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A clinical study of Kanglaite combined with comprehensive treatment based on radiotherapy for lung cancer

A clinical study of Kanglaite combined with comprehensive treatment based on radiotherapy for lung cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087432
Enrollment
Unknown
Registered
2024-07-26
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Kanglaite Group: Receive Kanglaite injection and (or) soft capsules and combined with comprehensive treatment based on radiotherapy:None
Non-Kanglaite Group: Receive comprehensive treatment based on radiotherapy:None

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female, aged = 18 years; 2. Diagnosed as lung cancer by pathology or cytology; 3. ECOG score = 2; 4. Expected survival = 3 months; 5. Own at least one measurable lesion according to criteria of RECIST version 1.1; 6. Participants voluntarily and strictly comply with the requirements of the study protocol and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Central nervous system disorders (such as epilepsy, brain tumours) and other psychiatric disorders; 2. Only have non-measurable lesions, such as hydrothorax, ascites, diffuse hepatic invasion, bone marrow invasion; 3. Women in pregnancy or lactation, or in child-bearing period refusing contraception; 4. Received CYP3A4 inducers within 4 weeks, or CYP3A4 substrates or potent, moderate CYP3A4 inhibitors within 1 week before the study initiation; 5. Those with factors which significantly affect the absorption of orally administered drugs, such as chronic diarrhoea and intestinal obstruction; 6. Be allergy to Kanglaite injection or soft capsules or the drugs in the treatment regimen; 7. Received other herbal injections or excipients for 2 full cycles; 8. Incomplete information.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival, PFS;Objective response rate, ORR;

Secondary

MeasureTime frame
Overall Survival, OS;Quality of Life;Tumor markers;Indicators of immune function;Safety;Clinical efficacy;

Countries

China

Contacts

Public ContactHongbing Ma

The Second Affiliated Hospital of Xi'an Jiaotong University

mhbxian@126.com+86 139 9184 5066

Outcome results

None listed

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