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PD-1 Blockade Combined With De-intensification Radical Chemoradiotherapy in Nasopharyngeal Carcinoma — DIAMOND  

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Toripalimab Combined With Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multi-center, Randomized Controlled Trial

Clinical Trial Summary

This is a phase 3, multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 blockade (toripalimab) combined with the de-intensification radical chemoradiotherapy sparing concurrent cisplatin (i.e., toripalimab plus induction chemotherapy followed by radiotherapy alone) in high-risk locoregionally advanced nasopharyngeal carcinoma.

Clinical Trial Description

This phase 3, multi-center, randomized controlled trial plans to enroll 520 patients with newly-diagnosed, pathologically-proven, untreated locoregionally advanced nasopharyngeal carcinoma (LANPC) at high-risk of distant metastasis (T4N1 and T1-4N2-3, according to American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC] 8th edition clinical staging system). Patients will receive 3 cycles of induction chemotherapy (IC; gemcitabine-cisplatin regimen) followed by 1) experimental arm (de-intensification group): intensity-modulated radiotherapy (IMRT) alone or 2) control arm (standard group): 2 cycles of concurrent cisplatin plus IMRT (CCRT). For both of the two arms, toripalimab will be adopted on day 1 of the first cycle IC and continue every 3 weeks for 6 cycles till the end of IMRT, with the first and last 3 cycles of toripalimab administrated along with IC and CCRT/IMRT, respectively. After three weeks of the completion of IMRT, adjuvant toripalimab will be used every 3 weeks for 11 cycles, and therefore the entire treatment process is expected to last for one year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04907370
Study type Interventional
Source Sun Yat-sen University
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 1, 2021
Completion date May 1, 2027
View Details
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