Actively Recruiting
Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2022-12-02
15
Participants Needed
1
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Untreated Salivary Gland Malignant Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a confirmed diagnosis of salivary gland cancer planned for curative surgery, including mucoepidermoid carcinoma, adenocarcinoma, adenoid cystic carcinoma, acinic cell carcinoma, or other histology
- Age between 18 and 80 years at study entry
- ECOG performance status of 0 or 1
- Measurable disease according to RECIST 1.1 criteria
- No prior immune-mediated therapy such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies (except therapeutic vaccines)
- Adequate liver and kidney function based on recent lab tests
- Adequate bone marrow function with specified blood count minimums
- Women of reproductive potential must have a negative pregnancy test and agree to use effective contraception for 23 weeks after last dose
- Men who are sexually active with women of reproductive potential must use contraception for 31 weeks after last dose
- Ability and willingness to provide informed consent and comply with study procedures
- Agreement to allow use of pre-treatment and post-operative tissue samples for research
You will not qualify if you...
- Participation in another investigational study within 4 weeks or unresolved adverse events from prior studies
- Another invasive cancer within 5 years or recent cancer treatment within 5 years
- Recent major surgery without adequate recovery
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days before treatment
- Active autoimmune diseases requiring systemic steroids or severe autoimmune history
- Active, known or suspected autoimmune disease except certain controlled conditions
- Evidence of interstitial lung disease or active pneumonitis
- Active infection requiring systemic therapy
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or similar immune checkpoint therapies
- History of allergic reaction to study drugs or similar compounds
- Any condition or abnormality that may interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant or breastfeeding women or those planning pregnancy during study and follow-up
- Known HIV infection
- Known active Hepatitis B or C
- Known history of active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
S
Song Fan, Doctor degrees
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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