- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04872582
Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study
February 21, 2023 updated by: XIANG YANQUN
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Yanqun Xiang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- HIV infection.
- Allogeneic organ transplantation
- Malignancy other than nasopharyngeal carcinoma.
- Pregnancy or breast feeding.
- Received other test drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PD-1 immune checkpoint inhibitor combined with bevacizumab
|
combined
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival (OS)
Time Frame: 2 years
|
Patients in clinical trials were randomized to the time of death from any cause
|
2 years
|
progression-free survival (PFS)
Time Frame: 2 years
|
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.
|
2 years
|
duration of response (DOR)
Time Frame: 2 years
|
The time between the first assessment of a tumor as CR or PR and the first assessment of PD or death from any cause.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yanqun Xiang, Dr., Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 29, 2021
Primary Completion (Actual)
January 4, 2023
Study Completion (Anticipated)
October 1, 2024
Study Registration Dates
First Submitted
May 2, 2021
First Submitted That Met QC Criteria
May 3, 2021
First Posted (Actual)
May 4, 2021
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
- Immune Checkpoint Inhibitors
Other Study ID Numbers
- B2021-078-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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