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LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC

ConditionsNasopharyngeal Cancinoma (NPC)Nasopharangeal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-65 years old.

Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II or III).

ECOG Performance Status score of 0-1.

At least one measurable lesion as per RECIST v1.1 criteria.

Disqualifiers

Disease progression within 6 months after completing standard treatment for locoregionally advanced nasopharyngeal carcinoma.

Absence of identifiable tumor lesions in both the primary site and locoregional lymph nodes, precluding the development of an LDRT plan.

Inability to undergo MRI due to reasons such as implanted metal devices or claustrophobia.

Requirement for systemic use of corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose or during the study. Inhaled or topical steroids and adrenal replacement steroid doses >10 mg/day prednisone equivalent are permitted in the absence of active autoimmune disease. Physiological replacement doses of corticosteroids (≤10 mg/day prednisone equivalent) are allowed.

Trial design

Design model

Single group

Treatments tested in this trial

  • Gemcitabine(GEM)

    Drug

    Gemcitabine 1000mg/m2, d1 \& 8 of every cycle, every 3 weeks for 4-6 cycles

  • Cisplatin

    Drug

    Cisplatin 80mg/m2, d1 of every cycle, every 3 weeks for 4-6 cycles

  • Toripalimab

    Drug

    Toripalimab 240 mg, d1of every cycle, every 3 weeks for 4-6 cycles. Toripalimab maintenance, 240 mg, d1of every cycle, every 3 weeks until disease progression or unacceptable toxicity.

  • LDRT

    Radiation

    Irradiation of the primary lesion and regional metastatic lymph nodes, 0.5 Gy per fraction for 4 fractions, d0-3, every 3 weeks for 4-6 cycles

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: LDRT + Toripalimab + GP chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) assessed by RECIST 1.1

PFS was defined as the time from enrollment to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
up to approximately 2 years

Secondary outcomes

1

Objective Response Rate（ORR）

The proportion of patients who achieved a complete response (CR) or partial response (PR), assessed according to RECIST v1.1.

Time frame
up to approximately 2 years
2

Progression-free survival (PFS) assessed by iRECIST

PFS was defined as the time from enrollment to the first occurrence of disease progression as determined according to iRECIST or death from any cause, whichever occurs first.

Time frame
up to approximately 2 years
3

Overall survival (OS)

OS was defined as the time from enrollment to death from any cause.

Time frame
up to approximately 4 years
4

Adverse events

All adverse event or serious adverse event that occurred during the study period according to CTCAE V5.0.

Time frame
up to approximately 2 years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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