This is a single-arm, multicenter, exploratory clinical study evaluating the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection (QL1706) and lenvatinib for perioperative treatment of resectable HCC (CNLC IIb-IIIa excluding Vp3/Vp4 or CNLC Ib-IIa with high-risk recurrence factors). Eligible subjects providing written informed consent will receive study treatment. The primary endpoint is MPR rate.
Voluntarily participate, sign ICF, demonstrate good expected compliance, and be willing to cooperate with follow-up.
Age 18-75 years, any gender.
HCC diagnosis confirmed by histopathology, cytology, or imaging.
Resectable HCC staged as CNLC IIb-IIIa (excluding Vp3 and Vp4) or CNLC Ib-IIa with high-risk recurrence factors, confirmed by multidisciplinary liver surgery expert panel.
Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed carcinoma (>30% ICC component), or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years or concurrently. Cured localized cancers are eligible.
Current or history of interstitial lung disease/pneumonitis requiring steroids, or other active lung disease potentially interfering with immune-related pulmonary toxicity evaluation/management, or active pneumonia/severe impaired pulmonary function on screening CT. Active tuberculosis.
Active autoimmune disease or history of autoimmune disease with potential recurrence. Vitiligo, psoriasis, alopecia not requiring systemic therapy, controlled Type I diabetes on insulin, or childhood asthma resolved in adulthood without intervention are eligible. Asthma requiring bronchodilators is excluded.
Systemic immunosuppressive therapy (>10 mg/day prednisone equivalent) within 2 weeks prior to intervention.
Single group
Radical surgery
Procedure/SurgeryRadical surgery
TACE treatment
Procedure/SurgeryTACE treatment (cTACE, Idarubicin): Preoperative: 1 session; Postoperative: 1 session.
Iparomlimab and Tuvonralimab Injection (QL1706)
DrugIparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, intravenous infusion, Day 1 of each cycle, Q3W. Neoadjuvant: 2 cycles; Adjuvant: up to 17 cycles.
Lenvatinib
DrugLenvatinib: 8mg (body weight \<60kg) or 12mg (body weight ≥60kg), orally (PO), once daily (QD), Q3W. Consistent daily timing. Neoadjuvant: 2 cycles.
Major Pathological Response (MPR) rate
Proportion of subjects achieving MPR (defined as ≤10% residual viable tumor cells in the original tumor bed after neoadjuvant therapy, i.e., ≥90% necrosis) among all enrolled subjects.
Pathological Complete Response (pCR) rate
Proportion of subjects achieving pCR (defined as no residual viable tumor cells in the original tumor bed after neoadjuvant therapy) among all enrolled subjects.
R0 resection rate
R0 resection rate
Objective Response Rate (ORR)
Proportion of subjects achieving Complete Response (CR) or Partial Response (PR) among all enrolled subjects (assessed by investigators per RECIST v1.1 and mRECIST).
Disease Control Rate (DCR)
Proportion of subjects achieving CR, PR, or Stable Disease (SD) among all enrolled subjects (assessed by investigators per RECIST v1.1 and mRECIST)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
