A real-world research clinical trial for Fuzheng Kang'ai prescription to reduce adverse reactions caused by immune checkpoint inhibitors in patients with advanced non-small cell lung cancer

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300069345

Enrollment

Unknown

Registered

2023-03-14

Start date

2023-03-01

Completion date

Unknown

Last updated

2023-05-29

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

Treatment group:PD-1/PD-L1 inhibitor combined with chemotherapy plus Fuzheng Kangai prescription

Control group:PD-1/PD-L1 inhibitor combined with chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis of non-small cell lung cancer; 2. Clinical diagnosis of TNM stage IV (AJCC 8th edition); 3. 18-80 years old; 4. PS score; 5. Local lesions and/or distant metastases can be measured or evaluated; 6. Normal bone marrow, liver, kidney, heart and lung function; 7. Informed consent to participate in this study, signed the informed consent form, good compliance, can be followed up.

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled symptomatic brain metastases; 2. Patients with active recurrent cancer; 3. Patients wit mental disorders; 4. Patients with active tuberculosis and other serious infectious diseases.

Design outcomes

Primary

Measure	Time frame
Incidence of adverse reactions;	—

Secondary

Measure	Time frame
life quality score;Immune cell level evaluation;	—

Countries

China

Contacts

Public ContactXiaoshu Chai

Guangdong Provincial Hospital of Chinese Medicine

chaixiaoshu@126.com+86 135 7030 1605

Outcome results

None listed

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