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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

ConditionsNasopharyngeal CarcinomaMetastasisChemotherapyImmunotherapySurvival
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Nasopharyngeal carcinoma diagnosed by pathology or cytology.

Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) is not amenable for local-regional treatment or curative treatment.

Has not received prior systemic treatment for metastatic nasopharyngeal carcinoma, except for neoadjuvant chemotherapy, concurrent chemoradiotherapy, or adjuvant chemotherapy 6 months prior to the first treatment.

The Karnofsky performance status score is at least 70 points (if the decreased score is caused by the tumor, the minimum score can be 50 points after the judgment of researchers.)

Disqualifiers

Allergic to monoclonal antibodies, any JS001 components, gemcitabine, cisplatin, or 5-fluorouracil.

Has prior therapy including anti-PD-1, anti-PD-L1, or CTLA4.

Major surgery within 28 days prior to the randomization (not including diagnostic surgery) or plan to be conducted during the study.

Active autoimmune disease requiring systemic treatment or has a history of autoimmune disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Triprilimab(JS001)

    Drug

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

  • Cisplatin

    Drug

    Maximum 6 cycles for combined therapy.

  • 5-Fluorouracil

    Drug

    Maximum 6 cycles for combined therapy.

  • Gemcitabine

    Drug

    Maximum 6 cycles for combined therapy.

Treatment groups

622 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 3 interventions
Group B: Control groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival

Time frame
Up to 5 years
2

OS

Overall survival

Time frame
Up to 5 years
3

Severe drug-related adverse events

grade III-V according to CTCAE v4.0

Time frame
Up to 2 approximately years

Secondary outcomes

1

ORR

Objective response rate

Time frame
Up to 2 approximately years
2

DCR

Disease control rate

Time frame
Up to 2 approximately years
3

DOR

Duration of response

Time frame
Up to 2 approximately years
4

Minor drug-related adverse events

grade I-II according to CTCAE v4.0

Time frame
Up to 2 approximately years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: