Nasopharyngeal CarcinomaPhase 2NCT05417139
Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter Study
A Phase 2 study testing Immunotherapy+induction chemotherapy+radiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To explore the progression-free survival rate (progression-free survival, PFS), overall survival (OS), objective response rate(objective response rate, ORR) and safety of patients with Sintilimab + GP chemotherapy combined with radiotherapy for newly diagnosed metastatic NPC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Immunotherapy+induction chemotherapy+radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2025
- 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
- Pathologically diagnosed nasopharyngeal cancer with distant metastasis; not received anticancer treatment.
- ECOG Score (PS score) 0 or 1.
- Neutrophil count > 1.5*10^9/L, hemoglobin > 90g/L, and platelet count > 100*10^9/L.
- ALT or AST level < 2.5 times upper normal limit (upper limit of normal, ULN), bilirubin level < 1.5 times ULN.
- Creatinine clearance level > 60 ml/min.
- Patients must sign an informed consent and must be willing and able to comply with the visit, treatment protocol, laboratory tests and other requirements specified in the study protocol.
- Pregnant female subjects must agree to use reliable contraception within 1 year from the screening visit to the last Sintilimab administration.
Who cannot join
- Age> 65 years old or <18 years old.
- HBsAg positive and HBV DNA> 10*10^3 copy number/ml.
- HCV antibody positive.
- Active, known, or suspected autoimmune diseases. Subjects with type I diabetes, hypothyroidism with only hormone replacement therapy, and skin disease without systemic treatment (such as vitiligo, psoriasis, or alopecia) can be selected.
- A history of interstitial lung disease.
- Received systemic hormone or other immunosuppressive therapy with an equivalent dose of> 10mg of prednisone per day within 28 days prior to signing the informed consent. Subjects with a systemic hormone dose of 10mg prednisone per day or inhaled / topical corticosteroids may be enrolled.
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- Received or will be vaccinated within 30 days before signing the informed consent.
- Pregnancy or breastfeeding women (pregnancy tests should be considered).
- Other malignancies within 5 years, except carcinoma in situ, fully treated non-melanoma skin cancer, and papillary thyroid carcinoma.
- previous allergies to macromolecular protein preparations, or any component of Sintilimab.
- Human immunodeficiency virus (HIV) infection.
- Other conditions that may affect the safety or trial compliance of the subject, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic treatment, mental illness or family and social factors.
Trial locations and contacts
1 site in 1 country.
About this study
To explore the progression-free survival rate (progression-free survival, PFS), overall survival (OS), objective response rate(objective response rate, ORR) and safety of patients with Sintilimab + GP chemotherapy combined with radiotherapy for newly diagnosed metastatic NPC.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Immunotherapy+induction chemotherapy+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.
Immunotherapy+induction chemotherapy+radiotherapyOther
All enrolled patients received Sintilimab (200mg, d1, q3w) + GP (gemcitabine 1000mg / m2, d1, d8 + cisplatin 80mg / m2, d1, q3w) for 4-6 cycles followed by radiotherapy of primary site and cervical metastasis, and Sintilimab (200mg, q3w) treatment was continued during and after radiotherapy until disease progression or toxicity or up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy+induction chemotherapy+radiotherapy | Experimental | Not described Receives: Other: Immunotherapy+induction chemotherapy+radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
from enrollment of treatment to the first disease progression, death, or the last follow-up
Measured: 1-year PFS
Secondary outcomes (1)
OS
from enrollment treatment to death of any cause, if not, to last follow-up
Measured: 1-year OS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2025 (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.
- 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First People's Hospital of Foshan
- Responsible party
- Principal investigator, Fang-Yun Xie, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417139
- Sponsor's protocol ID
- B2021-382
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter Study
- ClinicalTrials.gov ID
- NCT05417139
- Acronym / sponsor ID
- B2021-382
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First People's Hospital of Foshan
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 14 Jun 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 explore the progression-free survival rate (progression-free survival, PFS), overall survival (OS), objective response rate(objective response rate, ORR) and safety of patients with Sintilimab + GP chemotherapy combined with radiotherapy for newly diagnosed metastatic NPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy+induction chemotherapy+radiotherapy | Experimental | Other: Immunotherapy+induction chemotherapy+radiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically diagnosed nasopharyngeal cancer with distant metastasis; not received anticancer treatment.
- ECOG Score (PS score) 0 or 1.
- Neutrophil count > 1.5*10^9/L, hemoglobin > 90g/L, and platelet count > 100*10^9/L.
- ALT or AST level < 2.5 times upper normal limit (upper limit of normal, ULN), bilirubin level < 1.5 times ULN.
- Creatinine clearance level > 60 ml/min.
Key exclusion criteria (12 listed)
- Age> 65 years old or <18 years old.
- HBsAg positive and HBV DNA> 10*10^3 copy number/ml.
- HCV antibody positive.
- Active, known, or suspected autoimmune diseases. Subjects with type I diabetes, hypothyroidism with only hormone replacement therapy, and skin disease without systemic treatment (such as vitiligo, psoriasis, or alopecia) can be selected.
- A history of 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 |
|---|---|---|
| Immunotherapy+induction chemotherapy+radiotherapyAll enrolled patients received Sintilimab (200mg, d1, q3w) + GP (gemcitabine 1000mg / m2, d1, d8 + cisplatin 80mg / m2, d1, q3w) for 4-6 cycles followed by radiotherapy of primary site and cervical metastasis, and Sintilimab (200mg, q3w) treatment was continued during and after radiotherapy until disease progression or toxicity or up to 2 years. | Other | Immunotherapy+induction chemotherapy+radiotherapy |
Primary outcome
PFS
Time frame: 1-year PFS
from enrollment of treatment to the first disease progression, death, or the last follow-up
1 secondary outcome
OS
Time frame: 1-year OS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Immunotherapy+induction chemotherapy+radiotherapy in people with Nasopharyngeal Carcinoma, 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 7 inclusion and 12 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 14 Jun 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1-year PFS). 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 14 Jun 2022.