Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03407300
Status:
UNKNOWN
Last Update Posted:
2018-09-13
First Post:
2018-01-12
Brief Title:
A Safety and Efficacy Trial of Docetaxel With or Without XH1 in Non-small Cell Lung Cancer NSCLC Patients
Sponsor:
Haining Health-Coming Biotech Co Ltd
Organization:
Haining Health-Coming Biotech Co Ltd
Study Overview
Official Title:
A Prospective Randomized Clinical Study of Safety and Efficacy by Using Docetaxel With or Without Traditional Chinese Medicine XH1 in Patients With Stage ⅢB-Ⅳ Non-small Cell Lung Cancer NSCLC Who Failed With First-line Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomized multicenter clinical study designed to evaluate its safety and efficacy by using Docetaxel with or without Traditional Chinese Medicine XH1 in patients with Stage ⅢB-Ⅳ Non-small Cell Lung Cancer NSCLC who failed with first-line Chemotherapy The primary outcome measure includes progression-free survival PFS after treatment Secondary outcome measures include collecting biomarkers before and during treatment overall survival OS objective response rate ORR disease control rate DCR and patients quality of life
Detailed Description:
Lung cancer is one of the most common malignant tumors in the world and has become the No 1 cause of death from malignant tumors in China Non-small cell lung cancer NSCLC includes squamous cell carcinomas adenocarcinomas and large cell carcinomas and accounts for about 80-85 of all lung cancers NSCLC cancer cells divide slowly in a diffusive manner and metastasize at a relatively late stage compared to small cell carcinomas A majority of patients with NSCLC are already in advanced stages and have a low 5-year survival rate
Treatments for advanced NSCLC include chemotherapy and targeted therapies Platinum is currently used in the first-line treatment combination with Pemetrexed gemcitabine docetaxel paclitaxel vinorelbine and etc For EGFR mutation negative patients chemotherapy remains to be the preferred treatment of choice Selection of chemotherapy regimes should take full account of patients condition including patients physical condition Assessments regarding patients possible benefits from chemotherapy should include timely evaluation of efficacies close observation of adverse events and effective control of adverse reactions Traditional Chinese Medicine TCM has in recent years become an important adjunct for lung cancer treatment TCM has been shown to be effective in stabilizing the tumor prolonging patient survival increasing immune function improving clinical symptoms improving quality of life and reducing the adverse events of radiotherapy and chemotherapy
With the advent of new technologies TCM has been shown to have a variety of therapeutic effects towards multiple tumor-associated genes However it remains a major obstacle as to how to effectively screen and select TCM remedies that are effective against lung cancer and meet the efficacy standards of contemporary cancer care
Under the premises described above investigators developed a novel drug screening and selection model Alphacait in tumor microenvironment using Synthetic Lethal and accelerated RNA Speedup PDX aided by artificial intelligence calculation This model could provide new treatment options for patients with EGFR negative late-stage lung cancer through conducting synthetic lethal analysis in vitro and in vivo using patients own cancer cells and selecting the most effective combination therapies for these patients As this approach aims at selecting individualized medications for a specific patient using patients own cancer cells it enables rapid exclusion of false positives and accurate determination of potentially effective treatment regimens for each individual patient
The Alphacait model thus involves acquisition of patients cancer cells through biopsy combinatorial chemistry techniques cancer cell culture in vitro and cancer cell transplantation and growth in vivo in a microenvironment similar to that in a living human body Using this model investigators will be able to screen thousands of different TCM combinations in a matter of days The inhibitory curves of the Synthetic Lethal RNA expression for each drug combination specific to a patients cancer cells could be obtained within 72 hours to determine the most promising anticancer drug combinations The cancer cells will thereafter be transplanted into immune deficient rats for further testing and validation in vivo in a living microenvironment Investigators expect to complete the screening experiments in vitro and validation experiments in vivo within 6 weeks of biopsy and select the most effective drug combinations This information is then conveyed to the clinicians to guide the selection of therapeutic regimes involving TCM in conjunction with patients preferences and clinicians experiences
Investigators have screened a total of 250000 drug combinations using the Alphacait model and determined that approximately 100 drugs may be useful against NSCLC cancer cells Preliminary testing of the model in about 200 patients in China found that the TCM combination XH1 plus docetaxel were effective in a subgroup of patients with end-stage NSCLC The aim of the present study is to further confirm the efficacy of this combination in a randomized and controlled clinical trial
Treatments for advanced NSCLC include chemotherapy and targeted therapies Platinum is currently used in the first-line treatment combination with Pemetrexed gemcitabine docetaxel paclitaxel vinorelbine and etc For EGFR mutation negative patients chemotherapy remains to be the preferred treatment of choice Selection of chemotherapy regimes should take full account of patients condition including patients physical condition Assessments regarding patients possible benefits from chemotherapy should include timely evaluation of efficacies close observation of adverse events and effective control of adverse reactions Traditional Chinese Medicine TCM has in recent years become an important adjunct for lung cancer treatment TCM has been shown to be effective in stabilizing the tumor prolonging patient survival increasing immune function improving clinical symptoms improving quality of life and reducing the adverse events of radiotherapy and chemotherapy
With the advent of new technologies TCM has been shown to have a variety of therapeutic effects towards multiple tumor-associated genes However it remains a major obstacle as to how to effectively screen and select TCM remedies that are effective against lung cancer and meet the efficacy standards of contemporary cancer care
Under the premises described above investigators developed a novel drug screening and selection model Alphacait in tumor microenvironment using Synthetic Lethal and accelerated RNA Speedup PDX aided by artificial intelligence calculation This model could provide new treatment options for patients with EGFR negative late-stage lung cancer through conducting synthetic lethal analysis in vitro and in vivo using patients own cancer cells and selecting the most effective combination therapies for these patients As this approach aims at selecting individualized medications for a specific patient using patients own cancer cells it enables rapid exclusion of false positives and accurate determination of potentially effective treatment regimens for each individual patient
The Alphacait model thus involves acquisition of patients cancer cells through biopsy combinatorial chemistry techniques cancer cell culture in vitro and cancer cell transplantation and growth in vivo in a microenvironment similar to that in a living human body Using this model investigators will be able to screen thousands of different TCM combinations in a matter of days The inhibitory curves of the Synthetic Lethal RNA expression for each drug combination specific to a patients cancer cells could be obtained within 72 hours to determine the most promising anticancer drug combinations The cancer cells will thereafter be transplanted into immune deficient rats for further testing and validation in vivo in a living microenvironment Investigators expect to complete the screening experiments in vitro and validation experiments in vivo within 6 weeks of biopsy and select the most effective drug combinations This information is then conveyed to the clinicians to guide the selection of therapeutic regimes involving TCM in conjunction with patients preferences and clinicians experiences
Investigators have screened a total of 250000 drug combinations using the Alphacait model and determined that approximately 100 drugs may be useful against NSCLC cancer cells Preliminary testing of the model in about 200 patients in China found that the TCM combination XH1 plus docetaxel were effective in a subgroup of patients with end-stage NSCLC The aim of the present study is to further confirm the efficacy of this combination in a randomized and controlled clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None