Nasopharyngeal Carcinoma (NPC)Phase 2NCT06680115
Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma
A Phase 2 study testing Sintilimab in people with Nasopharyngeal Carcinoma (NPC), run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of neoadjuvant and adjuvant Sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage TanyN3M0 nasopharyngeal carcinoma. The primary endpoint was 2-year failure-free survival (FFS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Nov 2024to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma;
- Age≥18 years;
- Staging TanyN3M0 (AJCC/UICC 9th edition) ;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- White blood cell≥3.5×10^9/L,Neutrophils≥1.5×10^9/L, hemoglobin≥ 90 g/L, platelet (PLT)≥ 100x10^9/ L ;
- Transaminases≤2.5 times the upper limit of normal, total bilirubin <1.5 times the upper limit of normal;
- Creatinine clearance ≥60 ml/min;
- Signed informed consent form.
Who cannot join
- HBsAg positive and HBV DNA >1×103 copy/ml;
- Patients with positive HCV antibody test results;
- Active, known, or suspected autoimmune disease. Participants with type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, or hair loss, may be enrolled;
- History of interstitial lung disease;
- Received systemic sex hormone or other immunosuppressive therapy with equivalent dose > 10mg prednisone/day within 28 days before signing the informed consent. Participants with a systemic sex hormone dose ≤10mg prednisone/day or inhaled/topical corticosteroids were enrolled;
- Have received or will receive live vaccine within 30 days before signing the informed consent;
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- Pregnant or lactating women (pregnancy tests should be considered for sexually active, fertile women);
- Had other malignancies within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer;
- The subject is known to have a prior allergy to macromolecular protein preparations, or any of the components of sindillizumab;
- Human immunodeficiency virus (HIV) infection;
- Other conditions, as determined by the investigator, that may affect subjects' safety or compliance with the study include symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infection requiring systemic treatment, mental illness, or family and social factors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Rensheng Wang, 86+0771-5356509, 13807806008@163.com
About this study
Official title: Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma: a Multicenter, Open-label, Randomized Phase II Clinical Trial
To evaluate the efficacy and safety of neoadjuvant and adjuvant Sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage TanyN3M0 nasopharyngeal carcinoma. The primary endpoint was 2-year failure-free survival (FFS). Secondary endpoints included 2-year overall survival (OS), distant failure-free survival (DFFS), locoregional failure-free survival (LRFFS), and adverse events.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Sintilimab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Induction chemotherapy stage: Sintilimab combined with GP regimen chemotherapy; Adjuvant chemotherapy stage: Sintilimab combined with Capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab | Experimental | Not described Receives: Drug: Sintilimab |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival
Measured: 2 years
Secondary outcomes (3)
Overall survival
Measured: 2 years
Distant failure-free survival
Measured: 2 years
Locoregional failure-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680115
- Sponsor's protocol ID
- 2024-K395-01
- Status last verified
- Oct 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma: a Multicenter, Open-label, Randomized Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06680115
- Acronym / sponsor ID
- 2024-K395-01
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 Nov 2024 (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 efficacy and safety of neoadjuvant and adjuvant Sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage TanyN3M0 nasopharyngeal carcinoma. The primary endpoint was 2-year failure-free survival (FFS). Secondary endpoints included 2-year overall survival (OS), distant failure-free survival (DFFS), locoregional failure-free survival (LRFFS), and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab | Experimental | Drug: Sintilimab |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma;
- Age≥18 years;
- Staging TanyN3M0 (AJCC/UICC 9th edition) ;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- White blood cell≥3.5×10^9/L,Neutrophils≥1.5×10^9/L, hemoglobin≥ 90 g/L, platelet (PLT)≥ 100x10^9/ L ;
Key exclusion criteria (11 listed)
- HBsAg positive and HBV DNA >1×103 copy/ml;
- Patients with positive HCV antibody test results;
- Active, known, or suspected autoimmune disease. Participants with type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, or hair loss, may be enrolled;
- History of interstitial lung disease;
- Received systemic sex hormone or other immunosuppressive therapy with equivalent dose > 10mg prednisone/day within 28 days before signing the informed consent. Participants with a systemic sex hormone dose ≤10mg prednisone/day or inhaled/topical corticosteroids were enrolled;
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 |
|---|---|---|
| SintilimabInduction chemotherapy stage: Sintilimab combined with GP regimen chemotherapy; Adjuvant chemotherapy stage: Sintilimab combined with Capecitabine | Drug | Sintilimab |
Primary outcome
Failure-free survival
Time frame: 2 years
3 secondary outcomes
Overall survival
Time frame: 2 years
Distant failure-free survival
Time frame: 2 years
Locoregional failure-free survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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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.
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 Sintilimab in people with Nasopharyngeal Carcinoma (NPC), run by First Affiliated Hospital of Guangxi Medical 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 8 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: opening soon, as of the sponsor's last update on 8 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rensheng Wang (86-0771-5356509, 13807806008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival (time frame: 2 years). 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 8 Nov 2024.