Actively Recruiting
Surufatinib Combined with Envolizumab As Second-line Treatment for Recurrent/Metastatic HNSCC
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2025-03-14
24
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surufatinib Combined with Envolizumab As Second-line Treatment for Recurrent/Metastatic HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign the informed consent form
- Age between 18 and 75 years, male or female
- Pathologically or histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
- Disease progression after first-line systemic therapy within 6 months of completing chemoradiation
- Not eligible for salvage surgery or patient refuses surgery
- At least one measurable lesion by RECIST 1.1 criteria
- ECOG performance status score between 0 and 2
- Expected survival of at least 6 months
- Adequate vital organ function with specified blood counts and liver/kidney lab values
- Female patients of childbearing potential must use effective contraception during and after treatment period
- Male patients with partners of childbearing potential must use condoms during and after treatment period
You will not qualify if you...
- Previous treatment with Surufatinib and Envolizumab or anti-angiogenic agents within 6 months
- Systemic anti-tumor therapy or major surgery within 4 weeks before enrollment
- Participation in other investigational drug trials within 4 weeks before enrollment
- Blood clotting abnormalities or significant electrolyte imbalances
- Uncontrolled hypertension or poorly controlled diabetes
- Conditions affecting drug absorption or inability to take oral Surufatinib
- Active gastrointestinal ulcers, bleeding, or conditions causing bleeding risk
- Significant bleeding history or thromboembolic events within specified recent timeframes
- Clinically significant cardiovascular disease within 6 months
- Other malignancies within last 5 years except certain skin or cervical cancers
- Active serious infections or known HIV infection
- Significant liver disease or viral hepatitis with active infection
- Current or previous central nervous system metastases
- Unresolved toxicities from previous cancer therapies above Grade 1 except specified exceptions
- Pregnant or breastfeeding women
- Recent blood transfusions or hematopoietic factor use
- Tumor involving ulcerated skin or pharyngeal mucosa
- History of psychiatric drug abuse or mental disorders preventing participation
- Any other condition judged unsafe or interfering with study completion
- Urine protein abnormalities beyond specified levels
- Concomitant diseases that may affect safety or study completion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, China
Actively Recruiting
Research Team
G
guopei zhu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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