Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy

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.

Conditions

• Nasopharyngeal Carcinoma
• De-escalation Therapy

Interventions

DRUG

Cisplatin-based induction chemotherapy

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

DRUG

Full course of PD-1/PD-L1 blockades

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.

RADIATION

Reduced-dose IMRT

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

RADIATION

Standard-dose IMRT

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

DRUG

Concurrent Chemotherapy

Cisplatin 100mg/m2 every 3 weeks for 2 cycles

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Second Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The fifth Affiliated Hospital of Guangzhou Medcial University

  collaborator OTHER_GOV

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Ming-Yuan Chen, MD,PhD · Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-09

Primary Completion

2029-10-30

Completion

2031-10-30

Countries

• China

Study Locations