A prospective observational study of first-line systemic therapy in Thai advanced hepatocellular carcinoma patients

Not Applicable

• Conditions: efficacy of first line systemic therapy in HCC; HCC, first line, systemic therapy, chemotherapy, targeted therapy, PFS, OS

• Registration Number: TCTR20200921003
• Lead Sponsor: Thai society of clinical oncology (TSCO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-21
• Study Completion: 2023-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

1. Advanced stage HCC Diagnosis confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic patients)
1.1 Measurable lesion; follow modified RECIST criteria ≥ 1 cm in long axis and ≥ 1.5 cm in short axis for lymph node
2. BCLC stage C
3. CTP A-B
4. ECOG 0-2
5. Eligible for first line systemic therapy
6. life expectancy more than 3 months
7. Patient sign inform consent

Exclusion Criteria

1. Prior systemic therapy
2. Refuse or withdrawal
3. Pregnancy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate, Progression free survival and overall survival at progression and death Response rate, Progression free survival and overall survival

Secondary Outcome Measures

Name	Time	Method
toxicities at event of toxicities of treatment every cycles toxicities,quality of life every 3 month and end of treatment Questionaire: EORTC-C30 and HCC18 and EQ-5D-5L,cost-effectiveness every 3 months cost analysis questionnaire,biomarker every 3 month and end of treatment angiogenesis gene, polymorphism and extracellular vesicles