NCT04453813

Brief Summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P25-P50 for phase_3

Timeline
14mo left

Started Jul 2020

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jul 2020Jul 2027

First Submitted

Initial submission to the registry

June 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

July 3, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

5 years

First QC Date

June 27, 2020

Last Update Submit

September 24, 2020

Conditions

Nasopharyngeal CarcinomaChemotherapyRadiotherapyPD-1 Treatment

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival (PFS)

    Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

    3 years

Secondary Outcomes (7)

  • Overall Survival (OS)

    3 years

  • Distant Metastasis-Free Survival (DMFS)

    3 years

  • Locoregional Relapse-Free Survival (LRRFS)

    3 years

  • Incidence of treatment related acute complications

    up to 1 years

  • Incidence of treatment related late complications

    up to 3 years

  • +2 more secondary outcomes

Study Arms (2)

Toripalimab plus concurrent chemo-radiotherapy arm

EXPERIMENTAL

Concurrent chemo-radiotherapy plus concurrent and adjuvant toripalimab.

Drug: Toripalimab plus concurrent chemo-radiotherapy

Concurrent chemo-radiotherapy arm

ACTIVE COMPARATOR

Concurrent chemo-radiotherapy alone.

Drug: Concurrent chemo-radiotherapy

Interventions

Toripalimab plus concurrent chemo-radiotherapyDRUG

1. Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of toripalimab are concurrently used during radiotherapy and other 9 cycles of toripalimab are used after the end of radiotherapy. (A total of 11 cycles). 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy

Toripalimab plus concurrent chemo-radiotherapy arm
Concurrent chemo-radiotherapyDRUG

1. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 2. IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy

Concurrent chemo-radiotherapy arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed recurrent nasopharyngeal carcinoma.
  • The recurrence time is more than 12 months from the end of the first course of radiotherapy.
  • Tumor staged as rT2-4N0-3M0，rII-IVa (according to the 8th AJCC edition).
  • Subjects must have a measurable disease by CT or MRI per RECIST 1.1 criteria.
  • Karnofsky scale (KPS)≥70.
  • Normal bone marrow function.
  • Normal liver and kidney function:
  • total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
  • creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
  • Given written informed consent.

You may not qualify if:

  • Resectable nasopharyngeal diseases: rT2 (the tumour is confined in the superficial parapharyngeal spacer and is more than 0.5cm from the internal carotid artery) and rT3 (the tumour is confined in the base wall of the sphenoid sinus and is more than 0.5cm from the internal carotid artery and cavernous sinus).
  • The patients are suffering from severe nasopharyngeal necrosis, radiation induced brain injury, and fibrosis of the neck et. al, who are evaluated as unsuitable for secondary radiotherapy by the researchers.
  • 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 with HBV DNA copy number of ≥1000cps/ml 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

NOT YET RECRUITING

Yuebei People's Hospital

Shaoguan, Guangdong, 512025, China

NOT YET RECRUITING

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

NOT YET RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

NOT YET RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

: 86-20-87343624chmingy@mail.sysu.edu.cn

Rui You, MD, PhD

CONTACT

86-13580439820yourui@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief Doctor

Study Record Dates

First Submitted

June 27, 2020

First Posted

July 1, 2020

Study Start

July 3, 2020

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2027

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations

CN(6)