Tislelizumab Combined with TP in Patients with Locally Advanced Oral Squamous Cell Carcinoma: a Single-arm, Phase II Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064609

Enrollment

Unknown

Registered

2022-10-12

Start date

2022-10-10

Completion date

Unknown

Last updated

2023-05-15

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

Treatment group:Tislelizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old; 2. Patients with pathological diagnosis of oral squamous cell carcinoma, resectable and no distant metastasis as assessed by head and neck oncologists; 3. Patients who have not undergone systemic chemotherapy, radiotherapy or surgery; 4. Patients with clinical stage III-IVb (T3-4bN0-3) as assessed by imaging and pathological examination (AJCC8.0 version); 5. Patients with at least one evaluable lesion according to RECIST V1.1 criteria; 6. ECOG score 0-1; 7. Patients with normal heart, brain, lung, kidney, and other organ functions who can tolerate surgery; 8. Patients who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received or are receiving chemotherapy, radiotherapy, immunotherapy or targeted therapy; 2. Patients with distant metastasis or unresectable disease after head and neck physician evaluation; 3. Patients with other sites of tumors at the same time; 4. Patients with severe impairment of heart, liver and kidney function (cardiac function grade 3~4, ALT and/or AST more than 1.5 times the upper limit of normal, Cr more than 1.5 times the upper limit of normal); 5. Patients with a history of autoimmune diseases, who are receiving immunosuppressive therapy before enrollment, immunosuppressive dosage > 10 mg/day or oral prednisone for more than 2 weeks; 6. Severe allergic reactions; 7. Abnormal coagulation function: (PT > 16 s, APTT > 53 s, TT > 21 s, Fib < 1.5 g/L), bleeding tendency or thrombolytic and anticoagulant therapy; 8. Pregnancy or lactation period; 9. Other conditions that the investigator believes not suitable for enrollment

Design outcomes

Primary

Measure	Time frame
Complete pathological rate;	—

Secondary

Measure	Time frame
Objective response rate, ORR;Major pathologic response, MPR;Progression-free survival, PFS;Overall Survival, OS;Safety;	—

Countries

China

Contacts

Public ContactYanfeng Chen

Sun Yat-Sen University Cancer Center

chenyf@sysucc.org.cn+86 13710512669

Outcome results

None listed

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