Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy

Phase 2

Recruiting

• Conditions: Chemoradiotherapy
• Interventions: Drug: sodium glycididazole

• Registration Number: NCT06667622
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2024-05-29
• Status Verified: 2024-08
• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• Primary Completion: 2026-01-10
• Study Completion: 2026-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sodium glycididazole combined with concurrent chemoradiotherapy group	sodium glycididazole	Patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy are treated with sodium glycididazole during concurrent chemoradiotherapy.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of grade 3 and above radiation esophagitis	8 weeks	Radiation esophagitis of grade 3 or higher is graded according to the toxicity criteria of the CTCAE v5.0.
Incidence and severity of grade 2 and above radiation pneumonitis	8 weeks	Radiation pneumonitis of grade 2 or higher is graded according to the toxicity criteria of the CTCAE v5.0.

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China