High Risk Locally Advanced Nasopharyngeal CarcinomaPhase 3NCT06561763
TPC VS. GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
A Phase 3 study testing Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine and Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine in people with High Risk Locally Advanced Nasopharyngeal Carcinoma, run by Sun Yat-sen University.
Trial summary
We expect to conduct a clinical trial in high-risk locally advanced nasopharyngeal carcinoma patients to explore the efficacy and safety of sequential radical radiotherapy treatment after induction chemotherapy (TPC vs. GP) with combination therapy of nivolumab and triprolizumab. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Risk Locally Advanced Nasopharyngeal Carcinoma
- What is being tested?
- Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine and Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 20 Aug 2031
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-65 years old;
- Diagnosed with nasopharyngeal carcinoma through histopathology or cytology;
- Advanced nasopharyngeal carcinoma, AJCC 8th standard stage III-IVA, excluding T3-4N0/T3N1;
- ECOG score is 0-1;
- Sufficient organ or bone marrow function:
- Sign a written informed consent form
Who cannot join
- Diagnosed with other malignant tumors within 5 years prior to the first administration, excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ.
- Symptomatic congestive heart failure, with echocardiogram indicating a left ventricular ejection fraction (LVEF)<50%.
- Individuals infected with acute or chronic active hepatitis B or C, with hepatitis B virus (HBV) DNA>2000IU/ml or 10^4 copies/ml; Hepatitis C virus (HCV) RNA>10^3 copies/ml; Hepatitis B surface antigen (HbsAg) and anti HCV antibody were positive at the same time. After nucleotide antiviral treatment, if the score is lower than the above standard, it can be included in the group.
- Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases.
- Individuals with active pulmonary tuberculosis (TB) who are currently receiving anti tuberculosis treatment or have received anti tuberculosis treatment within one year prior to their first dose.
- Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infections requiring treatment.
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- Severe infections that are active or poorly controlled clinically. Within 4 weeks prior to the first administration, there was a severe infection, including but not limited to hospitalization due to infection, bacteremia, or complications of severe pneumonia.
- An active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to the first administration. Allow the use of alternative therapies such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency. Known history of primary immunodeficiency. Only patients with positive autoimmune antibodies need to confirm the presence of autoimmune diseases based on the researcher's judgment.
- Pregnant or lactating female patients.
- Has received radiotherapy, chemotherapy, or surgical treatment for nasopharyngeal and neck lesions (excluding biopsy).
- History of allergies to the drugs and their components used in this study
About this study
Official title: TPC Versus GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Localized Advanced Nasopharyngeal Carcinoma:Multi Center, Open Label, Randomized Controlled, Non Inferiority Design, Phase III Clinical Study
We expect to conduct a clinical trial in high-risk locally advanced nasopharyngeal carcinoma patients to explore the efficacy and safety of sequential radical radiotherapy treatment after induction chemotherapy (TPC vs. GP) with combination therapy of nivolumab and triprolizumab.
- Being tested
- Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine, Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabineDrug
Albumin paclitaxel 200g/m2, intravenous drip administration, d1; Cisplatin 60 mg/m2， Intravenous , d1; Capecitabine, 1000mg/m2, orally administered D1-14； Triprolizumab injection 240mg, intravenous D1; Nivolumab 400mg, intravenous D1; Q3W 1 cycle, 3 cycles Period, 3 weeks in total
Nimotuzumab,Toripalimab，Cisplatin, GemcitabineDrug
Cisplatin 80 mg/m2， Intravenous drip administration, d1; Gemcitabine, 1000mg/m2,Intravenous ，D1,D8； Triprolizumab injection 240mg, intravenous ； Nivolumab 400mg, intravenous； Q3W 1 cycle, 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| TPC+Triprolizumab+Nimotuzumab | Experimental | Not described Receives: Drug: Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine |
| GP+Triprolizumab+Nimotuzumab | Active comparator | Not described Receives: Drug: Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year event free survival
Measured: 3 years
Secondary outcomes (4)
adverse effects
chemotherapy side effectst
Measured: 3 years
3-year overall survival
Measured: 3 years
3-year distant disease free survival
Measured: 3 years
3-year local recurrence free survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion20 Aug 2028 (estimated)
- Study completion20 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Locally Advanced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIANG YANQUN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561763
- Sponsor's protocol ID
- SYSKY-2024-568-02
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 20 Aug 2024
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TPC Versus GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Localized Advanced Nasopharyngeal Carcinoma:Multi Center, Open Label, Randomized Controlled, Non Inferiority Design, Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT06561763
- Acronym / sponsor ID
- SYSKY-2024-568-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 20 Aug 2028 (estimated)
- Study completion
- 20 Aug 2031 (estimated)
- First posted
- 20 Aug 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.
We expect to conduct a clinical trial in high-risk locally advanced nasopharyngeal carcinoma patients to explore the efficacy and safety of sequential radical radiotherapy treatment after induction chemotherapy (TPC vs. GP) with combination therapy of nivolumab and triprolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPC+Triprolizumab+Nimotuzumab | Experimental | Drug: Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine |
| GP+Triprolizumab+Nimotuzumab | Active comparator | Drug: Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range: 18-65 years old;
- Diagnosed with nasopharyngeal carcinoma through histopathology or cytology;
- Advanced nasopharyngeal carcinoma, AJCC 8th standard stage III-IVA, excluding T3-4N0/T3N1;
- ECOG score is 0-1;
- Sufficient organ or bone marrow function:
Key exclusion criteria (11 listed)
- Diagnosed with other malignant tumors within 5 years prior to the first administration, excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ.
- Symptomatic congestive heart failure, with echocardiogram indicating a left ventricular ejection fraction (LVEF)<50%.
- Individuals infected with acute or chronic active hepatitis B or C, with hepatitis B virus (HBV) DNA>2000IU/ml or 10^4 copies/ml; Hepatitis C virus (HCV) RNA>10^3 copies/ml; Hepatitis B surface antigen (HbsAg) and anti HCV antibody were positive at the same time. After nucleotide antiviral treatment, if the score is lower than the above standard, it can be included in the group.
- Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases.
- Individuals with active pulmonary tuberculosis (TB) who are currently receiving anti tuberculosis treatment or have received anti tuberculosis treatment within one year prior to their first dose.
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 |
|---|---|---|
| Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabineAlbumin paclitaxel 200g/m2, intravenous drip administration, d1; Cisplatin 60 mg/m2， Intravenous , d1; Capecitabine, 1000mg/m2, orally administered D1-14； Triprolizumab injection 240mg, intravenous D1; Nivolumab 400mg, intravenous D1; Q3W 1 cycle, 3 cycles Period, 3 weeks in total | Drug | TPC+Triprolizumab+Nimotuzumab |
| Nimotuzumab,Toripalimab，Cisplatin, GemcitabineCisplatin 80 mg/m2， Intravenous drip administration, d1; Gemcitabine, 1000mg/m2,Intravenous ，D1,D8； Triprolizumab injection 240mg, intravenous ； Nivolumab 400mg, intravenous； Q3W 1 cycle, 3 cycles | Drug | GP+Triprolizumab+Nimotuzumab |
Primary outcome
3-year event free survival
Time frame: 3 years
4 secondary outcomes
adverse effects
Time frame: 3 years
3-year overall survival
Time frame: 3 years
3-year distant disease free survival
Time frame: 3 years
3-year local recurrence free survival rate
Time frame: 3 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 20 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine and Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine in people with High Risk Locally Advanced Nasopharyngeal Carcinoma, run by Sun Yat-sen University.
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 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
3-year event free survival (time frame: 3 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 20 Aug 2024.