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Trial Title:
Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial
NCT ID:
NCT06438627
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Apatinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TPC combined with Apatinib and Camrelizumab
Description:
Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and
Camrelizumab
Arm group label:
TPC+Apatinib+Camrelizumab
Intervention type:
Drug
Intervention name:
GP Combined With Camrelizumab
Description:
Gemcitabine, Cisplatin regimen Combined With Camrelizumab
Arm group label:
GP+ Camrelizumab
Summary:
This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel,
cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP
regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of
high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant
metastasis. The evaluation will be conducted through a prospective, controlled,
open-label, multicenter phase 3 clinical trial in areas with high incidence of
nasopharyngeal carcinoma.
Detailed description:
IMPORTANCE: Safe and effective therapies for untreated, advanced locally advanced
nasopharyngeal carcinoma remain an unmet need.
OBJECTIVE:This study aims to evaluate the efficacy and safety of the TPC regimen
(nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab
versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the
treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of
distant metastasis. The evaluation will be conducted through a prospective, controlled,
open-label, multicenter phase 3 clinical trial in areas with high incidence of
nasopharyngeal carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically confirmed WHO type II or III;
2. Staging TanyN3M0 (UICC/AJCC 8th edition);
3. Treatment-naive patients with no history of other malignancies;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
5. Age 18-65 years;
6. Neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90 g/L, transaminases
<2.5 times the upper limit of normal, total bilirubin <1.5 times the upper limit of
normal, creatinine <1.5 times the upper limit of normal; activated partial
thromboplastin time and international normalized ratio <1.5 times the upper limit of
normal;
7. Signed informed consent form.
Exclusion Criteria:
1. Known or suspected allergy to the study drugs, or pregnant/perinatal women;
2. Inability to comply with regular follow-up due to psychological, social, familial,
or geographical reasons;
3. Severe dysfunction of critical organs such as the heart, lungs, liver, or kidneys
(e.g., decompensated heart, lung, renal, or liver failure) that precludes tolerance
to chemoradiotherapy;
4. Severe uncontrolled infection or internal medical disease;
5. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥500
IU/ml, exclusion if normal liver function and on antiviral medication for more than
one week; hepatitis C defined as HCV-RNA above the lower limit of detection) or
coinfection with hepatitis B and C;
6. Factors affecting drug administration, distribution, metabolism, or excretion such
as psychiatric disorders, central nervous system abnormalities, chronic diarrhea,
ascites, or pleural effusion;
7. Poorly controlled hypertension despite antihypertensive treatment (systolic blood
pressure >140 mmHg or diastolic blood pressure >90 mmHg);
8. Long-term use of immunosuppressants post-organ transplantation;
9. Known history of substance abuse or drug addiction;
10. History of other malignancies prior to enrollment;
11. Presence of other severe physical or mental illnesses or abnormal laboratory
findings that may increase the risk of study participation, interfere with study
results, or deemed unsuitable for participation by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 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
Facility:
Name:
Sun Yat sen Memorial Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
He-Rui Yao, MD
Investigator:
Last name:
He-Rui Yao, MD
Email:
Principal Investigator
Start date:
May 30, 2024
Completion date:
May 30, 2029
Lead sponsor:
Agency:
XIANG YANQUN
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/NCT06438627
