Health TrialsbyHealthPanel

Adjuvant vs Surgery Only in Early-stage Recurrent NPC

ConditionRecurrent Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEye & ENT Hospital of Fudan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immunotherapy,Toripalimab Injection

    Drug

    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.

  • Chemotherapy,Gemcitabine based regimen

    Drug

    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.

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: The control groupNo intervention 0 interventions
Group B: The experimental groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

DFS

Disease free survival

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 outcomes

1

OS

Overall Survival

Time frame
From randomization to death of any cause,assessed up to 60 months
2

LRFS

Local recurrence free survival

Time frame
From randomization to local recurrence or death,assessed up to 24 months
3

DMFS

Distant metastasis free survival

Time frame
From randomization to distant metastasis or death, assessed up to 24 months
4

1-and 2-year DFS rate

one- and two-year disease free survival

Time frame
end of 1st year, end of 2nd year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Shanghai 6th People's Hospital

Collaborator

Changhai Hospital

Collaborator

Fujian Medical University Union Hospital

Collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborator

Shenzhen Second People's Hospital

Collaborator

Source ClinicalTrials.gov
Apply now