Nasopharyngeal Carcinoma (NPC)Phase 2NCT06987123
TC as Adjuvant Therapy After Surgery for Locally Recurrent Resectable Nasopharyngeal Carcinoma: a Single-arm Clinical Trial
A Phase 2 study testing Toripalimab, Capecitabine and salvage surgery in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University.
Trial summary
Regarding the application value of capecitabine metronome chemotherapy's regulatory effect on the immune microenvironment in nasopharyngeal carcinoma, many studies in recent years have confirmed that metronome chemotherapy and immunotherapy are safe and effective in resectable recurrent nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Toripalimab, Capecitabine and salvage surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2025to 1 Jun 2029
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed as locally recurrent nasopharyngeal carcinoma, according to the TNM staging of recurrent nasopharyngeal carcinoma (AJCC, 8th Edition, 2018), resectable nasopharyngeal diseases: rT1 (the tumor is confined to the nasopharynx, oropharynx and/or nasal cavity, and does not involve the parapharynx); rT2 (The tumor is confined to the superficial septum beside the pharynx, more than 0.5 cm away from the internal carotid artery) and rT3 (the tumor is confined to the basal wall of the sphenoid sinus, more than 0.5 cm away from the internal carotid artery and the cavernous sinus); Resectable recurrent regional lymph nodes (rN1-3), without involvement of the anterior vertebral fascia, cervical vertebrae or common carotid artery/internal carotid artery.
- It has been more than 6 months since the last radiotherapy
- Age: 18-70 years old, gender not limited;
- ECOG score: 0-1 point;
- The functions of the major organs are normal, that is, the following standards are met; (1) The blood routine examination standards must meet (no blood transfusion or blood products within 14 days) : a. HB≥90 g/L; b. ANC≥1.5×109/L; c. PLT≥80×109/L; (2) Biochemical tests must meet the following standards: a. TBIL<1.5× upper normal limit (ULN); b. ALT and AST<2.5×ULN; c. Serum Cr≤1.5×ULN or endogenous creatinine clearance rate > 45 ml/min;
- Women of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study (e.g Intrauterine devices, contraceptive pills or condoms; The serum or urine pregnancy test must be negative within 7 days before enrollment in the study, and the patient must be a non-lactating patient. Male patients who should agree that contraceptive measures must be adopted during the study period and within 6 months after the end of the study period;
- Sign the informed consent form and voluntarily participate in the clinical trial research project.
Who cannot join
- The tumor broke through the dura mater at the base of the skull and severely involved the brain parenchyma, with distant metastasis and obvious complications, and the patient could not be under general anesthesia.
- Patients with tumor recurrence or residual after re-radiotherapy.
- The patient has any active autoimmune diseases or a history of autoimmune diseases (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; Vitiligo Asthma that requires medical intervention with bronchodilators;
- Patients who are currently undergoing immunosuppressive therapy with immunosuppressants or systemic hormones to achieve the purpose of immunosuppression (dose >10mg/ day prednisone or other therapeutic hormones) and are still continuing to use them within 2 weeks before enrollment;
- Have received immunotherapy within the past six months;
- Patients with any severe and/or uncontrollable diseases, including: those with unsatisfactory blood pressure control (systolic) Patients with blood pressure >=160mmHg or diastolic blood pressure >=100 mmHg; Suffering from grade II or above myocardial ischemia or myocardial infarction, arrhythmia (including QT interval >=480ms), and grade II cardiac insufficiency; Active or uncontrolled severe infection; Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA>=104 copy number /ml or 2000IU/ml) or hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method);
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- Pregnant or lactating women; Patients with other malignant tumors within 8.5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ);
- Those with a history of abuse of psychotropic drugs and who are unable to quit or those with mental disorders;
- Patients who have participated in clinical trials of other similar drugs within three months;
- According to the researcher's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study;
- Those that the researchers consider unsuitable for inclusion.
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: Toripalimab in Combination With Capecitabine as Adjuvant Therapy After Surgery for Locally Recurrent Resectable Nasopharyngeal Carcinoma: a Single-arm Clinical Trial
Regarding the application value of capecitabine metronome chemotherapy's regulatory effect on the immune microenvironment in nasopharyngeal carcinoma, many studies in recent years have confirmed that metronome chemotherapy and immunotherapy are safe and effective in resectable recurrent nasopharyngeal carcinoma. Therefore, the investigators plan to conduct a "single-arm clinical study on adjuvant therapy of toripalimab combined with capecitabine after Surgery for locally recurrent resectable nasopharyngeal carcinoma" to explore the efficacy and safety of toripalimab combined with capecitabine as adjuvant therapy after salvage surgery for resectable recurrent nasopharyngeal carcinoma. If this study is confirmed, it is expected to provide a new treatment model for patients with resectable recurrent nasopharyngeal carcinoma.
Read the detailed description
Regarding the application value of capecitabine metronome chemotherapy's regulatory effect on the immune microenvironment in nasopharyngeal carcinoma, many studies in recent years have confirmed that metronome chemotherapy and immunotherapy are safe and effective in resectable recurrent nasopharyngeal carcinoma. Therefore, the investigators plan to conduct a "single-arm clinical study on adjuvant therapy of toripalimab combined with capecitabine after Surgery for locally recurrent resectable nasopharyngeal carcinoma" to explore the efficacy and safety of toripalimab combined with capecitabine as adjuvant therapy after salvage surgery for resectable recurrent nasopharyngeal carcinoma. If this study is confirmed, it is expected to provide a new treatment model for patients with resectable recurrent nasopharyngeal carcinoma.The diagnosis was pathologically confirmed as locally recurrent nasopharyngeal carcinoma. According to the TNM staging of recurrent nasopharyngeal carcinoma (AJCC, 8th Edition, 2018), resectable nasopharyngeal diseases: rT1 (the tumor was confined to the nasopharynx, oropharynx and/or nasal cavity, and did not involve the parapharynx); rT2 (The tumor is confined to the superficial septum beside the pharynx, more than 0.5 cm away from the internal carotid artery) and rT3 (the tumor is confined to the basal wall of the sphenoid sinus, more than 0.5 cm away from the internal carotid artery and the cavernous sinus); Resectable recurrent regional lymph nodes (rN1-3), without involvement of the anterior vertebral fascia, cervical vertebrae or common carotid artery/internal carotid artery.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Toripalimab, Capecitabine, salvage surgery
- Keywords
- recurrent nasopharyngeal carcinoma, salvage surgery, Toripalimab, capecitabine
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab 240 mg, administered on the first day, Q3W × 17 cycles
CapecitabineDrug
Capecitabine 650 mg/m2 twice a day, oral administration, d1-21, Q3W × 17 cycles
salvage surgeryProcedure or surgery
The specific steps of high-frequency electrosurgical knife treatment for localized recurrent nasopharyngeal carcinoma are as follows:
- It must be performed under general anesthesia, with the complete resection of the nasopharyngeal tumor and its sufficient safe boundary through both nasal cavities under the guidance of nasal endoscopy. When marking the surgical margin, the anterior margin should reach 1-2cm in front of the posterior column of the nasal septum, and the upper margin can reach about 0.5-1cm to the upper margin of the posterior nostril. The lateral and lower margins are designed individually based on the size and location of the tumor. The basic principle is to ensure a safe margin of 0.5-1.0cm, and then use low-temperature plasma ablation. Ablate the tumor tissue and the normal tissue at the resection margin layer by layer from the upper resection margin to the lower resection margin until no obvious tumor residue was observed with the naked eye.
- Rinse the surgical c
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Toripalimab in combination with capecitabine as adjuvant therapy after surgery for locally recurrent resectable nasopharyngeal carcinoma Receives: Drug: Toripalimab; Drug: Capecitabine; Procedure: salvage surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival
2-year progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start18 May 2025 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiJun Hua, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987123
- Sponsor's protocol ID
- 2024-FXY-459-NPC
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers who has been approveed can share.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab in Combination With Capecitabine as Adjuvant Therapy After Surgery for Locally Recurrent Resectable Nasopharyngeal Carcinoma: a Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06987123
- Acronym / sponsor ID
- 2024-FXY-459-NPC
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- recurrent nasopharyngeal carcinoma, salvage surgery, Toripalimab, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 May 2025 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 23 May 2025 (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.
Regarding the application value of capecitabine metronome chemotherapy's regulatory effect on the immune microenvironment in nasopharyngeal carcinoma, many studies in recent years have confirmed that metronome chemotherapy and immunotherapy are safe and effective in resectable recurrent nasopharyngeal carcinoma. Therefore, the investigators plan to conduct a "single-arm clinical study on adjuvant therapy of toripalimab combined with capecitabine after Surgery for locally recurrent resectable nasopharyngeal carcinoma" to explore the efficacy and safety of toripalimab combined with capecitabine as adjuvant therapy after salvage surgery for resectable recurrent nasopharyngeal carcinoma. If this study is confirmed, it is expected to provide a new treatment model for patients with resectable recurrent nasopharyngeal carcinoma.
Detailed description
Regarding the application value of capecitabine metronome chemotherapy's regulatory effect on the immune microenvironment in nasopharyngeal carcinoma, many studies in recent years have confirmed that metronome chemotherapy and immunotherapy are safe and effective in resectable recurrent nasopharyngeal carcinoma. Therefore, the investigators plan to conduct a "single-arm clinical study on adjuvant therapy of toripalimab combined with capecitabine after Surgery for locally recurrent resectable nasopharyngeal carcinoma" to explore the efficacy and safety of toripalimab combined with capecitabine as adjuvant therapy after salvage surgery for resectable recurrent nasopharyngeal carcinoma. If this study is confirmed, it is expected to provide a new treatment model for patients with resectable recurrent nasopharyngeal carcinoma.The diagnosis was pathologically confirmed as locally recurrent nasopharyngeal carcinoma. According to the TNM staging of recurrent nasopharyngeal carcinoma (AJCC, 8th Edition, 2018), resectable nasopharyngeal diseases: rT1 (the tumor was confined to the nasopharynx, oropharynx and/or nasal cavity, and did not involve the parapharynx); rT2 (The tumor is confined to the superficial septum beside the pharynx, more than 0.5 cm away from the internal carotid artery) and rT3 (the tumor is confined to the basal wall of the sphenoid sinus, more than 0.5 cm away from the internal carotid artery and the cavernous sinus); Resectable recurrent regional lymph nodes (rN1-3), without involvement of the anterior vertebral fascia, cervical vertebrae or common carotid artery/internal carotid artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Toripalimab, Drug: Capecitabine, Procedure: salvage surgeryToripalimab in combination with capecitabine as adjuvant therapy after surgery for locally recurrent resectable nasopharyngeal carcinoma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed as locally recurrent nasopharyngeal carcinoma, according to the TNM staging of recurrent nasopharyngeal carcinoma (AJCC, 8th Edition, 2018), resectable nasopharyngeal diseases: rT1 (the tumor is confined to the nasopharynx, oropharynx and/or nasal cavity, and does not involve the parapharynx); rT2 (The tumor is confined to the superficial septum beside the pharynx, more than 0.5 cm away from the internal carotid artery) and rT3 (the tumor is confined to the basal wall of the sphenoid sinus, more than 0.5 cm away from the internal carotid artery and the cavernous sinus); Resectable recurrent regional lymph nodes (rN1-3), without involvement of the anterior vertebral fascia, cervical vertebrae or common carotid artery/internal carotid artery.
- It has been more than 6 months since the last radiotherapy
- Age: 18-70 years old, gender not limited;
- ECOG score: 0-1 point;
- The functions of the major organs are normal, that is, the following standards are met; (1) The blood routine examination standards must meet (no blood transfusion or blood products within 14 days) : a. HB≥90 g/L; b. ANC≥1.5×109/L; c. PLT≥80×109/L; (2) Biochemical tests must meet the following standards: a. TBIL<1.5× upper normal limit (ULN); b. ALT and AST<2.5×ULN; c. Serum Cr≤1.5×ULN or endogenous creatinine clearance rate > 45 ml/min;
Key exclusion criteria (11 listed)
- The tumor broke through the dura mater at the base of the skull and severely involved the brain parenchyma, with distant metastasis and obvious complications, and the patient could not be under general anesthesia.
- Patients with tumor recurrence or residual after re-radiotherapy.
- The patient has any active autoimmune diseases or a history of autoimmune diseases (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; Vitiligo Asthma that requires medical intervention with bronchodilators;
- Patients who are currently undergoing immunosuppressive therapy with immunosuppressants or systemic hormones to achieve the purpose of immunosuppression (dose >10mg/ day prednisone or other therapeutic hormones) and are still continuing to use them within 2 weeks before enrollment;
- Have received immunotherapy within the past six months;
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 |
|---|---|---|
| ToripalimabToripalimab 240 mg, administered on the first day, Q3W × 17 cycles | Drug | Experimental group |
| CapecitabineCapecitabine 650 mg/m2 twice a day, oral administration, d1-21, Q3W × 17 cycles | Drug | Experimental group |
| salvage surgeryThe specific steps of high-frequency electrosurgical knife treatment for localized recurrent nasopharyngeal carcinoma are as follows: 1. It must be performed under general anesthesia, with the complete resection of the nasopharyngeal tumor and its sufficient safe boundary through both nasal cavities under the guidance of nasal endoscopy. When marking the surgical margin, the anterior margin should reach 1-2cm in front of the posterior column of the nasal septum, and the upper margin can reach about 0.5-1cm to the upper margin of the posterior nostril. The lateral and lower margins are designed individually based on the size and location of the tumor. The basic principle is to ensure a safe margin of 0.5-1.0cm, and then use low-temperature plasma ablation. Ablate the tumor tissue and the normal tissue at the resection margin layer by layer from the upper resection margin to the lower resection margin until no obvious tumor residue was observed with the naked eye. 2. Rinse the surgical c | Procedure or surgery | Experimental group |
Primary outcome
2-year progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
2-year progression-free survival
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 23 May 2025.
- Individual participant dataSharing planned: No. Researchers who has been approveed can share.
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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 2 study testing Toripalimab, Capecitabine and salvage surgery in people with Nasopharyngeal Carcinoma (NPC), 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 7 inclusion and 11 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 23 May 2025. 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 phase mean?
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 Yi-Jun Hua (18820019088, huayj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.). 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 23 May 2025.