Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy

Last updated: October 30, 2024
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Chemotherapy

Treatment

sodium glycididazole

Clinical Study ID

NCT06667622
NCC4420
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed non-small cell lungcancer.

  2. Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvanttherapy.

  3. ECOG PS 0-2

  4. Adequate organ and bone marrow function.

Exclusion

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 lungcancer.

  7. For any unmitigated toxicity during pre-study chemoradiotherapy.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: sodium glycididazole
Phase: 2
Study Start date:
May 29, 2024
Estimated Completion Date:
July 20, 2026

Study 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.

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.