Clinical trial NCT05735028: The Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer
Official title: A Preliminary Study on the Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lung Cancer
Keywords: lung cancer
Centipeda minima
efficacy
safty
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lung cancer has a high global cancer morbidity and mortality. At present, PD-1/PD-L1 inhibitors have been approved by FDA to treat different types of lung cancer, but the efficacy is not good. There is an urgent need to develop drugs that can significantly enhance the efficacy of PD-1/PD-L1 inhibitors to enable tumor patients to obtain lasting anti-tumor response. Centipeda minima (CM), as a commonly used traditional Chinese medicine, is relatively safe. Previous studies found that it can inhibit the growth of lung cancer cells. At the level of animal research, the combined use of CM and PD-1/PD-L1 inhibitors produced a stronger anti-lung cancer effect, and did not produce obvious side effects on mice. Based on previous studies, the main purpose of this study was to evaluate the efficacy and safety of PD-1/PD-L inhibitors combined with herbivorous herbivores (CM) in the treatment of lung cancer.


Eligibility criteria: 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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Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: through study completion, an average of 2 year.
measure: the temperature
timeFrame: through study completion, an average of 2 year.
measure: blood pressure
timeFrame: through study completion, an average of 2 year.
measure: complete blood count
timeFrame: through study completion, an average of 2 year.
measure: adverse event and severe adverse event
timeFrame: through study completion, an average of 2 year.
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: through study completion, an average of 2 year.
measure: disease control rate (DCR)
timeFrame: through study completion, an average of 2 year.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
Study officials:
affiliation: 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
name: Ying Dong, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: