Preceding RFA to STRIDE trial

JRCT ID: jRCTs041240049

Registered date:18/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 24/06/2024
• Target sample size: 48
• Study type: Interventional
• Intervention(s): Radiofrequency ablation, Durvalumab plus Tremelimumab

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall survival, Objective response rate, Tumor control rate, Subsequent therpay, Severe adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: clinically diagnosed as hepatocellular carcinoma; unsuitable for local therapy; previously treated by systemic therapy; Preserved liver function; 18 years or older; ECOG Performance status <=2; preservation of major organ function; written informed consent
• Exclude criteria: 1) Active double cancer 2) Receiving any combination of chemotherapy, investigational drugs, and biologic or hormonal therapy for the treatment of cancer 3) With previous radiotherapy 4) Active infection 5) Fever of 38 degrees Celsius or higher 6) Active autoimmune or inflammatory disease or a confirmed history of such disease 7) Taking antiplatelet or anticoagulant medication 8) Complicated by one or more of interstitial pneumonia, pulmonary fibrosis, or severe emphysema 9) Unhealed fistulas, ulcerative lesions, and active bleeding 10) Metastases to central nervous system 11) Moderate or severe ascites and/or pleural effusion 12) Severe complication 13) Poorly controlled diabetes 14) Pregnant or lactating women 15) Mental disorder 16) Patients who investigator regards as inappropriate for candidate

Related Information

• Primary Sponsor: Yamashita Taro
• Source(s) of Monetary Support: Astrazeneca