A randomized controlled clinical study of anti-cancer decoction no.2 combined with high intensity focused ultrasound in treating primary hepatic carcinoma

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003631

Enrollment

Unknown

Registered

2020-08-22

Start date

2020-10-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Liver Cancer

Interventions

1:High Intensity Focused Ultrasound(HIFU)

2:HIFU+Anti-cancer Decoction 2

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the clinical or (and) pathological diagnostic criteria for primary hepatic cancer; (2) Intermediate and advanced primary hepatic cancer without surgical indications; (3) Measurable primary lesion confirmed by CT or MRI imaging examination; (4) The patient's physical condition was good, with the physical condition score (Karnofsky) >= 60; (5) The expected survival time is more than 3 months; (6) The functions of all organs are basically normal; (7) Child-pugh A and B in liver function; (8) All the surgeries, radiotherapy, TACE and other treatments have been completed for more than 3 months, and all the adverse reactions have recovered after treatment; (9) Patients with obstructive jaundice must be treated with ERCP biliary stent drainage; (10) Voluntarily accept high energy focused ultrasound (HIFU) treatment and sign a written agreement with good compliance.

Exclusion criteria

Exclusion criteria: (1) There is skin rupture or infection in the ultrasound treatment channel; (2) Complicated with other serious basic diseases such as heart, lung and kidney failure; (3) Severe coagulation dysfunction or clear bleeding tendency; (4) Patients with moderate or above ascites; (5) Obvious calcified plaque exists in the arterial wall of the ultrasound treatment channel; (6) Previous severe psychological or mental abnormalities, and estimated insufficient compliance to participate in this study.

Design outcomes

Primary

Measure	Time frame
Overall survival;Disease-free survival;	—

Secondary

Measure	Time frame
CD4+T/ CD8+T;MDSCs;ECOG score;NK cell;CA-242;Treg;CA15-3;CD3+T;CD8+T;CA-125;Karnofsky score;CA72-4;C3;IgM;CA19-9;EORTC QLQ-HCC18;Alpha fetal protein;Carcinoembryonic antigen;IgA;C4;CD4+T;IgG;	—

Countries

China

Contacts

Public ContactYuli Wang

Shanghai Municipal Hospital of Traditional Chinese Medicine

505789385@qq.com+86 18918565850

Outcome results

None listed

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