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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04769076
• Other study ID #: 2020-241-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2021
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma

• The stage is ?-?A (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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Combination Product:
• Paclitaxel(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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	According to European Solid Tumor Efficacy Evaluation Standard (RECIST)	1 month after the end of all treatments