OncoMatch/Clinical Trials/NCT06876844
Surufatinib Combined with Envolizumab As Second-line Treatment for Recurrent/Metastatic HNSCC
Is NCT06876844 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies combination of Surufatinib and Envolizumab for head and neck cancer.
Treatment: combination of Surufatinib and Envolizumab — This study is a prospective,open-label,single-arm clinical trial to evaluate the efficacy and safety of s Surufatinib combined with envolizumab as second-line treatment of recurrent/metastatic head and neck squamous cell carcinoma . envolizumab: 300 mg subcutaneously every 3 weeks (Q3W); Surufatinib : 200 mg orally within 1 hour after breakfast, once daily continuously every 3 weeks as a treatment cycle until intolerable toxicity or disease progression. If any ≥ Grade 2 treatment-related adverse event occurs during treatment, the dose may be adjusted to 100 mg according to the investigator 's clinical assessment. The study is divided into 3 period: Screening, Treatment, and Follow-up. The treatment period is a 3-week treatment cycle. During the treatment period, tumor assessment will be performed by imaging method every 6 weeks (± 7 days) until disease progression (RECIST 1.1) or death (during treatment) or intolerable toxicity. The tumor treatment and survival status after disease progression should be recorded. Safety measures included: adverse events, laboratory tests, vital signs, and changes in electrocardiogram and cardiac ultrasound.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: first-line systemic therapy (platinum-based chemotherapy, cetuximab plus chemotherapy, immune checkpoint inhibitors) — first-line
Progressive or recurrent/metastatic disease following first-line systemic therapy within 6 months of completion of concurrent chemoradiation
Cannot have received: Surufatinib (Surufatinib)
Received previous treatment with Surufatinib
Cannot have received: envolizumab (envolizumab)
Received previous treatment with envolizumab
Cannot have received: anti-angiogenic agent
6 months with other anti-angiogenic agents
Cannot have received: systemic anti-tumor therapy
Received approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelets ≥ 90 × 10^9/L; Hemoglobin ≥ 9 g/dL; Serum albumin ≥ 3 g/dL
Kidney function
Serum creatinine ≤ 1.5 times ULN
Liver function
Bilirubin ≤ 1.5 times ULN; ALT and AST ≤ 2.5 times ULN; ALT and AST ≤ 5 times ULN if liver metastases
Vital organs functioning as defined below (no blood components or cell growth factors allowed within 14 days prior to enrollment): Absolute neutrophil count ≥ 1.5 x 10 9/L; Platelets ≥ 90 × 10 9/L ; Hemoglobin ≥ 9 g/dL ; Serum albumin ≥ 3 g/dL ; Bilirubin ≤ 1.5 times ULN ; ALT and AST ≤ 2.5 times ULN ; ( ALT and AST ≤ 5 times ULN if liver metastases ); Serum creatinine ≤ 1.5 times ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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