- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05869227
Maintenance Therapy With Treprilimumab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma
May 11, 2023 updated by: XIANG YANQUN
The Efficacy and Safety of Maintenance Therapy With Treprilimumab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma:Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study
The aim of this study is to investigate the efficacy and safety of the "capecitabine combined with trepril monoclonal antibody maintenance regimen" in improving the first-line treatment of recurrent and metastatic nasopharyngeal carcinoma after receiving remission through chemotherapy combined with anti PD-1 monoclonal antibody standard regimen.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
166
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yanqun Xiang
- Phone Number: 18666096623
- Email: xiangyq@syscc.org.cn
Study Contact Backup
- Name: Guoying Liu
- Phone Number: 18127919832
- Email: liugy0109@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- SunYat-senU
-
Contact:
- Yanqun Xiang, MD
- Phone Number: +86-18666096623
- Email: xiangyq@sysucc.org.cn
-
Contact:
- Weixiong Xia, MD
- Phone Number: +86-18520415699
- Email: xiawx@sysucc.org.cn
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The age at the time of diagnosis is 18-75 years old, regardless of gender;
- Histologically confirmed nasopharyngeal carcinoma;
- Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ;
- After receiving standard treatment for 4-6 cycles, the disease is control;
- ECOG score 0-1;
- Expected survival time of at least 12 weeks;
- Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ;
- According to RECIST 1.1 standard, at least 1 measurable lesion;
- Enough organ function;
- Sign an informed consent form;
- Female participants with fertility and male participants with fertility partners must agree to use reliable contraceptive measures within 6 months after screening and the last treatment.
Exclusion Criteria:
- Patients who are known to be intolerant to capecitabine or allergic to any therapeutic drug, or who are participating in clinical studies of other new drugs;
- Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction;
- Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma;
- Sever heart disease;
- Central nervous system metastasis with clinical symptoms;
- Serious infections ;
- Within 4 weeks of signing the informed consent form, receive systemic hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone per day. Subjects with a systemic hormone dose ≤ 10mg prednisone per day or inhaled/topical corticosteroids can be enrolled in the study;
- Patients with active chronic hepatitis B or active hepatitis C.
- A history of interstitial pneumonia or other autoimmune diseases.
- HIV infection;
- Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease;
- Less than 6 weeks after major organ surgery;
- Pregnant or breast feeding;
- Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent;
- Other researchers have determined that it is not suitable to participate in this trial.
- Those who refuse or are unable to sign the informed consent form.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Capecitabine combined with treprizumab maintenance group
Capecitabine, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle Treprizumab, 240mg, intravenously, day 1 and 21 days/cycle
|
Combined
|
Placebo Comparator: Placebo combined with teriprizumab maintenance group
Placebo, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle Treprizumab, 240mg, intravenously, day 1 and 21 days/cycle
|
Combined
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 2 years
|
Progression free survival is defined as the time interval between randomization and the first recording of tumor progression (evaluated according to RECIST 1.1 criteria, regardless of continued treatment) or death from any cause
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 28, 2023
Primary Completion (Anticipated)
April 28, 2026
Study Completion (Anticipated)
April 28, 2029
Study Registration Dates
First Submitted
May 11, 2023
First Submitted That Met QC Criteria
May 11, 2023
First Posted (Actual)
May 22, 2023
Study Record Updates
Last Update Posted (Actual)
May 22, 2023
Last Update Submitted That Met QC Criteria
May 11, 2023
Last Verified
May 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
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- SYSKY-2023-307-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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