New triple therapy offers hope for hard-to-treat nose and throat cancer
NCT ID NCT07320963
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Nasopharyngeal carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?
- Can a targeted drug outperform chemotherapy in Tough-to-Treat nasopharyngeal cancer?
- Can an experimental drug shrink advanced solid tumors?
- Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?
- Could adding extra chemo before standard therapy beat nasopharyngeal cancer?
- Smart T-Cell engager aims to outsmart tumors in first human test