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A Clinical Study on the Benefit of Kanglaite Injection for the Survival of Advanced Non-small Cell Lung Cancer

A Clinical Study on the Benefit of Kanglaite Injection for the Survival of Advanced Non-small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024319
Enrollment
Unknown
Registered
2019-07-06
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-12-16

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

Experimental group:Kanglaite Injection+Pemetrexed/Gemcitabine/Paclitaxel+Platinum
Control Group:Pemetrexed/Gemcitabine/Paclitaxel+Platinum

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Non-small cell lung cancer patients with stage III-IV initial chemotherapy confirmed by pathology or cytology; 2. Aged 18 to 75 years, male and female; 3. ECOG score 0-2; 4. The estimated survival time is more than 3 months; 5. According to RECIST 1.1 standard, there is at least one measurable lesion. 6. Voluntary participation in research and signing of informed consent, good compliance, with follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with brain metastasis; 2. Gene test results showed that EGFR or ALK or ROS1 positive or PD-L1 (> 50%) patients. 3. Patients with pleural effusion requiring therapeutic drainage and intrapleural injection of chemotherapeutic drugs; 4. Patients who are using or preparing to use targeted drugs; 5. Patients undergoing or preparing for pulmonary radiotherapy; 6. Patients undergoing or preparing immunotherapy for tumors; 7. Patients undergoing lipid-lowering therapy; 8. Pregnant or lactating women; women of childbearing age and their spouses can not take effective contraceptive measures during the period of clinical research and within 6 months after the end of the study; psychiatric patients; 9. Patients with severe uncontrolled organic lesions or infections, such as decompensated heart, lung and kidney failure, who are unable to tolerate chemotherapy; 10. Patients who received clinical trials of small molecular drugs within 10.28 days or macromolecular drugs within 3 months; 11. Patients known to be allergic or intolerable to drug allergies; 12. Researchers consider other conditions that prevent patients from participating in the trial.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
ORR;One-year survival rate;Quality of life;Cachexia signs;Living ability;blood fat;blood fat;Incidence of adverse reactions;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactJie Li

Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine Sciences

drjieli2007@126.com+86 15901270817

Outcome results

None listed

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