Surufatinib Combined with Envolizumab As Second-line Treatment for Recurrent/Metastatic HNSCC

NCT06876844 | Recruiting Phase 2 DMC

• 1 other identifier: HMPL-012-SH-HNSCC101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Cancer; Head and Neck Cancer Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate (ORR) (according to RECIST 1.1)

  1 year

Secondary Outcomes (4)

• DCR

  1 year

• DOR

  1 year

• PFS

  1 year

• OS

  1 year

Study Arms (1)

combination of Surufatinib and Envolizumab

EXPERIMENTAL

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.

Drug: combination of Surufatinib and Envolizumab

Interventions

combination of Surufatinib and Envolizumab DRUG

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.

combination of Surufatinib and Envolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria for enrollment:
• Have fully understood the study and voluntarily signed the informed consent form;
• Age: 18-75 years (calculated from the day of informed consent, including the boundary value), both male and female;
• Pathologically or histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
• Progressive or recurrent/metastatic disease following first-line systemic therapy within 6 months of completion of concurrent chemoradiation; (first-line systemic therapy includes platinum-based chemotherapy, cetuximab plus chemotherapy, immune checkpoint inhibitors alone or in combination.)
• Inability to perform salvage surgery as assessed by oral and maxillofacial surgeons or patient refusal of surgical treatment;
• Patients must have at least one measurable lesion (RECIST 1.1);
• ECOG performance status 0-2 score;
• Expected survival ≥ 6 months;
• 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 ;

You may not qualify if:

• Any of the following criteria must be excluded from the study plan:
• Received previous treatment with Surufatinib and envolizumab, and 6 months with other anti-angiogenic agents;
• Received approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy;
• Participated in other domestic clinical trials of drugs not approved or marketed within 4 weeks before enrollment and received the corresponding investigational drug;
• Any major surgery or invasive treatment or operation (except venous catheterization, puncture drainage, etc.) within 4 weeks before enrollment;
• International normalized ratio (INR) \> 1.5 or activated partial thromboplastin time (APTT) \> 1.5 × ULN ;
• Clinically significant electrolyte abnormalities as judged by the investigator;
• Patients with current hypertension uncontrolled by medications, defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg ;
• Patients with currently poorly controlled diabetes (fasting plasma glucose concentration ≥ 10 mmol/L after regular treatment);
• Patients with any current disease or condition affecting drug absorption, or patients unable to take oral Surufatinib;
• Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator;
• Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding \> 30 mL with hematemesis, melena, hematochezia within 3 months), hemoptysis (\> 5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months;
• Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment;
• Other malignancies within the last 5 years, except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix;
• Active or uncontrolled serious infection (≥ CTCAE Grade 2 infection);

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

guopei zhu, MD

CONTACT

021-23271699-5576; antica@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 14, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)