Toripalimab with three platinum-based induction chemotherapies for locally advanced nasopharyngeal carcinoma

Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma: A Randomized, Open-label, Controlled, Multicenter Phase II Trial

This trial tests whether adding toripalimab to one of three different platinum-based induction chemotherapy regimens before standard concurrent chemoradiotherapy can improve outcomes for adults with locally advanced nasopharyngeal carcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, Toripalimab
• Locations: 4 sites (Dongguan, Guangdong and 3 other locations)
• Trial ID: NCT07362979 on ClinicalTrials.gov

What this trial studies

This randomized Phase II trial enrolls adults with locally advanced, non-keratinizing nasopharyngeal carcinoma (AJCC 9th edition: any T with N2-3 or T4N1, M0) and assigns them 1:1:1 to receive one of three induction regimens combined with toripalimab: gemcitabine plus cisplatin, nab-paclitaxel plus cisplatin, or nab-paclitaxel plus cisplatin plus capecitabine. After induction therapy patients proceed to standard concurrent chemoradiotherapy. The study compares efficacy and safety across the three arms to identify which induction combination plus toripalimab offers the greatest survival benefit. Key eligibility includes age 18–70, ECOG 0–1, and adequate blood, liver, and kidney function.

Who should consider this trial

Good fit: Adults aged 18–70 with pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III), stage any T with N2-3 or T4N1 (M0), ECOG 0–1, and adequate organ function are ideal candidates.

Not a fit: Patients with distant metastases, poor performance status (ECOG ≥2), non-eligible histologies, significant organ dysfunction, pregnancy, or those outside the age range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the trial could identify the most effective induction chemo regimen to combine with toripalimab and thereby improve survival and response rates for patients with locally advanced NPC.

How similar studies have performed: Combinations of PD-1 inhibitors with chemotherapy have shown promising activity in nasopharyngeal carcinoma in prior trials, so this trial builds on emerging evidence rather than testing a wholly novel concept.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 70 years, male or non-pregnant female.
2. Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
3. Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).
4. ECOG performance status score of 0 or 1.
5. Adequate hematological function: Hemoglobin (HGB)≥90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5\*10\^9/L, and Platele (PLT) ≥100\*10\^9/L.
6. Adequate hepatic function: ALT and AST≤2.5\*Upper Limit of Normal (ULN), total bilirubin ≤2.0\*ULN, and serum albumin≥30g/L.
7. Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
8. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).

Exclusion Criteria:

1. Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.
2. Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
3. Prior history of radiotherapy or systemic chemotherapy.
4. Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.
5. HIV-positive status.
6. History of other malignancies (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
7. Patients previously treated with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
8. Patients with immunodeficiency diseases or a history of organ transplantation.
9. Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior.
10. Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
11. Concurrent use of other investigational drugs or current participation in another clinical trial.
12. Patients who refuse or are unable to provide signed informed consent for trial participation.
13. Patients with personality or psychiatric disorders, or those lacking legal capacity or with limited legal capacity.
14. Hepatitis B surface antigen (HBsAg) positive with peripheral blood Hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 copies/ml.
15. Patients with positive Hepatitis C virus (HCV) antibody test results are eligible only if the HCV ribonucleic acid (RNA) polymerase chain reaction test result is negative.
16. Arterial or venous thrombotic events within 6 months prior to screening initiation, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
17. Known history of active tuberculosis (TB). Subjects suspected of having active TB must be evaluated and ruled out via chest X-ray, sputum examination, and clinical signs and symptoms.

21.Any other severe, uncontrolled medical condition, infection, or treatment contraindication, or any other condition that, in the investigator's judgment, may pose a risk for receiving the investigational drug, or may interfere with the assessment of the investigational drug, subject safety, or interpretation of the study results.

Where this trial is running

Dongguan, Guangdong and 3 other locations

• Dongguan People's Hospital — Dongguan, Guangdong, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen — Shenzhen, Guangdong, China (Recruiting)
• Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Hai-Qiang Mai, Dr.

Conditions Nasopharyngeal Cancinoma; nasopharyngeal carcinoma; Toripalimab; different platinum-based induction chemotherapy