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RECRUITING
NCT06479473
PHASE1/PHASE2

Radiotherapy to All Residual Lesions After Chemoimmunotherapy

Sponsor: Anhui Provincial Hospital

View on ClinicalTrials.gov

Summary

Extensive-stage small-cell lung cancer is a lethal malignancy with an extremely poor prognosis. First-line chemotherapy could only achieve an overall survival of approximately 10 months. CREST study demonstrated that the addition of thoracic radiotherapy to the patients who responded to chemotherapy could increase the 2-year survival rate from 3% to 13%. CASPIAN and IMpower 133 trials have established the standard modality of first-line chemoimmunotherapy for extensive-stage small-cell lung cancer and prolonged the overall survival to 13 months. Both the addition of thoracic radiotherapy and immunotherapy to chemotherapy were able to improve the survival. Recently, several retrospective studies have demonstrated the effectiveness and safety of the combination of thoracic radiotherapy and chemoimmunotherapy. In a prospective study, 4-6 cycles of first-line chemotherapy with Adebrelimab followed by thoracic radiotherapy achieved the progression-free survival of 10.1 months and overall survival of 21.4 months, which was longer than chemoimmunotherapy. Another study demonstrated not only thoracic radiotherapy, but also radiotherapy to metastatic lesions could ameliorate survival. Therefore, we supposed that whether radiotherapy to all residual lesions after first-line chemoimmunotherapy could further improve survival for patients with extensive-stage small-cell lung cancer.

Official title: Chemoimmunotherapy Followed by All-residual-lesions Radiotherapy for Extensive-stage Small-cell Lung Cancer: A Phase I/II Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-06-01

Completion Date

2026-03-31

Last Updated

2024-08-09

Healthy Volunteers

No

Interventions

RADIATION

Radiotherapy to all residual lesions

Patients assigned to chemoimmunotherapy with radiotherapy group would first receive PET-CT and cranial contrasted MRI to ascertain residual lesions. All residual lesions would be irradiated in a hypofractionated manner.

DRUG

Chemoimmunotherapy

atients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of chemoimmunotherapy followed by consolidative immunotherapy

Locations (1)

Anhui Provincial Hospital

Hefei, Anhui, China