OncoMatch/Clinical Trials/NCT06494995
AK104 and Low-dose Radiation in Recurrent/Metastatic HNSCC After Failure of First-line Systemic Therapy
Is NCT06494995 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cadonilimab and Capecitabine for head and neck squamous cell carcinoma.
Treatment: Cadonilimab · Capecitabine — Currently, there is a lack of high-quality clinical evidence for subsequent treatment options for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) after first-line treatment, especially for subsequent treatment after first-line therapy combined with PD-1 inhibitors. Increasing evidence suggests that low-dose radiation (LDRT) can reshape the tumor microenvironment.Cadonilimab is a bispecific antibody that specifically binds to CTLA-4 and PD-1 proteins in the human body. Considering that low-dose radiotherapy and cadonilimab both have immunomodulatory effects, this study intends to select recurrent metastatic HNSCC patients who have failed first-line and above treatment to explore the safety and efficacy of cadonilimab combined with low-dose radiotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — first-line or above
progression on first-line treatment or above
Must have received: radiation therapy — radical
recurrence and metastasis within 6 months after radical radiotherapy
Cannot have received: anti-CTLA-4 therapy
Patients who have received anti-CTLA-4 antibodies
Cannot have received: checkpoint inhibitor
any other antibodies or drugs targeting T cell co-stimulation or checkpoint pathways
Cannot have received: tyrosine kinase inhibitor (lenvatinib, anlotinib, apatinib)
small molecule tyrosine kinase inhibitors, including lenvatinib, anlotinib, apatinib, etc.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Hemoglobin ≥9g/dL
Kidney function
Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤1.5×ULN, ALT, AST and/or ALP ≤3×ULN
Good organ function: ... see criteria for ANC, platelets, hemoglobin, albumin, bilirubin, ALT, AST, ALP, creatinine, creatinine clearance, APTT, INR
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify