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A randomized controlled multicenter clinical study of compound Kushen Injection combined with single-agent chemotherapy in elderly patients of advanced NSCLC

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-14005484
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

Non-small cell lung cancer

Interventions

A:Platinum-based two bites MDT
B:Single-acemotherapy combined compound Kuhshen Injectiongent

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 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 the informed consent; (2) Aged from 60 to 75 years old,Sex unlimited; (3) III-IV stage NSCLC must be diagnosis by pathology; (4) According to RECIST, At least 1 Measurable lesions without local treatment, Spiral CT or MRI, maximum diameter larger than at least 10mm (Malignant lymph nodes on CT scans short diameter larger than at least 15mm); (5) Eastern Cooperative Oncology Group (ECOG) performance status less than at least 2; (6) The basic normal organ function, WBC more than 3.0*10^9/L; NEUT# more than 1.5*10^9/L; PLT more than 60*10^9/L; HGB more than 8.0g/dl; BIL at normal level or less than 1.5*ULN; AST(SGOT), ALT(SGPT) less than 2.0*ULN); SCr less than 1.5*ULN; (7) Expected survival time must more than 3 months.

Exclusion criteria

Exclusion criteria: (1) Ever received compound Kushen therapy within 2 weeks; (2) Pregnancy or lactation women; (3) Only with immeasurable lesions such as pleural effusion,pulmonary lymphangitic carcinomatosis, ascites, peritoneal cancer lesions, diffuse hepatic involvement, bone metastasis; (4) Patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy; (5) participating in another clinical study or have participated in another clinical study within 30 days; (6) Aallergic to the testing compound.

Design outcomes

Primary

MeasureTime frame
Disease control rates;Objective response rate;Progression-free surial;

Secondary

MeasureTime frame
Overall survival;Quality of Life;Clinical Symptoms;Tumor markers;weight;Adverse reactions;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: Mar 2, 2026