Combining SBRT with Cardonilizumab and Lenvatinib for Unresectable Liver Cancer

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

This study is testing a new treatment that combines radiation therapy with two medications to see if it can help people with liver cancer that can't be surgically removed.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Guangxi Medical University (Academic / other)
• Drugs / interventions: lenvatinib, chemotherapy, cardonilizumab, lenvastinib
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT06040177 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of combining stereotactic body radiation therapy (SBRT) with the immune checkpoint inhibitor cardonilizumab and the targeted therapy lenvastinib in patients with unresectable hepatocellular carcinoma that has spread to the portal vein. It is a single-arm, multicenter study designed to assess how well this combination treatment works in managing the disease. Participants will be monitored for treatment response and safety outcomes throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with unresectable hepatocellular carcinoma and portal vein tumor thrombus.

Not a fit: Patients with liver cancer that is resectable or those with severe liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a new effective option for patients with advanced liver cancer that is not amenable to surgery.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and targeted therapies in treating liver cancer, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Nanning, Guangxi

• First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)

Study contacts

• Study coordinator: Ning Mo, professor

Conditions Hepatocellular Carcinoma Non-resectable; Portal Vein Tumor Thrombus; Immune Checkpoint Inhibitors; Hepatocellular Carcinoma; portal vein tumor thrombus; Efficacy