Camrelizumab Combined With Apatinib for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma

NCT04701060 | Completed Phase 2 FDA Drug

• 1 other identifier: OBU-TJ-HCC-II-004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is A prospective, one-arm, phase II clinical study of Camrelizumab combined with apatinib for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence

Conditions

Resectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response

  MPR

  post-operation

Secondary Outcomes (10)

• Disease free survival (DFS) rate of 1 year

  12 months

• Pathological complete response rate

  3 months

• Disease free survival (DFS) rate of 2 year

  24months

• Disease free survival

  24 months

• adverse reaction

  36 months

Other Outcomes (3)

• To explore genomic biomarkers of clinical remission/drug resistance (TMB, TNB, ITH, HLA subtype, HLA-LOH, etc.) in combination with Camrelizumab and Apatinib

  36months

• Identification of tumor microenvironmental biomarkers (tumor I nfiltrating lymphocytes, biomarkers expressed on T cells, etc.) for clinical remission/drug resistance in combination with Camrelizumab and apatinib

  36 months

• To investigate the clinical efficacy of PD-L1 expression in predicting the combination of Camrelizumab and apatinib

  36 months

Study Arms (1)

Camrelizumab combined with apatinib

EXPERIMENTAL

preoperative：Camrelizumab ：200mg， iv，d1 q2w；apatinib：250mg,po，qd，q2w；four cycles， operation postoperation 4-8weeks，Camrelizumab ：200mg， iv，d1 q2w；apatinib：250mg,po，qd，q2w；Up to one year

Drug: Camrelizumab:200mg， iv，d1 q2w;apatinib:250mg,po，qd，q2w

Interventions

Camrelizumab:200mg， iv，d1 q2w;apatinib:250mg,po，qd，q2w DRUG

preoperative：Camrelizumab ：200mg， iv，d1 q2w；apatinib：250mg,po，qd，q2w；four cycles， operation postoperation 4-8weeks，Camrelizumab ：200mg， iv，d1 q2w；apatinib：250mg,po，qd，q2w；Up to one year

Camrelizumab combined with apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients volunteered to participate in this study and signed informed consent;
• Age 18-75, male or female;
• ECOG PS score 0-1;
• Child-pugh liver function grading: Grade A
• The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to the indications for resectable operation in the Guidelines for diagnosis and Treatment of HCC (2019) edition;
• According to the preoperative evaluation of the researcher, the patient had a high risk of recurrence and met at least one of the risk factors:
• Ⅰb: a single tumor diameter \> 6.5 cm (except Mr Tian Bangxiong inflating) There were 2-3 tumors with the maximum diameter ≤3cm;Ⅱa : tumor 2-3, biggest \> 3 cm in diameter；Ⅱb: tumor 4 or higher；Ⅲa : there are visible to the naked eye vascular invasion;
• According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
• Expected survival ≥ 6 months;
• The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) :
• Blood routine:
• Neutrophils ≥1.5×109/L Platelet count ≥100×109/L Hemoglobin ≥90g/L;
• Liver and kidney function:
• Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 2.5 times the upper limit of normal value (ULN);Urine protein \<2+;If urinary protein ≥2+, 24-hour quantitative urine protein must be ≤1g;
• Normal coagulation function, no active bleeding and thrombotic disease A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN; C. Prothrombin time PT≤1.5ULN;

You may not qualify if:

• Have received radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapies before;
• Known hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibre-lamellar cell carcinoma;Active malignancies other than HCC within 5 years or concurrently;
• Having hypertension that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous history of hypertension crisis or hypertensive encephalopathy;
• Subject has previous or concurrent malignancies (except cured basal cell carcinoma of skin and carcinoma in situ of the cervix);
• Previous treatment with Karillizumab or other PD-1/PD-L1 treatment could not be enrolled;Subjects are known to have prior allergies to macromolecular protein preparations or to any carrylzumab or apatinib excipients;
• Subject has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism;Subjects with vitiligo or childhood asthma have been completely relieved and may be included as adults without any intervention;Asthma requiring medical intervention with bronchodilators will not be included);
• Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (\>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy within 2 weeks prior to enrollment;
• Ascites or pleural effusion with clinical symptoms require therapeutic puncture or drainage;
• Clinical symptoms or diseases of the heart that are not well controlled, such as:
• NYHA2 or above heart failure
• Unstable angina pectoris
• Myocardial infarction occurred within 1 year
• Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
• The patient currently (within 3 months) has gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding in unresected tumors, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation;
• Past or present severe bleeding (\>30 ml bleeding within 3 months), hemoptysis (\>5 ml fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or tia) within 12 months;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Insititute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

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: January 4, 2021
• First Posted: January 8, 2021
• Study Start: January 26, 2021
• Primary Completion: March 4, 2024
• Study Completion: October 4, 2024
• Last Updated: December 3, 2024

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)