NCT06356701

Tumor Nutritional Therapy in the First-line Treatment of Stage IV NSCLC

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The First Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Long-Term Effects Secondary to Cancer Therapy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules)	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

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: China