Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma

NCT05798793 | Recruiting Phase 3

• 1 other identifier: WuhanHStomatology
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Oral Squamous Cell Carcinoma

Keywords

Neoadjuvant; Oral squamous cell carcinoma; Anti-PD-1 immunotherapy; Camrelizumab; TP chemotherapy

Outcome Measures

Primary Outcomes (1)

• Event-free Survival (EFS) Rate on Each Treatment Arm.

  EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1.

  24 months.

Secondary Outcomes (4)

• Overall Survival (OS) on Each Treatment Arm.

  24 months.

• Radiographic Response.

  8 weeks.

• Pathologic Response.

  8 weeks.

• Adverse Events (AEs).

  24 months.

Other Outcomes (1)

• Changes in the Level of Circualting Exosomal PD-L1.

  24 months.

Study Arms (3)

Surgery followed by postoperative RT

NO INTERVENTION

The participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.

Neoadjuvant TP chemotherapy

EXPERIMENTAL

The participants will receive 2 courses of TP chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.

Drug: TP

Neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy

EXPERIMENTAL

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.

Drug: Camrelizumab plus TP

Interventions

Camrelizumab plus TP DRUG

The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.

Also known as: SHR-1210 plus Docetaxel, Cisplatin

Neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy

TP DRUG

The participants will receive docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.

Also known as: Docetaxel, Cisplatin

Neoadjuvant TP chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to ≤ 1 grade irAEs from previous treatment.
• History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years.
• Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways.
• Active autoimmune disease or history of refractory autoimmune disease.
• Active systemic infection requiring therapy.
• Patients who are receiving psychotropic drug or alcohol/drug abuse.
• Subjects with concurrent other active malignancies.
• HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella, etc) within 4 weeks before recruitment.
• Uncontrollable systemic diseases, including diabetes, hypertension, etc.
• History of stroke or transient ischemic attack within past 6 months.
• Distant metastases or inability to resect after physician evaluation.
• Serious cardiovascular, respiratory, immune system critical disease or other conditions that the researchers thought might increase the subjects' risk.

Sponsors & Collaborators

• Hospital of Stomatology, Wuhan University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (3)

Peking university Shenzhen hospital

Shenzhen, Guangdong, 518036, China

NOT YET RECRUITING

Hospital of Stomatology, Wuhan University

Wuhan, Hubei, 430079, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Gang Chen, M.D.

  Hospital of Stomatology, Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Chen, M.D.

CONTACT

+86 02787686215; geraldchan@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Professor

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 5, 2023
• Study Start: November 21, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)