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RECRUITING

NCT06926140

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

Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

View on ClinicalTrials.gov

Summary

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.

Official title: Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-06-21

Completion Date

2028-07-31

Last Updated

2025-07-24

Healthy Volunteers

Conditions

Lung Cancers

Interventions

DEVICE

Acupuncture

Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the acupuncture group is combined with acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the press needle treatment 4 times each, once a day, for four consecutive synergistic cycles, for a total of 24 times. The main acupuncture points are Guanyuan (Ren Mai 4), Shangyintang (EX-HN3), Taiyang (EX-HN5), Taichong (Liv-3), Zusanli (ST-36), and Xin (CO-15).

DEVICE

Sham Comparator

Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the sham acupuncture group is combined with sham acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of sham acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the sham press needle treatment 4 times each, once a day, for four consecutive synergistic cycles, for a total of 24 times. The main acupuncture points are Guanyuan (Ren Mai 4), Shangyintang (EX-HN3), Taiyang (EX-HN5), Taichong (Liv-3), Zusanli (ST-36), and Xin (CO-15).

Inclusion criteria: * 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%; * Non-small cell lung cancer adenocarcinoma patients do not have EGFR-sensitive mutations, ALK fusions, ROS1 fusions, BRAFV600 mutations, NTRK fusions, RET fusions, MET14 skipping mutations, and amplified gene-driven mutations by genetic testing; * Patients with no previous systemic therapy/first-line treatment; * Patients suitable for chemotherapy combined with immunotherapy; * Traditional Chinese Medicine (TCM) diagnosis of Qi Depression; * Having at least 1 measurable tumor lesion (diameter \> 1cm) or lymph node short diameter ≥ 1.5cm; * Sign the informed consent form and voluntarily participate in this study. Exclusion criteria: * 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; * Those with metal allergy or severe fear of needles; * Those who are pregnant or breastfeeding; * Those who are unable to cooperate to complete the assessment due to mental disorder, intellectual or language impairment; * Those with active severe infectious or inflammatory diseases; * Those who have received acupuncture treatment or other clinical trials within 1 month prior to randomization; * In the judgment of the investigator, persons who have a concomitant medical condition that seriously jeopardizes the safety of the participant or interferes with the completion of the study, or who are deemed to have other reasons for not being suitable for enrollment.

Locations (3)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital

Changsha, Hunan, China