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.
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. To standardize TACE efficacy and tolerability, conventional lipiodol-based TACE (cTACE) with idarubicin as the chemotherapeutic agent is employed. The treatment sequence is: Preoperative TACE (1 session) → Iparomlimab and Tuvonralimab Injection (QL1706) + Lenvatinib (Q3W, 2 cycles) → Radical surgery ± intraoperative microwave ablation → Postoperative TACE (1 session) → Iparomlimab and Tuvonralimab Injection (QL1706) (Q3W, ≤17 cycles). Safety Visits: Occur at screening, pre-TACE, Cycle D1 of neoadjuvant Iparomlimab and Tuvonralimab Injection (QL1706), pre-surgery, pre-postoperative TACE, Cycle D1 of adjuvant Iparomlimab and Tuvonralimab Injection (QL1706), and end of treatment. Survival Follow-up: Every 12 weeks after safety visits via clinic visit or phone call to collect survival status and subsequent anti-cancer therapy until death, loss to follow-up, sponsor termination, or study completion. Imaging Assessment: All lesions assessed per RECIST v1.1 and mRECIST. Consistent scanning parameters are required. Pathological Assessment: Post-surgery assessment of pathological response (MPR, pCR rates) and resection margin status (R0).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Radical surgery
TACE treatment (cTACE, Idarubicin): Preoperative: 1 session; Postoperative: 1 session.
Iparomlimab 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: 8mg (body weight \<60kg) or 12mg (body weight ≥60kg), orally (PO), once daily (QD), Q3W. Consistent daily timing. Neoadjuvant: 2 cycles.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
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.
Time frame: 60-day
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.
Time frame: 60-day
R0 resection rate
R0 resection rate
Time frame: 60-day
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).
Time frame: 6-month
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)
Time frame: 6-month
Event-Free Survival (EFS)
Time from the start of neoadjuvant therapy to the first occurrence of any of the following events: disease progression precluding surgery, postoperative recurrence or metastasis, or death from any cause.
Time frame: 3-year
Recurrence-Free Survival (RFS)
(For patients undergoing Radical surgery only) Time from the date of Radical surgery to tumor recurrence or death from any cause, whichever occurs first.
Time frame: 3-year
Overall Survival (OS)
Time from the start of neoadjuvant therapy to death from any cause.
Time frame: 3-year
Adverse event (AE)
Adverse events (AEs), Serious Adverse events (SAEs), surgery related safety.
Time frame: 3-year
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