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

Phase 2

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Combination Product: Paclitaxel（Albumin-bound）

• Registration Number: NCT04769076
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study First Submitted: 2021-01-25
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-24
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25
• Study Start: 2021-03-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel(Album-bound)	Paclitaxel（Albumin-bound）	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.

Primary Outcome Measures

Name	Time	Method
Objective response rate	1 month after the end of all treatments	According to European Solid Tumor Efficacy Evaluation Standard (RECIST)