The Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05735028

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Centipeda minima+PD-1/PD-L1 inhibitor Drug: PD-1/PD-L1 inhibitor	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Preliminary Study on the Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer

Anticipated Study Start Date :

Feb 7, 2023

Anticipated Primary Completion Date :

Feb 7, 2024

Anticipated Study Completion Date :

Feb 7, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CM group CM+PD-1/PD-L1 inhibitor	Drug: Centipeda minima+PD-1/PD-L1 inhibitor Before routine anti-PD-1/PD-L1 treatment, patients were treated with Centipeda minima, and15g Centipeda minima decoction was taken twice a day for 5 consecutive days.
Active Comparator: Control group PD-1/PD-L1 inhibitor	Drug: PD-1/PD-L1 inhibitor PD-1/PD-L1 inhibitor

Arm

Intervention/Treatment

Experimental: CM group

CM+PD-1/PD-L1 inhibitor

Drug: Centipeda minima+PD-1/PD-L1 inhibitor

Before routine anti-PD-1/PD-L1 treatment, patients were treated with Centipeda minima, and15g Centipeda minima decoction was taken twice a day for 5 consecutive days.

Active Comparator: Control group

PD-1/PD-L1 inhibitor

Drug: PD-1/PD-L1 inhibitor

PD-1/PD-L1 inhibitor

Outcome Measures

Primary Outcome Measures

Progression-free survival (PFS) [through study completion, an average of 2 year.]
Progression-free survival
the temperature [through study completion, an average of 2 year.]
Vital signs
blood pressure [through study completion, an average of 2 year.]
Vital signs
complete blood count [through study completion, an average of 2 year.]
laboratory index
adverse event and severe adverse event [through study completion, an average of 2 year.]
adverse event and severe adverse event, according to NCI-CTC V5.0

Secondary Outcome Measures

Objective Response Rate (ORR) [through study completion, an average of 2 year.]
Objective Response Rate
disease control rate (DCR) [through study completion, an average of 2 year.]
disease control rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Exclusion Criteria:

Patients who plan to receive other traditional Chinese medicine treatment at the same time during the study period.
Those who are hypersensitive to any research drugs or ingredients
Those who have severe acute infection and are not controlled; or those who have suppurative and chronic infection and whose wounds are not healed.
Obvious gastrointestinal diseases during screening, such as inability to swallow, chronic diarrhea, intestinal obstruction, gastric ulcer and so on.
Those who have participated in clinical trials of other drugs within 5 or 4 weeks.
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.
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.
Those with bleeding tendency; evidence of hereditary hemorrhagic physique or blood coagulation disorder
Severe allergic / allergic reaction to humanized antibody.
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).
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).
Vulnerable groups: such as patients with serious diseases, incapacitated, illiterate, mentally retarded / related mental disorders, children.