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An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC

NCT04890522 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 622

Last updated 2021-05-18

No results posted yet for this study

Summary

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Blocking the immune checkpoint is one of the effective strategies of tumor immunotherapy. Thus, we sought to find a proper chemotherapy regimen combined with PD-1 antibody JS001.

Conditions

  • Nasopharyngeal Carcinoma
  • Metastasis
  • Chemotherapy
  • Immunotherapy
  • Survival

Interventions

DRUG

Triprilimab(JS001)

Maximum 6 cycles for combined therapy and maintenance for up to 2 years.

DRUG

Cisplatin

Maximum 6 cycles for combined therapy.

DRUG

5-Fluorouracil

Maximum 6 cycles for combined therapy.

DRUG

Gemcitabine

Maximum 6 cycles for combined therapy.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yun-fei Xia, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-12-31
Completion
2028-12-31

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 NCT04890522 on ClinicalTrials.gov