OncoMatch/Clinical Trials/NCT06876844
Surufatinib Combined with Envolizumab As Second-line Treatment for Recurrent/Metastatic HNSCC
Is NCT06876844 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT06876844 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Surufatinib, envolizumab, anti-angiogenic agent 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