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A Randomized, Controlled, Multicenter Clinical Trial of Kangai Injection in Treatment Non-small Cell Lung Cancer in Elderly Patients (60-75 years old)

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003884
Enrollment
Unknown
Registered
2013-10-09
Start date
2013-04-23
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

NSCLC

Interventions

Experiment group:Kang ai injection 60 ml ivgtt D1-14 Q21d, combined with mono-chemotherapy
Control group:platinum-based doublet chemotherapy

Sponsors

Guang’anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of stage III-IV NSCLC according to pathology or cytology; 2. At least 1 objectively measurable Tumor lesion, maximum diameter>=20mm(via X-ray) or>=10mm (via CT); 3. ECOG PS score 0-2; 4. Expected survival>= 3 months; 5. Aged from 60 ~ 75; 6. Without operation indication or unwilling to surgical treatment; 7. with the indications of chemotherapy; 8. has stoped radiotherapy chemotherapy for at least 1 month; 9. Signed informed consent, with good compliance.

Exclusion criteria

Exclusion criteria: 1. Only with immeasurable lesions such as pleural effusion,pulmonary lymphangitic carcinomatosis, ascites, peritoneal cancer lesions, diffuse hepatic involvement, bone metastasis; 2. Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy; 3. using other experimental drugs or paticipate in other clinical trials at the same time; 4. patients allergic to the test drug; 5. psychiatric patients.

Design outcomes

Primary

MeasureTime frame
Disease Control Rate (DCR), Response Rate (RR), Overall survival (OS);

Secondary

MeasureTime frame
progression-free survival (PFS), Adverse Reactions, Clinical Symptoms, Weight, PS score, Quality of Life, Immunologic Function, Tumor Marker;

Countries

China

Contacts

Public ContactHongsheng Lin

Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences

drlinhongsheng@163.com+86 10 88001500

Outcome results

None listed

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