MedDataX Logo

Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy

NCT ID: NCT06667622

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-29

Study Completion Date

2026-07-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemoradiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sodium glycididazole combined with concurrent chemoradiotherapy group

Patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy are treated with sodium glycididazole during concurrent chemoradiotherapy.

Group Type EXPERIMENTAL

sodium glycididazole

Intervention Type DRUG

Sodium glycididazole is intravenously infused at a dose of 800mg at 60 min before radiotherapy and used on Mondays, Wednesdays and Fridays during radiotherapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sodium glycididazole

Sodium glycididazole is intravenously infused at a dose of 800mg at 60 min before radiotherapy and used on Mondays, Wednesdays and Fridays during radiotherapy.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sodium glycididazole combined with concurrent chemoradiotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lei Deng, MD

Role: STUDY_CHAIR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lei Deng, MD

Role: CONTACT

Phone: 010-87787692

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhengang Xu, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCC4420

Identifier Type: -

Identifier Source: org_study_id