Study of Spartalizumab with mDCF Chemotherapy and Radiotherapy for Adults with Metastatic Squamous Cell Anal Carcinoma

What this Trial Is About

This research aims to evaluate the feasibility of combining radiotherapy, chemotherapy docetaxel, cisplatin, and 5-fluorouracil, and spartalizumab an anti-PD-1 therapy in patients with metastatic squamous cell carcinoma of the anus SCCA. Patients with metastatic or recurrent SCCA often receive systemic chemotherapy, and recent studies have shown that taxane-based regimens like modified DCF mDCF can be effective. This study explores adding immunotherapy and radiotherapy to improve treatment outcomes and understand resistance mechanisms. The treatment involves multiple phases. Phase 1 includes delivering 8 Gy radiotherapy to target lesions. Phase 2 consists of combined mDCF chemotherapy every two weeks for 8 cycles alongside spartalizumab given intravenously every 4 weeks. Phase 3 addresses residual disease through multimodal treatments such as surgery, hypofractionated radiotherapy, or radiofrequency ablation, plus chemo-radiotherapy for local disease if there is no progression. Phase 4 provides maintenance treatment with spartalizumab every 4 weeks for up to 12 months from enrollment. Participants will undergo various assessments including CT and PET scans, blood sample collection for immune monitoring and circulating tumor DNA analysis at multiple time points, and regular clinical evaluations. Researchers will measure progression-free survival at 1 year as the primary outcome, along with response rates and overall survival over about 3 years. Safety monitoring and biomarker studies will help understand the potential combined effects of chemotherapy, immunotherapy, and radiotherapy in this patient group.

Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma