Nasopharyngeal CarcinomaPhase 3NCT06177301
Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC
A Phase 3 study testing Tislelizumab combined with GX and Tislelizumab combined with GP in people with Nasopharyngeal Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety and efficacy of tislelizumab combined with GX regimen versus tislelizumab combined with GP regimen in the first-line treatment of nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Tislelizumab combined with GX and Tislelizumab combined with GP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to Dec 2027
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological examination confirmed recurrence or metastasis of nasopharyngeal carcinoma;
- Patients who have not previously received systemic treatment for recurrent or metastatic diseases (For patients who have previously received induction chemotherapy, adjuvant chemotherapy or concurrent chemoradiotherapy, patients who relapsed at least 6 months after the cessation of chemotherapy can be enrolled).
- Age: 18-75 years old, male or female;
- Perfomance Status: 0~1;
- At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress);
- Blood routine examination: 1) Hemoglobin (HB)≥ 90g / L; 2) Neutrophil count (ANC) ≥ 1.5 × 109 / L; 3) platelets (PLT) ≥ 80 × 109 / L;
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- Liver function: 1) Serum total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT), aspartate aminotransferase (AST])< 2.5 × ULN; if liver metastasis, ALT and AST ≤ 5 × ULN; Renal function: Albumin ≥ 28g / L ；Serum creatinine (Cr) ≤ 1.5 × ULN，or creatinine clearance rate ≥ 60 ml / min ;
- Coagulation function : APTT and international normalized ratio (INR)< 1.5 × UNL;
- Patients of childbearing age agree to take appropriate contraceptive measures. Serum pregnancy test was negative in women of childbearing age within 2 weeks before enrollment.
- Patients agree to provide pathological tissue specimens (wax blocks or paraffin tissue sections 5-10 pieces) ;
- Expected survival ≥ 3 months;
- Patients volunteered to participate in this study and signed informed consent;
Who cannot join
- Patients with local recurrence and suitable for surgery or radiotherapy;
- Patients with a known history of severe allergies to monoclonal antibody therapy;
- Patients who had previously received PD-1 monoclonal antibody or PD-L1 monoclonal antibody or CTLA4 monoclonal antibody;
- Clinical significance of heart disease, including severe cardiac insufficiency : New York Heart Association (NYHA) cardiac insufficiency grade IV, unstable angina, acute myocardial infarction within 6 months before screening, congestive heart failure, Q-Tc interval greater than 500ms;
- Patients with autoimmune diseases requiring treatment, or patients with a history of systemic use of steroids / immunosuppressive agents, such as : hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism;
- Other serious and uncontrollable concomitant diseases that may affect the compliance of the program or interfere with the interpretation of the results, including uncontrolled diabetes, or lung diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchial spasm) ;
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- Known hepatitis B (HBV) (HBsAg positive and HBV-DNA ≥ 103IU / ml), hepatitis C ( HCV) infection (HCV antibody positive and HCV-RNA measurable) ; and other subjects with acquired and congenital immunodeficiency diseases, including, but not limited to, those infected with HIV;
- Severe active infection;
- Symptomatic patients with central nervous system metastasis;
- Patients with a history of other malignant tumors (unless those who have been cured for more than 5 years);
- Have a serious history of neurological or psychiatric disorders, including dementia or epilepsy;
- Drug abuse, medical, psychological or social conditions that may interfere with the participant 's participation in the study or the evaluation of the study results;
- Researchers believe that patients who are not suitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dongmei Ji, M.D, +8602164175590 ext. 88900, jidongmei2000@126.com
About this study
Official title: A Phase III Clinical Study of Tislelizumab Combined With GX Regimen Versus Tislelizumab Combined With GP Regimen in the First-line Treatment of Recurrence or Metastasis (R/M) Nasopharyngeal Carcinoma (NPC)
The study is being conducted to evaluate the safety and efficacy of tislelizumab combined with GX regimen versus tislelizumab combined with GP regimen in the first-line treatment of nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Tislelizumab combined with GX, Tislelizumab combined with GP
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab combined with GXDrug
Tislelizumab：200mg vgtt，q3w；treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.
Gemcitabine：1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid，po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.
Tislelizumab combined with GPDrug
Tislelizumab: 200mg vgtt，q3w；treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.
Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles； Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w，repeat 4 ~ 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with GX | Experimental | Patients will receive tislelizumab combined with GX regimen： Tislelizumab：200mg vgtt，q3w；treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.
Gemcitabine：1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid，po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Receives: Drug: Tislelizumab combined with GX |
| Tislelizumab combined with GP | Experimental | Patients will receive tislelizumab combined with GX regimen： Tislelizumab: 200mg vgtt，q3w；treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.
Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles； Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w，repeat 4 ~ 6 cycles. Receives: Drug: Tislelizumab combined with GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the progression-free survival of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECIST v1.1.
Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Measured: up to approximately 3 years
Secondary outcomes (1)
To compare the objective response rate of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECISTv1.1.
Complete remission rate+ partial remission rate
Measured: up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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 Fudan 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Dongmei, Fudan University
- Investigators
- Dongmei Ji, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177301
- Sponsor's protocol ID
- FUSCC-NC-001
- Status last verified
- Aug 2025
- First submitted
- 11 Dec 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study of Tislelizumab Combined With GX Regimen Versus Tislelizumab Combined With GP Regimen in the First-line Treatment of Recurrence or Metastasis (R/M) Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT06177301
- Acronym / sponsor ID
- FUSCC-NC-001
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Dec 2023 (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.
The study is being conducted to evaluate the safety and efficacy of tislelizumab combined with GX regimen versus tislelizumab combined with GP regimen in the first-line treatment of nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with GX | Experimental | Drug: Tislelizumab combined with GXPatients will receive tislelizumab combined with GX regimen： Tislelizumab：200mg vgtt，q3w；treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine：1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid，po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. |
| Tislelizumab combined with GP | Experimental | Drug: Tislelizumab combined with GPPatients will receive tislelizumab combined with GX regimen： Tislelizumab: 200mg vgtt，q3w；treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles； Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w，repeat 4 ~ 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological or cytological examination confirmed recurrence or metastasis of nasopharyngeal carcinoma;
- Patients who have not previously received systemic treatment for recurrent or metastatic diseases (For patients who have previously received induction chemotherapy, adjuvant chemotherapy or concurrent chemoradiotherapy, patients who relapsed at least 6 months after the cessation of chemotherapy can be enrolled).
- Age: 18-75 years old, male or female;
- Perfomance Status: 0~1;
- At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress);
Key exclusion criteria (13 listed)
- Patients with local recurrence and suitable for surgery or radiotherapy;
- Patients with a known history of severe allergies to monoclonal antibody therapy;
- Patients who had previously received PD-1 monoclonal antibody or PD-L1 monoclonal antibody or CTLA4 monoclonal antibody;
- Clinical significance of heart disease, including severe cardiac insufficiency : New York Heart Association (NYHA) cardiac insufficiency grade IV, unstable angina, acute myocardial infarction within 6 months before screening, congestive heart failure, Q-Tc interval greater than 500ms;
- Patients with autoimmune diseases requiring treatment, or patients with a history of systemic use of steroids / immunosuppressive agents, such as : hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism;
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 |
|---|---|---|
| Tislelizumab combined with GXTislelizumab：200mg vgtt，q3w；treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine：1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid，po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. | Drug | Tislelizumab combined with GX |
| Tislelizumab combined with GPTislelizumab: 200mg vgtt，q3w；treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles； Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w，repeat 4 ~ 6 cycles. | Drug | Tislelizumab combined with GP |
Primary outcome
To compare the progression-free survival of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECIST v1.1.
Time frame: up to approximately 3 years
Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
1 secondary outcome
To compare the objective response rate of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECISTv1.1.
Time frame: up to approximately 3 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 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Dongmei Ji, M.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab combined with GX and Tislelizumab combined with GP in people with Nasopharyngeal Carcinoma, run by Fudan University at 1 site in China.
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 12 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dongmei Ji, M.D (021-64175590 ext. 83650, jidongmei2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the progression-free survival of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECIST v1.1. (time frame: up to approximately 3 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 14 Aug 2025.