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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical surgery | Procedure | Radical surgery |
| |
| TACE treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60-day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60-day |
| R0 resection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuehao Wang | Contact | 86-025-68303211 | Wangxh@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xuehao Wang | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Yongxiang Xia | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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| Procedure |
TACE treatment (cTACE, Idarubicin): Preoperative: 1 session; Postoperative: 1 session. |
|
| Iparomlimab and Tuvonralimab Injection (QL1706) | Drug | 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 | Drug | Lenvatinib: 8mg (body weight <60kg) or 12mg (body weight ≥60kg), orally (PO), once daily (QD), Q3W. Consistent daily timing. Neoadjuvant: 2 cycles. |
|
R0 resection rate
| 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). | 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) | 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. | 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. | 3-year |
| Overall Survival (OS) | Time from the start of neoadjuvant therapy to death from any cause. | 3-year |
| Adverse event (AE) | Adverse events (AEs), Serious Adverse events (SAEs), surgery related safety. | 3-year |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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