Metastatic Nasopharyngeal CarcinomaPhase 2NCT04872582
Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study
A Phase 2 study testing PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab in people with Metastatic Nasopharyngeal Carcinoma and Chemotherapy Effect, run by XIANG YANQUN at 1 site in China.
Trial summary
To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Nasopharyngeal Carcinoma, Chemotherapy Effect
- What is being tested?
- PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2021to Oct 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment.
- Previous failure of first-line platinum-containing chemotherapy (single drug or combination).
- Previously diagnosed WHO classification type II or III by histological pathology.
- At least one measurable lesion (according to RECIST1.1).
- Age between 18 and 70.
- Eastern Cooperative Oncology Group (ECOG) 0-1, and life expectation at least 3 months.
- Enough blood test.
- Participate voluntarily and sign the informed consent.
Who cannot join
- Previously diagnosed WHO classification type I by histological pathology.
- Prior exposure to anti-PD-1/PD-L1 antibodies plus anti-VEGF antibodies.
- Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding.
- A history of interstitial pneumonia or other autoimmune diseases.
- Sever infection.
- Sever heart disease.
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- HIV infection.
- Allogeneic organ transplantation
- Malignancy other than nasopharyngeal carcinoma.
- Pregnancy or breast feeding.
- Received other test drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: A Single Center, Single Arm, Phase II Clinical Study.
To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.
Read the detailed description
To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.
- Being tested
- PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 Immune Checkpoint Inhibitor Combined With BevacizumabDrug
Also called Sintilimab
combined
| Study group | Role | What they receive |
|---|---|---|
| PD-1 immune checkpoint inhibitor combined with bevacizumab | Experimental | Not described Receives: Drug: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
The proportion of patients whose tumors shrink by a certain amount and remain in place for a certain amount of time, including complete response (CR) and partial response (PR).
Measured: 2 years
Secondary outcomes (3)
overall survival (OS)
Patients in clinical trials were randomized to the time of death from any cause
Measured: 2 years
progression-free survival (PFS)
36/5000 The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause.
Measured: 2 years
duration of response (DOR)
The time between the first assessment of a tumor as CR or PR and the first assessment of PD or death from any cause.
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 posted4 May 2021
- Study start29 Jul 2021
- Primary completion4 Jan 2023
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- XIANG YANQUN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XIANG YANQUN, Sun Yat-sen University
- Investigators
- Yanqun Xiang, Dr., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872582
- Sponsor's protocol ID
- B2021-078-01
- Status last verified
- Feb 2023
- First submitted
- 2 May 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lu N, Jiang YF, Xia WX, Huang Y, Xie CM, Xu C, Ye YF, Liu GY, Bei WX, Ke LR, Li WZ, Zhang C, Wang X, Liu Q, Chen X, Chen ZX, Xie C, Liang H, Xiang YQ. Efficacy and safety of sintilimab plus bevacizumab in metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy: an open-label phase 2 study. EClinicalMedicine. 2023 Aug 4;62:102136. doi: 10.1016/j.eclinm.2023.102136. eCollection 2023 Aug.
PubMed 37593221
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: A Single Center, Single Arm, Phase II Clinical Study.
- ClinicalTrials.gov ID
- NCT04872582
- Acronym / sponsor ID
- B2021-078-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- XIANG YANQUNUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 4 May 2021 (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.
To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.
Detailed description
To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 immune checkpoint inhibitor combined with bevacizumab | Experimental | Drug: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment.
- Previous failure of first-line platinum-containing chemotherapy (single drug or combination).
- Previously diagnosed WHO classification type II or III by histological pathology.
- At least one measurable lesion (according to RECIST1.1).
- Age between 18 and 70.
Key exclusion criteria (11 listed)
- Previously diagnosed WHO classification type I by histological pathology.
- Prior exposure to anti-PD-1/PD-L1 antibodies plus anti-VEGF antibodies.
- Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding.
- A history of interstitial pneumonia or other autoimmune diseases.
- Sever infection.
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 |
|---|---|---|
| PD-1 Immune Checkpoint Inhibitor Combined With BevacizumabAlso: Sintilimabcombined | Drug | PD-1 immune checkpoint inhibitor combined with bevacizumab |
Primary outcome
objective response rate (ORR)
Time frame: 2 years
The proportion of patients whose tumors shrink by a certain amount and remain in place for a certain amount of time, including complete response (CR) and partial response (PR).
3 secondary outcomes
overall survival (OS)
Time frame: 2 years
progression-free survival (PFS)
Time frame: 2 years
duration of response (DOR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 37593221Lu N, Jiang YF, Xia WX, Huang Y, Xie CM, Xu C, Ye YF, Liu GY, Bei WX, Ke LR, Li WZ, Zhang C, Wang X, Liu Q, Chen X, Chen ZX, Xie C, Liang H, Xiang YQ. Efficacy and safety of sintilimab plus bevacizumab in metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy: an open-label phase 2 study. EClinicalMedicine. 2023 Aug 4;62:102136. doi: 10.1016/j.eclinm.2023.102136. eCollection 2023 Aug.
- Individual participant dataSharing planned: Yes
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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.
Yanqun Xiang, Dr. principal investigator
Sun Yat-sen University
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 PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab in people with Metastatic Nasopharyngeal Carcinoma and Chemotherapy Effect, run by XIANG YANQUN 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 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: status not confirmed, as of the sponsor's last update on 23 Feb 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 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?
objective response rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872582, which also lists 1 linked publication.
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 23 Feb 2023.