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

NCT04826406 | Unknown Phase 2 DMC

• 1 other identifier: SHR-1210-IIT-HCC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Immune Checkpoint Inhibitors

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 (9)

• Progression-free survival(PFS)

  Up to approximately 12 months

• Time to objective response(TTR)

  Up to approximately 12 months

• Duration of Response (DoR)

  Up to approximately 12 months

• Disease Control Rate (DCR)

  Up to approximately 12 months

• 6-month survival rate

  Up to approximately 12 months

Study Arms (1)

Camrelizumab+Apatinib

EXPERIMENTAL

Drug: Camrelizumab combined Apatinib regimen

Interventions

Camrelizumab combined Apatinib regimen DRUG

Camrelizumab 200mg iv every 2 weeks; Apatinib,250 mg/day.

Camrelizumab+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 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).

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.
• 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.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

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

Central Study Contacts

Shanzhi Gu, MD

CONTACT

+86-731-88651900; gushanzhi@hnca.org.cn

Study Design

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

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: February 3, 2021
• Primary Completion: March 2, 2022
• Study Completion: August 30, 2023
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CN (1)