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Trial Title:
Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy
NCT ID:
NCT06667622
Condition:
Chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
sodium glycididazole
Description:
Sodium glycididazole is intravenously infused at a dose of 800mg at 60 min before
radiotherapy and used on Mondays, Wednesdays and Fridays during radiotherapy.
Arm group label:
Sodium glycididazole combined with concurrent chemoradiotherapy group
Other name:
Sodium glycididazole combined with concurrent chemoradiotherapy
Summary:
To evaluate the efficacy and toxicity of sodium glycididazole combined with concurrent
chemoradiotherapy in patients with unresectable locally advanced non-small cell lung
cancer after neoadjuvant chemoradiotherapy.
Detailed description:
1. To evaluate the efficacy and toxicity of concurrent chemoradiotherapy combined with
sodium glycididazole in patients with unresectable locally advanced non-small cell
lung cancer after neoadjuvant chemoradiotherapy, and to explore sodium glycididazole
as a new way to inhibit the occurrence of radiation esophagitis and reduce the
occurrence of radiation pneumonitis and lymphopenia.
2. To evaluate the sensitization effect of sodium glycididazole in the anti-tumor
activity during concurrent chemoradiotherapy, as well as the changes in the
anti-tumor immune response in peripheral blood, in order to screen out the dominant
population and the predictive biomarkers with fewer related toxic and side effects.
3. By exploring the correlation between the expression level of NLRP3 inflammasome
activation related molecules and imaging changes in peripheral blood after
radiotherapy and the toxicity of radiotherapy and chemotherapy, a risk model for
predicting radiation esophagitis after concurrent radiotherapy and chemotherapy for
non-small cell lung cancer was further constructed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must have histologically or cytologically confirmed non-small cell lung
cancer.
2. Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvant
therapy.
3. ECOG PS 0-2
4. Adequate organ and bone marrow function.
Exclusion Criteria:
1. History of previous radiotherapy.
2. The previous immune-related pneumonitis ≥ grade 2.
3. Local lesions require surgery.
4. History of another primary malignancy.
5. History of active primary immunodeficiency.
6. Histological findings showed mixed small cell lung cancer and non-small cell lung
cancer.
7. For any unmitigated toxicity during pre-study chemoradiotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengang Xu, MD
Phone:
+86 10 8778 8495
Start date:
May 29, 2024
Completion date:
July 20, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06667622
