Locally Advanced Nasopharyngeal CarcinomaPhase 2NCT06752382
Sintilimab Combined With Bevacizumab and TP Chemotherapy in the Treatment of High Risk Locally-advanced NPC
A Phase 2 study testing Experimental drug in people with Locally Advanced Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Nearly half of the world's nasopharyngeal cancer occurs in China, among which the highest incidence in Guangdong and Guangxi, so the nickname "Guangdong tumor". Due to the hidden position of the nasopharynx, 70% to 80% of patients are found in the middle and late stages. 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?
- Experimental drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Dec 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
- Signed a written informed consent form (ICF) voluntarily.
- Male or female, aged from 18 to 75 years.
- Histologically newly diagnosed patients with differentiated or undifferentiated non-keratinous carcinoma (according to World Health Organization [WHO] histological types).
- Patients with tumor stage TanyN2-3M0 (according to AJCC Edition 8).
- ECOG score 0-1.
- Adequate bone marrow/liver and kidney function/heart and lung and other physiological function reserves, expected to successfully complete chemoradiotherapy and immunotherapy.
Who cannot join
- subjects with pathologically diagnosed adenocarcinoma or sarcoma of the nasopharynx.
- subject has other malignancy within 3 years prior to first dose except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are excluded.
- Participated in treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose.
- active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.
- History of immunodeficiency; positive HIV antibody test; current chronic use of systemic corticosteroids or other immunosuppressive agents; local, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed.
- Patients who are pregnant or nursing (for women of childbearing age, pregnancy testing should be considered and the use of effective contraception during treatment should be emphasized).
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- Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection.
- known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 9. history of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis.
- serious infections within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active infections (excluding antiviral therapy for hepatitis B or C) that have received systemic anti-infective therapy within 2 weeks prior to the first dose.
- Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies/ml [200 IU/ml] or above the lower limit of detection) and anti-hepatitis B virus treatment during study treatment are required for subjects with hepatitis B; subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the lower limit of detection).
- any of the following cardiovascular and cerebrovascular diseases: a) myocardial infarction, unstable angina pectoris, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (Grade 2 and above according to the New York Heart Association functional classification), or any arterial thromboembolic event within 6 months before the first dose; b) history of venous thromboembolic events (NCI CTCAE 5.0 version 3 and above), pulmonary embolism, or other serious thromboembolism within 3 months before the first dose; c) presence of serious arrhythmia requiring long-term drug intervention; patients with asymptomatic atrial fibrillation with stable ventricular rate are allowed; d) presence of aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis and other major vascular diseases that may be life-threatening or require surgery within 6 months; e) previous history of myocarditis or cardiomyopathy.
- Known hypersensitivity to any component of any study drug; known history of serious hypersensitivity to other monoclonal antibodies.
- 13 known history of mental illness, drug abuse, alcoholism, or drug abuse; 15. pregnant or lactating women. 16. Any previous or current illness, treatment, or laboratory abnormality that may confound the results of the study, affect the subject 's full participation in the study, or that participation may not be in the subject' s best interest.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sintilimab Combined With Bevacizumab and Induction Chemotherapy in the Treatment of High Risk Advanced Nasopharyngeal Carcinoma Prospective, Single-arm, Multicenter Phase II Clinical Study
Nearly half of the world's nasopharyngeal cancer occurs in China, among which the highest incidence in Guangdong and Guangxi, so the nickname "Guangdong tumor". Due to the hidden position of the nasopharynx, 70% to 80% of patients are found in the middle and late stages. Immunotherapy plays a significant role in nasopharyngeal carcinoma. Professor Ma Jun of Sun Yat-sen University reported a phase 3 clinical study at ASCO meeting in 2023, which compared the efficacy of Sintilimab combined with GP chemotherapy versus GP chemotherapy alone in locally advanced nasopharyngeal carcinoma, and the results showed that EFS in the immune group decreased by 41% in 3 years. The risk of local recurrence-free survival and distant metastasis was reduced by 48% and 43%, respectively. However, a subgroup analysis of the study found that low-risk patients benefited more, while N2-N3 patients benefited only HR There is 0.78, new treatment options need to be explored in clinic. Therefore, the investigators plan to initiate a prospective study to evaluate the efficacy and safety of Sintilimab Combined With Bevacizumab and TP Chemotherapy for high-risk locally advanced nasopharyngeal carcinoma.
Read the detailed description
This study is a prospective, single-arm, multicenter, Phase II clinical study. This study was planned to include patients with histologically confirmed non-keratinized stage TanyN2-3M0 nasopharyngeal carcinoma (AJCC Version 8). Eligible enrolled patients will receive 3 cycles of induction therapy: sintilimab, bevacizumab, and TP regimen chemotherapy. After induction therapy, all patients received radical concurrent chemoradiotherapy and maintenance treatment with sintilimab.The primary endpoint is radiographic complete response rate after induction therapy.The secondary endpoint are two years PFS rate and safety which is the incidence and severity of AE evaluated according to the NCI CTCAE (version 5.0) classification of the severity of adverse events, and the correlation with the study drugs was analyzed.
