Nanocrystalline Megestrol + Immunochemo As 1st-Line for ES-SCLC Cachexia
ConditionSCLC, Extensive Stage
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital
About this trial
This study hypothesizes that nanocrystalline megestrol acetate can improve the cachexia condition in patients and enhance the efficacy of immunochemotherapy regimens. It plans to enroll patients newly diagnosed with extensive-stage small-cell lung cancer (ES-SCLC) who are in the pre-cachexia or cachexia stage of the cachexia trajectory. These patients will receive first-line standard immunochemotherapy combined with nanocrystalline megestrol acetate intervention. Compared to the use of the first-line standard immunochemotherapy regimen alone, the study will monitor changes in body weight and body composition, which are nutritional status indicators relative to baseline, to assess whether these changes can translate into improved survival benefits and enhanced quality of life for patients.
The objective of this clinical study are：1.To assess the change in body weight relative to baseline in malignant patients with ES-SCLC treated with a first-line standard immunochemotherapy regimen during treatment with a simultaneous co-administration of nanocrystalline megestrol supportive intervention, compared to standard treatment. 2.To assess the impact of simultaneous co-administration of nanocrystalline megestrol supportive intervention during treatment with a first-line standard immunochemotherapy regimen, compared to standard treatment, on survival benefit and quality of life in patients with ES-SCLC malignancy. 3.To explore the improvement in inflammatory and nutritional markers and changes in lymphocyte subpopulations in patients with ES-SCLC malignant disease with simultaneous co-administration of nanocrystalline megestrol supportive intervention during treatment with a first-line standard immunochemotherapy regimen, compared to standard treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Good compliance and voluntary signing of a written informed consent form (ICF).
Age at enrolment ≥18 years, ≤75 years, and gender-neutral (patients >75 years old will be enrolled in the RWS cohort).
Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2 (patients with PS 3 and above due to oncological factors can be enrolled in the CU cohort or RWS cohort).
Expected survival ≥ 6 months.
Disqualifiers
Presence of malignant conditions other than those caused by oncological etiology such as chronic respiratory failure requiring home oxygen support, chronic obstructive pulmonary disease, chronic and persistent congestive heart failure, acquired immunodeficiency syndrome, uncontrollable thyroid disease.
Presence of any condition that interferes with gastrointestinal absorption such as dysphagia, malabsorption, previous history of gastrectomy, or uncontrollable vomiting; being on tube feeding or parenteral nutrition; presence of anorexia nervosa, anorexia due to psychiatric disorders, or pain that makes it difficult to eat.
Being on other appetite or weight-increasing medications such as: adrenocortical steroids (except for short-term use of dexamethasone during chemotherapy), androgens, progesterone analogues, thalidomide, and anamorelin or other appetite stimulants.
Use of any proprietary or herbal medicine used for cancer control within 14 days prior to the first dose of study drug.
Trial design
Design model
Parallel
Treatments tested in this trial
Nanocrystalline Megestrol Acetate
DrugNanocrystalline Megestrol Acetate + Tislelizumab+ Chemotherapy (Carboplatin + Etoposide)
Tislelizumab
DrugTislelizumab combined with chemotherapy (Carboplatin + Etoposide)
PTOC
DrugNanocrystalline Megestrol Acetate+PD-(L)1 inhibitors+chemotherapy
Treatment groups
250 Participants
are divided into 4 treatment groupsGroup A: criteria-fulfilled (CF) cohortExperimental treatment 1 intervention
Group B: Criteria-fulfilled(CF) cohortActive comparator 1 intervention
Group C: compassionate use (CU) cohortOther 1 intervention
Group D: prospective real-world study (RWS) cohortOther 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of weight increase relative to baseline > 5% (Week 12)
The proportion of weight increase relative to baseline \> 5% (Week 12)
Time frame
after 12 weeks of treatmentSecondary outcomes
1
Objective Response Rate
Proportion of patients with reduction in stable in tumor burden of a predefined amount，Baseline until partial response (PR) or complete response (CR), whichever occurs first，assessed up to 12 months
Time frame
From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months2
Progression Free Survival (PFS)
Time from random to either radiological progression or death
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months3
overall survival (OS )
Time from the first treatment to death from any cause or the end of the study
Time frame
From date of randomization until the date of first documented date of death from any cause, assessed up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: