NCT04778956

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P25-P50 for phase_3

Timeline
83mo left

Started Mar 2021

Longer than P75 for phase_3

Geographic Reach
1 country

7 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 Progress43%
Mar 2021Mar 2033

First Submitted

Initial submission to the registry

February 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2033

Expected
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

4 years

First QC Date

February 25, 2021

Last Update Submit

March 3, 2021

Conditions

Nasopharyngeal CarcinomaPD-1Surgery

Keywords

Nasopharyngeal carcinomaRecurrentSalvage surgeryAnti-programmed death-1 antibodyDisease free survival

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.

    2 years

Secondary Outcomes (7)

  • Objective Response Rate

    3-5 weeks

  • Major Pathological Response Rate

    4-6 weeks

  • Overall Survival

    2 years

  • Distant Metastasis-Free Survival

    2 years

  • Locoregional Relapse-Free Survival

    2 years

  • +2 more secondary outcomes

Study Arms (2)

Toripalimab plus salvage surgery

EXPERIMENTAL

1. Toripalimab: Toripalimab treatment before and after salvage surgery. 2. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.

Drug: ToripalimabProcedure: salvage surgery

Salvage surgery alone

ACTIVE COMPARATOR

1\. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.

Procedure: salvage surgery

Interventions

ToripalimabDRUG

Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.

Also known as: PD-1 antibody
Toripalimab plus salvage surgery
salvage surgeryPROCEDURE

Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.

Salvage surgery aloneToripalimab plus salvage surgery

Eligibility Criteria

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

You may qualify if:

  • The recurrence time is more than 6 months from the end of radiotherapy.
  • Histologically confirmed recurrent nasopharyngeal carcinoma.
  • Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)
  • Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)
  • Given written informed consent.

You may not qualify if:

  • Karnofsky Performance Status (KPS) ≤70.
  • Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
  • Has known subjects with other malignant tumors.
  • Has participated in other drug trials within 3 months of planned start of study treatment.
  • Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
  • Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
  • Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (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 hepatitis B virus (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 treatment.
  • Pregnancy or breast feeding.
  • Cannot complete regular follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

NOT YET RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510700, China

NOT YET RECRUITING

The First People's Hospital of Foshan

Guangzhou, Guangdong, 528000, China

NOT YET RECRUITING

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

NOT YET RECRUITING

The Tenth Affiliated Hospital, Sun Yat-Sen University

Nanchang, Jiangxi, 330008, China

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal CarcinomaRecurrence

Interventions

toripalimabspartalizumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ming-Yuan Chen, MD, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

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

You-Ping Liu, MD, PhD

CONTACT

86-20-87343379liuyoup@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

February 25, 2021

First Posted

March 3, 2021

Study Start

March 3, 2021

Primary Completion

March 3, 2025

Study Completion (Estimated)

March 3, 2033

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations

CN(7)