Nasopharyngeal CarcinomaPhase 2NCT06364826
Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma
A Phase 2 study testing Sintilimab, bevacizumab, gemcitabine and IMRT in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital.
Trial summary
This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. 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?
- Sintilimab, bevacizumab, gemcitabine and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2024to 22 Apr 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Sign a written informed consent before implementing any procedures related to the trial; 2. No gender limitation, age ≥18 years old, ≤75 years old; 3. Histological or cytological determination of advanced nasopharyngeal carcinoma assessed by the investigator without any treatment (stage III-IVA, except T3N0M0); 4. Not suitable for platinum therapy (patients > 70 years old, PS > 2, hearing impairment, renal insufficiency (creatinine clearance < 50ml/min) or grade 1 neuropathy;2023 CSCO Guidelines for the Diagnosis and Treatment of Head and Neck Tumors) or patients do not receive platinum therapy; 5. The ECOG PS score is 0-1; 6. According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there is at least one radiographically measurable lesion; 7. Expected survival time > 6 months; 8. Adequate organ function.
Who cannot join
- 1. Patients with uncured malignancies other than advanced nasopharyngeal carcinoma diagnosed within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 3. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Previously received anti-angiogenic therapy, including but not limited to anti-angiogenic monoclonal antibodies, anti-angiogenic TKI, etc.; 5. Received systemic systemic treatment with proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeks before the first administration; 6. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration.Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Known active ingredients or excipients of Sintilimab and bevacizumab in this study, and allergic patients to chemotherapy drugs in this study; 9. Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss); 10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 11. Other researchers did not consider it appropriate to study enrollment
About this study
Official title: Gemcitabine, Sintilimab, Bevacizumab Plus IMRT in Patients With Cisplatin Ineligible Locoregionally Advanced Nasopharyngeal Carcinoma
This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.
Read the detailed description
Platinum deplatinization has been extensively explored in patients with posterior nasopharyngeal carcinoma who have received multiple platinum treatments, including target-free combination, GEP, etc. Our center also published in 2022 CSCO a study on the preliminary efficacy of pembrolizumab combined with gemcitabine in the first-line treatment of metastatic NPC with or without cisplatin or anlotinib. Enrolled patients were treated with pembrolizumab + anlotinib +GP (group A), pembrolizumab +GP (group B), and pembrolizumab + anlotinib +G (group C), with ORR of 80% (4/5), 80% (4/5), and 100% (7/7), respectively. Among them, there were 1 CR and 6 PR in group C. Compared to group B, group C with anlotinib in place of cisplatin showed a better safety profile with fewer grade 3 adverse reactions (57.1% vs 100%). In summary, we designed this study to evaluate the efficacy and safety of gemcitabine, sintilimab and bevacizumab combined with IMRT in patients with advanced nasopharyngeal carcinoma not suitable for platinum-based treatment, and to explore new therapeutic approaches for patients with advanced stage nasopharyngeal carcinoma who cannot tolerate platinum therapy or are unwilling to receive platinum therapy.
This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Sintilimab, bevacizumab, gemcitabine, IMRT
- Keywords
- locoregionally advanced Nasopharyngeal carcinoma, sintilimab, bevacizumab, IMRT
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab, bevacizumab, gemcitabineDrug
This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.
IMRTRadiation
IMRT
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab, bevacizumab, gemcitabine | Experimental | Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles. Receives: Drug: Sintilimab, bevacizumab, gemcitabine; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Event-free survival rate
The time between the start of treatment and the first occurrence of any of the following events: disease progression, local or distant recurrence, death from any cause, whichever occurs first
Measured: 3 years
Secondary outcomes (5)
Objective Response Rate
Proportion of total subjects in complete response (CR) and partial response (PR)
Measured: 3 years
Disease Control Rate
Proportion of subjects defined as complete response (CR), partial response (PR), and stable disease (SD)
Measured: 3 years
Progression-Free Survival
The time between the start of treatment and first radiographic disease progression or death, whichever occurs first
Measured: 3 years
Overall survival
The time of treatment until the subject dies from any cause
Measured: 3 years
adverse events(AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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 posted15 Apr 2024
- Study start22 Apr 2024 (estimated)
- Primary completion22 Apr 2026 (estimated)
- Study completion22 Apr 2026 (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 Zhejiang Cancer HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaozhong, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364826
- Sponsor's protocol ID
- NPC-202403
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 15 Apr 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine, Sintilimab, Bevacizumab Plus IMRT in Patients With Cisplatin Ineligible Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06364826
- Acronym / sponsor ID
- NPC-202403
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- locoregionally advanced Nasopharyngeal carcinoma, sintilimab, bevacizumab, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 22 Apr 2026 (estimated)
- Study completion
- 22 Apr 2026 (estimated)
- First posted
- 15 Apr 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.
This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.
Detailed description
Platinum deplatinization has been extensively explored in patients with posterior nasopharyngeal carcinoma who have received multiple platinum treatments, including target-free combination, GEP, etc. Our center also published in 2022 CSCO a study on the preliminary efficacy of pembrolizumab combined with gemcitabine in the first-line treatment of metastatic NPC with or without cisplatin or anlotinib. Enrolled patients were treated with pembrolizumab + anlotinib +GP (group A), pembrolizumab +GP (group B), and pembrolizumab + anlotinib +G (group C), with ORR of 80% (4/5), 80% (4/5), and 100% (7/7), respectively. Among them, there were 1 CR and 6 PR in group C. Compared to group B, group C with anlotinib in place of cisplatin showed a better safety profile with fewer grade 3 adverse reactions (57.1% vs 100%). In summary, we designed this study to evaluate the efficacy and safety of gemcitabine, sintilimab and bevacizumab combined with IMRT in patients with advanced nasopharyngeal carcinoma not suitable for platinum-based treatment, and to explore new therapeutic approaches for patients with advanced stage nasopharyngeal carcinoma who cannot tolerate platinum therapy or are unwilling to receive platinum therapy.
This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab, bevacizumab, gemcitabine | Experimental | Drug: Sintilimab, bevacizumab, gemcitabine, Radiation: IMRTPatients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Sign a written informed consent before implementing any procedures related to the trial; 2. No gender limitation, age ≥18 years old, ≤75 years old; 3. Histological or cytological determination of advanced nasopharyngeal carcinoma assessed by the investigator without any treatment (stage III-IVA, except T3N0M0); 4. Not suitable for platinum therapy (patients > 70 years old, PS > 2, hearing impairment, renal insufficiency (creatinine clearance < 50ml/min) or grade 1 neuropathy;2023 CSCO Guidelines for the Diagnosis and Treatment of Head and Neck Tumors) or patients do not receive platinum therapy; 5. The ECOG PS score is 0-1; 6. According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there is at least one radiographically measurable lesion; 7. Expected survival time > 6 months; 8. Adequate organ function.
Key exclusion criteria (1 listed)
- 1. Patients with uncured malignancies other than advanced nasopharyngeal carcinoma diagnosed within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 3. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Previously received anti-angiogenic therapy, including but not limited to anti-angiogenic monoclonal antibodies, anti-angiogenic TKI, etc.; 5. Received systemic systemic treatment with proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeks before the first administration; 6. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration.Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Known active ingredients or excipients of Sintilimab and bevacizumab in this study, and allergic patients to chemotherapy drugs in this study; 9. Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss); 10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 11. Other researchers did not consider it appropriate to study enrollment
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 |
|---|---|---|
| Sintilimab, bevacizumab, gemcitabineThis is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles. | Drug | Sintilimab, bevacizumab, gemcitabine |
| IMRTIMRT | Radiation | Sintilimab, bevacizumab, gemcitabine |
Primary outcome
3-year Event-free survival rate
Time frame: 3 years
The time between the start of treatment and the first occurrence of any of the following events: disease progression, local or distant recurrence, death from any cause, whichever occurs first
5 secondary outcomes
Objective Response Rate
Time frame: 3 years
Disease Control Rate
Time frame: 3 years
Progression-Free Survival
Time frame: 3 years
Overall survival
Time frame: 3 years
adverse events(AEs)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 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. This study is not recruiting at the moment.
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 2 study testing Sintilimab, bevacizumab, gemcitabine and IMRT in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital.
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 1 inclusion and 1 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 15 Apr 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?
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?
3-year Event-free survival rate (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 15 Apr 2024.