Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma

NCT ID: NCT04649476

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2024-08-10

Brief Summary

The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.

Detailed Description

The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced OSCC. And on this basis, we will explore the changes of the profiles and functions of immune cells within tumors, lymph nodes and peripheral blood after the experimental interventions, as well as their correlation with the patients' response and prognosis.

Conditions

Oral Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant PD-1 blockade alone

The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.

Neoadjuvant PD-1 blockade plus TPF induction chemotherapy

The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.

Group Type: EXPERIMENTAL

Camrelizumanb plus TPF

Intervention Type: 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, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.

Interventions

Camrelizumab

The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.

Intervention Type: DRUG

Camrelizumanb plus TPF

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, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.

Intervention Type: DRUG

Other Intervention Names

SHR-1210; Docetaxel, Cisplatin, 5-Fluorouracil

Eligibility Criteria

Inclusion Criteria

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

2. Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-3M0, T3-4aN0-3M0) with resection option for potential cure, as assessed by a faculty surgeon at Hospital of Stomatology, Wuhan University.

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

4. 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.

5. ECOG performance status 0-1.

6. 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.

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

Exclusion Criteria

1. History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to ≤ 1 grade irAEs from previous treatment.

2. History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years.

3. 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.

4. Active autoimmune disease or history of refractory autoimmune disease.

5. Active systemic infection requiring therapy.

6. Patients who are receiving psychotropic drug or alcohol/drug abuse.

7. Subjects with concurrent other active malignancies.

8. HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella, etc) within 4 weeks before recruitment.

9. Uncontrollable systemic diseases, including diabetes, hypertension, etc.

10. History of stroke or transient ischemic attack within past 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Hospital of Stomatology, Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Gang Chen

Chief physician, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital of Stomatology, Wuhan University

Locations

Hospital of Stomatology, Wuhan University

Wuhan, Hubei, China

Countries

China

References

Liu YT, Liu HM, Ren JG, Zhang W, Wang XX, Yu ZL, Fu QY, Xiong XP, Jia J, Liu B, Chen G. Immune-featured stromal niches associate with response to neoadjuvant immunotherapy in oral squamous cell carcinoma. Cell Rep Med. 2025 Mar 18;6(3):102024. doi: 10.1016/j.xcrm.2025.102024.

Reference Type: DERIVED

PMID: 40107247 (View on PubMed)

Liu HM, Xiong XP, Yu ZL, Shao Z, Chen GL, Liu YT, Wang XX, Fu QY, Cheng XX, Li J, Zhang JL, Li B, Gong HY, Zhong YH, Zhang W, Jia J, Liu B, Chen G. Neoadjuvant immunotherapy with or without chemotherapy in locally advanced oral squamous cell carcinoma: Randomized, two-arm, phase 2 trial. Cell Rep Med. 2025 Feb 18;6(2):101930. doi: 10.1016/j.xcrm.2025.101930. Epub 2025 Jan 30.

Reference Type: DERIVED

PMID: 39889711 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

HStomatologyWuhan

Identifier Type: -

Identifier Source: org_study_id