Nasal Cavity CancerPhase 2NCT05114707
Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses
A Phase 2 study testing camrelizumab in people with Nasal Cavity Cancer and Paranasal Sinus Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. All the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-FU2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Cavity Cancer, Paranasal Sinus Cancer, Camrelizumab
- What is being tested?
- camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2021to 16 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed squamous cancer of nasal cavity and paranasal sinuses
- T4bN0-3M0 (AJCC8th) or unresectable lymph nodes or refusal of surgery
- KPS≥70
- NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
- ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
- creatinine clearance rate ≥ 60 ml/min (calculated by Cockcroft-Gault)
Who cannot join
- older than 65 or younger than 18
- HBsAg (+) and HBV DNA >1×10E3 copiers /mL
- HCV (+)
- HIV (+)
- autoimmune diseases
- interstitial lung diseases
- had other cancers before
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fei Han, M.D., +86 13822113698, hanfei@sysucc.org.cn
Pu-Yun OuYang, M.D., +86 18565382769, ouyangpy@sysucc.org.cn
About this study
Official title: Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses: a Phase II Multicenter Study
Patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. All the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-FU2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative intensity modulated radiotherapy. Besides, camrelizumab (200mg) is administrated every three weeks for a total of 11 cycles since the first day of induction chemotherapy. We aim to evaluate the three years failure free survival of these patients by the combination of camrelizumab with curative radiotherapy and chemotherapy.
- Conditions
- Nasal Cavity Cancer, Paranasal Sinus Cancer, Camrelizumab, Induction Chemotherapy, Intensity Modulated Radiotherapy, Concurrent Chemotherapy
- Being tested
- camrelizumab
- Medical subject headings
- Paranasal Sinus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumabDrug
Camrelizumab was administrated with 200mg each time, every three weeks for a total of 11 cycles since the first day of induction chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab group | Experimental | Not described Receives: Drug: camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year failure free survival
time from the randomization to the first treatment failure or death
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start16 Apr 2021
- Primary completion16 Apr 2024 (estimated)
- Study completion16 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Cavity CancerStudies of the same condition, open and under way.
- More trials run by 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Han, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114707
- Sponsor's protocol ID
- B2021-040-01
- Status last verified
- Nov 2021
- First submitted
- 31 Oct 2021
- Last updated
- 10 Nov 2021
- 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 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses: a Phase II Multicenter Study
- ClinicalTrials.gov ID
- NCT05114707
- Acronym / sponsor ID
- B2021-040-01
- Conditions
- Nasal Cavity Cancer, Paranasal Sinus Cancer, Camrelizumab, Induction Chemotherapy, Intensity Modulated Radiotherapy, Concurrent Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 16 Apr 2024 (estimated)
- Study completion
- 16 Apr 2024 (estimated)
- First posted
- 10 Nov 2021 (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.
Patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. All the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-FU2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative intensity modulated radiotherapy. Besides, camrelizumab (200mg) is administrated every three weeks for a total of 11 cycles since the first day of induction chemotherapy. We aim to evaluate the three years failure free survival of these patients by the combination of camrelizumab with curative radiotherapy and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| camrelizumab group | Experimental | Drug: camrelizumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed squamous cancer of nasal cavity and paranasal sinuses
- T4bN0-3M0 (AJCC8th) or unresectable lymph nodes or refusal of surgery
- KPS≥70
- NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
- ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
Key exclusion criteria (7 listed)
- older than 65 or younger than 18
- HBsAg (+) and HBV DNA >1×10E3 copiers /mL
- HCV (+)
- HIV (+)
- autoimmune diseases
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 |
|---|---|---|
| camrelizumabCamrelizumab was administrated with 200mg each time, every three weeks for a total of 11 cycles since the first day of induction chemotherapy. | Drug | camrelizumab group |
Primary outcome
3-year failure free survival
Time frame: 3-year
time from the randomization to the first treatment failure or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing camrelizumab in people with Nasal Cavity Cancer and Paranasal Sinus Cancer, run by 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 6 inclusion and 7 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 10 Nov 2021. 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 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 Fei Han (+86 13822113698, hanfei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year failure free survival (time frame: 3-year). 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 10 Nov 2021.