Actively Recruiting
Comparison of Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for Locally Advanced Nasopharyngeal Carcinoma: A Prospective, Phase II, Multicenter, Randomized Controlled Study
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-07-01
208
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for patients with locally advanced nasopharyngeal carcinoma to compare the tumor response and long-term survival outcomes between two cycles and three cycles of induction chemotherapy combined with immunotherapy. This phase II, multicenter, randomized controlled study aims to provide insights into whether fewer cycles of chemotherapy combined with camrelizumab can achieve similar results with potentially fewer side effects. The study compares two treatment groups: one receiving two cycles of induction chemotherapy plus immunotherapy, and the other receiving three cycles of the same regimen. Each cycle lasts 21 days and includes drugs nab-paclitaxel, cisplatin, and oral S1 at doses adjusted by body surface area, along with camrelizumab administered intravenously on day 1 of each cycle. This design follows recent guidelines recommending immunotherapy during induction therapy for this cancer. Participants will undergo evaluations of their tumor response at the end of their assigned cycles. Researchers will also monitor survival outcomes over three years, including progression-free survival and overall survival. Regular assessments will include laboratory tests, imaging to measure tumor response, and monitoring for adverse effects. The total study duration extends through long-term follow-up to assess outcomes and safety.
CONDITIONS
Brief Title
Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Confirmed nasopharyngeal carcinoma with clinical staging T1-4N2-3M0 based on UICC/AJCC TNM system (8th edition)
- No prior systemic treatments such as surgery, radiotherapy, or chemotherapy
- At least one measurable lesion on imaging according to RECIST criteria version 1.1
- ECOG Performance Status of 0 or 1
- Expected survival of at least 3 months
- Use contraception from the first dose until 24 weeks after the last dose if male or a woman of childbearing potential
- Normal function of major organs with acceptable hematology, biochemistry, and coagulation test results
- Investigator believes treatment will provide survival benefit
You will not qualify if you...
- Active, known, or suspected autoimmune disease
- Uncontrolled hypertension despite medication (systolic >160 mmHg or diastolic >90 mmHg)
- History of hereditary bleeding or coagulation disorders, recent significant bleeding within 12 weeks or excessive bleeding in 24 hours
- Poorly controlled cardiac symptoms or diseases
- Interstitial lung disease, drug-induced pneumonia, steroid-treated radiation pneumonitis, active pneumonia with symptoms, or severe lung dysfunction
- Active hepatitis B or C infection above specified viral load thresholds
- Allergy to any study drugs
- Pregnant or breastfeeding women
- Any other condition judged by the investigator to risk early study termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two or three cycles of 21 days each
Participants receive either two or three cycles of induction chemotherapy combined with immunotherapy. Each cycle lasts 21 days, including chemotherapy drugs nab-paclitaxel, cisplatin, oral S1, and immunotherapy with camrelizumab administered intravenously on the first day of each cycle.
2 to 3 treatment visits (in-person), one per cycle
Duration - Up to 3 years
Participants are monitored for progression-free survival and overall survival outcomes for up to 3 years after treatment.
Periodic visits for up to 3 years
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
2
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China, 363099
Actively Recruiting
3
Hainan General Hospital
Haikou, Hainan, China, 570311
Actively Recruiting
Research Team
S
San-Gang Wu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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