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NOT YET RECRUITING
NCT07320963
PHASE1/PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Single-Arm, Phase Ib/II Clinical Trial of Chidamide in Combination With Toripalimab and Anlotinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Failed at Least One Prior Line of Therapy

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-03-31

Completion Date

2028-03-28

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

Chidamide

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.

BIOLOGICAL

Toripalimab

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.

DRUG

Anlotinib

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.