The Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Phase II Clinical Trial of Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Locally Advanced Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Combination Product: Paclitaxel（Albumin-bound）


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel(Album-bound)<br>Subjects will receive neoadjuvant therapy with paclitaxel (albumin-bound) combined with cisplatin and PD-1 inhibitor (sintilimab) as well as radical concurrent radiotherapy and chemotherapy. | Combination Product: Paclitaxel（Albumin-bound）<br>* 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<br>* Other names: Radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | According to European Solid Tumor Efficacy Evaluation Standard (RECIST) | 1 month after the end of all treatments |