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Phase III Trial of EBV-DNA-Guided Adaptive Immunotherapy for Advanced Nasopharyngeal Carcinoma

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

About this trial

This trial evaluated the efficacy of two adjuvant regimens following identical induction and concurrent chemoradiotherapy (IC+CCRT) in locoregionally advanced nasopharyngeal carcinoma (LANPC) patients with persistent EBV DNA positivity or stable disease after three IC cycles. The control arm received adjuvant adebrelimab, while the experimental arm received adebrelimab plus capecitabine.

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 II-III disease (AJCC 9th edition), excluding T3N0-1.

Disqualifiers

Patients with persistent EBV DNA positivity or stable disease following 3 cycles of induction chemotherapy (gemcitabine, cisplatin, and adebrelimab).

Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.

Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).

Disease progression after induction chemotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab (PD-L1 inhibitor)

    Drug

    Adebrelimab 1200mg will be given every 3 weeks for 5 cycles in adjuvant chemotherapy

  • Cisplatin (100mg/m2)

    Drug

    Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

  • Intensity-modulated radiotherapy

    Radiation

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

  • Capecitabine

    Drug

    Capecitabine was administered at 650 mg/m² orally twice daily for one year.

Treatment groups

516 Participants
are divided into 2 treatment groups
Group A: adebrelimab plus capecitabineExperimental treatment 4 interventions
Group B: adebrelimabActive comparator 3 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, assessed up to 74 months

Time frame
3 year

Secondary outcomes

1

Overall survival (OS)

From date of randomization until the date of death from any cause, whichever came first, assessed up to 74 months

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, assessed up to 74 months.

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, assessed up to 74 months.

Time frame
3 years
4

Tumor response

Evaluation of tumor response as CR, PR, SD, PD, NA by clinicians

Time frame
the time of completion of induction chemotherapy, radiotherapy, and adjuvant immunotherapy; from the date of enrollment until the date of the last time that tumorimaging and assessment of disease has been done, assessed up to 74 weeks

Other outcomes

1

Correlation between pre-treatment PD-L1 expression level and FFS

Pre-treatment PD-L1 expression level of tumor cell is evaluated centrally by means of immunohistochemical testing.

Time frame
3 years
2

Evaluate failure-free survival in the subgroup of plasma Epstein-Barr virus DNA level

Subgroup analysis

Time frame
3 years

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: