Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy
This study evaluates the effect of the serum level of Superoxide Dismutase (SOD),
Malondialdehyde (MDA), pro-inflammatory factors, stress hormones and Glutathione peroxidase
(GSH-PX)in tumor patients with the treatment of Ganoderma lucidum spore based combination
chemotherapy. Half of participants will receive Ganoderma lucidum spore and chemotherapy in
combination, and the other half will receive a placebo and chemotherapy.
Study design: Phase 2. Experimental: Ganoderma lucidum spore & Chemotherapy; Placebo
Comparator: Placebo & Chemotherapy.
Outcome Measure:
1. The life quality of participants was assessed with use of the Functional Assessment of
Cancer Therapy-General (FACT-G) questionnaire at the initial diagnosis (baseline) and
at 42 days after the treatment;
2. Investigators assessed Procedural mortality factor ligand 1(PD-L1)expression
prospectively on tumour cells and tumour-infiltrating immune cells with the VENTANA
PD-L1 immunohistochemistry assay;
3. National Cancer Institute Common Toxicity Criteria.
Statistical analysis: All experiment results were analyzed with Statistical Product and
Service Solutions (SPSS) software (version 16.0). Data are presented as mean±standard
deviation and analysed by one-way ANOVA. Semi-quantitative data were compared using the
Kruskal- Wallis nonparametric analysis. The results were considered statistically
significant at P<0.05.
Ganoderma lucidum spore, as a natural substance is widely recognized and used in tumor
patients for its nutritive value. The effect has proved that Ganoderma lucidum spore which
has polysaccharide, triterpene compounds and the other trace elements, combined with
chemotherapy can reduce toxicity and enhance efficacy in patients.
Ganoderma lucidum spore can reduce bone narrow depression, gastrointestinal mucosal damage
and enhance the immunity. Previous studies have reported that Ganoderma lucidum spore have
antivirus, antineoplastic, decreasing blood lipids, hypoglycemic and anti-hypoxic
activities. The objective of this study is to observe the effect of Ganoderma lucidum spore
based combination chemotherapy in treatment of patients. And then to detect the serum level
of SOD, MDA, pro-inflammatory factors, stress hormones and GSH-PX.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
| Completed |
NCT04426825 -
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
| Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
Phase 3 | |
| Completed |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
| Recruiting |
NCT04592523 -
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
|
||
| Recruiting |
NCT04838548 -
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT04077463 -
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05167604 -
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
|
||
| Recruiting |
NCT04603807 -
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
|
Phase 3 | |
| Completed |
NCT04948411 -
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
|
||
| Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
| Not yet recruiting |
NCT04255836 -
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
| Completed |
NCT01953913 -
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
|
Phase 3 | |
| Recruiting |
NCT05715229 -
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
|
Phase 2 | |
| Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
| Suspended |
NCT05421936 -
Osimertinib for NSCLC With Uncommon EGFR Mutations
|
||
| Completed |
NCT02847377 -
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
|
N/A | |
| Completed |
NCT04427072 -
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
|
Phase 3 | |
| Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A |