Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040177
• Other study ID #: GuangxiMUMJ1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 2, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: Ning Mo, professor
• Phone: 15289662269
• Email: 369895025[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2025
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ? The Lesion can be accurately measured at least in the range of 1.0cm;

? 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable
• Immune Checkpoint Inhibitors
• Portal Vein Tumor Thrombus
• Thrombosis

Intervention

Drug:
• Cadonilimab
Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years

Radiation:
• Stereotactic radiotherapy
Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry

Drug:
• Renvatinib
Renvatinib: 8mg (weight <60kg) or 12mg (weight 60kg) once a day until disease progression, intolerable toxicity

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Up to approximately 2 years
Secondary	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
Secondary	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
Secondary	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