Clinical trial · Interventional
Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus#a Prospective, Multicenter, Single-arm Clinical Study
NCT06040177CI-TRIAL-00069642unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Non-resectable | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Portal Vein Tumor Thrombus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab | Drug | — | UNRESOLVED |
| Renvatinib | Drug | — | UNRESOLVED |
| Stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT+cardonilizumab+lenvastinib Group
- description
- 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
- interventionNames
- Drug: Cadonilimab
- Radiation: Stereotactic radiotherapy
- Drug: Renvatinib
Primary outcomes (1)
- measure
- Objective response rate(ORR)
- timeFrame
- Up to approximately 2 years
- description
- ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18-70 years old; 2. Eastern Cooperative Oncology Group (ECOG) -Performance Status(PS):0-2 points; 3. Hepatocellular carcinoma was diagnosed according to histopathology or the 2022 diagnostic criteria for primary liver cancer; 4. Expected survival period≥3 months; 5. Liver function grade Child-Pugh A or better grade B (7 points); 6. 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 lesion shows enhanced intratumoral arteries on computed tomography (CT) or magnetic resonance imaging (MRI); Non-liver lesion In at least one dimension, the short axis of lymphadenopathy (LN) is≥1.5cm. Longest diameter of non-nodular lesions is≥1.0cm 7. 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: 1. Patients diagnosed with hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibrolaminar cell carcinoma; 2. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation; 3. Patients have hepatic encephalopathy (West Haven Standard Grade III, Level IV) or have moderate or severe ascites (i.e., patients requiring therapeutic puncture drainage) or have uncontrolled pleural or pericardial effusion; 4. Patients have symptomatic, untreated, or progressive central nervous system (CNS) or leptomeningeal metastases.If all the following criteria are met, asymptomatic subjects with treated CNS lesions can be enrolled.
References
Publications (2)
- DERIVEDLiang X, Li Y, Liang M, Zeng Z, Hu K, Yang L, Yan H, Li M, Zeng J, Tang J, Lv Y, Liang L, Meng J, Su H, Ma J, Mo N. Association between gut microbiota characteristics and therapeutic efficacy of multimodal combination therapy in hepatocellular carcinoma with portal vein tumor thrombus: a secondary analysis of a prospective phase II trial. Front Immunol. 2026 Aug 18;17:1864941. doi: 10.3389/fimmu.2026.1864941. eCollection 2026. PMID 42682622
- DERIVEDMo 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. PMID 41293180