Nasopharyngeal CarcinomaPhase 2NCT05229315
PD-1 Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma
A Phase 2 study testing Toripalimab and Intensity modulated radiotherapy in people with Nasopharyngeal Carcinoma and T2-3N0 or T1-2N1, run by XIANG YANQUN at 1 site in China.
Trial summary
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, T2-3N0 or T1-2N1, EBV-DNA≤4000 Copy/ml
- What is being tested?
- Toripalimab and Intensity modulated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2022to Dec 2023
- 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
- Newly diagnosed patients who have not received radiotherapy or chemotherapy
- Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, WHO classification type II or type III).
- T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml (AJCC 8th version) and EBV-DNA≤4000copies/ml
- Male or non-pregnant female
- Age between 18 and 65
- Eastern Cooperative Oncology Group（ECOG）score of 0-1.
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- Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.
- Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <2.0 times the upper limit of normal (ULN); total bilirubin <2.0×ULN.
- Renal function: creatinine clearance rate ≥60ml/min or serum creatinine <1.5×ULN.
- The patient has signed the informed consent
Who cannot join
- The pathology is keratinizing squamous cell carcinoma (WHO classification is type I).
- Patients with recurrence and distant metastasis.
- Patients who have undergone radiotherapy or chemotherapy.
- Active hepatitis B (HBV-DNA≥500).
- Patients with autoimmune diseases.
- Patients with HIV infection.
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- At the same time suffering from other uncontrolled serious diseases.
- Persons with abnormal functions of the heart, brain, lungs and other important organs.
- Age> 65 years.
- pregnancy or breast feeding.
- Persons with personality or mental illness, without or with limited capacity for civil conduct
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yanqun Xiang
Guangzhou, Guangdong, 510000
Yanqun Xiang, Dr., +8618666096623, xiangyq@sysucc.org.cn
Weixiong Xia, Dr., +8618520415699, xiawx@sysucc.org.cn
About this study
Official title: PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma (T2-3N0 or T1-2N1 and EBV-DNA≤4000 Copy/ml),A Single-arm, Phase II Clinical Trial
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).
Read the detailed description
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).The primary end point is safety, the secondary end points are short-term efficacy,overall survival (OS), progression-free survival (PFS),Distant metastasis-free survival(DMFS),adverse effects ,quality of life and immune status assessment.
- Being tested
- Toripalimab, Intensity modulated radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called Programmed cell death protein 1(PD-1)；Immune checkpoint inhibitors（ICIs)
PD-1 Immune Checkpoint Inhibitor Combined With IMRT,used at 2 weeks before radiotherapy, once every 2 weeks, 10 cycles in total
Intensity modulated radiotherapyProcedure or surgery
Intensity modulated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy | Experimental | Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total Receives: Drug: Toripalimab; Procedure: Intensity modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The severity of adverse events will be determined by the investigator based on CTCAE v 5.0
Measured: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
Secondary outcomes (4)
overall survival (OS)
Patients in clinical trials were randomized to the time of death from any cause
Measured: 2 years
progression-free survival (PFS)
The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause
Measured: 2 years
Distant metastasis-free survival(DMFS)
Patients in clinical trials were randomized to the time of distant metastasis
Measured: 2 years
Response rate (based on RECIST ver1.1)
According to the remission assessment criteria of solid tumors，divided into CR, PR, SD, PD.
CR(complete response) All target lesions disappeared and no new lesions appeared PR ( partial response) reduction of the sum of the largest diameters of target lesions by ≥30%) SD(stable disease)the sum of the largest diameters of target lesions does not shrink to PR, or increases to PD PD(progressive disease) The sum of the largest diameters of target lesions increases by at least 20%, or new lesions appear
Measured: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start12 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XIANG YANQUN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XIANG YANQUN, Sun Yat-sen University
- Investigators
- Yanqun Xiang, Dr, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229315
- Sponsor's protocol ID
- B2021-292-01
- Status last verified
- Apr 2023
- First submitted
- 25 Jan 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma (T2-3N0 or T1-2N1 and EBV-DNA≤4000 Copy/ml),A Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05229315
- Acronym / sponsor ID
- B2021-292-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- XIANG YANQUNUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Feb 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.
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).
Detailed description
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).The primary end point is safety, the secondary end points are short-term efficacy,overall survival (OS), progression-free survival (PFS),Distant metastasis-free survival(DMFS),adverse effects ,quality of life and immune status assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy | Experimental | Drug: Toripalimab, Procedure: Intensity modulated radiotherapyIntensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Newly diagnosed patients who have not received radiotherapy or chemotherapy
- Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, WHO classification type II or type III).
- T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml (AJCC 8th version) and EBV-DNA≤4000copies/ml
- Male or non-pregnant female
- Age between 18 and 65
Key exclusion criteria (11 listed)
- The pathology is keratinizing squamous cell carcinoma (WHO classification is type I).
- Patients with recurrence and distant metastasis.
- Patients who have undergone radiotherapy or chemotherapy.
- Active hepatitis B (HBV-DNA≥500).
- Patients with 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 |
|---|---|---|
| ToripalimabAlso: Programmed cell death protein 1(PD-1)；Immune checkpoint inhibitors（ICIs)PD-1 Immune Checkpoint Inhibitor Combined With IMRT,used at 2 weeks before radiotherapy, once every 2 weeks, 10 cycles in total | Drug | PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy |
| Intensity modulated radiotherapyIntensity modulated radiotherapy | Procedure or surgery | PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy |
Primary outcome
Adverse events
Time frame: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
The severity of adverse events will be determined by the investigator based on CTCAE v 5.0
4 secondary outcomes
overall survival (OS)
Time frame: 2 years
progression-free survival (PFS)
Time frame: 2 years
Distant metastasis-free survival(DMFS)
Time frame: 2 years
Response rate (based on RECIST ver1.1)
Time frame: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: Yes
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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.
Yanqun Xiang, Dr principal investigator
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 2 study testing Toripalimab and Intensity modulated radiotherapy in people with Nasopharyngeal Carcinoma and T2-3N0 or T1-2N1, run by XIANG YANQUN 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 10 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 13 Apr 2023. 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 Yanqun Xiang, Dr (+86-18666096623, xiangyq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment). 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 Apr 2023.