Nasopharyngeal Cancinoma (NPC)
Conditions
Brief summary
We expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (TPC vs. GP) with combination therapy of Camrelizumab.
Detailed description
The therapeutic effect of patients with metastatic nasopharyngeal carcinoma has been further improved. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) have strong activity in treated metastatic nasopharyngeal carcinoma patients, with an objective response rate (ORR) of 20-34%. In addition, immunotherapy has also achieved good results in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. In 2021, the clinical results of a study on the treatment of recurrent/metastatic nasopharyngeal carcinoma with pembrolizumab were published. The median PFS of the pembrolizumab combined with chemotherapy group was 9.7 months, significantly prolonging PFS, with an HR value of 0.54, and reducing the risk of disease progression by 46%. Based on this, the 2022 CSCO guidelines will use pembrolizumab combined with GP chemotherapy as a new first-line treatment for metastatic nasopharyngeal carcinoma.We conducted a study comparing the efficacy of GP regimen and nab TPC regimen, and found that nab TPC regimen significantly improved the survival of patients with metastatic nasopharyngeal carcinoma compared to GP regimen, and the nab TPC regimen group had milder grade 3-4 toxic side effects.This study aims to design a prospective phase III clinical trial on the safety and efficacy of GP combined with Carilizumab compared to nab TPC regimen combined with Carilizumab chemotherapy for recurrent and metastatic nasopharyngeal carcinoma
Interventions
DRUGCamrelizumab combined GP chemotherapy
Camrelizumab was intravenously given at dose of 200 mg on day 1. The GP regimen included gemcitabine administered at a dose of 1 g/m2 on day 1 and day 8, cisplatin at a dose of 80 mg/m2 on day 1.Q3W 1 cycle, 4-6 cycles.
DRUGCamrelizumab combined TPC chemotherapy
Camrelizumab was intravenously given at dose of 200 mg on day 1. The TPC regimen included nab-paclitaxel administered at a dose of 200 mg/m2 on day 1, cisplatin at a dose of 60 mg/m2 on day 1, and capecitabine at a dose of 1000 mg/m2, taken orally twice a day on days 1 to 14, for each cycle. Q3W 1 cycle, 4-6 cycles.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 18 years. 2. ECOG score of 0-1. 3. Expected survival of at least 12 weeks. 4. Recurrent/Metastatic Nasopharyngeal Carcinoma. 5. At least 4 weeks since the previous chemotherapy. 6. At least one (according to RECIST) measurable lesion, lesions that have been previously irradiated can not be considered target lesions. 7. had adequate organ function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | 15 months | The primary endpoint was PFS, which was assessed as the time from randomization to disease progression per RECIST v1.1 assessed by IRC or death, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 1,3,5 years | The secondary endpoint was OS, which was assessed as the time from randomization to death according to RECIST v1.1 or PERCIST, whichever occurred first. |
| Safety and Adverse Events | 3 months | Adverse events occurring during chemotherapy |
Countries
China
Contacts
Primary ContactXIANG YANQUN
Outcome results
None listed