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Exploratory and observational study for traditional chinese medicine decoction on advanced primary hepatocellular carcinoma

Exploratory and observational study for traditional chinese medicine decoction on advanced primary hepatocellular carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024700
Enrollment
Unknown
Registered
2019-07-22
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

Primary hepatocellular carcinoma

Interventions

Sponsors

Beijing Changli Chenghua Medical Clinic
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years, both male and female; (2) According to the Standard for Diagnosis and Treatment of Primary Hepatocellular Carcinoma (2017 edition), patients with advanced primary hepatocellular carcinoma whose stage IIb is over and cannot be resected surgically are unable to receive palliative surgical treatment, and there is at least one measurable lesion (according to RECIST 1.1 edition, the length of spiral CT scanning of the measurable lesion is more than 10 mm). Or enlarged lymph nodes with short diameter (> 15 mm) and maximum tumors (< 10 cm): (3) those with a life expectancy of more than 12 weeks; (4) Child-Pugh score of liver function was less than 7, and BCLC stage was B or C. (5) The main organs have normal functions and no other organs fail. (6) Those willing to accept research intervention and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Complete embolization of the main portal vein with few collateral vessels; (2) Extrahepatic diffusion, including patients with inferior vena cava invasion; (3) Patients preparing for liver transplantation, radiotherapy, chemotherapy or other operations; (4) Patients with diffuse hepatocellular carcinoma; (5) In the past (within 5 years) or concurrently with other incurable malignant tumors, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; (6) Coagulation dysfunction (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), prone to bleeding or undergoing thrombolysis or anticoagulation therapy; coagulation function was severely impaired and could not be corrected; (7) There are many factors affecting oral medicines (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption). (8) Suffered from myocardial ischemia or myocardial infarction above grade II and arrhythmia with poor control (including QTc interval (>= 450ms for males and (>= 470ms for females); (9) Patients with severe abnormal pulmonary function; (10) Tumor volume exceeded 70% of liver volume. (11) Patients with central nervous system metastasis or known brain metastasis; (12) Patients with active hemorrhage, gastric varices, bone metastasis, brain metastasis and anemia; (13) patients with gastrointestinal ulcer, intestinal perforation or intestinal obstruction; (14) Patients with past and present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of pulmonary function by pulmonary function tests; (15) In patients with hypertension, blood pressure was still poorly controlled by antihypertensive drugs (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg). (16) Urinary routine showed that urinary protein (++) or confirmed 24-hour urinary protein quantification (>1.0g); (17) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures; (18) Having a history of mental illness or abuse of psychotropic drugs; (19) Patients with HIV infection; (20) Other researchers do not consider it appropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
CT/MRI;AFP;survival status;staging of hepatocellular carcinoma;B-mode ultrasonography;blood routine;urine routine;liver and kidney function;electrocardiogram;coagulation function;death;surgical treatment;surgical treatment;radiotherapy and chemotherapy;12 weeks after treatment;

Secondary

MeasureTime frame
complications;patient demographic information;combined drug use;

Countries

China

Contacts

Public ContactChang Yongliang

Beijing Changli Chenghua Medical Clinic

changyonglianghao@163.com+86 13810782495

Outcome results

None listed

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