UnknownNot Applicable

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

China20 participantsStarted 2021-08-01

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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);

Objective response rate (ORR)

Timeframe: up to 12 months

NCT IDNCT05013515

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09

Min Ruan, MD

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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);