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NCT Number: NCT06667622

Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Zhengang Xu, MD

CONTACT

+86 10 8778 8495

About this study

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have histologically or cytologically confirmed non-small cell lung cancer.
  • Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvant therapy.
  • ECOG PS 0-2
  • Adequate organ and bone marrow function.

Exclusion criteria

  • History of previous radiotherapy.
  • The previous immune-related pneumonitis ≥ grade 2.
  • Local lesions require surgery.
  • History of another primary malignancy.
  • History of active primary immunodeficiency.
  • Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
  • For any unmitigated toxicity during pre-study chemoradiotherapy.

Treatment and study plan

Sodium Glycididazole

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.

Other names: Sodium glycididazole combined with concurrent chemoradiotherapy

Primary outcomes

  1. Incidence and severity of grade 3 and above radiation esophagitis

    Time frame: 8 weeks

    Radiation esophagitis of grade 3 or higher is graded according to the toxicity criteria of the CTCAE v5.0.

  2. Incidence and severity of grade 2 and above radiation pneumonitis

    Time frame: 8 weeks

    Radiation pneumonitis of grade 2 or higher is graded according to the toxicity criteria of the CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Deng, MD

CONTACT

[email protected]

010-87787692

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Sodium Glycididazole Reduces Chemoradiotherapy-related Adverse Reactions During Concurrent Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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