Neoadjuvant immunochemotherapy to shrink advanced oral and oropharyngeal cancers before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.