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Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma

ConditionsNasopharyngeal Cancinoma (NPC)Nasopharyngeal Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤65 years

Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.

Eastern Cooperative Oncology Group performance score of 0-1.

Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition).

Disqualifiers

Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1×10 copies/mL, positive for anti-hepatitis C virus (HCV) antibody, positive for anti-hepatitis C virus (HCV) antibody

Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).

Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received con dirmed and regular anti-tuberculosis treatment.

Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.

Trial design

Design model

Parallel

Treatments tested in this trial

  • tislelizumab

    Drug

    Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 3 cycles.

  • tislelizumab

    Drug

    Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 5 cycles.

  • Gemcitabine + cisplatin (GP)

    Drug

    neoadjuvent gemcitabine (1000 mg/m2 d1, d8) and cisplatin (80 mg/m2 d1) every 3 weeks for 3 cycles

  • Cisplatin (100mg/m2)

    Drug

    Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

  • intensity-modulated radiotherapy

    Radiation

    Defnitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

Treatment groups

418 Participants
are divided into 2 treatment groups
Group A: tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant)Experimental treatment 4 interventions
Group B: tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

Failure-free survival (FFS)

From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.

Time frame
3 years

Secondary outcomes

1

Overall survival (OS)

From date of randomization until the date of death from any cause, whichever came first

Time frame
3 years
2

Distant metastasis-free survival (DMFS)

From date of randomization until the date of first documented distant metastasis, whichever occurred first

Time frame
3 years
3

Locoregional recurrence-free survival (LRRFS)

From date of randomization until the date of first documented locoregional recurrence, whichever occurred first

Time frame
3 years
4

Adverse events (AEs)

Graded according to CTCAE V5.0

Time frame
within 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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