NCT06527898 Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer
| NCT ID | NCT06527898 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Small-cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2024-07-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Concurrent chemoradiotherapy has long been the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. With the introduction of immune checkpoint inhibitors, ADRIATIC study concluded that consolidative Durvalumab after concurrent chemoradiotherapy could achieve a far longer median overall survival of 55.9 months compared with 33.4 months for concurrent chemoradiotherapy. Recently, several studies have demonstrated the safety and efficacy of hypofractionated radiotherapy (3 to 4 Gy) for limited-stage small-cell lung cancer. Hypofractionated radiotherapy processes the advantage of short treatment duration compared with conventional fractionated radiotherapy, which may allow the early participation of immunotherapy. Therefore, we suppose that whether hypofractionated radiotherapy combined with immunotherapy could improve the survival of limited-stage of small-cell lung cancer.
Eligibility Criteria
Inclusion Criteria: * 18-70 years old; * ECOG 0-1; * Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy; * Small-cell lung cancer; * Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; * Signature of inform consent. Exclusion Criteria: * Younger than 18 years old or older than 70 years old; * ECOG\>1; * Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy; * Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma; * Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; * No signature of inform consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06527898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Small-cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06527898 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06527898 currently recruiting?
Yes, NCT06527898 is actively recruiting participants. Contact the research team at qiandong@ustc.edu.cn for enrollment information.
Where is the NCT06527898 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06527898 clinical trial?
NCT06527898 is sponsored by Anhui Provincial Hospital. The trial plans to enroll 45 participants.
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