IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma.

NCT03854838 | Unknown Phase 2 DMC

• 1 other identifier: 2019-FXY-020
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intensity-modulated radiation therapy combined with toripalimab in patients with the unresectable locally recurrent nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases; Head and Neck Neoplasm

Keywords

toripalimab; IMRT; Intensity-Modulated Radiation Therapy; PD-1

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• PFS

  up to 3 years

• OS

  up to 3 years

• Incidence of Treatment-Emergent Adverse Events

  Through study completion, an average of half a year

Study Arms (1)

Toripalimab +Radiotherapy

EXPERIMENTAL

Radiotherapy, intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks ) will be administered as an intravenous infusion over 60 minutes.

Drug: Tolipalimab; Radiation: Reirradiation

Interventions

Tolipalimab DRUG

Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks) will be administered as an intravenous infusion over 60 minutes.

Also known as: JS001

Toripalimab +Radiotherapy

Reirradiation RADIATION

intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks

Toripalimab +Radiotherapy

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed Recurrent Nasopharyngeal Carcinoma ( the recurrence time was more than 12 months from the end of the first course of radiotherapy)
• Patients with histologically confirmed nasopharyngeal carcinoma(WHO type II-III)
• Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
• Can provide either a newly obtained or archival tumor tissue sample.
• Tumor staged as rT0-4N1-3M0 or T2-4N0M0，II-IVa (according to the 8th AJCC edition).
• Years to 65 Years
• Eastern Cooperative Oncology Group performance status ≤1
• Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
• Life expectancy ≥ 3months
• Subjects must be willing to participate in the research and sign an informed consent form (ICF)
• Female of child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 60 days after the last dose of Toripalimab.
• Male subjects with WOCBP partner must be willing to use adequate contraception for the course of the study through 120 days after the last dose of Toripalimab.

You may not qualify if:

• operable recurrence of nasopharyngeal cancer: rT1N0M0 rT2N0M0 (the tumour was confined in the superficial parapharyngeal spacer) rT3N0M0 (the tumour was confined in the base wall of the sphenoid sinus) rT0N1-3M0 (the tumour was not invasion into the cervical vertebrae, brachial plexus, deep muscles of the neck, or carotid artery)
• Has known allergy to large molecule protein products or any compound of study therapy
• Has known Subjects with other malignant tumors
• Has any active autoimmune disease or history of autoimmune disease
• Has a history of psychiatric substance abuse, alcoholism, or drug addiction;
• the laboratory examination value does not meet the relevant standards within 7 days before enrollment
• Received a systematic Glucocorticoid therapy within 4 weeks of the first dose of study medication.
• Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
• Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
• Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy) Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
• Has a known history of human immunodeficiency virus (HIV).
• Has hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV) antibody positive
• Has received a live vaccine within 4 weeks of planned start of study therapy
• Pregnancy or breast feeding

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Hua Y, You R, Wang Z, Huang P, Lin M, Ouyang Y, Xie Y, Zou X, Liu Y, Duan C, Liu Y, Gu C, Liu R, Yang Q, Jiang R, Zhang M, Ding X, Chen S, Lin C, Sun R, Chen M. Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial. J Immunother Cancer. 2021 Nov;9(11):e003290. doi: 10.1136/jitc-2021-003290.

  PMID: 34782428 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases; Head and Neck Neoplasms

Interventions

Re-Irradiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Retreatment

Study Officials

• Ming-Yuan Chen, MD,PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

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: principal investigator

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 26, 2019
• Study Start: May 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)