Temporal Bone Squamous Cell CarcinomaPhase 4NCT05444673
A Prospective, Single-arm Clinical Study of Pabrolizumab in Combination With Cisplatin + 5-FU for the Neoadjuvant Treatment of Unresectable, Advanced Squamous Carcinoma of the Temporal Bone Single-arm Clinical Study
A Phase 4 study testing Paprizumab combined with cisplatin and 5-FU in people with Temporal Bone Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Temporal bone cancer accounts for 0.2% of head and neck cancers. Advanced temporal bone cancer often involves structures such as apices, internal carotid artery canals, and dura mater, and negative margins cannot be obtained during surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Temporal Bone Squamous Cell Carcinoma
- What is being tested?
- Paprizumab combined with cisplatin and 5-FU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Dec 2024
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced temporal bone carcinoma evaluated by an otolaryngologist as non-R0 resectable; CPS score > 20.
- Patients who had undergone surgery, chemotherapy, radiotherapy, etc.
- Patients with T4 advanced temporal bone cancer, Patients with nasopharyngeal carcinoma after radiotherapy
- Hematology, biochemistry, and organ function:
- Hemoglobin ≥100 g/L (can be maintained or exceeded by transfusion);
- Neutrophil absolute count ≥2.0×109/L;
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- Platelet count ≥100×109/L;
- Total bilirubin ≤1.5 times the upper limit of normal;
- Alt and ASPARTate aminotransferase ≤2.5 times the upper limit of normal value;
- Creatinine ≤1.25 times the upper limit of normal; The creatinine clearance rate was ≥60mL/min.
- Women of childbearing age (18-49 years) must exclude pregnancy.
- General admission criteria:
- Obtain informed consent signed by the patient or his legal representative;
- Good patient compliance;
- Medications can be taken orally;
- Male or female aged ≥18 years and < 75 years;
- ECOG behavior status score 0-1, life expectancy > 12 weeks;
- Both men and women of reproductive age agreed to use a reliable method of contraception before entering the trial, during the study, and up to 8 weeks after stopping the drug.
Who cannot join
- Patients who had cancer other than temporal bone cancer during the five years before the initiation of treatment in this study were excluded from: fully cured with surgery and disease-free survival of at least 5 years; carcinoma in situ of the cervix; cured basal cell carcinoma; bladder epithelial neoplasms (including Ta and Tis);
- Known allergy to carboplatin, 5-FU, or any of the ingredients in this product;
- Confirmed or suspected active immune disease. The following conditions can be included: the absence of a specific external stimulus will not develop; Systemic treatment is not required.
- systemic use of steroid hormones (> 10mg/ day equivalent of prednisone) or immunosuppressants within 14 days before first administration. Aerosolized inhalation or topical administration of steroid steroids may be used in the absence of active immune disease.
- Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;
- Any unstable systemic disease, including: Active infection, uncontrolled hypertension, unstable angina, the onset of angina within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] Class II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney, or metabolic disease;
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- Known human immunodeficiency virus (HIV) infection, active hepatitis B or C;
- Patients with mixed small cell lung cancer components;
- Pregnant or lactating women;
- A clear history of neurological or psychiatric disorders, including epilepsy or dementia;
- Conditions deemed unsuitable for inclusion by other researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510030
Suijun CHEN, doctor, 13609757219, Chensuijun1974@163.com
About this study
Official title: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Temporal bone cancer accounts for 0.2% of head and neck cancers. Advanced temporal bone cancer often involves structures such as apices, internal carotid artery canals, and dura mater, and negative margins cannot be obtained during surgery. The recurrence rate after surgery is as high as 70%, and the 2-year survival rate is only 11%. Crestor, or paprolizumab, is a monoclonal antibody to PD1 that blocks the interaction between PD1 and the dura mater. The NCCN guidelines recommend that paprolizumab be used in combination with platinum-based anti-tumor agents. The NCCN guidelines recommend pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent, unresectable head and neck squamous carcinoma, but this regimen is not recommended for the treatment of recurrent, unresectable head and neck squamous carcinoma. This study is intended to investigate the use of pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent unresectable squamous head and neck cancer. This study investigates the effectiveness of pablizumab in combination with cisplatin and 5-FU for the adjuvant treatment of recurrent, unresectable temporal bone cancer. temporal bone cancer.
