Oral Squamous Cell CarcinomaPhase 2B2023-153NCT06130007
A Prospective, Single-arm Phase II Clinical Trial of Tislelizumab Combined With Platinum Doublet Neoadjuvant Therapy to Improve Mandibular Preservation in Resectable Locally Advanced Oral Squamous Cell Carcinoma.
A Phase 2 study testing Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy in people with Oral Squamous Cell Carcinoma, run by Xuekui Liu.
Trial summary
Given the feasibility of induction chemotherapy in oral cancer and the encouraging remission rates achieved, we explore the clinical application prospects of using tislelizumab in combination with traditional standard chemotherapy as induction treatment in oral cancer patients who have no radiological evidence of… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- What is being tested?
- Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2023to 25 Oct 2024
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must have a confirmed diagnosis of untreated primary oral squamous cell carcinoma, originating from the buccal mucosa, gums, tongue, or floor of the mouth, with clinical imaging confirming no mandibular invasion. Even in the absence of mandibular invasion, patients must still require mandibular segment resection.
- Clinical staging should be T3-4N0-3M0 (Stage III-IVb, excluding T1-2) according to the AJCC 8th edition staging.
- Patients must be aged between 18 and 70 years. Performance Status (PS) score should be 0-1. Evaluation by a head and neck oncologist should confirm eligibility for surgical resection.
- Patients should have at least one evaluable lesion according to RECIST V1.1 criteria.
- Adequate organ function is defined as follows:
- Hematology: White blood cells ≥ 4000/μL, neutrophils ≥ 2,000/μL, hemoglobin ≥ 90 g/dL, platelets ≥ 100,000/μL.
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- Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin levels ≤ 3 times ULN may be eligible), AST and ALT ≤ 3 times ULN, and alkaline phosphatase ≤ 3 times ULN, with albumin ≥ 3 g/dL.
- Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min according to the Cockcroft-Gault formula.
- Coagulation parameters (APTT and INR) should be ≤ 1.5 × ULN (patients on stable anticoagulation therapy such as low molecular weight heparin or warfarin within the expected therapeutic range may be screened).
- Thyroid-stimulating hormone (TSH) should be ≤ ULN. If abnormal, T3 and T4 levels should be assessed, and patients with normal T3 and T4 levels may be eligible.
- Patients must have provided informed consent and must be willing and able to adhere to the study plan, visit schedule, treatment plan, laboratory tests, and other study procedures.
- Reproductive-age females must agree to use contraceptive measures (e.g., intrauterine device, birth control pills, or condoms) during the treatment period and for three months after treatment completion. A negative serum or urine pregnancy test within 7 days before study entry is required, and patients must not be breastfeeding. Male patients must also agree to use contraceptive measures during the study and for three months after study completion.
Who cannot join
- History of severe hypersensitivity reactions to other monoclonal antibodies or PD-1 monoclonal antibodies or any of their components.
- Known or suspected autoimmune diseases, including dementia and epileptic seizures.
- Presence of measurable residual disease or new tumor/metastasis according to RECIST1.1 criteria, or patients deemed inoperable following evaluation by a head and neck specialist.
- Abnormal coagulation function: (PT > 16s, APTT > 53s, TT > 21s, Fib < 1.5g/L), a tendency to bleed, or current treatment with thrombolytic or anticoagulant agents.
- Severe cardiac or pulmonary dysfunction, with heart or lung function rated below Grade 3 (inclusive).
- Abnormal laboratory values within 7 days before enrollment.
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- History of any of the following treatments:
- Prior use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co-stimulatory or checkpoint pathways).
- Receipt of any investigational drug within 4 weeks before the first dose of the study drug.
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or a follow-up study for a new clinical trial.
- Pre-existing conditions requiring long-term use of immunosuppressive drugs or the use of corticosteroids at doses with immunosuppressive effects, either systemically or locally.
- Vaccination with anti-tumor vaccines or receipt of live vaccines within 4 weeks before the first dose of the study drug.
- Major surgery or severe trauma within 4 weeks before the first dose of the study drug.
- Experienced severe infections (CTC AE Grade > 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, septicemia, or complications of infection requiring hospitalization; baseline chest imaging indicating active lung inflammation; presence of symptoms and signs of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotics (excluding prophylactic antibiotic use).
- HIV-positive individuals, those testing positive for HBsAg with concurrent detection of positive HBV DNA copy numbers (quantitative test ≥ 1000 cps/ml); positive screening for chronic hepatitis C (HCV antibody-positive).
- History of other malignant tumors in the past 5 years, except for cured basal cell carcinoma, in situ cervical carcinoma, and papillary thyroid carcinoma.
- Positive pregnancy test in women of childbearing age and breastfeeding women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 替雷利珠单抗联合含铂双药新辅助治疗用于提高可切除局部晚期口腔鳞癌下颌骨保留的前瞻性、单臂Ⅱ期临床试验
Given the feasibility of induction chemotherapy in oral cancer and the encouraging remission rates achieved, we explore the clinical application prospects of using tislelizumab in combination with traditional standard chemotherapy as induction treatment in oral cancer patients who have no radiological evidence of mandibular erosion but require mandibulectomy due to the tumor's proximity to the mandible, aiming to shrink tumor size and increase the rate of mandible preservation. Therefore, we propose to conduct a prospective, single-arm, single-center phase II exploratory clinical trial: we plan to select patients with locally advanced resectable primary oral squamous cell carcinoma T3-4N0-3M0 (stages III-IVb, excluding T1-2) after multidisciplinary consultation and assessment by imaging and clinical evaluation. We aim to explore the feasibility of a three-week treatment regimen combining tislelizumab with polyaletin paclitaxel and a platinum-based triplet, preliminarily assess its clinical efficacy, adverse reactions, and postoperative mandible preservation rate, to provide the best comprehensive treatment plan for the preservation rate of the mandible in oral squamous cell carcinoma.
Read the detailed description
In this study, eligible subject will be enrolled into study arm to accept study treatment mandibular Preservation Rate will be the primary outcome measures.
- Conditions
- Oral Squamous Cell Carcinoma
- Being tested
- Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy
- 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.
Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple TherapyDrug
Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Treatment with Trastuzumab in Combination with Platinum-Based Doublet | Experimental | A first-line chemotherapy regimen for oral squamous cell carcinoma involves combining paclitaxel with platinum agents. PD-1 antibodies have shown promise in cases where the cancer has recurred, metastasized, or didn't respond to platinum-based treatments. Research is ongoing on using immune induction therapy with surgery or chemoradiotherapy for locally advanced, resectable oral squamous cell carcinoma. Trastuzumab, in combination with standard chemotherapy, is being explored as an induction treatment for patients needing mandibulectomy due to tumor proximity to the mandible. This study is a prospective, single-arm, single-center Phase II explora. Receives: Drug: Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular Preservation Rate;
Mandibular Preservation Rate
Measured: 12 weeks
Secondary outcomes (11)
ORR
Objective Response Rate
Measured: 12 weeks
CR
Complete Response
Measured: 12 weeks
PR
Partial Response
Measured: 12 weeks
SD
Stable Disease
Measured: 12 weeks
PD
Disease Progression
Measured: 12 weeks
MPR
major pathological response
Measured: 12 weeks
pCR
complete pathological response rate
Measured: 12 weeks
PFS
progression-free survival
Measured: 3 years
DFS
disease-free survival
Measured: 3 years
OS
overall survival
Measured: 3 years
AE
Percentage of adverse events that are possibly, probably related to study treatment per Criteria for Adverse Events version 5(CTCAE v5.0)
Measured: 90 days after the first dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start25 Nov 2023 (estimated)
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Oct 2024 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuekui Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuekui Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130007
- Sponsor's protocol ID
- B2023-153
- Acronym
- B2023-153
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 替雷利珠单抗联合含铂双药新辅助治疗用于提高可切除局部晚期口腔鳞癌下颌骨保留的前瞻性、单臂Ⅱ期临床试验
- ClinicalTrials.gov ID
- NCT06130007
- Acronym / sponsor ID
- B2023-153 / B2023-153
- Conditions
- Oral Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Xuekui LiuUniversity, hospital or other
- Study start
- 25 Nov 2023 (estimated)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Oct 2024 (estimated)
- First posted
- 13 Nov 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.
Given the feasibility of induction chemotherapy in oral cancer and the encouraging remission rates achieved, we explore the clinical application prospects of using tislelizumab in combination with traditional standard chemotherapy as induction treatment in oral cancer patients who have no radiological evidence of mandibular erosion but require mandibulectomy due to the tumor's proximity to the mandible, aiming to shrink tumor size and increase the rate of mandible preservation. Therefore, we propose to conduct a prospective, single-arm, single-center phase II exploratory clinical trial: we plan to select patients with locally advanced resectable primary oral squamous cell carcinoma T3-4N0-3M0 (stages III-IVb, excluding T1-2) after multidisciplinary consultation and assessment by imaging and clinical evaluation. We aim to explore the feasibility of a three-week treatment regimen combining tislelizumab with polyaletin paclitaxel and a platinum-based triplet, preliminarily assess its clinical efficacy, adverse reactions, and postoperative mandible preservation rate, to provide the best comprehensive treatment plan for the preservation rate of the mandible in oral squamous cell carcinoma.
Detailed description
In this study, eligible subject will be enrolled into study arm to accept study treatment mandibular Preservation Rate will be the primary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Treatment with Trastuzumab in Combination with Platinum-Based Doublet | Experimental | Drug: Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple TherapyA first-line chemotherapy regimen for oral squamous cell carcinoma involves combining paclitaxel with platinum agents. PD-1 antibodies have shown promise in cases where the cancer has recurred, metastasized, or didn't respond to platinum-based treatments. Research is ongoing on using immune induction therapy with surgery or chemoradiotherapy for locally advanced, resectable oral squamous cell carcinoma. Trastuzumab, in combination with standard chemotherapy, is being explored as an induction treatment for patients needing mandibulectomy due to tumor proximity to the mandible. This study is a prospective, single-arm, single-center Phase II explora. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have a confirmed diagnosis of untreated primary oral squamous cell carcinoma, originating from the buccal mucosa, gums, tongue, or floor of the mouth, with clinical imaging confirming no mandibular invasion. Even in the absence of mandibular invasion, patients must still require mandibular segment resection.
- Clinical staging should be T3-4N0-3M0 (Stage III-IVb, excluding T1-2) according to the AJCC 8th edition staging.
- Patients must be aged between 18 and 70 years. Performance Status (PS) score should be 0-1. Evaluation by a head and neck oncologist should confirm eligibility for surgical resection.
- Patients should have at least one evaluable lesion according to RECIST V1.1 criteria.
- Hematology: White blood cells ≥ 4000/μL, neutrophils ≥ 2,000/μL, hemoglobin ≥ 90 g/dL, platelets ≥ 100,000/μL.
Key exclusion criteria (17 listed)
- History of severe hypersensitivity reactions to other monoclonal antibodies or PD-1 monoclonal antibodies or any of their components.
- Known or suspected autoimmune diseases, including dementia and epileptic seizures.
- Presence of measurable residual disease or new tumor/metastasis according to RECIST1.1 criteria, or patients deemed inoperable following evaluation by a head and neck specialist.
- Abnormal coagulation function: (PT > 16s, APTT > 53s, TT > 21s, Fib < 1.5g/L), a tendency to bleed, or current treatment with thrombolytic or anticoagulant agents.
- Severe cardiac or pulmonary dysfunction, with heart or lung function rated below Grade 3 (inclusive).
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 |
|---|---|---|
| Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple TherapyThree-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy | Drug | Neoadjuvant Treatment with Trastuzumab in Combination with Platinum-Based Doublet |
Primary outcome
Mandibular Preservation Rate;
Time frame: 12 weeks
Mandibular Preservation Rate
11 secondary outcomes
ORR
Time frame: 12 weeks
CR
Time frame: 12 weeks
PR
Time frame: 12 weeks
SD
Time frame: 12 weeks
PD
Time frame: 12 weeks
MPR
Time frame: 12 weeks
pCR
Time frame: 12 weeks
PFS
Time frame: 3 years
DFS
Time frame: 3 years
OS
Time frame: 3 years
AE
Time frame: 90 days after the first dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy in people with Oral Squamous Cell Carcinoma, run by Xuekui Liu.
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 12 inclusion and 17 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Qi Fang Fang, MD (8613856534831 ext. 8613856534831, fangqi@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular Preservation Rate; (time frame: 12 weeks). 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 13 Nov 2023.