A Study of Camrelizumab Combined Apatinib in Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors (ICIs).

Hepatocellular Carcinoma Clinical Trial

Official title:

Camrelizumab Combined Apatinib in Patients With Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors: A Single-Arm, Open-Label, Phase II Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826406
• Other study ID #: SHR-1210-IIT-HCC
• Status: Recruiting
• Phase: Phase 2
• Start date: February 3, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: March 2021
• Source: Hunan Cancer Hospital
• Contact: Shanzhi Gu, MD
• Phone: +86-731-88651900
• Email: gushanzhi[@]hnca.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe and preliminary explore the efficacy and safety of the combination of Camrelizumab and Apatinib regimen in treating advanced hepatocellular carcinoma (HCC) participants who have progressed following prior Immune Checkpoint Inhibitors (ICIs) treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 30, 2023
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years old, both genders.
• Conform to the clinical diagnosis 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 score less than or equal to 7.
• Barcelona Clinic Liver Cancer stage Category B or C.
• Disease progression following prior Immune Checkpoint Inhibitors (PD-1/PD-L1 or CTLA4 inhibitors) treatment for HCC, for at least 2 consecutive treatment cycles. Receipt of no more than 2 prior systemic therapies for advanced HCC.
• 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.
• The prior ICIs treatments were discontinued by intolerable adverse events.
• 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.
• 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.
• 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.
• Prior Camrelizumab or Apatinib treatments.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Immune Checkpoint Inhibitors

Intervention

Drug:
• Camrelizumab combined Apatinib regimen
Camrelizumab 200mg iv every 2 weeks; Apatinib,250 mg/day.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Hunan Cancer Hospital	Jiangsu Hengrui Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival(PFS)	Progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).	Up to approximately 12 months
Secondary	Time to objective response(TTR)	Time to objective response(TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Up to approximately 12 months
Secondary	Duration of Response (DoR)	Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).	Up to approximately 12 months
Secondary	Disease Control Rate (DCR)	Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).	Up to approximately 12 months
Secondary	6-month survival rate	6-month survival rate	Up to approximately 12 months
Secondary	9-month survival rate	9-month survival rate	Up to approximately 12 months
Secondary	12-month survival rate	12-month survival rate	Up to approximately 12 months
Secondary	Overall survival(OS)		Up to approximately 24 months
Secondary	Safety as measured by the rate of AEs, SAEs and laboratory abnormalities	Safety as measured by the rate of AEs, SAEs and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4 )	From the first assignment of informed consent form up to 90 days after the last dose