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A randomized controlled trial of traditional Chinese medicine in the treatment of primary liver cancer

A randomized controlled trial of traditional Chinese medicine in the treatment of primary liver cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-07000033
Enrollment
Unknown
Registered
2007-03-01
Start date
2006-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Hepatocellular carcinoma

Interventions

Group 4:Advanced liver cancer. 1. TACE
2. Cinobufotalin 50ml ivgtt. q.d for Day 1 – 10
Kangsaidi 0.75g po. Bid. or Huai-er 20g po. Bid
TCM decoction 100ml po. Bid. Cinobufotalin be used between the first and the second TACE
then use one therapy course every two months or every two months after a year
Group 3:TACE for advanced liver cancer. Perform CT or MRI every 1.5 or 2 months after the first TACE,every 2 or 3 months after the second TACE, only if lesions active. If there are contraindications,
Group 2:Postoperative small hepatocellular carcinoma. Inject epirubicin, fluotouracil, mitomycin, lipiodol in proper left or right hepatic artery and form emulsion embolism with ultra-fluid lipiodol.
Group 1:TCM for postoperative small hepatocellular carcinoma. (1) Cinobufotalin 50ml ivgtt. q.d. (2) Cinobufotalin 2 pills po. t.i.d. (3) TCM decoction 100ml po. t.i.d. Use one course (10 days) every

Sponsors

Changhai Hospital, The Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Study one: 1. patients with small hepatocellular carcinoma in age of 18 to 70 years; 2. radical correction was received, a maximum single tumor diameter of 5 cm or less in perioperative discover; 3. in three mouthes after radical correction; 4. ECOG score less than 3; 5. patients partaked voluntary and signed in the informed consent. Study two: 1. patients with advanced primary liver cancer in age of 18 to 70 years; 2. A confirmed diagnosis in all patients consistent with diagnostic criteria of HCC was made by the academic congress about diagnosis HCC in China in 2001; 3. IIa, IIb, IIIa stages, are performed in compliance with diagnostic criteria of HCC was made by the academic congress about diagnosis HCC in China in 2001; 4. survival time more than 3 months; 5. ECOG score less than 3.

Exclusion criteria

Exclusion criteria: Study one: 1. Child-Pugh class A or B of Liver function; 2. recrudescence and metabasis in or out liver; 3. the patients have treated by TACE or other methods of antineoplaston; 4. active hepatitis are treating with antiviral therapy; 5. renal inadequacy, Cr=133 umol/L; 6. other diseases may impact the therapeutic effects; 7. accompanied with history of other Malignant tumor; 8. attending other medicine trail in the same time; 9. pregnant or lactant female, patients are of supersensitivity, or the definite adverse effect or taboo to the schema. Study two: 1. serious hepatosis, Child-pugh class C; 2. portal hypertension accompany antidrom-blood current and block in main portal vein, but less blood vessel branch formed; 3. over 70 percents volume occupied by tumour; 4. renal inadequacy, chronic kidney disease (CKD) was three stage or less; 5. white blood cell less than 3.0*10^9/L; 6. exhaustion of condition in body; 7. other anti-tumor medicines may effect blood routine and immune function; 8. the definite adverse effect or taboo to the schema; 9. accompanied with history of other Malignant tumor; 10. accompanied other diseases may impact the therapeutic effects.

Design outcomes

Primary

MeasureTime frame
Time To Progression (TTP);Relapse rate;Mortality;Quality of life;TCM syndrome;

Secondary

MeasureTime frame
AFP;Adverse effects;Immune function;Angiogenesis related factors;Remission rate;

Countries

China

Contacts

Public ContactLing Chang-quan
lingchangquan@hotmail.com+86 21 25070881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 24, 2026