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A multicentered, double-blind, randomized study of Fuzheng syndrome differentiation treatment combined with chemotherapy as the first-line treatment of driver mutation-negative advanced NSCLC

A multicentered, double-blind, randomized study of Fuzheng syndrome differentiation treatment combined with chemotherapy as the first-line treatment of driver mutation-negative advanced NSCLC

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036074
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-07

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, NSCLC

Interventions

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Stage IV NSCLC patients diagnosed by pathology or cytology; 2. Tissue or blood test negative for driver mutation; 3. Did not receive any first-line anti-tumor therapy; 4. TCM syndrome differentiation as Qi deficiency type, Yin deficiency type or Yin deficiency type; 5. Expected survival >= 3 months; 6. Age between 18 and 75 years old (including 18 and 75 years old); 7. PS 1.5 x10^9/L, PTL > 100 x 10^9/L, Hb > 100mg/dl, liver and kidney function is basically normal; 9. The patient has good compliance, can understand the situation of this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. PD-L1 TPS >= 50%; 2. With serious diseases of other systems; 3. Pregnant or breastfeeding women; 4. With history of uncontrollable mental illness; 5. Allergic to study drugs.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Treg;sPD-L1;1-year survival;Quality of Life;

Countries

China

Contacts

Public ContactLingshuang Liu

Longhua Hospital Shanghai University of Traditional Chinese Medicine

liuls107@163.com+86 18917763369

Outcome results

None listed

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