CompletedPhase 2

A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Advanced HCC(RESCUE)

China190 participantsStarted 2018-03-08

Plain-language summary

The purpose of this study is to observe and preliminary explore the efficacy and safety of combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged 18 years old, both genders.
✓. Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1.
✓. Liver function status Child-Pugh Class A.
✓. Barcelona Clinic Liver Cancer stage Category B or C.
✓. Failure or intolerance to prior treatment with targeted therapy.
✓. Eastern Cooperative Oncology Group Performance Status of 0 or 1.
✓. Life expectancy of at least 12 weeks.
✓. Adequate bone marrow, liver and renal function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment).

Exclusion criteria

✕. Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
✕. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
✕. More than one regimen.
✕. Known history of hypersensitivity to any components of the SHR-1210 formulation, or other antibody formulation.
✕. Known or occurrence of central nervous system (CNS) metastases or hepatic encephalopathy.
✕. Patients with tumor burden ≥50% of the liver volume or received liver transplantation.
✕. Patients with clinical symptoms of ascites.
✕. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg.

What they're measuring

Objective Response Rate (ORR)

Timeframe: Up to approximately 12 months

Trial details

NCT IDNCT03463876

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-10

Results submitted2023-04-18

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