This proposed study will evaluate the efficacy and safety of preoperative administration Sintilimab combined with nab-paclitaxel and carboplatin in salivary gland malignant neoplasms who are about to undergo surgery. Monoclonal antibodies, such as Sintilimab, 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.
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.
Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0.
If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Single group
Sintilimab , Carboplatin, Nab-paclitaxel
DrugPatients receive Sintilimab IV on day 1, paclitaxel IV on day 1 and carboplatin IV on day 1 . Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
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).
Percentage of participants demonstrating pathological response
Pathologic response in the primary tumor was assessed using a quantitative grading scheme: pathologic tumor response ，PTR0 = no or \<10% PTR1 = ≥10% PTR2 = ≥50%
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.
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.
Overall survival（OS）
Overall survival will be defined as the time from day 1 of study treatment until death from any cause.
Radiographic Response
Radiographic response to treatment as defined by RECIST 1.1.
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