search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Cadonilimab
Stereotactic radiotherapy
Renvatinib
Sponsored by
First Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Hepatocellular Carcinoma, portal vein tumor thrombus, Immune Checkpoint Inhibitors, Efficacy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • First Affiliated Hospital of Guangxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT+cardonilizumab+lenvastinib Group

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

3-month PFS rate
3-month PFS rate is the percentage of patients whose disease has not progressed within 3 months.
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.
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.
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.
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause

Full Information

First Posted
July 13, 2023
Last Updated
September 13, 2023
Sponsor
First Affiliated Hospital of Guangxi Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT06040177
Brief Title
Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Non-resectable, Portal Vein Tumor Thrombus, Immune Checkpoint Inhibitors
Keywords
Hepatocellular Carcinoma, portal vein tumor thrombus, Immune Checkpoint Inhibitors, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT+cardonilizumab+lenvastinib Group
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Cadonilimab
Other Intervention Name(s)
AK104
Intervention Description
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
Radiation
Intervention Name(s)
Stereotactic radiotherapy
Intervention Description
Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry
Intervention Type
Drug
Intervention Name(s)
Renvatinib
Intervention Description
Renvatinib: 8mg (weight <60kg) or 12mg (weight 60kg) once a day until disease progression, intolerable toxicity
Primary Outcome Measure Information:
Title
Objective response rate(ORR)
Description
ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
3-month PFS rate
Description
3-month PFS rate is the percentage of patients whose disease has not progressed within 3 months.
Time Frame
Up to approximately 2 years
Title
progression-free survival (PFS)
Description
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.
Time Frame
Up to approximately 2 years
Title
Disease control rate (DCR)
Description
DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.
Time Frame
Up to approximately 2 years
Title
Duration of response (DOR)
Description
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.
Time Frame
Up to approximately 2 years
Title
Overall Survival (OS)
Description
Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Mo, professor
Phone
15289662269
Email
369895025@qq.com
Facility Information:
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ning mo
Phone
15289662269
Email
369895025@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs