Nasopharyngeal Carcinoma
Conditions
Brief summary
The purpose of this study in to observe the effectiveness and safety of paclitaxel (albumin-bound type) combined with cisplatin, PD-1 inhibitor and IMRT in the treatment of locally advanced nasopharyngeal carcinoma.
Detailed description
This trial is a prospective, open, single-arm phase II clinical trial. The trial will enroll 40 patients with nasopharyngeal cancer stage III-IVA (UICC 8th edition). Subjects will receive paclitaxel (albumin-bound) combined with cisplatin and PD-1 inhibitor (sintilimab) neoadjuvant therapy and radical concurrent chemotherapy and radiotherapy.
Interventions
COMBINATION_PRODUCTPaclitaxel（Albumin-bound）
Three courses of albumin-bound paclitaxel combined with cisplatin and PD-1 monoclonal antibody neoadjuvant treatment followed by cisplatin combined with IMRT (intensity modulated conformal radiotherapy) concurrent radiotherapy and chemotherapy
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma * The stage is Ⅲ-ⅣA (UICC 8th edition) * Initial treatment patients without anti-tumor therapy * No history of other malignant tumors * Male or female, aged 18\ 70 years old * Sufficient liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min * Sufficient blood function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL * No serious heart, lung, liver, kidney and other important organ dysfunction * Karnofsky score ≥70 points * No autoimmune diseases * Sign informed consent
Exclusion criteria
* Has performed anti-tumor treatment, including chemotherapy, radiotherapy, and surgery * Discovery of distant metastases before treatment * Receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period * Active, known or suspected autoimmune diseases * Known history of primary immunodeficiency * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * Women who are pregnant or breastfeeding * Disagree to sign the informed consent form * Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons * Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research) * Known allergic to possible chemotherapy drugs * Accompanied by serious uncontrollable infections or medical diseases * Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, unable to tolerate radiotherapy and chemotherapy * Laboratory examination: total bilirubin\>upper limit of normal (ULN); AST and/or ALT\>1.5 times ULN and accompanied by alkaline phosphatase\>2.5 times ULN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 1 month after the end of all treatments | According to European Solid Tumor Efficacy Evaluation Standard (RECIST) |
Outcome results
None listed