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

NCT07320963 | Not Yet Recruiting Phase 1

• 1 other identifier: CSIIT-Q113
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

HDACi; PD-1 antibody; NPC; chidamide; anti-angiogenesis

Outcome Measures

Primary Outcomes (2)

• MTD

  2 years

• Objective Response Rate (ORR)

  2 years

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  2 years

• Duration of response (DoR)

  2 years

• Overall Survival (OS)

  2 years

Study Arms (1)

Chidamide , Toripalimab and Anlotinib

EXPERIMENTAL

Drug: Chidamide; Biological: Toripalimab; Drug: Anlotinib

Interventions

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.

Chidamide , Toripalimab and Anlotinib

Toripalimab BIOLOGICAL

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.

Chidamide , Toripalimab and Anlotinib

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.

Chidamide , Toripalimab and Anlotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Age: ≥18 years and ≤70 years, gender unrestricted. 2. Diagnosis: Histologically/pathologically confirmed metastatic nasopharyngeal carcinoma (NPC) that has failed at least one prior line of therapy (including cisplatin-containing regimens) or is intolerant to existing therapies (relapse within 6 months after completion of adjuvant/neoadjuvant concurrent chemoradiotherapy is eligible).
• \. Performance Status: ECOG performance status 0-1. Measurable Disease: At least one measurable lesion per RECIST 1.1 criteria. 4. Prior Immunotherapy:
• Patients who have received PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors, or other therapies targeting T-cell co-stimulation/checkpoint pathways:
• Must have achieved complete response (CR), partial response (PR), or stable disease (SD) ≥6 months during treatment.
• Only one prior immunotherapy regimen is allowed (e.g., neoadjuvant and adjuvant regimens using the same immunotherapy are considered one regimen).
• Switching to a different immunotherapy regimen for non-immunotherapy-related progression is permissible if cumulative SD duration ≥6 months.
• \. Organ Function:
• Hematology:
• ANC ≥1.5×10⁹/L, PLT ≥75×10⁹/L, Hb ≥90 g/L. No blood product transfusion or growth factor support (e.g., G-CSF, EPO) within 2 weeks prior to screening.
• Hepatology:
• TBIL ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases present).
• Renal Function:
• Serum Cr ≤1.5×ULN or CrCl \>60 mL/min.
• Thyroid Function:
• TSH, FT4, FT3 within CTC AE Grade 0-1. 7. Survival Expectancy: ≥3 months. 8. Informed Consent: Voluntary participation and signed written informed consent.

You may not qualify if:

• 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.
• Washout period determined by clinical resolution of adverse events (AEs) and prior treatment regimens.
• Palliative radiotherapy to localized lesions within 4 weeks prior to enrollment, unless the lesion is non-target and other measurable target lesions exist.
• Grade ≥3 irAEs during prior immunotherapy.
• Prior treatment with HDAC inhibitors or anti-angiogenic agents.
• Urine protein ≥2+ or 24-hour urinary protein ≥1 g.
• Systolic BP \>140 mmHg or diastolic BP \>90 mmHg despite treatment.
• Persistent toxicity from prior antitumor therapy (per NCI CTCAE v5.0) \>Grade 1, excluding: alopecia, Grade 2 fatigue, Grade 2 anemia, or asymptomatic lab abnormalities.
• Symptomatic CNS metastases (e.g., edema, steroid requirement) or leptomeningeal disease.
• Systemic immunosuppressive drugs (excluding topical/inhaled corticosteroids or physiological doses ≤10 mg/day prednisone equivalent) or corticosteroids for contrast allergy within 4 weeks prior to enrollment.
• Active autoimmune diseases (e.g., interstitial pneumonia, colitis, thyroiditis) or history of severe autoimmune conditions requiring systemic therapy.
• Exceptions: Vitiligo, childhood asthma (resolved without treatment), or mild asthma managed without bronchodilators.
• Ongoing anti-tuberculosis therapy or treatment within 1 year prior to screening.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fujian Cancer Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; toripalimab; anlotinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Huiqiang Huang

CONTACT

020-87343350; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 6, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share