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Recruiting NCT06228079

Adjuvant vs Surgery Only in Early-stage Recurrent NPC

Phase III Interventional Recurrent Nasopharyngeal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immunotherapy,Toripalimab Injection, Chemotherapy,Gemcitabine based regimen.
Who it may be relevant to
Registry conditions: Recurrent Nasopharyngeal Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Overview

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Detailed description

This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.

Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

Interventions

  • Drug Immunotherapy,Toripalimab Injection
    Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
  • Drug Chemotherapy,Gemcitabine based regimen
    Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

Primary outcome measures

  • DFS [Time frame: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months]
Secondary outcome measures (5)
  • OS [Time frame: From randomization to death of any cause,assessed up to 60 months]
  • LRFS [Time frame: From randomization to local recurrence or death,assessed up to 24 months]
  • DMFS [Time frame: From randomization to distant metastasis or death, assessed up to 24 months]
  • 1-and 2-year DFS rate [Time frame: end of 1st year, end of 2nd year]
  • 1-and 2-year OS rate [Time frame: end of 1st year, end of 2nd year]

Eligibility criteria

Inclusion criteria

  • Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
  • Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery >5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
  • Cervical lymph node metastasis can be controlled locally
  • Age 18 to 75 years;
  • Without distant metastasis;
  • Informed consent forms signed;
  • ≥6months from the accomplishment of radiation to recurrence
  • previously radiotherapy for only 1 course;
  • ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
  • Sufficient organ function;
  • Undergone endoscopic surgery with negative pathological margin;

Exclusion criteria

  • Participation in other interventional clinical trials;
  • Uncontrolled illnesses which will interfere with the ability to undergo therapy;
  • Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
  • Any contradiction to immune and chemotherapy;
  • With serious autoimmune disease;
  • Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
  • Severe allergic reactions to other monoclonal antibodies;
  • History of radioactive particle planting;
  • Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
  • Female patients who are at pregnancy or lactation;
  • Other situations that the researchers believe are not suitable for enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 7 centers
  • Eye& ENT Hospital, Fudan University — Shanghai
  • Fujian Medical University Union Hospital — Fuzhou
  • The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning
  • Changhai Hospital — Shanghai
  • Shanghai Sixth People's Hospital — Shanghai
  • Shanghai Zhongshan Hospital — Shanghai
  • Shenzhen Second People's Hospital — Shenzhen

Identifiers

NCT: NCT06228079 · early-rNPC-RCT-adj

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