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A prospective randomized controlled study of erzhu Jiedu Decoction combined with antiviral therapy for advanced hepatitis B associated liver cancer (spleen deficiency damp-heat type primary liver

A prospective randomized controlled study of erzhu Jiedu Decoction combined with antiviral therapy for advanced hepatitis B associated liver cancer (spleen deficiency damp-heat type primary liver

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005654
Enrollment
Unknown
Registered
2022-02-23
Start date
2022-03-01
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

HBV-related hepatocellular carcinoma

Interventions

Control group:conventional western treatment
therapy group:Ershu Jiedu Decoction Granules on the basis of conventional western treatment

Sponsors

Shuguang Hospital affiliated with Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who met the western and Traditional Chinese diagnostic criteria for hepatitis B associated liver cancer, were unable to accept surgery, TACE and ablation, and were unable to tolerate or unwilling to accept palliative first-line (sorafenib, renvaritinib) and second-line (regolfinib) system treatment. ?(2) Aged between 18 and 70, male or female. ?(3) China liver cancer staging (CNLC) was stage IIIa, IIIb or IV. ?(4) Karnofsky Performance Scale (KPS) score =60. ?(5) Child-Pugh score of liver function =9. ?(6) Estimated survival =3 months. ?(7) Patients and their families are willing to cooperate with follow-up. ?(8) Agree to participate in the project and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women. (2) Patients with obvious coagulation mechanism disorder and bleeding tendency. (3) patients with serious heart, brain, lung and other important organ diseases or serious complications (complicated with hepatic encephalopathy, refractory ascites, hepatorenal syndrome etc.) or with systemic severe infection. (4) Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
lab indication;Quality of life;Safety index;liver imageological examination;the syndrome of traditional chinese medicine;

Countries

China

Contacts

Public ContactYang Cheng
drchengyang@126.com13817231670

Outcome results

None listed

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