MedTrace Logo

Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

NCT04557020 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-05-01

No results posted yet for this study

Summary

This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

PD-1 antibody

neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy

DRUG

Gemcitabine

neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles

DRUG

Cisplatin

neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT

RADIATION

IMRT

70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions

Sponsors & Collaborators

  • Jiangxi Provincial Cancer Hospital

    lead OTHER

Principal Investigators

  • Jingao Li, M.D. · Jiangxi Provincial Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04557020 on ClinicalTrials.gov