Clinical trial NCT04769076: The Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Nasopharyngeal Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: 1 month after the end of all treatments
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: