The randomized controlled multicenter clinical study of compound Kushen Injection to reduce the radiotherapy related adverse reactions in lung cancer

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-14005482

Enrollment

Unknown

Registered

2014-10-16

Start date

2014-10-25

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

Lung cancer

Interventions

A:Radiatherapy

B:Radiatherapy +compound Kushen Injection

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Before the start of the study, All patients have been fully understood the reseach and the must sign the informed consent; (2) To be aged from 18 to 75 years old, both gender; (3) The lung cancer diagnosis must be proved by pathology; (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 more than at least 10mm (Malignant lymph nodes on CT scans short diameter less than at least 15 mm); (5) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2; (6) Lung function FEV1 more than at least 1Land more than 50% A normal value; (7) The function of each organ is basically normal :ANC more than 1.5*10^9/L, Platelet count more than 100*10^9/L, Hb more than 9.0g/dl, BIL at normal level or less than 1.5*ULN, AST (SGOT), ALT (SGPT) less than 2.5*ULN(less than 5*ULN, if with liver metastases), SCr less than 1.5*ULN; (8) The expected survival tme must more than 6 months.

Exclusion criteria

Exclusion criteria: (1) Lung or mediastinal have received radiotherapy before or ever treated with Compound Kushen Injection within 2weeks; (2) Pregnancy or lactation women; (3) Patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy; (4) paticipating or within the last 30 days participated in other clinical trials; (5) Hypersensitiveness to any kind of trial regime; (6) Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence; (7) Estimating the compliance of patients to participate in this clinical trial is insufficient.

Design outcomes

Primary

Measure	Time frame
The incidence and the degree of adverse reactions caused by RT;	—

Secondary

Measure	Time frame
The rate of completing radiotherapy;Clinical Symptoms;Quality of Life;Weight;ECOG PS;	—

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