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A randomized controlled clinical study of Yizhong Sanjie Decoction combined with high-intensity focused ultrasound for the treatment of CNLC stage IIB-IIIB hepatocellular carcinoma

A randomized controlled clinical study of Yizhong Sanjie Decoction combined with high-intensity focused ultrasound for the treatment of CNLC stage IIB-IIIB hepatocellular carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001292
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-06-05
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Chinese herbal group:Basic treatment+HIFU+Chinese herbal granules
Control group:Basic treatment+HIFU

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the clinical or/or pathological diagnostic criteria for primary hepatocellular carcinoma; (2) CNLC stage IIB-IIIB advanced liver cancer; (3) Those who are unable to tolerate invasive local treatments such as TACE or who are resistant to TACE treatment or ineffective treatment; (4) Measurable primary lesions confirmed by CT or MRI imaging examination; (5) The patient's physical condition is still good and the physical condition score (Karnofsky) = more than 60 points; (6) The function of all important organs is basically normal and the expected survival time is more than 3 months; (7) All those who have completed surgery radiotherapy TACE and other treatments for more than 3 months and the adverse reactions have recovered after treatment; (8) If it is combined with obstructive jaundice it must be treated with ERCP biliary stent drainage; (9) Voluntarily accept HIFU treatment and sign the informed consent form with good compliance.

Exclusion criteria

Exclusion criteria: (1) Skin ulceration or infection at the ultrasound treatment channel; (2) Combined with other serious underlying diseases such as heart lung and renal failure; (3) Severe coagulation dysfunction or clear bleeding tendency; (4) Patients with moderate or above ascites; (5) There were obvious calcified plaques in the arterial wall of the ultrasound treatment channel; (6) Child-Pugh grade C of liver function; (7) Have severe psychological or psychiatric abnormalities in the past and the compliance with the estimated participation in this study is insufficient.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
progression free survival;Dynamic contrast enhanced magnetic resonance imaging parameter;Tumor markers;Karnofsky score;

Countries

CHina

Contacts

Public ContactYuli Wang

Shanghai Municipal Hospital of Traditional Chinese Medicine

wangyuli_tcm9403@shutcm.edu.cn+86 189 1856 5850

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026