Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer

ConditionLung Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

About this trial

This study will be an evaluation of the efficacy and safety of acupuncture to enhance the response rate of immunotherapy in advanced lung cancer. The main questions it aims to answer are 1. Does acupuncture heighten the response rate of immunotherapy in advanced lung cancer? 2. Does acupuncture heighten the safety of immunotherapy in advanced lung cancer? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could enhance the response rate of immunotherapy in advanced lung cancer. Both groups will receive a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy), and the experimental and control groups will be treated with 4 cycles of acupuncture or sham-acupuncture on top of the anti-tumor treatment regimen, respectively. Patients were followed up every three weeks for the first three months and every three months thereafter to record any disease progression, adverse events, survival or mortality status, and so on.

Eligibility criteria

Qualifiers

Age 18-75 years;

ECOG/PS score of grade 0-1 and expected survival ≥ 3 months;

Non-small cell lung cancer AJCC lung cancer staging of stage IIIB-IV, or small cell lung cancer staging of extensive stage;

PD-L1 immunohistochemistry detection of tumor cell positive proportion score (TPS) <50%;

Disqualifiers

Combined with other primary malignant tumors;

Those who have contraindications to immunotherapy after basic assessment of immunotherapy;

Those with autoimmune diseases or those who need long-term treatment with systemic steroids or immunosuppressants;

Those with combined serious and uncontrolled primary diseases of heart, cerebrovascular, liver, kidney, hematopoietic system and so on;

Trial design

Treatments tested in this trial

  • Acupuncture
  • Sham Comparator

Treatment groups

240 Participants
are divided into 2 treatment groups