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New triple therapy offers hope for hard-to-treat nose and throat cancer

NCT ID NCT07320963

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of three drugs (chidamide, toripalimab, and anlotinib) in 52 adults with recurrent or metastatic nasopharyngeal carcinoma that has failed at least one prior treatment. The goal is to find the safest dose and see how many patients' tumors shrink. Participants must be 18-70 years old and in good general health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- 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). 3\. 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. 6\. 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. Exclusion Criteria: 1. Known severe hypersensitivity (≥Grade 3) to any monoclonal/polyclonal antibody, chidamide, or anlotinib components. 2. Necrotic lesions identified within 4 weeks prior to enrollment, with investigator-judged risk of major bleeding. 3. 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. 4. Palliative radiotherapy to localized lesions within 4 weeks prior to enrollment, unless the lesion is non-target and other measurable target lesions exist. 5. Grade ≥3 irAEs during prior immunotherapy. 6. Prior treatment with HDAC inhibitors or anti-angiogenic agents. 7. Urine protein ≥2+ or 24-hour urinary protein ≥1 g. 8. Systolic BP \>140 mmHg or diastolic BP \>90 mmHg despite treatment. 9. 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. 10. Symptomatic CNS metastases (e.g., edema, steroid requirement) or leptomeningeal disease. 11. 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. 12. 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. 13. Ongoing anti-tuberculosis therapy or treatment within 1 year prior to screening. 14. Conditions requiring long-term immunosuppressive therapy or systemic corticosteroids at immunosuppressive doses. 15. Severe Cardiac Disease or Significant Cardiac Symptoms. 16. Other Circumstances Deemed Unsuitable by the Investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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