Hepatocellular CarcinomaPhase 2NCT03463876
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Advanced HCC(RESCUE)
A Phase 2 study testing SHR 1210+apatinib in people with Hepatocellular Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SHR 1210+apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2018to 10 Mar 2021
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention.
- Coagulation abnormalities (INR>2.0、PT>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
- Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency, such as: esophageal varices, local active ulcerative lesions, gastric ulcer and duodenal ulcer, the ulcerous colitis, gastrointestinal diseases such as portal hypertension or resection of tumor with bleeding risk, etc.
- Previous Arterial/venous thrombosis events within 3 months.
- Proteinuria ≥ (++) and 24 hours total urine protein > 1.0 g.
- Prior systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, surgery or target therapy within 4 weeks (Or 5 half-life of the drug, calculate the longer ) before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
- Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing.
- History of immunodeficiency or human immunodeficiency virus (HIV) infection.
- HBV DNA>2000 IU/ml（or 104copies/ml），HCV RNA>103copies/ml，HBsAg+ and anti-HCV+；
- Patients with other malignant tumor (except cured skin basal cell carcinoma and cervical carcinoma).
- Patients who has bone metastasis, has received Palliative radiotherapy (radiotherapy area > 5% marrow area).
- Patients must not have had prior treatment with SHR-1210 or any other PD-L1 or PD-1 antagonists or apatinib.
- Patients who may receive live vaccine during the study, or previous had vaccination within 4 weeks.
- Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
About this study
Official title: A Phase II, Single-arm, Open-label Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Advanced HCC
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.
Read the detailed description
SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).
Patients with advanced HCC who failed or intolerable to sorafenib will receive apatinib 250mg orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SHR 1210+apatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR 1210+apatinibDrug
SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks;Apatinib,250 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210+Apatinib | Experimental | Patients will receive apatinib orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks. Receives: Drug: SHR 1210+apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 12 months
Secondary outcomes (7)
Duration of Response (DoR)
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 12 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 12 months
Time to Objective Response(TTR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time to objective response，TTR
Measured: Up to approximately 12 months
9-month Survival Rate
9-month survival rate
Measured: Up to approximately 9 months
12-month Survival Rate
12-month survival rate
Measured: Up to approximately 12 months
Overall Survival(OS)
Overall survival(OS)
Measured: Up to approximately 36 months
Progression-free Survival(PFS)
Progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start8 Mar 2018
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463876
- Sponsor's protocol ID
- SHR-1210-APTN-Ⅱ-208-HCC
- Status last verified
- Jun 2022
- First submitted
- 7 Mar 2018
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou X, Cao J, Topatana W, Xie T, Chen T, Hu J, Li S, Juengpanic S, Lu Z, Zhang B, Wang K, Feng X, Shen J, Chen M. Evaluation of PD-L1 as a biomarker for immunotherapy for hepatocellular carcinoma: systematic review and meta-analysis. Immunotherapy. 2023 Apr;15(5):353-365. doi: 10.2217/imt-2022-0168. Epub 2023 Feb 27.
PubMed 36852452Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.
PubMed 33087333