Health TrialsbyHealthPanel

Adebrelimab and Chemoradiotherapy in High-risk LANPC

ConditionsNasopharyngeal CarcinomaNasopharyngeal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with histologically confirmed nasopharyngeal carcinoma.

Tumor staged as IVA+T3N2M0 (AJCC 8th).

Eastern Cooperative Oncology Group performance status ≤1.

Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.

Disqualifiers

Age > 65 or < 18.

Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml

Hepatitis C virus (HCV) antibody positive

Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Drug: Adebrelimab Adebrelimab 1200mg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 9 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively. Other Names: PD-L1 antibody Drug: Gemcitabine Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation. Other Names: GEM Drug: Cisplatin Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation Other Names: DDP Radiation: Intensity-modulated radiotherapy Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions. Other Names: IMRT

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Adebrelimab armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Failure-free survival (FFS)

calculated from enrolment to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.

Time frame
3 years

Secondary outcomes

1

Overall survival (OS)

calculated from enrolment to the date of death from any cause.

Time frame
3 years
2

Distant metastasis-free survival (DMFS)

calculated from enrolment to the date of first distant metastasis.

Time frame
3 years
3

Locoregional recurrence-free survival (LRRFS)

calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence.

Time frame
3 years
4

Adverse events (AEs) and serious adverse events (SAEs)

Graded according to CTCAE V5.0.

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Nanfang Hospital, Southern Medical University

Collaborator

West China Hospital

Collaborator

The First Affiliated Hospital of Xiamen University

Collaborator

Source ClinicalTrials.gov
Apply now