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

NCT ID: NCT06040177

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2025-02-01

Brief 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

Conditions

Hepatocellular Carcinoma Non-resectable; Portal Vein Tumor Thrombus; Immune Checkpoint Inhibitors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT+cardonilizumab+lenvastinib Group

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

Group Type: EXPERIMENTAL

Cadonilimab

Intervention Type: 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

Stereotactic radiotherapy

Intervention Type: RADIATION

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

Renvatinib

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Stereotactic radiotherapy

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

Intervention Type: RADIATION

Renvatinib

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

Intervention Type: DRUG

Other Intervention Names

AK104

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jie Ma

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ning Mo, professor

Role: CONTACT

369895025@qq.com

15289662269

Facility Contacts

ning mo

Role: primary

369895025@qq.com

15289662269

Other Identifiers

GuangxiMUMJ1

Identifier Type: -

Identifier Source: org_study_id