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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT06494995 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CTLA-4 therapy, checkpoint inhibitor, tyrosine kinase inhibitor disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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 qualifyRelated pages