A Study of Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Radical Resection or Ablation

NCT06546280 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-KY-220-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of camrelizumab plus apatinib as adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after radical resection or ablation.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year recurrence free survival rate

  Proportion of patients who did not experience recurrence of hepatocellular carcinoma within 1 year of enrollment

  Assessed up to 12 months

Secondary Outcomes (5)

• Recurrence free survival

  Assessed up to 24 months

• Time to recurrence

  Assessed up to 24 months

• Overall survival

  Assessed up to 24 months

• 2-year recurrence free survival rate

  Assessed up to 24 months

• Adverse events

  Assessed up to 12 months

Study Arms (1)

Experimental group

EXPERIMENTAL

Drug: Camrelizumab; Drug: Apatinib

Interventions

Camrelizumab DRUG

Camrelizumab 200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.

Experimental group

Apatinib DRUG

Apatinib 250 mg will be taken orally once daily.

Experimental group

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily join this study and sign informed consent form;
• Age≥18 years, male or female;
• Patients were diagnosed with hepatocellular carcinoma by histology or pathology or clinical diagnostic criteria for hepatocellular carcinoma in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)", and have undergone radical resection or ablation for hepatocellular carcinoma;
• No macrovascular invasion (allowing intraoperative or postoperative pathologic findings of Vp1/Vp2 type portal vein invasion) or extrahepatic metastases assessed by imaging prior to radical treatment;
• Have high-risk recurrence risk factors, the assessment of which should be based on pre-procedure/ablation imaging;
• Child-Pugh liver function classification: Grade A;
• ECOG PS score: 0-1;
• Full recovery from surgical resection or ablation within 4 weeks prior to enrollment.
• Have not received anti-tumor treatment for hepatocellular carcinoma before enrollment, including systemic treatment and local treatment (except for 1-2 times of prophylactic TACE or HAIC treatment 4-8 weeks after radical treatment);
• Patients who underwent radical therapy are allowed to receive 1-2 prophylactic TACE/HAIC treatments (as needed, not mandatory) 4-8 weeks postoperatively, and are required to have fully recovered from TACE/HAIC within 4 weeks prior to receiving study treatment;
• Patients infected with hepatitis B virus (HBV) who started anti-HBV treatment at the screening stage and are willing to receive antiviral treatment (according to local guidelines, e.g., entecavir, etc.) throughout the study period and be monitored regularly can be included; Hepatitis C virus (HCV) ribonucleic acid (RNA)-positive patients must receive antiviral treatment according to guidelines and have a liver function within the CTCAE grade 1 elevation;
• For female patients of childbearing potential and male patients whose partners are women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use reliable and effective contraceptive methods for at least 120 days from the time of signing the informed consent form until the last dose of study drug.
• Adequate hematologic and organ function.

You may not qualify if:

• Known sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma and cholangiocarcinoma or fibrolamellar hepatocellular carcinoma;
• History of other malignant tumors within 5 years or simultaneously;
• Severe functional impairment of other vital organs such as heart, brain, lung and kidney;
• Immune deficiency or active autoimmune disease or history of autoimmune disease and the disease may relapse;
• Evidence of tumor recurrence or metastasis before enrollment;
• History of hepatic encephalopathy;
• Known hypersensitivity to the active ingredients and excipients contained in the investigational drugs (camrelizumab, apatinib) of this study, or known history of severe allergy to any other monoclonal antibody or anti-angiogenesis targeted drug;
• Patients with active or history of interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan that may interfere with the detection and management of immune-related pulmonary toxicity; patients with severely impaired lung function; previous radiation pneumonitis in the radiation field is allowed; patients with active tuberculosis;
• Cardiac clinical symptom or cardiovascular disease that is not well controlled;
• History of gastrointestinal hemorrhage or clear tendency of gastrointestinal haemorrhage within 6 months prior to the start of study treatment;
• Severe infection within 4 weeks prior to the start of study treatment; therapeutic antibiotics given orally or intravenously within 2 weeks prior to the start of study treatment;
• Immunosuppressive or systemic hormone therapy for immunosuppression (dose \>10 mg/day prednisone or other equipotent hormone) within 14 days prior to the start of study treatment;
• Patients who are preparing for or have previously received an organ or allogeneic bone marrow transplantation;
• Subjects with hypertension that is not well controlled or history of hypertensive crisis or hypertensive encephalopathy;
• Significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to the start of study treatment; ular heparin is permitted)

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510220, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumab; apatinib

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

Study Officials

• Mingxin Pan

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingxin Pan

CONTACT

+8618928918216; panmx@smu.edu.cn

Yaohong Wen

CONTACT

+8613676201434; 1240219972@qq.com

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: August 6, 2024
• First Posted: August 9, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)