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

NCT03463876 | Completed Phase 2 Results

• 1 other identifier: SHR-1210-APTN-Ⅱ-208-HCC
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

  Up to approximately 12 months

Secondary Outcomes (7)

• Duration of Response (DoR)

  Up to approximately 12 months

• Disease Control Rate (DCR)

  Up to approximately 12 months

• Time to Objective Response(TTR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

  Up to approximately 12 months

• 9-month Survival Rate

  Up to approximately 9 months

• 12-month Survival Rate

  Up to approximately 12 months

Study Arms (1)

SHR-1210+Apatinib

EXPERIMENTAL

Patients will receive apatinib orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks.

Drug: SHR 1210+apatinib

Interventions

SHR 1210+apatinib DRUG

SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks;Apatinib,250 mg/day.

SHR-1210+Apatinib

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

Location

Related Publications (2)

• 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.

  PMID: 36852452 DERIVED

• Xu 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.

  PMID: 33087333 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Quanren Wang, MD
• Organization: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

quanren.wang@hengrui.com

021-50118402

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 13, 2018
• Study Start: March 8, 2018
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2022-06

Locations

CN (1)