Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas

NCT05013515 | Unknown

• 1 other identifier: HMPL-012-SPRING-HNC101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to investigate the efficacy and safety of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma.

Conditions

Salivary Gland Carcinomas

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  CR + PR rate according to the RECIST version 1.1 guidelines.

  up to 12 months

Secondary Outcomes (4)

• Major pathological response rate (MPR)

  up to 12 months

• Progression Free Survival (PFS)

  up to 36 months

• Assess the anti-tumor activity:DCR

  up to 12 months

• Overall survival time

  through study completion, an average of 1 year

Study Arms (1)

Salivary Gland Carcinomas

EXPERIMENTAL

Patients with Salivary Gland Carcinomas were given Surufatinib .

Drug: Surufatinib

Interventions

Surufatinib DRUG

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.

Also known as: radiotherapy or chemoradiotherapy

Salivary Gland Carcinomas

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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);

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

Interventions

surufatinib; Radiotherapy; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy; Drug Therapy

Study Officials

• Min Ruan, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Ruan, MD

CONTACT

15150667249; doctorruanmin@sjtu.edu.cn

Shuyang Sun, MD

CONTACT

18019790962; sunshuyang@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: August 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: June 1, 2024
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CN (1)