A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With FOLFOX4 in Subjects With Advanced HCC Who Have Never Received Prior Systemic Treatment.

NCT03605706 | Unknown Phase 3

• 1 other identifier: SHR-1210-III-305-HCC
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1210 plus FOLFOX4 in subjects with advanced HCC who have never received prior systemic treatment compared to placebo plus FOLFOX4. The primary study hyposis is that Camrelizumab combined with FOLFOX4 treatment can improve Overall Survival when compared with placebo in combination with FOLFOX4 Regimen.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  OS was defined as the time from randomization to death due to any cause

  Up to approximately 3 years

Secondary Outcomes (7)

• Objective Response Rate (ORR) per RECIST 1.1 in all participants

  Up to approximately 6 months

• Time to Progression (TTP) per RECIST 1.1 in all participants

  Up to approximately 3 years

• Duration of Response (DoR) per RECIST 1.1 in all participants

  Up to approximately 3 years

• Disease Control Rate (DCR) per RECIST 1.1 in all participants

  Up to approximately 3 years

• Progression-free Survival (PFS) per RECIST 1.1 in all participants

  Up to approximately 3 years

Study Arms (2)

SHR-1210

EXPERIMENTAL

SHR-1210+FOLFOX4

Drug: SHR-1210; Drug: FOLFOX4

CONTROL

EXPERIMENTAL

SHR-1210+Placebo

Drug: FOLFOX4; Drug: Placebo

Interventions

SHR-1210 DRUG

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

SHR-1210

FOLFOX4 DRUG

Subjects receive FOLFOX4 treatment on D1-D2 of every 2 weeks

CONTROL; SHR-1210

Placebo DRUG

Subjects receive placebo of SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has not received prior systemic treatment for their advanced/metastatic HCC. Has measurable disease according to RECIST v1.1. ECOG Performance Status of 0 or 1. Child-Pugh Class A or B with 7 points. Life Expectancy of at least 12 weeks. HBV DNA\<500 IU/ml. Adequate organ function： 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 120 days after the last dose of study drug.

You may not qualify if:

• Known fibrolamellar HCC, Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
• Known or occurrence of central nervous system (CNS) metastases. Ascites with clinical symptoms. Known or evidence of GI hemorrhage within the past 6 months. Known or occurrence of hemorrhage/ thrombus. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
• Grade III\~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%.
• Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 150mmHg, diastolic blood pressure \> 90 mmHg).
• History of hepatic encephalopathy. Known history of human immunodeficiency virus (HIV) infection. Active infection or an unexplained fever \> 38.5°C during screening visits. Prior or planning to organ transplantation including liver transplantation. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
• Proteinuria≥ 2+ and 24 hours total urine protein \> 1.0 g. Active known, or suspected autoimmune disease. 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.
• Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.
• Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.
• Pregnant or breast-feeding women. According to the investigator, other conditions that may lead to stop the research.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

81 Hospital Nanjing

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Folfox protocol

Study Officials

• Shukui Qing, MD

  China, Jiangsu 81 Hospital Nanjing

  STUDY CHAIR

Central Study Contacts

Linna Wang, MD

CONTACT

021-60453196; wanglinna@hrglobe.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: July 30, 2018
• Study Start: May 31, 2019
• Primary Completion: February 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)