The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma

NCT06609850 | Recruiting

• 1 other identifier: Liver Projiect 10
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.

Conditions

Recurrent Hepatocellular Carcinoma; Lenvatinib; Local Therapy; Ablation; Systemic Therapy

Keywords

Lenvatinb; Hepatocellular carcinoma; Microwave ablation; Radiofrequency ablation; Cryoablation

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.

  24 months

Secondary Outcomes (2)

• Overall survival (OS)

  36 month

• Objective response rate (ORR)

  12 months

Study Arms (2)

TACE plus Lenvatinib

ACTIVE COMPARATOR

TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure. Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )

Procedure: TACE; Drug: Lenvatinb

TACE plus Lenvatinib and ablation

EXPERIMENTAL

TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure. Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day ) Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.

Procedure: TACE; Procedure: Ablation; Drug: Lenvatinb

Interventions

TACE PROCEDURE

TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.

TACE plus Lenvatinib; TACE plus Lenvatinib and ablation

Ablation PROCEDURE

Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.

TACE plus Lenvatinib and ablation

Lenvatinb DRUG

Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )

TACE plus Lenvatinib; TACE plus Lenvatinib and ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years;
• RHCC diagnosed by imaging;
• intermediate-stage RHCC (two to three lesions which at least one was \>3 cm in size or more than three tumors);
• the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;
• absence of extrahepatic metastasis or macrovascular invasion;
• Child-Pugh class A or B;
• TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.
• life expectance \>3 months;

You may not qualify if:

• under 18 years or over 75 years of age;
• primary intermediate-stage HCC;
• RHCC with more than six tumors, or single RHCC
• (5) RHCC \>5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Chinese PLA General hospital

Beijing, None Selected, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Feng Duan

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Qunfang Zhou

CONTACT

86 19868000115; zhouqun988509@163.com

Feng Duan

CONTACT

86 13910984586; duanfeng@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 30, 2028
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

CN (1)