Clinical trial NCT04639180: A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
Official title: A Randomized, Open-Label, Multi-Center, Phase Ⅲ Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 687
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Camrelizumab Combined with Rivoceranib (Apatinib) Versus Active Surveillance
Primary purpose: TREATMENT

Brief summary: A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.


Eligibility criteria: Inclusion Criteria:

* Subjects with a histopathological diagnosis of HCC
* Subjects who have undergone a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only)
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* Absence of major macrovascular invasion
* No extrahepatic spread
* Full recovery from Curative resection or ablation within 4 weeks prior to randomization
* High risk for HCC recurrence after resection or ablation
* For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
* Child-Pugh Class: Grade A
* ECOG-PS score: 0 or 1
* Subjects with HCV- RNA (+) must receive antiviral therapy
* Adequate organ function

Exclusion Criteria:

* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously
* Evidence of residual lesion, recurrence, and metastasis at randomization;
* Moderate-to-severe ascites with clinical symptoms
* History of hepatic encephalopathy
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage
* Active or history of autoimmune disease
* Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
* Cardiac clinical symptom or cardiovascular disease that is not well controlled
* Severe infection within 4 weeks prior to the start of study treatment
* HIV infection
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Serious non-healing or dehiscing wound
* Major Curative procedure within four weeks
* Factors to affect oral administration
* Previous or current presence of metastasis to central nervous system

Primary outcomes:
measure: Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC)
timeFrame: Randomization up to approximately 43 months
Secondary outcomes:
measure: RFS Rate at 24 and 36 Months, as Assessed by the Investigator
timeFrame: Randomization up to 24 months and up to 36 months
measure: Time to Recurrence (TTR) as determined by the investigator and by BIRC
timeFrame: Randomization up to approximately 43 months
measure: Overall Survival (OS)
timeFrame: Randomization up to approximately 43 months
measure: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
timeFrame: Baseline up to approximately 43 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Nanjin
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangzhou
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
state: Guizhou
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: