Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas
Primary Purpose
Salivary Gland Carcinomas
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surufatinib
Sponsored by
About this trial
This is an interventional treatment trial for Salivary Gland Carcinomas
Eligibility Criteria
Inclusion Criteria:
- Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- aged between 18 and 75 years are eligible;
- Male and Female are available;
- Patients with locally advanced primary salivary gland adenocarcinoma confirmed by pathology or histology (except nasopharyngeal carcinoma);At least one measurable lesion (≥10mm on spiral CT scan, meeting RECIST 1.1 criteria);
- Patients have not received chemotherapy or radiotherapy, targeted therapy, or surgery for any previous reason;
- Patients with indications for surgery;
- Primary TNM stage Ⅲ-ⅣA (T1-2/N1-2/M0 or T3-4A/CN0-2 /M0, AJCC2018);
- Patients should not be accompanied by any other anticancer therapy;
- It is not concomitant with long-term treatment (≥3 months) with ≥20mg daily dose of methylprednisolone or equivalent dose of corticosteroids;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Predicted survival ≥12 weeks;
Screening laboratory values must meet the following criteria (within past 14 days):
- neutrophils ≥3.0×109/L ;
- platelets ≥100×109/L;
- 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; Endogenous creatinine clearance >50ml/min (Cockcroft- Gault formula);
- 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:
- Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6 months;
- Prior antitumor therapy with chemotherapy, radical radiation therapy ,biological immunotherapy,targeted therapy within 4 weeks.
- Prior participation in other clinical trials not approved or listed in China within past 4 weeks;
- Prior major surgery within past 4 weeks (Venous catheterization, puncture and drainage are excluded);
- International standardized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN;
- Clinically significant severe electrolyte abnormality judged by investigator ;
- Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg;
- Currently suffering from poorly controlled diabetes (after regular treatment, fasting plasma glucose concentration ≥10mmol/L);
- The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally;
- 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;
- 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;
- Cardiovascular disease of significant clinical significance (myocardial infarction, unstable arrhythmia or unstable angina ,Coronary Artery Bypass Grafting within past 6 months,);
- 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);
- Active or uncontrolled severe infection (≥CTCAE2 infection);
- Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml);
- Evidence with active CNS disease or previous brain metastases;
- The toxicity associated with previous anti-tumor treatment has not recovered to ≤CTCAE1, except for peripheral neurotoxicity and alopecia ≤CTCAE2 caused by oxaliplatin;
- Pregnant or nursing;
- 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;
- Tumor involving skin and/or pharyngeal mucosa with ulceration;
- Patients with a history of psychotropic drug abuse and unable to quit or with mental disorders;
- 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.
- Routine urine indicated that urine protein ≥2+, and the 24-hour urine protein volume >1.0g;
- 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
Sites / Locations
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Salivary Gland Carcinomas
Arm Description
Patients with Salivary Gland Carcinomas were given Surufatinib .
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Secondary Outcome Measures
Major pathological response rate (MPR)
the reduction of the active tumor below an established clinically significant node.
Progression Free Survival (PFS)
To assess the efficacy of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Assess the anti-tumor activity:DCR
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Overall survival time
OS was calculated from the date of pharmacy to death from any cause.
Full Information
NCT ID
NCT05013515
First Posted
August 16, 2021
Last Updated
August 16, 2021
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT05013515
Brief Title
Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas
Official Title
A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma:a Single-arm, Prospective,Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective is to investigate the efficacy and safety of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma.
Detailed Description
The purpose of this study was to explore whether the efficacy and survival time of patients with local advanced primary salivary gland adenocarcinoma could be further improved through the treatment of Surufatinib neoadjuvant for local advanced primary salivary gland adenocarcinoma, and to explore the safety and tolerability of this regimen.A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma:a Single-arm, Prospective,Open Label Study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Carcinomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Salivary Gland Carcinomas
Arm Type
Experimental
Arm Description
Patients with Salivary Gland Carcinomas were given Surufatinib .
Intervention Type
Drug
Intervention Name(s)
Surufatinib
Other Intervention Name(s)
radiotherapy or chemoradiotherapy
Intervention Description
Patients receive oral Surufatinib at a dose of 300mg/d (once-daily dosing continuously, every 28-day treatment cycle), A total of 2 cycles were performed, and efficacy evaluation was performed at the end of each cycle or was determined to be required by the investigator. If disease progression or unacceptable toxicity occurred during the period, induction therapy was terminated early, and after corresponding treatment, surgical treatment was entered as early as possible.
Surufatinib treatment was interrupted 4-7 days before surgical treatment to maintain organ function; Note: Postoperative radiotherapy or chemoradiotherapy is permitted after radical surgery at the discretion of the investigator.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
CR + PR rate according to the RECIST version 1.1 guidelines.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Major pathological response rate (MPR)
Description
the reduction of the active tumor below an established clinically significant node.
Time Frame
up to 12 months
Title
Progression Free Survival (PFS)
Description
To assess the efficacy of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time Frame
up to 36 months
Title
Assess the anti-tumor activity:DCR
Description
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time Frame
up to 12 months
Title
Overall survival time
Description
OS was calculated from the date of pharmacy to death from any cause.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
aged between 18 and 75 years are eligible;
Male and Female are available;
Patients with locally advanced primary salivary gland adenocarcinoma confirmed by pathology or histology (except nasopharyngeal carcinoma);At least one measurable lesion (≥10mm on spiral CT scan, meeting RECIST 1.1 criteria);
Patients have not received chemotherapy or radiotherapy, targeted therapy, or surgery for any previous reason;
Patients with indications for surgery;
Primary TNM stage Ⅲ-ⅣA (T1-2/N1-2/M0 or T3-4A/CN0-2 /M0, AJCC2018);
Patients should not be accompanied by any other anticancer therapy;
It is not concomitant with long-term treatment (≥3 months) with ≥20mg daily dose of methylprednisolone or equivalent dose of corticosteroids;
Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
Predicted survival ≥12 weeks;
Screening laboratory values must meet the following criteria (within past 14 days):
neutrophils ≥3.0×109/L ;
platelets ≥100×109/L;
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; Endogenous creatinine clearance >50ml/min (Cockcroft- Gault formula);
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:
Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6 months;
Prior antitumor therapy with chemotherapy, radical radiation therapy ,biological immunotherapy,targeted therapy within 4 weeks.
Prior participation in other clinical trials not approved or listed in China within past 4 weeks;
Prior major surgery within past 4 weeks (Venous catheterization, puncture and drainage are excluded);
International standardized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN;
Clinically significant severe electrolyte abnormality judged by investigator ;
Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg;
Currently suffering from poorly controlled diabetes (after regular treatment, fasting plasma glucose concentration ≥10mmol/L);
The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally;
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;
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;
Cardiovascular disease of significant clinical significance (myocardial infarction, unstable arrhythmia or unstable angina ,Coronary Artery Bypass Grafting within past 6 months,);
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);
Active or uncontrolled severe infection (≥CTCAE2 infection);
Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml);
Evidence with active CNS disease or previous brain metastases;
The toxicity associated with previous anti-tumor treatment has not recovered to ≤CTCAE1, except for peripheral neurotoxicity and alopecia ≤CTCAE2 caused by oxaliplatin;
Pregnant or nursing;
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;
Tumor involving skin and/or pharyngeal mucosa with ulceration;
Patients with a history of psychotropic drug abuse and unable to quit or with mental disorders;
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.
Routine urine indicated that urine protein ≥2+, and the 24-hour urine protein volume >1.0g;
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Ruan, MD
Phone
15150667249
Email
doctorruanmin@sjtu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shuyang Sun, MD
Phone
18019790962
Email
sunshuyang@sjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Ruan, MD
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Ruan, MD
Phone
15150667249
Email
doctorruanmin@sjtu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas
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