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Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma

NCT05097209 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-03-23

No results posted yet for this study

Summary

This trial plans to enroll patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or 3 cycles of induction chemotherapy with gemcitabine and cisplatin and radiation plus Camrelizumab. All patients will receive intensity-modulated radiotherapy (IMRT). Camrelizumab will begin on day 1 of induction chemotherapy every 3 weeks for 3 cycles and continue every 2 weeks for 9 cycles.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Camrelizumab

Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.

DRUG

Gemcitabine

Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation

DRUG

Induction Cisplatin

Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation

RADIATION

intensity-modulated radiotherapy

Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

DRUG

Concurrent cisplatin

Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

Sponsors & Collaborators

  • Wuzhou Red Cross Hospital

    collaborator OTHER

  • Guangxi Nanxishan Hospital

    collaborator UNKNOWN

  • Laibin People's Hospital

    collaborator OTHER

  • Lingshan people's Hospital

    collaborator UNKNOWN

  • Wei Jiang

    lead OTHER

Principal Investigators

  • Bin Zhang, M.D. · Wuzhou Red Cross Hospital

  • Yu-fei Pan, M.D. · Guangxi Nanxishan Hospital

  • Yi-xin Su, M.D. · Lingshan people's Hospital

  • Jian Zhang, M.D. · Laibin People's Hospital

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
2022-04-06
Primary Completion
2025-04-06
Completion
2026-04-06

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 NCT05097209 on ClinicalTrials.gov