- Conditions
- Temporal Bone Squamous Cell Carcinoma
- Being tested
- Paprizumab combined with cisplatin and 5-FU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paprizumab combined with cisplatin and 5-FUDrug
Patients with advanced temporal bone cancer were treated with pabulizumab combined with cisplatin and 5-FU
| Study group | Role | What they receive |
|---|---|---|
| Paprizumab combined with cisplatin and 5-FU | Experimental | Patients received four cycles of paprizumab (200mg iv, 21-day cycle) in combination with 5-fu (500mg/m2 iv) plus cisplatin (80mg/m2 iv, 21-day cycle). Reassessment after completion of neoadjuvant chemotherapy was performed in operable patients. Receives: Drug: Paprizumab combined with cisplatin and 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
The resectability rate of pablizumab in combination with cisplatin and 5-FU for unresectable temporal bone squamous carcinoma as neoadjuvant therapy
Resectability rate of tumors
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal Bone Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suijun CHEN, doctor, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444673
- Sponsor's protocol ID
- 2022-KY-068
- Status last verified
- Jul 2022
- First submitted
- 26 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- ClinicalTrials.gov ID
- NCT05444673
- Acronym / sponsor ID
- 2022-KY-068
- Conditions
- Temporal Bone Squamous Cell Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Jul 2022 (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.
Temporal bone cancer accounts for 0.2% of head and neck cancers. Advanced temporal bone cancer often involves structures such as apices, internal carotid artery canals, and dura mater, and negative margins cannot be obtained during surgery. The recurrence rate after surgery is as high as 70%, and the 2-year survival rate is only 11%. Crestor, or paprolizumab, is a monoclonal antibody to PD1 that blocks the interaction between PD1 and the dura mater. The NCCN guidelines recommend that paprolizumab be used in combination with platinum-based anti-tumor agents. The NCCN guidelines recommend pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent, unresectable head and neck squamous carcinoma, but this regimen is not recommended for the treatment of recurrent, unresectable head and neck squamous carcinoma. This study is intended to investigate the use of pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent unresectable squamous head and neck cancer. This study investigates the effectiveness of pablizumab in combination with cisplatin and 5-FU for the adjuvant treatment of recurrent, unresectable temporal bone cancer. temporal bone cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paprizumab combined with cisplatin and 5-FU | Experimental | Drug: Paprizumab combined with cisplatin and 5-FUPatients received four cycles of paprizumab (200mg iv, 21-day cycle) in combination with 5-fu (500mg/m2 iv) plus cisplatin (80mg/m2 iv, 21-day cycle). Reassessment after completion of neoadjuvant chemotherapy was performed in operable patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients with advanced temporal bone carcinoma evaluated by an otolaryngologist as non-R0 resectable; CPS score > 20.
- Patients who had undergone surgery, chemotherapy, radiotherapy, etc.
- Patients with T4 advanced temporal bone cancer, Patients with nasopharyngeal carcinoma after radiotherapy
- Hematology, biochemistry, and organ function:
- General admission criteria:
Key exclusion criteria (11 listed)
- Patients who had cancer other than temporal bone cancer during the five years before the initiation of treatment in this study were excluded from: fully cured with surgery and disease-free survival of at least 5 years; carcinoma in situ of the cervix; cured basal cell carcinoma; bladder epithelial neoplasms (including Ta and Tis);
- Known allergy to carboplatin, 5-FU, or any of the ingredients in this product;
- Confirmed or suspected active immune disease. The following conditions can be included: the absence of a specific external stimulus will not develop; Systemic treatment is not required.
- systemic use of steroid hormones (> 10mg/ day equivalent of prednisone) or immunosuppressants within 14 days before first administration. Aerosolized inhalation or topical administration of steroid steroids may be used in the absence of active immune disease.
- Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;
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 |
|---|---|---|
| Paprizumab combined with cisplatin and 5-FUPatients with advanced temporal bone cancer were treated with pabulizumab combined with cisplatin and 5-FU | Drug | Paprizumab combined with cisplatin and 5-FU |
Primary outcome
The resectability rate of pablizumab in combination with cisplatin and 5-FU for unresectable temporal bone squamous carcinoma as neoadjuvant therapy
Time frame: up to three months
Resectability rate of tumors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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.
Suijun CHEN, doctor study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paprizumab combined with cisplatin and 5-FU in people with Temporal Bone Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site 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 18 inclusion and 11 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 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Suijun CHEN, doctor (13609757219, Chensuijun1974@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The resectability rate of pablizumab in combination with cisplatin and 5-FU for unresectable temporal bone squamous carcinoma as neoadjuvant therapy (time frame: up to three 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 6 Jul 2022.