A Randomized, Controlled, Multicenter Clinical Trial of Compound Kushen Injection for preventiing the radiotherapy related adverse reactions in cervical 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-14005483

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

cervical carcinoma

Interventions

A:CCRT

B:CCRT combined with Compound Kushen Injection

Eligibility

Sex/Gender

Female

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Before the start of the study, All patients have been fully understood and the willingness to sign informed consent; (2) Age from 18 to 75 years; (3) The cervical carcinoma diagnosis must be proved by pathology, and tend to will recieve radiotherapy; (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 smaller than at least 15 mm); (5) Eastern Cooperative Oncology Group (ECOG) performance status less than at least 2; (6) 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; (7) The survival time must more than 6 months of expected.

Exclusion criteria

Exclusion criteria: (1) Ever received Compound Kushen Injection therapy within 2 weeks; (2) The patients of the pelvic ave hreceived radiotherapy before; (3) Pregnant or lactating women; (4) Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart, lung,kidney failure can lead to tolerance of chemotherapy; (5) paticipating or within the last 30 days participated in other clinical trials; (6) Hypersensitiveness to any kind of trial regime; (7) Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence; (8) 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;The rate of completing radiotherapy;Clinical Symptoms;	—

Secondary

Measure	Time frame
Quality of life;Objective Response Rate (ORR);Weight;ECOG PS;Tumor Marker;	—

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