Neoadjuvant immunochemotherapy to shrink advanced oral and oropharyngeal cancers before surgery
A Bidirectional Observational Clinical Study of Tumor Regression Patterns in Patients With Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy
This project tests two cycles of neoadjuvant immunochemotherapy (tislelizumab with paclitaxel plus cisplatin or carboplatin) in people with locally advanced oral or oropharyngeal squamous cell carcinoma to see tumor response and survival outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | tislelizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07133958 on ClinicalTrials.gov |
What this trial studies
This bidirectional, single-center case series at Zhujiang Hospital enrolled 35 patients from April 2023 onward with locally advanced (T3–4) oral or oropharyngeal squamous cell carcinoma who received two cycles of neoadjuvant immunochemotherapy (tislelizumab + paclitaxel + cisplatin/carboplatin). Data were collected retrospectively and prospectively to describe treatment safety, tumor regression patterns, and short- and longer-term outcomes including 2-year progression-free survival and 5-year overall survival. Eligible patients were adults age 18–80 without distant metastases and with adequate blood, liver, kidney and organ function who could tolerate surgery. The study is single-arm and observational, documenting real-world responses rather than comparing treatment arms.
Who should consider this trial
Good fit: Adults aged 18–80 with locally advanced (T3–4) oral or oropharyngeal squamous cell carcinoma without distant metastasis who have adequate blood, liver, renal and overall organ function and can tolerate chemoimmunotherapy and surgery.
Not a fit: Patients with distant metastases, poor organ function, pregnancy or lactation, or those unable to tolerate combination chemoimmunotherapy or planned surgery are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce tumor size before surgery, potentially improving resectability and longer-term survival.
How similar studies have performed: Other neoadjuvant immunotherapy or chemo‑immunotherapy studies in head and neck cancers have reported promising tumor shrinkage and pathologic responses, though definitive long-term survival benefits remain under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Oral squamous cell carcinoma or oropharyngeal squamous cell carcinoma diagnosed as locally advanced (T3-4) according to the AJCC criteria 2. Their age ranged from 18 to 80 years 3. There was no history of other malignant tumors or treatment 4. Adequate blood function: white blood cell count (WBC) ≥3.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L; Hemoglobin concentration (HGB) ≥90g/L 5. Adequate liver function: total bilirubin (TBIL) ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal 6. "Adequate renal function: urinary white blood cells \< 10, red blood cells \< 10, cast count \< 5 per high-power field, and creatinine (CRE) ≤ the upper limit of normal. 7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI and surgical treatment 8. PS score ≤2 Exclusion Criteria: 1. Presence of distant metastasis 2. Women who are pregnant or lactating 3. Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons 4. Receiving investigational treatment in addition to other clinical studies (in the treatment phase of a clinical study) 5. Accompanied by severe uncontrolled infection or medical illness 6. Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate NACI or surgical treatment 7. There are factors affecting surgery or anesthesia, such as severe organ dysfunction 8. Long-term use of immunosuppressive agents after organ transplantation 9. Patients with a history of other malignant tumors before enrollment
Where this trial is running
Guangzhou, Guangdong
- Department of Stomatology, Zhujiang Hospital, Southern Medical University,Guangzhou, Guangdong — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xiaozhi LV
- Email: lxzsurgeon@126.com
- Phone: +86-020-62782092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.