CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 586 target
Drug / intervention
Full course of PD-1/PD-L1 blockades +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/NCT06675214
NCT06675214Phase 3RecruitingOn TrackUpdated 19mo ago
CompareCT.gov

Under Whole-course of Immunotherapy, Gradient Fractionated Radiotherapy with Concurrent Chemotherapy Versus Standard Fractionated Radiotherapy with Concurrent Chemotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Partial Response After Induction Chemotherapy: a Randomized, Open-label, Multicenter, Phase III Trial.

Sun Yat-sen University·interventional·Posted Nov 5, 2024·Updated Nov 5, 2024

In Brief

A Phase 3 clinical trial evaluating Full course of PD-1/PD-L1 blockades, Cisplatin-based induction chemotherapy, and 3 other interventions for Nasopharyngeal Carcinoma and De-escalation Therapy. Currently recruiting, targeting 586 participants across 1 site.

Detailed Summary

This prospective trial aims to enroll patients with stage III-IVA (AJCC 8th,) locoregionally advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved radiological partial response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1 ratio to receive gradient radiotherapy (reducing the irradiation dose of PET-CT areas without metabolic abnormalities, while maintaining adequate irradiation dose of areas with metabolic abnormalities) or standard dose radiotherapy with concurrent chemotherapy. It is expected to provide a new therapeutic option for locally advanced nasopharyngeal carcinoma at moderate risk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Carcinoma, De-escalation Therapy
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
202520262027202820292030
First PostedNov 5, 2024
Enrollment StartJul 30, 2024
Primary CompletionJul 31, 2027
Study CompletionJul 31, 2030
TodayJul 1, 2026
Enrollment to primary: 3.0 yearsPosted 1.7 years agoPrimary completion in 1.1 years

Interventions

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.

Cisplatin-based induction chemotherapydrug

Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy.

Standard-dose IMRTradiation

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

Gradient Fractionated IMRTradiation

GTVresidue: 68Gy/30Fr/2.27Gy GTVmcr: 60Gy/30F/2Gy CTV1:54Gy/30F/1.8Gy CTV2: 48GY/30F/1.60Gy

Concurrent Chemotherapydrug

Cisplatin 100mg/m2 every 3 weeks for 2 cycles