Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Salivary Gland Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Oral Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

* Sintilimab (IV), dose= 200mg , day=1 , cycle length: 21 days.
* Carboplatin (IV), dose=300mg/m2, day= 1, cycle length: 21 days.
* Nab-paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.

Patients 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.

Sintilimab , Carboplatin, Nab-paclitaxel

Song Fan, Doctor degrees

Song Fan, Doctor degree

Jinsong Li, Doctor degree

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.

Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms

Phase II Trial of Sintilimab, an Anti-PD-1 Monoclonal Antibody, in Combination With Combination Carboplatin and Nab-paclitaxel , as a Novel Neoadjuvant Pre-Surgical Therapy for Salivary Gland Malignant Neoplasms

Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

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 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.

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 will be defined as the time from day 1 of study treatment until death from any cause.

Radiographic response to treatment as defined by RECIST 1.1.

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.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Associate Professor

* Toripalimab (IV), dose= 240mg , day=1 , cycle length: 21 days.
* Carboplatin (IV), dose=300mg/m2, day= 1, cycle length: 21 days.
* Nab-paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.

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.

Toripalimab , Carboplatin, Nab-paclitaxel

Tingting Cai, Bachelor's Degrees

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.

Neoadjuvant Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms

Phase II Trial of Toripalimab, an Anti-PD-1 Monoclonal Antibody, in Combination With Combination Carboplatin and Nab-paclitaxel , as a Novel Neoadjuvant Pre-Surgical Therapy for Salivary Gland Malignant Neoplasms

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%

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms	NCT05000892	Salivary Gland ... Salivary Gland ...	Sintilimab , Ca...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms	NCT05000892	Salivary Gland ... Salivary Gland ...	Sintilimab , Ca...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms	NCT04825938	Salivary Gland ... Salivary Gland ...	Toripalimab , C...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms	NCT04825938	Salivary Gland ... Salivary Gland ...	Toripalimab , C...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms	NCT04825938	Salivary Gland ... Salivary Gland ...	Toripalimab , C...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for salivary gland malignant neoplasms