A Multi-Center, Randomized Phase III Study of Neoadjuvant Anti-PD-1 Immunotherapy Plus TP Chemotherapy Versus TP Chemotherapy or Up-Front Surgery in Resectable Locally Advanced Oral Squamous Cell Carcinoma

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to investigate the survival benefit of neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy compared with TP chemotherapy or up-front surgery in resectable locally advanced oral squamous cell carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Histologically documented oral squamous cell carcinoma (biopsy required).

• Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-2M0, T3-4aN0-2M0) with resection option for potential cure, as assessed by a faculty surgeon at Hospital of Stomatology, Wuhan University.

• Distant metastasis is excluded by chest CT and emission computed tomograph.

• Adequate organ function as follows: 1) Leukocyte count ≥ 2,000/mm3; 2) Absolute neutrophil count ≥ 1,000/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90 g/L; 5) Serum albumin ≥30 g/L; 6) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) \< 2.5 × ULN; 8) ALP ≤ 2.5 × ULN; 9) Prothrombin time-international normalized ratio ≤ 1.5; 10) Serum creatinine ≤ 1.5 × ULN; 11) INR/PT≤ 1.5; 12) TSH ≤ ULN.

• ECOG performance status 0-1.

• Female patient tested HCG negative in serum or urine within 7 days prior to the start of investigational product. Both patient and partner must agree to use contraception prior to study entry and for the duration of study participation and for up to 120 days after the last dose of PD-1 blockade.

• Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form.

Locations
Other Locations
China
Xiangya Hospital of Central South University
RECRUITING
Changsha
Peking university Shenzhen hospital
NOT_YET_RECRUITING
Shenzhen
Hospital of Stomatology, Wuhan University
RECRUITING
Wuhan
Contact Information
Primary
Gang Chen, M.D.
geraldchan@whu.edu.cn
+86 02787686215
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 309
Treatments
No_intervention: Surgery followed by postoperative RT
The participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Experimental: Neoadjuvant TP chemotherapy
The participants will receive 2 courses of TP chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Experimental: Neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy
The participants will receive 3 doses of PD-1 blockade and 2 courses of TP chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Related Therapeutic Areas
Sponsors
Leads: Hospital of Stomatology, Wuhan University
Collaborators: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov