Locally Advanced Nasopharyngeal CarcinomaPhase 2NCT06490341
GP Combined With Nimotuzumab and Sintilimab as Induction Therapy for Nasopharyngeal Carcinoma
A Phase 2 study testing GP Regimen, Nimotuzumab, Sintilimab in people with Locally Advanced Nasopharyngeal Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
The goal of this clinical trial is to learn if the regimen of gemcitabine, cisplatin combined with nimotuzumab and sintilimab works to treat locally advanced nasopharyngeal carcinoma before chemoradiotherapy. It will also learn about the safety of the regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Nasopharyngeal Carcinoma
- What is being tested?
- GP Regimen, Nimotuzumab, Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2024to 20 Jul 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years, inclusive, without gender restriction.
- ECOG Performance Status (PS) score of 0 or 1.
- Histologically confirmed diagnosis of locally advanced nasopharyngeal carcinoma, staged as III-IVa according to the 2018 American Joint Committee on Cancer (AJCC) staging system, with T3-4N2M0 or T1-4N3M0 classification. Tumor types include WHO type II and III.
- Presence of at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and patients who have not undergone definitive treatment.
- Expected survival duration of at least 3 months.
- White blood cell count ≥ 3 × 10^9/L; absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L; hemoglobin level ≥ 90 g/L.
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- Serum creatinine level ≤ 1.2 mmol/L or creatinine clearance ≥ 60 ml/min.
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (in case of liver metastasis, ≤ 3.0 × ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (in case of liver metastasis, ≤ 5.0 × ULN).
- Female patients must have a negative urine pregnancy test prior to study enrollment (this criterion does not apply to patients with bilateral ovarian resection and/or hysterectomy or postmenopausal patients).
- Signed written informed consent form.
Who cannot join
- Subjects who have received radiotherapy, chemotherapy, immunosuppressive agents, monoclonal antibodies, oral epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), or anti-angiogenic drugs within the past six months.
- Subjects who have participated in another interventional clinical trial, undergone major surgical procedures, or scheduled for surgery within 30 days prior to screening.
- Patients with severe underlying diseases that preclude tolerance to the treatment.
- History of other malignancies, except for cured cervical carcinoma in situ, skin basal cell carcinoma, or malignancies cured for more than 5 years without recurrence.
- Presence of uncontrolled comorbidities such as heart failure, diabetes mellitus, hypertension, thyroid disorders, psychiatric illnesses, etc.
- Subjects with contraindications to immunotherapy, including those with immune dysfunction diseases (such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus, HIV infection, hepatitis B, hepatitis C, chronic use of steroids for autoimmune diseases), recipients of allogeneic transplants, patients with interstitial lung disease, or those with meningeal metastasis or progressive brain metastasis.
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- Allergy to any of the drugs or their components used in the study protocol.
- Grade 2 or higher peripheral neuropathy or hearing loss according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
- Pregnant women (confirmed by blood or urine human chorionic gonadotropin [HCG] test) or lactating mothers, or subjects of reproductive age who are unwilling or unable to adopt effective contraceptive measures until at least 6 months after the last treatment in the study.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of GP Regimen Combined With Nimotuzumab and Sintilimab as Induction Therapy in Locally Advanced Nasopharyngeal Carcinoma: a Single-center, Prospective, Single-arm Phase II Clinical Study
The goal of this clinical trial is to learn if the regimen of gemcitabine, cisplatin combined with nimotuzumab and sintilimab works to treat locally advanced nasopharyngeal carcinoma before chemoradiotherapy. It will also learn about the safety of the regimen. The main questions it aims to answer are:
- Does the regimen increase the number of participants who has a significant tumor shrinkage?
- What medical problems do participants have when taking the regimen? Researchers will evaluate the safety and efficacy of the regimen.
Participants will:
- Take the regimen every 21 days, for twice.
- Visit the clinic weekly for drug administration, checkups and tests.
- Keep a diary of their symptoms.
Read the detailed description
The study is to investigate the efficacy and safety of combining nimotuzumab and sintilimab with the GP regimen for induction chemotherapy in patients with locally advanced nasopharyngeal carcinoma.
This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each treatment cycle will be three weeks long, with a total of two cycles.
After screening, eligible patients will be enrolled in the study. Patients will receive two cycles of gemcitabine, cisplatin, nimotuzumab, and sintilimab as induction therapy. Patients will undergo regular follow-up visits, and researchers will collect data on efficacy and safety. Short-term outcomes will be assessed according to the RECIST 1.1 criteria, and adverse events will be evaluated using the CTCAE 5.0.
- Being tested
- GP Regimen, Nimotuzumab, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP Regimen, Nimotuzumab, SintilimabDrug
Also called no other invention names
gemcitabine,ciplatin, nimotuzumab, sintilimab
| Study group | Role | What they receive |
|---|---|---|
| GP Combined with Nimotuzumab and Sintilimab | Experimental | GP regimen(gemcitabine plus cisplatin) in combination with nimotuzumab and sintilimab Receives: Drug: GP Regimen, Nimotuzumab, Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate
Measured: 3 months
Secondary outcomes (6)
mPFS
median progression-free survival
Measured: 1 year
mOS
median overall survival
Measured: 2 years
PFS rate
3-year progression-free survival rate
Measured: 3 years
OS rate
3-year overall survival rate
Measured: 3 years
Adverse events
EGFR and PD-L1 expression, MRD, and others
Measured: 1 year
Radiographic down-staging
stage change according to radiography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start20 Jul 2024 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Xiaohui, Principal investigator, Cancer Hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490341
- Sponsor's protocol ID
- NPCTIR001
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of GP Regimen Combined With Nimotuzumab and Sintilimab as Induction Therapy in Locally Advanced Nasopharyngeal Carcinoma: a Single-center, Prospective, Single-arm Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06490341
- Acronym / sponsor ID
- NPCTIR001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 8 Jul 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.
The goal of this clinical trial is to learn if the regimen of gemcitabine, cisplatin combined with nimotuzumab and sintilimab works to treat locally advanced nasopharyngeal carcinoma before chemoradiotherapy. It will also learn about the safety of the regimen. The main questions it aims to answer are:
- Does the regimen increase the number of participants who has a significant tumor shrinkage?
- What medical problems do participants have when taking the regimen? Researchers will evaluate the safety and efficacy of the regimen.
Participants will:
- Take the regimen every 21 days, for twice.
- Visit the clinic weekly for drug administration, checkups and tests.
- Keep a diary of their symptoms.
Detailed description
The study is to investigate the efficacy and safety of combining nimotuzumab and sintilimab with the GP regimen for induction chemotherapy in patients with locally advanced nasopharyngeal carcinoma.
This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each treatment cycle will be three weeks long, with a total of two cycles.
After screening, eligible patients will be enrolled in the study. Patients will receive two cycles of gemcitabine, cisplatin, nimotuzumab, and sintilimab as induction therapy. Patients will undergo regular follow-up visits, and researchers will collect data on efficacy and safety. Short-term outcomes will be assessed according to the RECIST 1.1 criteria, and adverse events will be evaluated using the CTCAE 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GP Combined with Nimotuzumab and Sintilimab | Experimental | Drug: GP Regimen, Nimotuzumab, SintilimabGP regimen(gemcitabine plus cisplatin) in combination with nimotuzumab and sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18 and 75 years, inclusive, without gender restriction.
- ECOG Performance Status (PS) score of 0 or 1.
- Histologically confirmed diagnosis of locally advanced nasopharyngeal carcinoma, staged as III-IVa according to the 2018 American Joint Committee on Cancer (AJCC) staging system, with T3-4N2M0 or T1-4N3M0 classification. Tumor types include WHO type II and III.
- Presence of at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and patients who have not undergone definitive treatment.
- Expected survival duration of at least 3 months.
Key exclusion criteria (10 listed)
- Subjects who have received radiotherapy, chemotherapy, immunosuppressive agents, monoclonal antibodies, oral epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), or anti-angiogenic drugs within the past six months.
- Subjects who have participated in another interventional clinical trial, undergone major surgical procedures, or scheduled for surgery within 30 days prior to screening.
- Patients with severe underlying diseases that preclude tolerance to the treatment.
- History of other malignancies, except for cured cervical carcinoma in situ, skin basal cell carcinoma, or malignancies cured for more than 5 years without recurrence.
- Presence of uncontrolled comorbidities such as heart failure, diabetes mellitus, hypertension, thyroid disorders, psychiatric illnesses, 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 |
|---|---|---|
| GP Regimen, Nimotuzumab, SintilimabAlso: no other invention namesgemcitabine,ciplatin, nimotuzumab, sintilimab | Drug | GP Combined with Nimotuzumab and Sintilimab |
Primary outcome
ORR
Time frame: 3 months
objective response rate
6 secondary outcomes
mPFS
Time frame: 1 year
mOS
Time frame: 2 years
PFS rate
Time frame: 3 years
OS rate
Time frame: 3 years
Adverse events
Time frame: 1 year
Radiographic down-staging
Time frame: 3 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 8 Jul 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.
He Xiaohui principal investigator
Cancer Hospital, CAMS
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GP Regimen, Nimotuzumab, Sintilimab in people with Locally Advanced Nasopharyngeal Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 10 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 Jul 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 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 Yang Sheng (86-10-87788507, medart@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 3 months). 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 Jul 2024.