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

NCT06040177 | Unknown Phase 1

• 1 other identifier: GuangxiMUMJ1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Hepatocellular Carcinoma; portal vein tumor thrombus; Immune Checkpoint Inhibitors; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 3-month PFS rate

  Up to approximately 2 years

• progression-free survival (PFS)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

Study Arms (1)

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

Drug: Cadonilimab; Radiation: Stereotactic radiotherapy; Drug: Renvatinib

Interventions

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

Also known as: AK104

SBRT+cardonilizumab+lenvastinib Group

Stereotactic radiotherapy RADIATION

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

SBRT+cardonilizumab+lenvastinib Group

Renvatinib DRUG

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

SBRT+cardonilizumab+lenvastinib Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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
• 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.

You may not qualify if:

• Patients diagnosed with hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibrolaminar cell carcinoma；
• Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation；
• 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；
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41293180 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ning Mo, professor

CONTACT

15289662269; 369895025@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: September 15, 2023
• Study Start: February 2, 2023
• Primary Completion: February 2, 2023
• Study Completion: February 1, 2025
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

CN (1)