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Trial Title:
Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma
NCT ID:
NCT05869227
Condition:
Nasopharyngeal Carcinoma
Maintenance Therapy
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine/Placebo combined with toripalimab
Description:
Combined
Arm group label:
Capecitabine combined with toripalimab maintenance group
Arm group label:
Placebo combined with toripalimab maintenance group
Summary:
The aim of this study is to investigate the efficacy and safety of the "capecitabine
combined with toripalimab 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The age at the time of diagnosis is 18-75 years old, regardless of gender;
2. Histologically confirmed nasopharyngeal carcinoma;
3. Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma
patients or recurrent nasopharyngeal carcinoma patients who cannot receive local
treatment. ;
4. After receiving standard treatment for 4-6 cycles, the disease is control;
5. ECOG score 0-1;
6. Expected survival time of at least 12 weeks;
7. Patients who have not received systemic chemotherapy within 6 months prior to
diagnosis ;
8. According to RECIST 1.1 standard, at least 1 measurable lesion;
9. Enough organ function;
10. Sign an informed consent form;
11. 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:
1. 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;
2. Diseases that may interfere with oral medication treatment, including but not
limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction;
3. Previous or current history of other tumors, excluding cured cervical carcinoma in
situ, skin basal cell carcinoma, and thyroid papillary carcinoma;
4. Sever heart disease;
5. Central nervous system metastasis with clinical symptoms;
6. Serious infections ;
7. 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;
8. Patients with active chronic hepatitis B or active hepatitis C.
9. A history of interstitial pneumonia or other autoimmune diseases.
10. HIV infection;
11. Individuals with significant organ dysfunction or uncontrollable comorbidities,
including but not limited to uncontrollable hypertension, decompensated liver
cirrhosis, active peptic ulcer, or hemorrhagic disease;
12. Less than 6 weeks after major organ surgery;
13. Pregnant or breast feeding;
14. Patients with mental illness, those with a history of alcohol or drug abuse, or
those who are unable to obtain informed consent;
15. Other researchers have determined that it is not suitable to participate in this
trial.
16. Those who refuse or are unable to sign the informed consent form.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
SunYat-senU
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanqun Xiang, MD
Phone:
+86-18666096623
Email:
xiangyq@sysucc.org.cn
Contact backup:
Last name:
Weixiong Xia, MD
Phone:
+86-18520415699
Email:
xiawx@sysucc.org.cn
Start date:
April 28, 2023
Completion date:
April 28, 2029
Lead sponsor:
Agency:
XIANG YANQUN
Agency class:
Other
Collaborator:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Zhujiang Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05869227
