Nasopharyngeal CarcinomaPhase 3NCT06026878
GNT Induction Treatment in Locally Advanced NPC
A Phase 3 study testing gemcitabine,nimotuzumab, toripalimab and gemcitabine, cisplatin in people with Nasopharyngeal Carcinoma, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The goal of this clinical trial is to compare overall response rate between gemcitabine, nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine in paitents with locally advanced nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- gemcitabine,nimotuzumab, toripalimab and gemcitabine, cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Sep 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old.
- Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma.
- Patients suitable for radical radiochemotherapy.
- ECOG PS score of 0-1.
- According to the RECIST 1.1 criteria, there is at least one measurable lesion. Basic hematological parameters are normal: white blood cell count ≥4×10^9/L; absolute neutrophil count ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L.
- Basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl) > 60 mL/min (using the Cockcroft-Gault formula): For females: CrCl = (140-age) x weight (kg) x 0.85 / (72 x Scr mg/dl) For males: CrCl = (140-age) x weight (kg) x 1.00 / (72 x Scr mg/dl)
- Basically normal liver function: serum total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) ≤2.5×ULN; alanine aminotransferase (ALT) ≤2.5×ULN.
- Signed written informed consent.
Who cannot join
- Patients who have previously undergone immunotherapy or targeted therapy.
- Participated in any other interventional clinical trials within 30 days before screening.
- History of other malignancies (except for cured skin basal cell carcinoma).
- History of primary immunodeficiency.
- Presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.).
- Known HIV infection, active viral hepatitis, or tuberculosis.
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- Major surgery within 90 days before the first dose of the study drug, or planned surgery.
- Allergic to the drugs used in this protocol or their components.
- Pregnant (confirmed by blood or urine HCG tests) or breastfeeding women, or those of childbearing age unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.
- The investigator believes the subject is not suitable for this study.
- Unwilling to participate in this study or unable to sign the informed consent form.
- Live vaccinations within 30 days of dosing.
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, 1 recruiting
- Recruiting
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Mei Shi, MD, +86-029-84775425, mshifmmu@yahoo.com
Mei Shi, MD
About this study
Official title: Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study
The goal of this clinical trial is to compare overall response rate between gemcitabine, nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine in paitents with locally advanced nasopharyngeal carcinoma. It aims to answer whether gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared to GP induction chemotherapy. Participants will be randomly divided into two induction treatment groups.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- gemcitabine,nimotuzumab, toripalimab, gemcitabine, cisplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine,nimotuzumab, toripalimabDrug
Also called GNT
same as before
gemcitabine, cisplatinDrug
Also called GP
same as before
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine, nimotuzumab and toripalimab induction treatment | Experimental | Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 every 3 weeks for two cycles.
nimotuzumanb 400mg every 3 weeks for two cycles. toripalimab 240mg every 3 weeks for two cycles. Receives: Drug: gemcitabine,nimotuzumab, toripalimab |
| gemcitabine and cisplatin | Active comparator | Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 and cisplatin at a dose of 80 mg per square meter on day 1 were administered intravenously once every 3 weeks for two cycles. Receives: Drug: gemcitabine, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
the proportion of patients who achieve complete response and partial response after induction therapy
Measured: three weeks after induction therapy
Secondary outcomes (3)
2-year overall survival
2-year survival rate of patients enrolled in this study
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
2-year distant metastasis-free survival
2-year distant metastasis-free survival rate of patients enrolled in this study
Measured: From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months
2-year local regional recurrence-free survival
2-year local regional recurrence-free survival rate of patients enrolled in this study
Measured: From date of randomization until the date of local and/or lymph node recurrence or last follow-up time,, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Shi, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026878
- Sponsor's protocol ID
- AFMMUChina
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 7 Sep 2023
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06026878
- Acronym / sponsor ID
- AFMMUChina
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Sep 2023 (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.
The goal of this clinical trial is to compare overall response rate between gemcitabine, nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine in paitents with locally advanced nasopharyngeal carcinoma. It aims to answer whether gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared to GP induction chemotherapy. Participants will be randomly divided into two induction treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gemcitabine, nimotuzumab and toripalimab induction treatment | Experimental | Drug: gemcitabine,nimotuzumab, toripalimabGemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 every 3 weeks for two cycles. nimotuzumanb 400mg every 3 weeks for two cycles. toripalimab 240mg every 3 weeks for two cycles. |
| gemcitabine and cisplatin | Active comparator | Drug: gemcitabine, cisplatinGemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 and cisplatin at a dose of 80 mg per square meter on day 1 were administered intravenously once every 3 weeks for two cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years old.
- Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma.
- Patients suitable for radical radiochemotherapy.
- ECOG PS score of 0-1.
- According to the RECIST 1.1 criteria, there is at least one measurable lesion. Basic hematological parameters are normal: white blood cell count ≥4×10^9/L; absolute neutrophil count ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L.
Key exclusion criteria (12 listed)
- Patients who have previously undergone immunotherapy or targeted therapy.
- Participated in any other interventional clinical trials within 30 days before screening.
- History of other malignancies (except for cured skin basal cell carcinoma).
- History of primary immunodeficiency.
- Presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.).
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 |
|---|---|---|
| gemcitabine,nimotuzumab, toripalimabAlso: GNTsame as before | Drug | gemcitabine, nimotuzumab and toripalimab induction treatment |
| gemcitabine, cisplatinAlso: GPsame as before | Drug | gemcitabine and cisplatin |
Primary outcome
overall response rate
Time frame: three weeks after induction therapy
the proportion of patients who achieve complete response and partial response after induction therapy
3 secondary outcomes
2-year overall survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
2-year distant metastasis-free survival
Time frame: From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months
2-year local regional recurrence-free survival
Time frame: From date of randomization until the date of local and/or lymph node recurrence or last follow-up time,, whichever came first, assessed up to 100 months
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 7 Sep 2023.
- 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.
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gemcitabine,nimotuzumab, toripalimab and gemcitabine, cisplatin in people with Nasopharyngeal Carcinoma, run by Air Force Military Medical University, China 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 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: looking for participants now, as of the sponsor's last update on 7 Sep 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: three weeks after induction therapy). 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 7 Sep 2023.