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

NCT04769076 | Unknown Phase 2

• 1 other identifier: 2020-241-02
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  According to European Solid Tumor Efficacy Evaluation Standard (RECIST)

  1 month after the end of all treatments

Study Arms (1)

Paclitaxel(Album-bound)

EXPERIMENTAL

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）

Interventions

Paclitaxel（Albumin-bound） COMBINATION_PRODUCT

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

Also known as: Cisplatin, PD-1 inhibitor (sintilimab), Radiotherapy

Paclitaxel(Album-bound)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Taxes; Cisplatin; Immune Checkpoint Inhibitors; sintilimab; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 24, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 25, 2021

Record last verified: 2021-02