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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC

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)

Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC (NCT06177301) is a Phase 3 interventional studying Nasopharyngeal Carcinoma, sponsored by Fudan University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Nasopharyngeal Carcinoma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 266 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Nasopharyngeal Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Histological or cytological examination confirmed recurrence or metastasis of nasopharyngeal carcinoma; 2. 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). 3. Age: 18-75 years old, male or female; 4. Perfomance Status: 0\~1; 5. 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); 6. Blood routine examination: 1) Hemoglobin (HB)≥ 90g / L; 2) Neutrophil count (ANC) ≥ 1.5 × 109 / L; 3) platelets (PLT) ≥ 80 × 109 / L; 7. 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 ; 8. Coagulation function : APTT and international normalized ratio (INR)\< 1.5 × UNL; 9. 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. 10. Patients agree to provide pathological tissue specimens (wax blocks or paraffin tissue sections 5-10 pieces) ; 11. Expected survival ≥ 3 months; 12. Patients volunteered to participate in this study and signed willing to sign a consent form; Who Should NOT Join This Trial: 1. Patients with local recurrence and suitable for surgery or radiotherapy; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Histological or cytological examination confirmed recurrence or metastasis of nasopharyngeal carcinoma; 2. 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). 3. Age: 18-75 years old, male or female; 4. Perfomance Status: 0\~1; 5. 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); 6. Blood routine examination: 1) Hemoglobin (HB)≥ 90g / L; 2) Neutrophil count (ANC) ≥ 1.5 × 109 / L; 3) platelets (PLT) ≥ 80 × 109 / L; 7. 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 ; 8. Coagulation function : APTT and international normalized ratio (INR)\< 1.5 × UNL; 9. 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. 10. Patients agree to provide pathological tissue specimens (wax blocks or paraffin tissue sections 5-10 pieces) ; 11. Expected survival ≥ 3 months; 12. Patients volunteered to participate in this study and signed informed consent; Exclusion Criteria: 1. Patients with local recurrence and suitable for surgery or radiotherapy; 2. Patients with a known history of severe allergies to monoclonal antibody therapy; 3. Patients who had previously received PD-1 monoclonal antibody or PD-L1 monoclonal antibody or CTLA4 monoclonal antibody; 4. 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; 5. 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; 6. 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) ; 7. 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; 8. Severe active infection; 9. Symptomatic patients with central nervous system metastasis; 10. Patients with a history of other malignant tumors (unless those who have been cured for more than 5 years); 11. Have a serious history of neurological or psychiatric disorders, including dementia or epilepsy; 12. 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; 13. Researchers believe that patients who are not suitable for enrollment.

Treatments Being Tested

DRUG

Tislelizumab combined with GX

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.

DRUG

Tislelizumab combined with GP

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06177301), the sponsor (Fudan University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06177301 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06177301?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06177301?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06177301. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06177301. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.