PD-1 inhibitors plus platinum-based chemotherapy with or without electroacupuncture in patients with previously untreated advanced NSCLC: A pilot study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064572

Enrollment

Unknown

Registered

2022-10-12

Start date

2022-11-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Lung cancer

Interventions

Group 1:PD-1 inhibitors plus platinum-based chemotherapy with electroacupuncture

Group 2:PD-1 inhibitors plus platinum-based chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Locally advanced or metastatic non-small cell lung cancer diagnosed by tissue or cytopathology without bone metastasis; 2. Genetic testing shows that the driver genes (EGFR, ALK) are negative; 3. Have not received anti-tumor therapy (chemotherapy, radiotherapy, targeted, immune and radiotherapy, etc.) in the past; 4. PS score (ECOG) = 60 ml/min; normal liver function: total serum bilirubin level <= 1.5 times the upper limit of normal (ULN), serum aspartate Transaminase (AST) & alanine aminotransferase (ALT) 2.5 times ULN; 8. Sign the informed consent form, the patient voluntarily accepts the treatment of this program, and those with good compliance.

Exclusion criteria

Exclusion criteria: 1. Unable to complete the baseline assessment form; 2. Pregnant and lactating women; 3. Skin ulceration at selected acupuncture points affects treatment; 4. Combined with other serious diseases, including uncontrolled active infection, severe electrolyte disturbance, and obvious bleeding tendency; 5. Combined with autoimmune diseases, blood system diseases, or long-term use of hormones or immunosuppressants; 6. Combined with other uncontrolled tumors; 7. Combined with serious brain disease or mental disease that affects the patient's self-prosecution ability; 8. History of combined organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); 9. Persons without legal capacity, medical or ethical reasons that affect the continuation of the research.

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR);	—

Secondary

Measure	Time frame
Progression free survival (PFS);Disease control rate (DCR);Overall survival (OS);Generalized Anxiexy Disorde-7 (GAD-7);Patient health question-9 (PHQ-9);Adreno-cortico-tropic-hormone (ACTH);Cortisol (CORT);lymphocyte subsets;Gut microbiome;	—

Countries

China

Contacts

Public ContactZhang Haibo

Guangdong Provincial Hospital of Chinese Medicine

haibozh@gzucm.edu.cn+86 1324123615

Outcome results

None listed

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