A Phase II Study of TPF With PD-1 Inhibitor Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma

Summary

NPC is one of the most common malignant tumors in the head and neck region of China. Currently, the main treatment regimen for LA-NPC is radical concurrent chemoradiotherapy combined with induction or adjuvant chemotherapy. However, after radical radiotherapy and chemotherapy treatment, 15% -30% of patients still experience recurrence or distant metastasis. At present, the treatment options for R/M-NPC are very limited, especially for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed second-line treatment, there is no standard treatment plan. Therefore, it is urgent to study a new treatment mode to improve the therapeutic efficacy of LA-NPC, thereby reducing the recurrence and metastasis rates.

This study explores the safety and efficacy of TPF combined with immune checkpoint inhibitor induction therapy in LA-NPC patients through prospective research. The results of this study are expected to provide new ideas and methods for the treatment of LA-NPC and provide reference for clinical practice. The investigators believe that induction chemotherapy combined with immunotherapy has broad application prospects in the field of LA-NPC, and is expected to bring better treatment effects and quality of life to patients, bringing new hope to the medical community and patients.

According to the inclusion criteria, eligible patients will be included:

Induction chemotherapy with Tislelizumab combined with TPF regimen, administered every 3 weeks: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and PD-1 inhibitor (Tislelizumab 200mg).

All patients received 3 cycles of induction therapy followed by radical concurrent chemoradiotherapy combined with Tislelizumab (200mg) treatment, Q3W. The cisplatin in the synchronous chemoradiotherapy regimen is administered once a week, with a dose of 40mg/m2 per dose, and the total dose of cisplatin does not exceed 100mg/m2. For patients who cannot tolerate cisplatin during synchronous radiotherapy and chemotherapy, cisplatin may not be combined. The IMRT radiotherapy area includes the primary tumor volume (GTVp), the total tumor volume of the affected lymph nodes (GTVn), the high-risk clinical target volume (CTV1), and the low-risk clinical target volume (CTV2). PTVp, PTV1, and PTV2 are respectively expanded by 3mm on GTVp, CTV1, and CTV2. The prescription doses for PTVp, PTVn, PTV1, and PTV2 are 70-72 Gy, 66-70 Gy, 60-68 Gy, and 54-58 Gy, respectively, with a total of 30-33 divided exposures.

After the completion of synchronous radiotherapy and chemotherapy, adjuvant therapy with Tislelizumab (Tislelizumab 200mg d1, once every 3 weeks, for a total of 8 courses) is administered. For patients with high-risk recurrence factors (T4 or N2), combination chemotherapy with capecitabine 625mg/m2 po bid is performed for one year.

Treat until any of the following conditions occur:

Disease progression; No clinical benefit; Intolerable toxicity; Withdrawal of informed consent; Or maintain treatment for up to six months.

Conditions

• TPF
• Immunotherapy
• Nasopharyngeal Carcinoma
• Phase II Clinical Study

Interventions

DRUG

albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg).

Induction chemotherapy with PD-1 inhibitor combined with TPF regimen, administered every 3 weeks: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and PD-1 inhibitor ( 200mg). All patients received 3 cycles of induction therapy followed by radical concurrent chemoradiotherapy combined with tislelizumab (200mg) treatment, Q3W. The cisplatin in the synchronous chemoradiotherapy regimen is administered once a week, with a dose of 40mg/m2 per dose, and the total dose of cisplatin does not exceed 100mg/m2. For patients who cannot tolerate cisplatin during synchronous radiotherapy and chemotherapy, cisplatin may not be combined.

Sponsors & Collaborators

• Weiwei Zhang

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-20

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• China

Study Locations