Overview

Surufatinib in Recurrent/Metastatic Head and Neck Adenocarcinomas

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
This is a non-randomized, phase II, open label study of Surufatinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Criteria
Inclusion Criteria:

1. Provision of written Informed Consent Form (ICF) prior to any study specific
procedures;

2. Male and Female aged between 18 and 75 years are eligible;

3. Histologically or cytologically confirmed that recurrent or metastatic adenocarcinomas
of the head and neck;

4. Patients with recurrent or metastatic head and neck adenocarcinoma who are not
candidates for curative surgery or refusing surgical treatment;

5. Presence of at least one measurable target lesion for further evaluation according to
RECIST criteria;

6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;

7. Predicted survival ≥6 months;

8. Screening laboratory values must meet the following criteria (within past 14 days):

- neutrophils ≥1.5×109/L ;

- platelets ≥9g/dL;

- hemoglobin ≥ 9.0 g/dL;

- albumin≥3g/dL;

- total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST)
and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic
metastasis; serum creatinine ≤1.5╳ULN;

9. Males or female of childbearing potential must: agree to use using a reliable form of
contraception (eg, oral contraceptives, intrauterine device, control sex desire,
double barrier method of condom and spermicidal) during the treatment period and for
at least 6 months after the last dose of study drug.

Exclusion Criteria:

- 1. Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6
months; 2. Prior antitumor therapy with chemotherapy, radical radiation therapy
,biological immunotherapy,targeted therapy within 4 weeks.

3. Prior participation in other clinical trials not approved or listed in China within
past 4 weeks; 4. Prior major surgery within past 4 weeks (diagnostic surgery
excluded); 5. International standardized ratio (INR) >1.5 or partially activated
prothrombin time (APTT) >1.5×ULN; 6. Clinically significant severe electrolyte
abnormality judged by investigator ; 7. Hypertension that is not controlled by the
drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg; 8. Currently suffering from
poorly controlled diabetes (after regular treatment, fasting plasma glucose
concentration ≥10mmol/L); 9. The patient currently has disease or condition that
affects the absorption of the drug, or the patient cannot be administered orally; 10.
Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis
or unresected tumor, or other conditions determined by the investigator that may cause
gastrointestinal bleeding and perforation; 11. Evidence of bleeding tendency or
history within 3 months, or thromboembolic event (including a stroke event and/or a
transient ischemic attack) occurred within 12 month; 12. Cardiovascular disease of
significant clinical significance (myocardial infarction, unstable arrhythmia or
unstable angina ,Coronary Artery Bypass Grafting within past 6 months,); 13. Had other
malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell
carcinoma, cervical carcinoma in situ that have been effectively controlled); 14.
Active or uncontrolled severe infection (≥CTCAE2 infection); 15. Positive tests for
HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml); 16. Evidence
with active CNS disease or previous brain metastases; 17. The toxicity associated with
previous anti-tumor treatment has not recovered to ≤CTCAE1, except for peripheral
neurotoxicity and alopecia ≤CTCAE2 caused by oxaliplatin; 18. Pregnant or nursing; 19.
Transfusion therapy, blood products and hematopoietic factors, such as albumin and
granulocyte colony stimulating factor (G-CSF), had been received within 14 days before
enrollment; 20. Tumor involving skin and/or pharyngeal mucosa with ulceration; 21.
Patients with a history of psychotropic drug abuse and unable to quit or with mental
disorders; 22. Any other disease, with clinical significance of metabolic
abnormalities, abnormal physical examination or laboratory abnormalities, according to
researchers, there is reason to doubt is not suitable for the use of study drugs in
patients with a disease or condition (such as have a seizure and require treatment),
or will affect the interpretation of results, or make the patients at high risk.

23. Routine urine indicated that urine protein ≥2+, and the 24-hour urine protein
volume >1.0g; 24. Underlying medical condition that, in the Investigator's opinion,
would increase the risks of study drug administration or obscure the interpretation of
toxicity determination or adverse events.