Metastatic Nasopharyngeal Carcinoma
Conditions
Brief summary
To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.
Interventions
DRUGPenplimab Injection
Penplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle. Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.
DRUGAntitinib Hydrochloride Capsules
10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks.
DRUGGemcitabine
Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.
Sponsors
Chen Xiaozhong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The participants voluntarily signed an informed consent form. 2. Age of ≥ 18 years and ≤ 75 years at the time of enrollment. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. xpected survival of ≥ 3 months. 5. Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th). 6. Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy. 7. At least one measurable tumor lesion per RECIST 1.1 criteria. 8. Adequate organ function. 9. Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days before study entry and must not be lactating. Male participants must agree to use contraception during the study and for 6 months after the end of the study. 10. The subjects are willing and able to comply with the visit schedule, treatment plan, laboratory examination, and other requirements of the study.
Exclusion criteria
1. ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded. 2. Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing. 3. Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration. 4. Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy maintenance). 5. Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease. 6. Patients with recurrent nasopharyngeal lesions after radiotherapy and who have received secondary radiotherapy. 7. Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism. 8. Previously received anti angiogenic therapy. 9. According to the judgment of the investigator, there are subjects with concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study, or subjects who believe that there are other reasons that are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Baseline up to 2 years | PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Baseline up to 2 years | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD) |
| Overall survival (OS) | Baseline up to 2 years | OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up |
| Time to Response (TTR) | Baseline up to 2 years | TTR defined as the time from randomization to the first recorded CR or PR |
| Objective Response Rate（ORR） | Baseline up to 2 years | Percentage of subjects achieving complete response (CR) and partial response (PR) |
| PD-L1 expression | Tumor tissue samples must be provided to the research center prior to initial administration | Evaluating the correlation between PD-L1 expression and efficacy in tumor tissue samples. |
| Blood EBV level | Baseline up to 2 years | Evaluate the correlation between the copy number of EBV DNA in the blood of subjects and their efficacy. |
| Evaluate the health-related quality of life (HRQoL) of subjects | Baseline up to 2 years | Evaluate the health-related quality of life (HRQoL) of subjects using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire scale。The minimum values is 1，the maximum values is 4，and whether higher scores mean a worse outcome. |
| Duration of Response (DOR) | Baseline up to 2 years | DOR defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. |
Countries
China
Contacts
Primary ContactXiaozhong Chen, Doctor
Outcome results
None listed