Salivary Gland CarcinomasNCT05013515
Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas
A study testing Surufatinib in people with Salivary Gland Carcinomas, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The objective is to investigate the efficacy and safety of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Salivary Gland Carcinomas
- What is being tested?
- Surufatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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；
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- 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.
Who cannot join
- 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 ;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai
Min Ruan, MD, 15150667249, doctorruanmin@sjtu.edu.cn
About this study
Official title: A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma：a Single-arm, Prospective,Open Label Study
The objective is to investigate the efficacy and safety of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma.
Read the 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.
- Conditions
- Salivary Gland Carcinomas
- Being tested
- Surufatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Also called radiotherapy or chemoradiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Salivary Gland Carcinomas | Experimental | Patients with Salivary Gland Carcinomas were given Surufatinib . Receives: Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
Secondary outcomes (4)
Major pathological response rate (MPR)
the reduction of the active tumor below an established clinically significant node.
Measured: up to 12 months
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).
Measured: up to 36 months
Assess the anti-tumor activity:DCR
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
Overall survival time
OS was calculated from the date of pharmacy to death from any cause.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Aug 2021
- Primary completionSep 2022 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland CarcinomasStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Ruan, MD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013515
- Sponsor's protocol ID
- HMPL-012-SPRING-HNC101
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma：a Single-arm, Prospective,Open Label Study
- ClinicalTrials.gov ID
- NCT05013515
- Acronym / sponsor ID
- HMPL-012-SPRING-HNC101
- Conditions
- Salivary Gland Carcinomas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 19 Aug 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salivary Gland Carcinomas | Experimental | Drug: SurufatinibPatients with Salivary Gland Carcinomas were given Surufatinib . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
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 |
|---|---|---|
| SurufatinibAlso: radiotherapy or chemoradiotherapyPatients 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. | Drug | Salivary Gland Carcinomas |
Primary outcome
Objective response rate (ORR)
Time frame: up to 12 months
CR + PR rate according to the RECIST version 1.1 guidelines.
4 secondary outcomes
Major pathological response rate (MPR)
Time frame: up to 12 months
Progression Free Survival (PFS)
Time frame: up to 36 months
Assess the anti-tumor activity:DCR
Time frame: up to 12 months
Overall survival time
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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. This study is not recruiting at the moment.
Min Ruan, MD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surufatinib in people with Salivary Gland Carcinomas, 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 24 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: status not confirmed, as of the sponsor's last update on 19 Aug 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Ruan, MD (15150667249, doctorruanmin@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 12 months). 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 19 Aug 2021.