Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

The goal of this study is to learn the efficacy and safety of nimotuzumab combined with toripalimab and gemcitabine/cisplatin regimen treatment recurrent/distant-metastasis nasopharyngeal carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Nimotuzumab

    Drug

    nimotuzumab, toripalimab, gemcitabine, cisplatin

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Nimotuzumab combine with TGPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR[RECIST1.1]

objective response rate assessed by RECIST 1.1

Time frame
3 months

Secondary outcomes

1

mPFS

median progression-free survival assessed by RECIST 1.1

Time frame
1 year
2

OS

median overall survival

Time frame
2 years
3

2-year PFS rate

2-year progression-free survival rate assessed by RECIST 1.1

Time frame
2 years
4

DCR

disease control rate assessed by RECIST 1.1

Time frame
3 months

Other outcomes

Sponsors and contacts

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