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Status unknownNCT05798793NEOPCOSCCUpdated Apr 2, 2024

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

A Phase 3 interventional study of Camrelizumab plus TP and TP in Oral Squamous Cell Carcinoma, sponsored by Hospital of Stomatology, Wuhan University. Status unknown at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by Hospital of Stomatology, Wuhan University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
309
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

On the basis of preliminary study, this study is to further verify the efficacy and safety of neoadjuvant anti-PD-1 immunotherapy plus chemotherapy. The further 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. And on this basis, the investigators 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.

02

Conditions studied

  • Oral Squamous Cell Carcinoma

Keywords

  • Neoadjuvant
  • Oral squamous cell carcinoma
  • Anti-PD-1 immunotherapy
  • Camrelizumab
  • TP chemotherapy
03

In context

Squamous Cell Carcinoma of Head and Neck

1,711 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 544 are open to participants now.

This study's planned enrollment of 309 is above the median of 50 across 1,456 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Hospital of Stomatology, Wuhan University is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Histologically documented oral squamous cell carcinoma (biopsy required).
  2. 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.
  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

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.
  11. Distant metastases or inability to resect after physician evaluation.
  12. Serious cardiovascular, respiratory, immune system critical disease or other conditions that the researchers thought might increase the subjects' risk.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
309 participants (estimated)

Study arms

  • 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.

    Drug: TP

  • 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.

    Drug: Camrelizumab plus TP

Interventions

  • DrugCamrelizumab plus TP

    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

  • DrugTP

    Drug pages: Docetaxel · Cisplatin

    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

06

What researchers measure

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.

    Time frame: 24 months.

Secondary outcomes

  1. Overall Survival (OS) on Each Treatment Arm.

    OS is the time from randomization to death due to any cause.

    Time frame: 24 months.

  2. Radiographic Response.

    Clinical response of tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy, as evaluated by radiographic examinations and defined by RECIST 1.1. Clinical response of tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy, as evaluated by radiographic examinations and defined by RECIST 1.1.

    Time frame: 8 weeks.

  3. Pathologic Response.

    Pathologic response of resected tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy. Pathologic response is defined as sum of pathologic complete response and major pathologic response. Pathologic complete response is defined as the absence of viable residual tumor in resected specimen. The rate of major pathologic response, defined as \<10% residual viable tumor cells in the resected specimen.

    Time frame: 8 weeks.

  4. Adverse Events (AEs).

    Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions.

    Time frame: 24 months.

Other outcomes

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

    The level of circulating exosomal PD-L1 at serial time points pre- and on-treatment, as detected by enzyme-linked immunosorbent assay (ELISA).

    Time frame: 24 months.

07

Study locations

2 of 3 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Jul 2026, 31 months after the start.

Of 66 phase 3 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 121. This study's planned 31 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2023
First posted
Apr 5, 2023
StartActual
Nov 21, 2023
Primary completionEst.
Jul 1, 2026
CompletionEst.
Oct 1, 2026
Last update
Apr 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05798793
Lead sponsor
Hospital of Stomatology, Wuhan University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Gang Chen (Chief physician, Professor, Hospital of Stomatology, Wuhan University) — Principal investigator
First posted
Apr 5, 2023
Start date
Nov 21, 2023
Primary completion
Jul 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Apr 2, 2024

Study contacts

Gang Chen, M.D.
Contact
geraldchan@whu.edu.cn
+86 02787686215
Gang Chen, M.D.
principal investigator · Hospital of Stomatology, Wuhan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Docetaxel · Cisplatin

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