Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This proposed study will evaluate the efficacy and safety of preoperative administration Toripalimab combined with nab-paclitaxel and carboplatin in salivary gland malignant neoplasms who are about to undergo surgery.Monoclonal antibodies, such as Toripalimab , may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.This trial will be helpful for comprehensive exploratory characterization of tumor immune microenvironment and circulating immune cells in these patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab + Carboplatin + Nab-paclitaxel | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab , Carboplatin, Nab-paclitaxel | Drug | Patients receive toripalimab IV on day 1, paclitaxel IV on day 1 and carboplatin IV on day 1 . Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events graded by CTCAE v5.0 | Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0). | 90 days after the first dose of study treatment |
| Percentage of participants demonstrating pathological response | Pathologic response in the primary tumor was assessed using a quantitative grading scheme: pathologic tumor response [nonviable tumor] PTR0 = no or <10% PTR1 = ≥10% PTR2 = ≥50% | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | DFS is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease relapse. | 2 years |
Not provided
Inclusion Criteria:
Patients must have a histologically confirmed diagnosis of salivary gland cancers which is planned for treatment with curative intent including surgical resection: mucoepidermoid carcinoma, adenocarcinoma, adenoidcystic carcinoma, acinic cell carcinoma, or other histology .
Greater than or equal to 18 and less than 80 years of age at time of study entry.
ECOG performance status of 0 or 1.
Measurable disease as per RECIST 1.1.
Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines.
Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
Adequate hepatic and renal function as demonstrated by
Serum creatinine < 1.5 X ULN or CrCl > 40mL/min (if using the Cockcroft-Gault formula below):
AST/ALT ≤ 3 x ULN
Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Adequate bone marrow function as demonstrated by:
Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of study enrollment.
Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; "women of reproductive potential" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Subjects must agree to allow use of any pre-treatment tissue remaining after definitive diagnosis is made (ie, archival and or fresh tissue) for research purposes. In addition, subjects must consent to allow use of their residual post-operative tissue for research purposes.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Fan, Doctor degrees | Contact | 13570536658 | fansong2@mail.sysu.edu.cn | |
| Tingting Cai, Bachelor's Degrees | Contact | 17520060409 | caitt23@mail2.sysu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital | Guangzhou | Guangdong | 510000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Overall survival(OS) | Overall survival will be defined as the time from day 1 of study treatment until death from any cause. | 5 years |
| Radiographic Response | Radiographic response to treatment as defined by RECIST 1.1. | 5 weeks |
| Pathologic Response | Pathologic response to neoadjuvant treatment in resected tumor and lymph nodes. The rate of major pathologic response, defined as <10% residual viable tumor cells in the resection specimen will be compared to historic data with neoadjuvant chemotherapy | 6 weeks |
| Rate of surgery delay | Rate of patients with an Unplanned Delay to Surgery defined as any change to scheduled surgery date considered to be at least possibly related to neoadjuvant treatment. | 8 weeks after the patient receives their last dose |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided