Health TrialsbyHealthPanel

Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk 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 aimed to evaluate the efficacy of anlotinib hydrochloride combined with benmelstobart, induction chemotherapy, and concurrent chemoradiotherapy (IC+CCRT), versus a regimen of benmelstobart plus IC+CCRT, in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC).

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.

Tumor staged as T4N2 and T1-4N3 (AJCC 9th)

Eastern Cooperative Oncology Group performance score of 0-11.

Disqualifiers

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).

Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1×103 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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anlotinib Hydrochloride Capsules

    Drug

    Anlotinib hydrochloride (10mg, d1-d14) will be given every 3 weeks for 3 cycles in induction chemotherapy.

  • Gemcitabine (GEM)

    Drug

    Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.

  • Cisplatin

    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.

  • Benmelstobart

    Drug

    Benmelstobart 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.

Treatment groups

412 Participants
are divided into 2 treatment groups
Group A: anlotinib hydrochloride ArmExperimental treatment 5 interventions
Group B: PD-L1+Chemoradiation ArmActive 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 year

Secondary outcomes

1

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 62 weeks
2

Overall survival (OS)

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

Time frame
3 years
3

Distant metastasis-free survival (DMFS)

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

Time frame
3 years
4

Locoregional recurrence-free survival (LRRFS)

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

Time frame
3 years

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
3

Evaluate failure-free survival in the subgroup of clinical stage

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: