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Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma.

ConditionNasopharyngeal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

To explore and evaluate the dose-limiting toxicity (DLT) profile of the fixed-dose combination of toripalimab, anlotinib, and chidamide in patients with recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), and to determine the maximum tolerated dose (MTD) of chidamide, thereby informing subsequent clinical dosing regimens.

To assess the objective response rate (ORR) of the combination regimen in this patient population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Known severe hypersensitivity (≥Grade 3) to any monoclonal/polyclonal antibody, chidamide, or anlotinib components.

Necrotic lesions identified within 4 weeks prior to enrollment, with investigator-judged risk of major bleeding.

Chemotherapy, targeted therapy, or immunomodulatory agents (including thymosin, interferon, IL-2, etc.) within 2 weeks prior to enrollment.

Palliative radiotherapy to localized lesions within 4 weeks prior to enrollment, unless the lesion is non-target and other measurable target lesions exist.

Trial design

Design model

Single group

Treatments tested in this trial

  • Chidamide

    Drug

    Phase Ib: Dose selection based on study progression (15 mg, 20 mg, or 30 mg). Phase II: PR2D Timing: Orally 30 minutes after dinner, twice weekly (e.g., Days 1, 4, 8, 11, 15, 18 of each 3-week cycle), with ≥3 days between doses. Duration: Until disease progression or unacceptable toxicity, up to 24 months.

  • Toripalimab

    Biological/Vaccine

    Fixed Dose: 240 mg per infusion. Timing: Intravenous infusion over 30 minutes on Day 1 of each 3-week cycle. Duration: Until disease progression or unacceptable toxicity, up to 24 months.

  • Anlotinib

    Drug

    Timing: Orally once daily before breakfast, Days 1-14 of each 3-week cycle. Duration: Until disease progression or unacceptable toxicity, up to 24 months.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Chidamide , Toripalimab and AnlotinibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

MTD

Time frame
2 years
2

Objective Response Rate (ORR)

Time frame
2 years

Secondary outcomes

1

Progression-Free Survival (PFS)

Time frame
2 years
2

Duration of response (DoR)

Time frame
2 years
3

Overall Survival (OS)

Time frame
2 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

Fujian Cancer Hospital

Collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

Source ClinicalTrials.gov

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