Efficacy of neoadjuvant toripalimab combined with docetaxel and cisplatin in the treatment of locally advanced oral squamous cell carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400082112

Enrollment

Unknown

Registered

2024-03-21

Start date

2024-03-21

Completion date

Unknown

Last updated

2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral squamous cell carcinoma

Interventions

Experimental group:Toripalimab combined with docetaxel and cisplatin

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: a. Age: 18-75 years; b. Gender: Male, Female; c. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-1; d. Histopathologically diagnosed with oral squamous cell carcinoma (including tongue, gums, cheek, floor of the mouth, palate, retromolar area); e. Primary tumor with a clinical stage of III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2/M0); f. Complete blood count: White Blood Cells > 3000/mm3, Hemoglobin > 8g/L, Platelets > 80000/mm3; g. Liver function: Alanine Aminotransferase/Aspartate Aminotransferase (ALAT/ASAT) < 2.5 times the upper limit of normal, Bilirubin < 1.5 times the upper limit of normal; h. Renal function: Serum creatinine < 1.5 times the upper limit of normal; i. Signed informed consent form.

Exclusion criteria

Exclusion criteria: a. Unresolved toxicity of grade 2 or higher from previous cancer treatment (CTCAE 5.0); b. Known grade 3-4 allergic reactions to drugs used in the treatment; c. Active severe clinical infection (Grade 2 or higher infection according to NCI-CTCAE Version 5.0); d. Uncontrolled hypertension or active cardiovascular disease, such as cerebrovascular accidents (=6 months), myocardial infarction (=6 months), unstable angina, congestive heart failure classified as class II or higher according to the New York Heart Association (NYHA Appendix 5), or severe arrhythmias that are uncontrollable or potentially affecting the trial; e. Patients with chronic diseases requiring immunotherapy or hormone therapy; f. Pregnant or breastfeeding women; g. Participation in another clinical trial within 30 days prior to enrollment; h. Any other conditions deemed by the researcher as unsuitable for participation in the trial.

Design outcomes

Primary

Measure	Time frame
Pathological response;The Response Evaluation Criteria In Solid Tumors, RECIST;	—

Secondary

Measure	Time frame
Overall survial;	—

Countries

China

Contacts

Public ContactXu Ding

The Affiliated Stomatological Hospital of Nanjing Medical University

dingxunj@hotmail.com+86 138 1399 8180

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026