Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

NCT06644430 | Recruiting

• 1 other identifier: CHEST-002
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

Ablation has been an effective therapy in treating intrathoracic metastases. However, for hepatocellular carcinoma with pulmonary oligometastasis, ablation of metastases remains relatively unexplored and still needs clinical evidence.

Conditions

Advanced Hepatocellular Carcinoma; Lung Cancer; Oligometastasis; Ablation; Systemic Therapy

Keywords

Advanced hepatocellular carcinoma; Lenvatinib; Sorafeinib; Camrelizumab; Tislelizumab; Sintilimab; Toripalimab; Apatinib

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival

  Progression was defined as progressive disease by independent radiologic review

  12 months

Secondary Outcomes (2)

• Overall survival (OS)

  24 months

• Objective response rate (ORR)

  12 months

Study Arms (2)

Ablation+system group

Participants received ablation of plumonary combined systemic therapy

Procedure: Ablation; Drug: system therapy

System group

Participants received systemic therapy

Drug: system therapy

Interventions

Ablation PROCEDURE

Ablation including (microwave ablation, radiofrequency ablation, cryoblation), this surgery was conducted under CT guidence. The pulmonary was completely ablated.

Ablation+system group

system therapy DRUG

Paticipants received systemic therapy according the instructions.

Ablation+system group; System group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Thermal ablation, as a minimal therapy, has been recommended as a favorable therapy for metastases worldwide. However, for advanced hepatocellular carcinoma with pulmonary oligometastasis, the standard of care is system therapy. However, the evidence of ablating the oligometastasis is limited. In this multicenter study, we want to indicate that compared with systemic therapy, patients received thermal ablation of pulmonary oligometastasis plus system therapy showed significantly longer survival. This study will supplement the current situation where system therapy is the standard of care for hepatocellular carcinoma with oligometastasis.

You may qualify if:

• diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
• presence of pulmonary oligometastasis, the metastases found within three month of HCC diagnosis;
• metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
• receipt of first-line systemic therapy for minimum of 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);
• undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;
• classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• no history of other malignancies.
• life expectancy more than 3 months;
• agreed to participated in this clinical trial;
• Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

You may not qualify if:

• intermediate HCC;
• age \< 18 years or \> 75 years;
• advanced HCC with more than five metastases;
• no response to Lenvatinib;
• metastases size \> 5 cm;
• life expectancy less than 3 months.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Chinese PLA General hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Feng Duan, MD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Feng Duan, MD

CONTACT

86 13910984586; duanfeng@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 16, 2024
• Study Start: October 4, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

CN (1)