Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
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ClinicalTrials.gov Identifier: NCT06040177 |
Recruitment Status :
Recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma Non-resectable Portal Vein Tumor Thrombus Immune Checkpoint Inhibitors | Drug: Cadonilimab Radiation: Stereotactic radiotherapy Drug: Renvatinib | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 2, 2023 |
Actual Primary Completion Date : | February 2, 2023 |
Estimated Study Completion Date : | February 1, 2025 |
Arm | Intervention/treatment |
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Experimental: 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
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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
Other Name: AK104 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 |
- Objective response rate(ORR) [ Time Frame: Up to approximately 2 years ]ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
- 3-month PFS rate [ Time Frame: Up to approximately 2 years ]3-month PFS rate is the percentage of patients whose disease has not progressed within 3 months.
- progression-free survival (PFS) [ Time Frame: Up to approximately 2 years ]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) [ Time Frame: Up to approximately 2 years ]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) [ Time Frame: Up to approximately 2 years ]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) [ Time Frame: Up to approximately 2 years ]Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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);
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040177
Contact: Ning Mo, professor | 15289662269 | 369895025@qq.com |
China, Guangxi | |
First Affiliated Hospital of Guangxi Medical University | Recruiting |
Nanning, Guangxi, China | |
Contact: ning mo 15289662269 369895025@qq.com |
Responsible Party: | Jie Ma, Clinical Professor, First Affiliated Hospital of Guangxi Medical University |
ClinicalTrials.gov Identifier: | NCT06040177 |
Other Study ID Numbers: |
GuangxiMUMJ1 |
First Posted: | September 15, 2023 Key Record Dates |
Last Update Posted: | September 15, 2023 |
Last Verified: | September 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatocellular Carcinoma portal vein tumor thrombus Immune Checkpoint Inhibitors Efficacy |
Carcinoma Carcinoma, Hepatocellular Thrombosis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |