Head and Neck CancerPhase 2HNSCCNCT06876844
Surufatinib Combined with Envolizumab As Second-line Treatment for Recurrent/Metastatic HNSCC
A Phase 2 study testing combination of Surufatinib and Envolizumab in people with Head and Neck Cancer and Head and Neck Cancer Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Cancer Squamous Cell Carcinoma
- What is being tested?
- combination of Surufatinib and Envolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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 ;
- ALT and AST ≤ 2.5 times ULN ; ( ALT and AST ≤ 5 times ULN if liver metastases );
- Serum creatinine ≤ 1.5 times ULN ; 10. Female patients of childbearing potential voluntarily used highly effective contraception from screening through the designated time after the last dose of study drug (within 1 month after the last dose of Surufatinib or within 2 months after the last dose of envolizumab, whichever came later) and agreed not to donate ovum (oocytes) for reproductive purposes during this period.
- All female patients will be considered to be of childbearing potential unless they are naturally postmenopausal, have undergone artificial menopause, or have undergone sterilization (eg, hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation). Male patients with sexual partners of childbearing potential who are willing to use condoms during sex from screening through 3 months after the last dose of study drug and should refrain from donating or freezing sperm during this period.
Who cannot join
- 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 ;
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- 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);
- Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [known hepatitis B (HBV) carriers must exclude active HBV infection, ie, HBV DNA positive (> 1 × 10 4 copies/mL or > 2000 IU/ml); Known hepatitis C virus infection (HCV) and HCV RNA positive (> 1 × 10 3 copies/mL), or other hepatitis, cirrhosis];
- Patients with current central nervous system (CNS) metastasis or previous brain metastasis;
- Unresolved toxicities above CTCAE Grade 1 due to any prior anticancer therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity of ≤ Grade 2 ;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Received blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days prior to enrollment;
- Tumor involving skin and/or pharyngeal mucosa accompanied by ulceration;
- Patients who have a history of psychiatric drug abuse and cannot quit or have mental disorders;
- Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, would reasonably suspect that the patient has a disease or condition that would make the use of study drug inappropriate (eg, having a seizure and requiring treatment) or would compromise the interpretation of study results or put the patient at high risk.
- Urine routine showed urine protein ≥ 2 + , and 24 hour urine protein > 1.0g ;
- Patients with other concomitant diseases that, in the judgment of the investigator, might jeopardize the patient 's safety or might affect the patient' s completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai
guopei zhu, MD, 086+02123271699-5576, antica@gmail.com
About this study
Official title: Phase II Clinical Study on the Combination of Surufatinib and Envolizumab As Second-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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.
Read more
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.
- Being tested
- combination of Surufatinib and Envolizumab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of Surufatinib and EnvolizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: combination of Surufatinib and Envolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate (ORR) (according to RECIST 1.1)
Measured: 1 year
Secondary outcomes (4)
DCR
disease control rate
Measured: 1 year
DOR
duration of response
Measured: 1 year
PFS
progression-free survival
Measured: 1 year
OS
overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start30 Dec 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876844
- Sponsor's protocol ID
- HMPL-012-SH-HNSCC101
- Acronym
- HNSCC
- Status last verified
- Dec 2024
- First submitted
- 20 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on the Combination of Surufatinib and Envolizumab As Second-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06876844
- Acronym / sponsor ID
- HNSCC / HMPL-012-SH-HNSCC101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination of Surufatinib and Envolizumab | Experimental | Drug: combination of Surufatinib and Envolizumabenvolizumab: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects must meet all of the following criteria for enrollment:
- Absolute neutrophil count ≥ 1.5 x 10 9/L;
- Platelets ≥ 90 × 10 9/L ;
- Hemoglobin ≥ 9 g/dL ;
- Serum albumin ≥ 3 g/dL ;
Key exclusion criteria (25 listed)
- Any of the following criteria must be excluded from the study plan:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of Surufatinib and Envolizumabenvolizumab: 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 |
Primary outcome
ORR
Time frame: 1 year
objective response rate (ORR) (according to RECIST 1.1)
4 secondary outcomes
DCR
Time frame: 1 year
DOR
Time frame: 1 year
PFS
Time frame: 1 year
OS
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing combination of Surufatinib and Envolizumab in people with Head and Neck Cancer and Head and Neck Cancer Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact guopei zhu, MD (021-23271699-5576, antica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.