Actively Recruiting
Phase II Trial of Sintilimab with Reduced Chemotherapy Cycles as Neoadjuvant Treatment for Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-03-26
43
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of sintilimab combined with a reduced number of chemotherapy cycles (carboplatin and nab-paclitaxel) in patients with oral cavity or oropharyngeal squamous cell carcinoma who are planning surgery. This Phase II trial aims to provide important data to guide future studies of anti-PD-1 therapies and other immunotherapies for these cancers. Participants receive neoadjuvant therapy consisting of three cycles: the first cycle includes sintilimab 200mg IV, carboplatin 300mg/m2 IV, and nab-paclitaxel 260mg/m2 IV on day 1; the second and third cycles include sintilimab 200mg IV on day 1, each cycle lasting 21 days. After surgery, high-risk patients based on pathology may receive sintilimab intravenously every three weeks for up to one year, starting once acute toxicities from post-operative chemotherapy and radiation resolve to grade 1 or less. During the study, patients undergo surgery and receive follow-up evaluations including safety monitoring for adverse events, radiographic assessments, and survival tracking for up to five years. The primary outcome is pathological tumor response at surgery. Secondary outcomes include adverse event rates, disease-free survival at two years, overall survival at five years, radiographic response at five weeks, and rate of surgery delay within eight weeks after treatment. Participants are monitored closely throughout treatment and follow-up periods.
CONDITIONS
Brief 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 surgery
- Age 18 to less than 80 years
- ECOG performance status of 0 or 1
- Measurable disease per RECIST 1.1
- No prior immune-mediated therapy including anti-CTLA-4 or anti-PD-1/PD-L1 antibodies
- Adequate liver, kidney, and bone marrow function based on lab tests within 14 days before registration
- Negative pregnancy test for women of reproductive potential within 21 days before enrollment
- Use of effective contraception for women and men during and after the study as specified
- Ability to understand and sign informed consent
- Willingness and ability to comply with study protocol and visits
- Consent to allow use of pre- and post-operative tissue samples for research purposes
You will not qualify if you...
- Participation in another investigational study within 4 weeks before first dose or unresolved side effects from previous treatments
- History of other invasive malignancies or recent cancer treatments within 5 years
- Inadequate recovery from major surgery unrelated to the cancer
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 14 days before day -5, except certain permitted steroids
- Active or severe autoimmune disease requiring systemic steroids or immunosuppressants
- Evidence of interstitial lung disease or active pneumonitis
- Active infection requiring systemic therapy
- Prior therapy with immune checkpoint inhibitors
- Allergic reactions to similar compounds
- Conditions or abnormalities interfering with trial participation or results
- Psychiatric or substance abuse disorders impacting cooperation
- Pregnancy, breastfeeding, or planning conception during the study period
- Known HIV infection
- Active Hepatitis B or C infection
- History of active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive neoadjuvant therapy consisting of Sintilimab combined with Nab-paclitaxel and Carboplatin over three 21-day cycles before surgery.
3 treatment visits every 3 weeks
Duration - 1 week or as per surgical recovery
Participants undergo standard of care surgical resection of the tumor.
1 surgical visit with immediate post-operative assessments
Duration - Up to 1 year
Participants considered high-risk after surgery receive adjuvant Sintilimab intravenously once every 3 weeks for up to 1 year, after resolution of acute toxicities from post-operative chemotherapy and radiation.
Treatment visits every 3 weeks
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
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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