Clinical trial NCT04826406: A Study of Camrelizumab Combined Apatinib in Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors (ICIs).
Official title: Camrelizumab Combined Apatinib in Patients With Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors: A Single-Arm, Open-Label, Phase II Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Immune Checkpoint Inhibitors
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
First posted: 2021-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Progression-free survival(PFS)
timeFrame: Up to approximately 12 months
measure: Time to objective response(TTR)
timeFrame: Up to approximately 12 months
measure: Duration of Response (DoR)
timeFrame: Up to approximately 12 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 12 months
measure: 6-month survival rate
timeFrame: Up to approximately 12 months
measure: 9-month survival rate
timeFrame: Up to approximately 12 months
measure: 12-month survival rate
timeFrame: Up to approximately 12 months
measure: Overall survival(OS)
timeFrame: Up to approximately 24 months
measure: Safety as measured by the rate of AEs, SAEs and laboratory abnormalities
timeFrame: From the first assignment of informed consent form up to 90 days after the last dose
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References: