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

NCT05000892 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-12-02

No results posted yet for this study

Summary

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.

Conditions

  • Salivary Gland Malignant Neoplasms
  • Salivary Gland Tumors

Interventions

DRUG

Sintilimab , Carboplatin, Nab-paclitaxel

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2023-06-01
Completion
2027-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05000892 on ClinicalTrials.gov