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AzTrials

Long-Term Effects Secondary to Cancer TherapyPhase 1NCT06356701

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

A Phase 1 study testing Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules) in people with Long-Term Effects Secondary to Cancer Therapy, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules)
How many people
120 participants
Where
1 siteChina
Study dates
15 Apr 2024to 31 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in this clinical study
  • Fully understand and know this research and sign the informed consent form.
  • Be 18-75 years old (inclusive) on the day of signing ICF.
  • Stage IV non-small cell lung cancer first diagnosed by histology or cytology. There is no known epidermal growth factor receptor (EGFR) sensitive mutation, anaplasticlymphomakinase (ALK) gene rearrangement and ros sarcoma oncogenic factor 1- receptor tyrosine kinase (ROS1) gene fusion.
  • The physical condition of 4.ECOG is 0-2, and the expected survival time is more than three months
  • It must have measurable target lesions judged by researchers according to RECIST v1.1.
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  • Subjects should provide tumor tissue samples collected at or after the diagnosis of stage IV NSCLC, which are fixed by formalin and can be used to determine the expression level of PD-L1.
  • Subjects must have sufficient organ function, which is evaluated according to the following laboratory examination results (and have not received medical support treatment such as blood transfusion, infusion of apheresis components, erythropoietin and granulocyte colony stimulating factor within 14 days before the administration of the study drug):
  • Except for hearing loss, alopecia and fatigue, all toxicity caused by previous anti-tumor treatments must have been restored to ≤ 1 grade.
  • Fertile women must have a serum pregnancy test within 7 days before the first medication, and the result is negative.
  • No obvious heart disease, no myocardial infarction in the past 6 months. Obvious congestive heart failure, obvious supraventricular arrhythmia, conduction block above grade II, acute myocardial ischemia or prolonged QT interval.
  • No antibiotics, probiotic foods or microecological agents were used in the first two weeks.

Who cannot join

  • Histologically identified as small cell lung cancer or with small cell components
  • Active or untreated central nervous system metastasis and/or cancerous meningitis.
  • Received major surgery except diagnostic biopsy within 4 weeks before the first medication, and received radical radiotherapy within 6 months before medication.
  • People with active autoimmune diseases, or those who have suffered from autoimmune diseases and are likely to recur.
  • Currently receiving systemic hormone therapy or using any other form of immunosuppressive therapy within 14 days before the first administration.
  • Other primary malignant tumors have appeared in the past five years, except for locally curable malignant tumors after radical treatment.
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  • Have received any antibody/drug (including PD-1, PD-L1, CTLA4, TIM3, LAG3, etc.) targeting T cell co-regulatory proteins (immune checkpoints).
  • Suffering from interstitial lung disease, or having a history of interstitial lung disease in the past and needing hormone therapy
  • Previous history of idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia and idiopathic pneumonia
  • Or those with active pneumonia proved by chest CT in screening period.
  • Received live vaccine inoculation within 28 days before the first drug administration.
  • Participated in other clinical research trials within 28 days before the first administration of the research drug, and received research drug treatment or used research equipment.
  • Chinese medicines with anti-tumor indications have been used within 14 days before the first administration of the study drug.
  • Have a history of inflammatory enteritis or have inflammatory bowel disease (such as Crohn's disease and ulcerative colitis).
  • There are serious acute and chronic infections.
  • Pleural effusion or pericardial effusion that cannot be controlled after appropriate intervention, or ascites that needs repeated drainage (once a month or more frequently).
  • Known history of alcoholism or drug abuse.
  • Pregnant or lactating women.
  • Have a history of drug allergy, such as pemetrexed, carboplatin, carboplatin or other platinum compounds, or their preventive drugs
  • Have an allergic history to paclitaxel or protein-bound paclitaxel components
  • Or asthma is not controlled.
  • Suffering from major cardiovascular diseases
  • Acute myocardial infarction, unstable angina pectoris, stroke and transient ischemic attack occurred in the first 6 months
  • Suffering from congestive heart failure (NYHA≥2)
  • Severe arrhythmia requiring medical treatment.
  • The researcher thinks that the subject's complications or other circumstances may affect the compliance with the protocol or be unsuitable for participating in this study.

Trial locations and contacts

1 site in 1 country.

DongYan Dong contact

18098876750

dongyan979828@hotmail.com

China1 site, 1 recruiting

  • DongYan

    Dalian, Liaoning, 116000

    DongYan Dong, 18098876750, dongyan979828@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: 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

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

Read the 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.

Being tested
Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules)
Keywords
lung cancer, Effect of nutritional therapy
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules)Dietary supplement

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    The time from the date of randomization until progression of disease according to RECIST 1.1 and iRECIST or death

    Measured: through study completion, an average of 1 year

  2. Assessment of global disorders in patients with cancer

    Quality of life of patients with NSCLC assessed by QLQ-C30

    Measured: "through study completion, an average of 1 year".

  3. 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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start15 Apr 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356701
Sponsor's protocol ID
dongyandl
Status last verified
Jan 2024
First submitted
20 Mar 2024
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules) in people with Long-Term Effects Secondary to Cancer Therapy, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact DongYan Dong (18098876750, dongyan979828@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06356701.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

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