Oral Squamous Cell CarcinomaPhase 3NEOPCOSCCNCT05798793
Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma
A Phase 3 study testing Camrelizumab plus TP and TP in people with Oral Squamous Cell Carcinoma, run by Hospital of Stomatology, Wuhan University at 3 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- What is being tested?
- Camrelizumab plus TP and TP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 3 sitesChina
- Study dates
- 21 Nov 2023to 1 Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Tong Su, M.D., 0731-89753046, sutong@csu.edu.cn
- Not yet recruiting
Peking university Shenzhen hospital
Shenzhen, Guangdong, 518036
Hong-Yu Yang, M.D., 0755-83923333, hyyang192@hotmail.com
- Recruiting
Hospital of Stomatology, Wuhan University
Wuhan, Hubei, 430079
Gang Chen, M.D., +86 02787686215, geraldchan@whu.edu.cn
About this study
Official title: 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
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.
- Conditions
- Oral Squamous Cell Carcinoma
- Being tested
- Camrelizumab plus TP, TP
- Keywords
- Neoadjuvant, Oral squamous cell carcinoma, Anti-PD-1 immunotherapy, Camrelizumab, TP chemotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab plus TPDrug
Also called SHR-1210 plus Docetaxel, Cisplatin
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.
TPDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Camrelizumab plus TP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months.
Secondary outcomes (4)
Overall Survival (OS) on Each Treatment Arm.
OS is the time from randomization to death due to any cause.
Measured: 24 months.
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.
Measured: 8 weeks.
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.
Measured: 8 weeks.
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.
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start21 Nov 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital of Stomatology, Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Gang Chen, Hospital of Stomatology, Wuhan University
- Investigators
- Gang Chen, M.D., Principal investigator, Hospital of Stomatology, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798793
- Sponsor's protocol ID
- WuhanHStomatology
- Acronym
- NEOPCOSCC
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05798793
- Acronym / sponsor ID
- NEOPCOSCC / WuhanHStomatology
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Neoadjuvant, Oral squamous cell carcinoma, Anti-PD-1 immunotherapy, Camrelizumab, TP chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Hospital of Stomatology, Wuhan UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: TPThe participants will receive 2 courses of TP chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary. |
| Neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy | Experimental | Drug: Camrelizumab plus TPThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab plus TPAlso: SHR-1210 plus Docetaxel, CisplatinThe 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. | Drug | Neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy |
| TPAlso: Docetaxel, CisplatinThe participants will receive docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles. | Drug | Neoadjuvant TP chemotherapy |
Primary outcome
Event-free Survival (EFS) Rate on Each Treatment Arm.
Time frame: 24 months.
EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1.
4 secondary outcomes
Overall Survival (OS) on Each Treatment Arm.
Time frame: 24 months.
Radiographic Response.
Time frame: 8 weeks.
Pathologic Response.
Time frame: 8 weeks.
Adverse Events (AEs).
Time frame: 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Chen, M.D. principal investigator
Hospital of Stomatology, Wuhan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Camrelizumab plus TP and TP in people with Oral Squamous Cell Carcinoma, run by Hospital of Stomatology, Wuhan University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Chen, M.D. (+86 02787686215, geraldchan@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free Survival (EFS) Rate on Each Treatment Arm. (time frame: 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.