RecruitingPhase 1Phase 2NCT06479473

Radiotherapy to All Residual Lesions After Chemoimmunotherapy

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


Sponsor

Anhui Provincial Hospital

Enrollment

150 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving radiation therapy to all remaining visible tumor sites after completing immunotherapy and chemotherapy improves survival for patients with extensive-stage small cell lung cancer — an aggressive form of lung cancer that has spread widely. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed extensive-stage small cell lung cancer (spread beyond one lung) - Your performance status is adequate (ECOG 0–1) - Your organ function can tolerate chemotherapy, immunotherapy, and radiation combined **You may NOT be eligible if...** - You are younger than 18 or older than 70 - You have non-small cell lung cancer - Your organ function is too impaired to tolerate combined treatment - Your ECOG performance status is above 1 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy 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.

DRUGChemoimmunotherapy

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

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NCT06479473


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