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

Phase 1

Conditions: iver Cancer

Registration Number: ITMCTR2000003631

Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

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

(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.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival;Disease-free survival;

Secondary Outcome Measures

Name	Time	Method
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;