A randomized controlled multicenter clinical study of compound Kushen Injection combined with TACE in treating the primary hepatic carcinoma.

Post-marketing Clinical Research on compound Kushen Injection in Treatment of Malignant Neoplasm

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15005894

Enrollment

Unknown

Registered

2014-12-29

Start date

2014-12-23

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

primary hepatic carcinoma

Interventions

A:TACE

B:TACE combined with Compound Kushen Injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1)Before the start of the study, All patients have been fully understood and the willingness to sign the informed consent; (2)Age from 18 to 75 years old, Sex unlimited; (3)Middle and advanced primary liver cancer, Unable to surgery,The proportion of ?tumor of the liver less than 70%; (4)According to RECIST (version 1.1), At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter larger than at least 10mm (Malignant lymph nodes on CT scans short diameter larger than at least 15 mm); (5)Child-PughScore less than 10; (6)Eastern Cooperative Oncology Group (ECOG) performance status less than 2; (7)The function of each organ is basically normal: WBC more than 3.0*10^9/L, Platelet count more than 70*10^9/L, Hb more than 9.0g/dl, SCr less than 1.5*ULN; (8)Expected survival time must more than 3 months.

Exclusion criteria

Exclusion criteria: (1)Ever received compound Kushen therapy within 2 weeks; (2)Blood coagulation function has Serious declined,and unable to correct. (3)Portal venous trunk was completely stuffed with tumor emboli,and less collateral circulation formation. (4)extrahepatic metastasis. (5)Plans for a liver transplantation. (6)Pregnancy or lactation women; (7)Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart, lung,kidney failure can lead to tolerance of chemotherapy; (8)participating in another clinical study or have participated in another clinical study within 30 days; (9)Aallergic to the testing compound; (10)Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence; To be expected with poor compliance.

Design outcomes

Primary

Measure	Time frame
The incidence of adverse reactions and degree(liver injury,pain);	—

Secondary

Measure	Time frame
Clinical Symptoms;pain;Quality of Life;DCR;Weight;KPS;immune function;Tumor markers;	—

Countries

China

Contacts

Public ContactHongsheng Lin

dr.liujie@163.com+86 13718716339

Outcome results

None listed

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