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Toripalimab and Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma.

NCT04405622 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-02-06

No results posted yet for this study

Summary

This is an open-label, single center, pilot trial to evaluate the safety and efficacy of toripalimab and gemcitabine in patients with recurrent or metastatic nasopharyngeal carcinoma.

Conditions

  • Nasopharyngeal Carcinoma
  • Recurrent Nasopharyngeal Carcinoma
  • Metastatic Nasopharyngeal Carcinoma
  • Chemotherapy Effect
  • Immunotherapy

Interventions

DRUG

Toripalimab plus gemcitabine

Subjects receive gemcitabine 1000mg/m2 (Day 1 and Day 8) and Toripalimab , 240mg, (Day 1) of each 21 days for at most 6 cycles, followed by Toripalimab 240mg every three weeks (Q3W) maintenance. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-05-30
Primary Completion
2023-03-31
Completion
2023-05-31

Countries

  • China

Study Locations

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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 NCT04405622 on ClinicalTrials.gov