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This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of SBRT combined with cardonilizumab and lenvastinib in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT+cardonilizumab+lenvastinib Group | Experimental | Renvatinib: 8mg (weight <60kg) or 12mg (weight ≥60kg) once a day until disease progression, intolerable toxicity Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab | Drug | Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month PFS rate | 3-month PFS rate is the percentage of patients whose disease has not progressed within 3 months. | Up to approximately 2 years |
| progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first. |
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Inclusion Criteria:
Age: 18-70 years old;
Eastern Cooperative Oncology Group (ECOG) -Performance Status(PS):0-2 points;
Hepatocellular carcinoma was diagnosed according to histopathology or the 2022 diagnostic criteria for primary liver cancer;
Expected survival period≥3 months;
Liver function grade Child-Pugh A or better grade B (7 points);
At least one measurable lesion:
Liver lesion ① The Lesion can be accurately measured at least in the range of 1.0cm;
② The Lesion is suitable for repeated measurement;
The Barcelona liver cancer staging system is stage C (BCLC-C), which meets one of the following conditions:
(1) Liver tumor can be resected, which is combined with Vp 3-4 portal vein cancer thrombus; (2) Liver tumor is unresectable or has distant metastasis, and is combined with Vp1-4 type portal vein cancer thrombus; 8. The patient had not received prior systemic therapy including sorafenib, lenvatinib, chemotherapy; 9. The patient had previously received locoregional therapy (including radiofrequency or ablation therapy, percutaneous ethanol or acetic acid injection, cryotherapy, high intensity focused ultrasound, hepatic artery chemoembolization, hepatic artery embolization, etc., and the local treatment area had definite progression (according to RECIST v1.1 criteria); 10. Baseline blood routine and biochemical indicators meet the following criteria: Hemoglobin≥90g / L; Absolute neutrophil count (ANC)≥1.5× 10 ^ 9 / L; Platelet≥75×10 ^ 9 / L; ALT,AST ≤3×upper normal value (ULN); Serum total bilirubin ≤ 1.5 ×ULN; Serum creatinine ≤1.5 × ULN; Serum albumin was used for≥30g / L.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Mo, professor | Contact | 15289662269 | 369895025@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41293180 | Derived | Mo N, Hu K, Zeng Z, Yang L, Fang Y, Zeng J, Li Y, Yang Z, Tang J, Zhang T, Ma F, Liu C, Zheng H, Qiu J, Jiang Y, Lv Y, Liang L, Huang X, Liao X, Wang Y, Lu X, Ning L, Lao Guo S, Ma J, Wang R. Stereotactic body radiation therapy combined with cadonilimab and lenvatinib in the treatment of hepatocellular carcinoma with Vp3 or Vp4 portal vein tumor thrombus: a prospective, multicenter, single-arm, phase II clinical trial. Front Immunol. 2025 Nov 10;16:1687344. doi: 10.3389/fimmu.2025.1687344. eCollection 2025. |
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| Stereotactic radiotherapy | Radiation | Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry |
|
| Renvatinib | Drug | Renvatinib: 8mg (weight <60kg) or 12mg (weight 60kg) once a day until disease progression, intolerable toxicity |
|
| Up to approximately 2 years |
| Disease control rate (DCR) | DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1. | Up to approximately 2 years |
| Duration of response (DOR) | Duration of Response (DOR) is defined as the time between the first assessment of a tumor as Complete Response(CR)or Partial Response(PR)and the first assessment of Progressive Disease (PD) or death from any cause. | Up to approximately 2 years |
| Overall Survival (OS) | Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause | Up to approximately 2 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| 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 |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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