S, Ren Z, Meng Z, Chen Z, Chai X, Xiong J, Bai Y, Yang L, Zhu H, Fang W, Lin X, Chen X, Li E, Wang L, Chen C, Zou J. Camrelizumab in patients with previously treated advanced hepatocellular carcinoma: a multicentre, open-label, parallel-group, randomised, phase 2 trial. Lancet Oncol. 2020 Apr;21(4):571-580. doi: 10.1016/S1470-2045(20)30011-5. Epub 2020 Feb 26.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 25, 2017): 220
• Original Estimated Enrollment (submitted: December 8, 2016): 60
• Actual Study Completion Date: March 3, 2020
• Actual Primary Completion Date: March 3, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
2. Failed or intolerable to at least one prior systemic treatment for advanced HCC
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. HBV DNA<500 IU/ml
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

Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Known liver transplant or plan to transplant
3. GI hemorrhage with 6 months
4. History or current brain metastases
5. Active known, or suspected autoimmune disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02989922
• Other Study ID Numbers: SHR-1210-II/III-HCC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jiangsu HengRui Medicine Co., Ltd.
• Verification Date: December 2017