- Being tested
- Experimental drug
- Keywords
- PD-1, Bevacizumab, TP Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental drugDrug
Also called sintilimab ,bevacizumab and TP chemotherapy
Induction therapy was sintilimab 200mg IV d1, bevacizumab 7.5mg/kg IV d1, albumin-bound paclitaxel 260mg/m2 IV d1 and cisplatin 80mg/m2 IV d1, once every 3 weeks, a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Eligible enrolled patients will receive 3 cycles of induction Guided treatment and concurrent chemoradiotherapy. Then all patients received 2 cycles of concurrent chemoradiotherapy cisplatin 100mg/m2 with Intensity modulated radiotherapy for 70Gy/33Fr.Then patients received sintilimab 200mg IV every three weeks with no more than 8 cycles. Receives: Drug: Experimental drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic complete response rate
CR rate was evaluated according to recist 1.1 criteria
Measured: At the end of Cycle 3 (each cycle is 21 days)
Secondary outcomes (2)
progression-free survival
The time from the time the patient receives treatment to the time the disease progresses or death (whatever the cause)
Measured: 2 years
AE
The incidence and severity of acute effects were evaluated according to the NCI CTCAE (version 5.0) classification of the severity of adverse events, and the correlation with the study drugs was analyzed. Safety and tolerability of changes in vital signs, physical examination, and laboratory tests during the study were evaluated according to the severity of adverse events (AE) according to NCI CTCAE (version 5.0).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start31 Dec 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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 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
- Model description
- Eligible enrolled patients will receive 3 cycles of induction therapy: sintilimab, bevacizumab, and TP regimen chemotherapy
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Feng, Zhejiang Cancer Hospital
- Investigators
- feng jiang, PhD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752382
- Sponsor's protocol ID
- IIT-2024-363
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- 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 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Bevacizumab and Induction Chemotherapy in the Treatment of High Risk Advanced Nasopharyngeal Carcinoma Prospective, Single-arm, Multicenter Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06752382
- Acronym / sponsor ID
- IIT-2024-363
- Keywords
- PD-1, Bevacizumab, TP Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Dec 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.
Nearly half of the world's nasopharyngeal cancer occurs in China, among which the highest incidence in Guangdong and Guangxi, so the nickname "Guangdong tumor". Due to the hidden position of the nasopharynx, 70% to 80% of patients are found in the middle and late stages. Immunotherapy plays a significant role in nasopharyngeal carcinoma. Professor Ma Jun of Sun Yat-sen University reported a phase 3 clinical study at ASCO meeting in 2023, which compared the efficacy of Sintilimab combined with GP chemotherapy versus GP chemotherapy alone in locally advanced nasopharyngeal carcinoma, and the results showed that EFS in the immune group decreased by 41% in 3 years. The risk of local recurrence-free survival and distant metastasis was reduced by 48% and 43%, respectively. However, a subgroup analysis of the study found that low-risk patients benefited more, while N2-N3 patients benefited only HR There is 0.78, new treatment options need to be explored in clinic. Therefore, the investigators plan to initiate a prospective study to evaluate the efficacy and safety of Sintilimab Combined With Bevacizumab and TP Chemotherapy for high-risk locally advanced nasopharyngeal carcinoma.
Detailed description
This study is a prospective, single-arm, multicenter, Phase II clinical study. This study was planned to include patients with histologically confirmed non-keratinized stage TanyN2-3M0 nasopharyngeal carcinoma (AJCC Version 8). Eligible enrolled patients will receive 3 cycles of induction therapy: sintilimab, bevacizumab, and TP regimen chemotherapy. After induction therapy, all patients received radical concurrent chemoradiotherapy and maintenance treatment with sintilimab.The primary endpoint is radiographic complete response rate after induction therapy.The secondary endpoint are two years PFS rate and safety which is the incidence and severity of AE evaluated according to the NCI CTCAE (version 5.0) classification of the severity of adverse events, and the correlation with the study drugs was analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible enrolled patients will receive 3 cycles of induction therapy: sintilimab, bevacizumab, and TP regimen chemotherapy
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: Experimental drugEligible enrolled patients will receive 3 cycles of induction Guided treatment and concurrent chemoradiotherapy. Then all patients received 2 cycles of concurrent chemoradiotherapy cisplatin 100mg/m2 with Intensity modulated radiotherapy for 70Gy/33Fr.Then patients received sintilimab 200mg IV every three weeks with no more than 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed a written informed consent form (ICF) voluntarily.
- Male or female, aged from 18 to 75 years.
- Histologically newly diagnosed patients with differentiated or undifferentiated non-keratinous carcinoma (according to World Health Organization [WHO] histological types).
- Patients with tumor stage TanyN2-3M0 (according to AJCC Edition 8).
- ECOG score 0-1.
Key exclusion criteria (13 listed)
- subjects with pathologically diagnosed adenocarcinoma or sarcoma of the nasopharynx.
- subject has other malignancy within 3 years prior to first dose except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are excluded.
- Participated in treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose.
- active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.
- History of immunodeficiency; positive HIV antibody test; current chronic use of systemic corticosteroids or other immunosuppressive agents; local, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed.
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 |
|---|---|---|
| Experimental drugAlso: sintilimab ,bevacizumab and TP chemotherapyInduction therapy was sintilimab 200mg IV d1, bevacizumab 7.5mg/kg IV d1, albumin-bound paclitaxel 260mg/m2 IV d1 and cisplatin 80mg/m2 IV d1, once every 3 weeks, a total of 3 cycles. | Drug | experimental |
Primary outcome
radiographic complete response rate
Time frame: At the end of Cycle 3 (each cycle is 21 days)
CR rate was evaluated according to recist 1.1 criteria
2 secondary outcomes
progression-free survival
Time frame: 2 years
AE
Time frame: 2 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 30 Dec 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.
feng jiang, PhD principal investigator
Zhejiang Cancer Hospital
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 Experimental drug in people with Locally Advanced Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital 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 6 inclusion and 13 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 30 Dec 2024. 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?
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 feng jiang, PhD (0086-571-88128202, jiangfeng@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic complete response rate (time frame: At the end of Cycle 3 (each cycle is 21 days)). 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 30 Dec 2024.