CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 424 target
Drug / intervention
Adjuvant immunotherapy +2 moredrug
Likely dose
Adjuvant immunotherapy 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05877872
NCT05877872Phase 3RecruitingOn TrackUpdated 37mo ago
Long Recruiting
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Reduced-target Resection Compared With Full-target Resection After Induction Chemotherapy in Resectable Recurrent Nasopharyngeal Carcinoma: a Multicentre, Randomised, Open-label, Phase 3 Trial

Sun Yat-sen University·interventional·Posted May 26, 2023·Updated May 26, 2023

In Brief

A Phase 3 clinical trial evaluating Reduced-target resection, Full-target resection, and 1 other intervention for Nasopharyngeal Carcinoma and De-escaltion Therapy. Currently recruiting, targeting 424 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Carcinoma, De-escaltion Therapy
CountriesChina
CollaboratorsFirst Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Fifth Affiliated Hospital of Guangzhou Medical University

Timeline

Phase 3Recruiting
202420252026202720282029
First PostedMay 26, 2023
Enrollment StartMay 20, 2023
Primary CompletionMar 30, 2029
TodayJul 1, 2026
Enrollment to primary: 5.9 yearsPosted 3.1 years agoPrimary completion in 2.7 years

Interventions

Reduced-target resectionprocedure

Patients receive surgery according to pSTV-post-IC.

Full-target resectionprocedure

Patients receive surgery according to pSTV-pre-IC.

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.