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OncoMatch/Clinical Trials/NCT05561634

Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Is NCT05561634 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Vismodegib for basal cell carcinoma.

Phase 2RecruitingUniversity Hospital, LilleNCT05561634Data as of May 2026

Treatment: VismodegibLocally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Prior therapy

Must have received: Sonic Hedgehog pathway inhibitor — first course

complete response after first course of SHHi

Cannot have received: radiation therapy

Exception: to the region of the studied cancer that would result in overlap of radiation therapy fields

Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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