Nasopharyngeal CarcinomaPhase 1/2NCT07320963
Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma.
A Phase 1/2 study testing Chidamide, Toripalimab and Anlotinib in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Chidamide, Toripalimab and Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 28 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Conditions requiring long-term immunosuppressive therapy or systemic corticosteroids at immunosuppressive doses.
- Severe Cardiac Disease or Significant Cardiac Symptoms.
- Other Circumstances Deemed Unsuitable by the Investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Chidamide, Toripalimab, Anlotinib
- Keywords
- HDACi, PD-1 antibody, NPC, chidamide, anti-angiogenesis
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
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.
ToripalimabBiological
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.
AnlotinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide , Toripalimab and Anlotinib | Experimental | Not described Receives: Drug: Chidamide; Biological: Toripalimab; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Measured: 2 years
Objective Response Rate (ORR)
Measured: 2 years
Secondary outcomes (3)
Progression-Free Survival (PFS)
Measured: 2 years
Duration of response (DoR)
Measured: 2 years
Overall Survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start31 Mar 2026 (estimated)
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320963
- Sponsor's protocol ID
- CSIIT-Q113
- Status last verified
- Mar 2026
- First submitted
- 2 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07320963
- Acronym / sponsor ID
- CSIIT-Q113
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- HDACi, PD-1 antibody, NPC, chidamide, anti-angiogenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2028 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide , Toripalimab and Anlotinib | Experimental | Drug: Chidamide, Biological: Toripalimab, Drug: Anlotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChidamidePhase 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. | Drug | Chidamide , Toripalimab and Anlotinib |
| ToripalimabFixed 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. | Biological | Chidamide , Toripalimab and Anlotinib |
| AnlotinibTiming: Orally once daily before breakfast, Days 1-14 of each 3-week cycle. Duration: Until disease progression or unacceptable toxicity, up to 24 months. | Drug | Chidamide , Toripalimab and Anlotinib |
Primary outcome
MTD
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 years
Duration of response (DoR)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chidamide, Toripalimab and Anlotinib in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huiqiang Huang (020-87343350, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.