Combining PD-1/PD-L1 inhibitors with Centipeda minima for lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of combining PD-1/PD-L1 inhibitors with Centipeda minima (CM) in patients with non-small cell lung cancer (NSCLC). Previous animal studies indicated that this combination may enhance anti-tumor effects without significant side effects. Participants will receive either the combination treatment or PD-1/PD-L1 inhibitors alone, with the aim of determining if CM can improve treatment outcomes. The study will involve patients aged 18-70 who have a confirmed diagnosis of NSCLC and meet specific health criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with non-small cell lung cancer diagnosed by histopathology and intended to be treated with PD-1/PD-L1 inhibitors alone meet the following conditions:

1. Patients fully understand this study and voluntarily participate in and sign informed consent.
2. Patients with non-small cell lung cancer (NSCLC) confirmed by histopathology will be treated with PD-1/PD-L1 alone.
3. 18-70 years old, and the expected survival time is more than 6 months.
4. The indexes of stool routine are normal.

Exclusion Criteria:

1. Patients who plan to receive other traditional Chinese medicine treatment at the same time during the study period.
2. Those who are hypersensitive to any research drugs or ingredients
3. Those who have severe acute infection and are not controlled; or those who have suppurative and chronic infection and whose wounds are not healed.
4. Obvious gastrointestinal diseases during screening, such as inability to swallow, chronic diarrhea, intestinal obstruction, gastric ulcer and so on.
5. Those who have participated in clinical trials of other drugs within 5 or 4 weeks.
6. Patients with severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease and intractable hypertension.
7. Suffering from uncontrollable neurological, mental illness or mental disorders, poor compliance, unable to cooperate and describe the treatment response. Primary brain tumor or central nervous system metastasis is not controlled, with obvious intracranial hypertension or neuropsychiatric symptoms.
8. Those with bleeding tendency; evidence of hereditary hemorrhagic physique or blood coagulation disorder
9. Severe allergic / allergic reaction to humanized antibody.
10. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiological doses of glucocorticoids (prednisone or equivalent for ≤ 10mg/ days).
11. Exclude subjects with active, known or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes).
12. Vulnerable groups: such as patients with serious diseases, incapacitated, illiterate, mentally retarded / related mental disorders, children.

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Where it's running

• The Second Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, China Recruiting

Study contacts

• Principal investigator: Ying Dong, Doctorate — 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Ying Dong, Doctorate
• Email: dongying74@zju.edu.cn
• Phone: 13666669105

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.