Actively Recruiting
Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002)
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-03-26
43
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the efficacy and safety of sintilimab in combination with reduction of cycles of chemotherapy (carboplatin and nab-paclitaxel) in patients with oral cavity or oropharyngeal squamous cell carcinoma who are about to undergo surgery. Data obtained in this trial will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in oral cavity or oropharyngeal squamous cell carcinoma.
CONDITIONS
Official Title
Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of oral cavity or oropharyngeal squamous cell carcinoma planned for curative surgical resection
- Age 18 to less than 80 years at study entry
- ECOG performance status 0 or 1
- Measurable disease as per RECIST 1.1
- No prior immune-mediated therapy including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies (except therapeutic anticancer vaccines)
- Screening labs within 14 days before registration showing adequate liver, kidney, and bone marrow function
- Negative pregnancy test within 21 days before enrollment for women of reproductive potential
- Use of effective contraception during and after study as specified for women and men of reproductive potential
- Ability and willingness to sign informed consent
- Willingness and ability to comply with study protocol and visits
- Agreement to allow use of pre- and post-operative tissue samples for research
You will not qualify if you...
- Participation in another investigational study within 4 weeks before treatment or unresolved adverse events from prior studies
- History of another invasive cancer within 5 years or treatment for such cancer within 5 years prior to study
- Incomplete recovery from major surgery unrelated to study treatment
- Use of systemic corticosteroids (>10 mg prednisone equivalent) or immunosuppressants within 14 days before study start (except certain steroids)
- Active autoimmune disease requiring systemic steroids within past 3 months or severe autoimmune disease history
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Prior therapy with immune checkpoint inhibitors
- Allergic reactions to similar compounds used in this study
- Any condition or laboratory abnormality that might interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnancy, breastfeeding, or plans to conceive during the study period
- Known HIV infection
- Active Hepatitis B or C infection
- Known active tuberculosis infection
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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