A Single-center, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Tumor Nutritional Therapy Combined With Immune Checkpoint Inhibitors and Chemotherapy in the First-line Treatment of Stage IV NSCLC Without Driver Gene Mutations
Main purpose: Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules) combined with immune checkpoint inhibitors and chemotherapy in the first-line treatment of stage IV non-small cell lung cancer without driver gene mutations efficacy in.Secondary purpose: Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules) combined with immune checkpoint inhibitors and chemotherapy in the first line of stage IV non-small cell lung cancer without driver gene mutations Safety in treatment.Exploratory purpose: Tumor nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules) combined with immune checkpoint inhibitors and chemotherapy in the first line of stage IV non-small cell lung cancer without driver gene mutations The relationship between the number of T cell subpopulations and changes in inflammatory factors during treatment and the therapeutic effect, and whether the T cell subpopulation analysis method can effectively monitor and evaluate the status of the tumor immune microenvironment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Medication for Research : * Spirulina Bifidobacterium Capsules * Fish Oil Grape Seed Blueberry Soft Capsules; * Ganoderma Lucidum Sporoderm Oil Soft Capsules; oral administration. non-squamous cell carcinoma Drug: Pemetrexed+Cisplatin (or carboplatin) * Sintilimab Injection/Camrelizumab/Tislelizumab/Atezolizumab Injection IV infusion squamous cell carcinoma Drug:Paclitaxel+ Cisplatin (or carboplatin) * Sintilimab Injection/Camrelizumab/Tislelizumab/Atezolizumab Injection IV infusion
DongYan
Dalian, Liaoning, China
RECRUITINGPFS
The time from the date of randomization until progression of disease according to RECIST 1.1 and iRECIST or death
Time frame: through study completion, an average of 1 year
Assessment of global disorders in patients with cancer
Quality of life of patients with NSCLC assessed by QLQ-C30
Time frame: "through study completion, an average of 1 year".
ORR
The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per RECIST 1.1 and iRECIST
Time frame: through study completion, an average of 1 year
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