NCT05877872

Brief Summary

The goal of this clinical trial is to compare efficacy of two different resection extension in patients with resectable recurrent nasopharyngeal carcinoma after induction chemotherapy. The main question it aims to answer is that whether tumor regress areas after induction chemotherapy required complete resection. Patients will be randomly assigned to receive reduced-target resection or full-target resection after induction chemotherapy. Researchers will compare these two groups to see if the efficacy of reduced-target resection is not inferior to full-target resection.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
424

participants targeted

Target at P50-P75 for phase_3

Timeline
35mo left

Started May 2023

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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 Progress51%
May 2023Mar 2029

First Submitted

Initial submission to the registry

May 18, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

May 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

5.9 years

First QC Date

May 18, 2023

Last Update Submit

May 25, 2023

Conditions

Nasopharyngeal CarcinomaDe-escaltion Therapy

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened

    3 years

Secondary Outcomes (11)

  • The incidence of Severe Adverse events

    3 years

  • Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall

    3 years

  • In-field recurrence rate

    3 years

  • Progression-free survival (PFS)

    3 years

  • Loco-regional relapse-free survival (LRRFS)

    3 years

  • +6 more secondary outcomes

Study Arms (2)

Reduced-target resection group

EXPERIMENTAL

Patients receive surgery according to pSTV-post-IC and adjuvant immunotherapy.

Procedure: Reduced-target resectionDrug: Adjuvant immunotherapy

Full-target resection group

ACTIVE COMPARATOR

Patients receive surgery according to pSTV-pre-IC and adjuvant immunotherapy.

Procedure: Full-target resectionDrug: Adjuvant immunotherapy

Interventions

Reduced-target resectionPROCEDURE

Patients receive surgery according to pSTV-post-IC.

Reduced-target resection group
Full-target resectionPROCEDURE

Patients receive surgery according to pSTV-pre-IC.

Full-target resection group
Adjuvant immunotherapyDRUG

Toripalimab(240 mg d1) continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.

Full-target resection groupReduced-target resection group

Eligibility Criteria

Age18 Years - 75 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). If the tumor invaded the internal carotid artery, or the instance from the internal carotid artery was less than 0.5cm, but the invasion area did not exceed the external edge of the internal carotid artery, the patients could be enrolled after internal carotid artery pretreatment (including internal carotid artery embolization or stent implantation).
  • After 3 cycles induction chemotherapy (Platinum based chemotherapy \[gemcitabine/paclitaxel and platinum\] and immunotherapy\[PD-1/PD-L1 antibody\] or a GAP regmen\[gemcitabine, Apatinib and immunotherapy\[PD-1/PD-L1 antibody\]), patients achieved at least PR according to RECIST criteria, and the reduction of pSTV after induction chemotherapy more than 50%.
  • 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.
  • Tumor confined to the roof or the posterior wall of nasopharynx, without expected benefit from reduced-target resection.
  • Unresectable recurrent regional lymph node diseases (recurrent N1-3) with prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement (according to the 8th edition of AJCC staging system).
  • Clinically diagnosed with metastatic NPC.
  • Has known subjects with other malignant tumors (except for cured skin basal cell carcinoma or cervical carcinoma in situ).
  • 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 (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ming-Yuan Chen, MD, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

86-20-8734-3361chmingy@mail.sysu.edu.cn

Youping Liu, PhD

CONTACT

86-13751763276liuyoup@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
Deputy director

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 26, 2023

Study Start

May 20, 2023

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

March 30, 2029

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations

CN(1)