Sintilimab Combined With Lenvatinib Versus HAIC for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma

NCT05519410 | Unknown Phase 2

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, Two-arm, randomized，phase II clinical study of Sintilimab Combined With Lenvatinib Versus HAIC for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence.

Conditions

Resectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year DFS%

  1-year disease-free survival rate

  12month

Secondary Outcomes (4)

• ORR

  3 months

• Percentage of MVI

  4 months

• Percentage of pCR

  4 months

• 2-year DFS%

  24 months

Study Arms (2)

Sintilimab Combined With Lenvatinib

EXPERIMENTAL

Pre-operation: 2-3 cycles;

Drug: Sintilimab and Lenvatinib

HAIC

ACTIVE COMPARATOR

Pre-operation: HAIC-FOLFOX 2-3 cycles;

Drug: HAIC-FOLFOX

Interventions

Sintilimab and Lenvatinib DRUG

Tislelizumab, 200mg, ivd,q3w; Lenvatinib,8mg/kg,po,qd.

Sintilimab Combined With Lenvatinib

HAIC-FOLFOX DRUG

hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.

HAIC

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:
• b: 2-3 tumors with the maximum diameter ≤3cm; IIa: tumor 2-3,biggest \> 3 cm in diameter
• 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;
• Subjects have good compliance and cooperate with the follow-up.

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 Tislelizumab or other PD-1/PD-L1 treatment could not be enrolled; Subjects are known to have prior allergies to macromolecular protein reparations or to any Tislelizumab or Lenvatinib 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;
• Subject has active infection or unexplained fever of \>38.5 degrees during screening and before first administration (subject's fever due to tumor can be enrolled according to the investigator's judgment);
• Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, severe impairment of lung function, etc.;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Interventions

sintilimab; lenvatinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 29, 2022
• Study Start: August 23, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

CN (1)