Actively Recruiting
LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC
Led by Sun Yat-sen University · Updated on 2026-05-01
55
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.
CONDITIONS
Official Title
LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II or III)
- ECOG Performance Status score of 0 or 1
- At least one measurable lesion according to RECIST v1.1 criteria
- Newly diagnosed metastatic NPC, or locoregionally advanced NPC with metastasis 6 months or recurrence 12 months after radical radiotherapy/chemotherapy
- No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent/metastatic lesions
- Adequate organ function based on blood counts, liver and kidney tests, coagulation, heart function, and thyroid function within 7 days before treatment
- Women of childbearing potential must use reliable contraception and have a negative pregnancy test within 7 days before enrollment; men must agree to use contraception or be surgically sterile
- Voluntary signed informed consent and good compliance
You will not qualify if you...
- Disease progression within 6 months after standard treatment for locoregionally advanced nasopharyngeal carcinoma
- No identifiable tumor lesions in primary site and regional lymph nodes preventing LDRT planning
- Inability to undergo MRI due to metal implants or claustrophobia
- Use of systemic corticosteroids (>10 mg prednisone equivalent daily) or immunosuppressants within 14 days prior to first dose or during study (with some exceptions)
- Recurrent lesions suitable for curative surgery or second radiotherapy
- History of active autoimmune disease or organ transplantation (some exceptions apply)
- Active or uncontrolled severe infection within 4 weeks prior to enrollment
- Active tuberculosis within past year without adequate treatment
- Uncontrolled hypertension (systolic 150 mmHg or diastolic 9 mmHg) despite medication
- Significant bleeding disorders or high bleeding risk within 1 year post-radiotherapy
- Urine protein 1.0 g/24h confirmed
- Recent serious heart conditions or low heart function
- Other malignancies within 5 years except certain cured cancers
- Central nervous system metastases
- Certain infectious diseases requiring treatment
- Participation in another anti-tumor drug trial within 4 weeks
- Live attenuated vaccine within 30 days prior
- Contraindications to radiotherapy
- Known allergy or severe reaction to study drugs or monoclonal antibodies
- History of drug abuse or psychiatric disorders
- Any condition posing safety or compliance risk as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jun Ma, M.D.
CONTACT
Z
Zhe Li, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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