At a glance

ClinicalIndex Comparison Record

Phase 3Recruiting· 504 target

Drug / intervention

Cisplatin-based induction chemotherapy +4 moredrug

Likely dose

Full course of PD-1/PD-L1 blockades 200mgfrom 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/NCT06092957

NCT06092957Phase 3RecruitingOn TrackUpdated 30mo ago

Compare CT.gov

Reduced-dose Radiotherapy With/Without Concurrent Chemotherapy Versus Standard Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Complete Response After Induction Chemotherapy Plus Immunotherapy: a Randomized, Open-label, Multicenter, Phase III Trial

Sun Yat-sen University·interventional·Posted Oct 23, 2023·Updated Dec 15, 2023

In Brief

A Phase 3 clinical trial evaluating Cisplatin-based induction chemotherapy, Full course of PD-1/PD-L1 blockades, and 3 other interventions for Nasopharyngeal Carcinoma and De-escalation Therapy. Currently recruiting, targeting 504 participants across 1 site.

Detailed Summary

This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNasopharyngeal Carcinoma, De-escalation Therapy

CountriesChina

CollaboratorsFirst Affiliated Hospital, Sun Yat-Sen University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, Second Affiliated Hospital, Sun Yat-Sen University, The fifth Affiliated Hospital of Guangzhou Medcial University, Zhongshan People's Hospital, Guangdong, China, Hunan Cancer Hospital, Tongji Hospital

Timeline

Phase 3Recruiting

202420252026202720282029203020312032

Enrollment StartOct 2023

First PostedOct 2023

TodayJul 2026

Primary CompletionOct 2029

Study CompletionOct 2031

First PostedOct 23, 2023

Enrollment StartOct 9, 2023

Primary CompletionOct 30, 2029

Study CompletionOct 30, 2031

TodayJul 1, 2026

Enrollment to primary: 6.1 yearsPosted 2.7 years agoPrimary completion in 3.3 years

Interventions

Cisplatin-based induction chemotherapydrug

Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy including GP, TP, and TPF regimen.

Full course of PD-1/PD-L1 blockadesdrug

a) Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment.

Reduced-dose IMRTradiation

GTVnx:60Gy/30F/2.0Gy，CTV1:54Gy/30F/1.8Gy，CTV2:48Gy/30F/1.6Gy

Standard-dose IMRTradiation

GTVnx：69.96Gy/33Fr/2.12Gy；CTV1：60.60Gy/33Fr/1.82y；CTV2：54.12Gy/33Fr/1.64Gy

Concurrent Chemotherapydrug

Cisplatin 100mg/m2 every 3 weeks for 2 cycles