RecruitingPhase 2NCT06811844

Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC

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


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

208 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective, phase II, multicenter, randomized controlled study aims to compare the complete response rate and long-term survival outcomes of two-cycle and three-cycle induction therapy with modified TPF regimens combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing 2 versus 3 cycles of a chemotherapy regimen (modified TPF) combined with an immunotherapy drug (camrelizumab) as initial (induction) treatment for locally advanced nasopharyngeal carcinoma — a type of cancer at the back of the nose, near the base of the skull. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with nasopharyngeal carcinoma at a specific advanced stage (T1-4, N2-3, M0) - You have not had any prior cancer treatment (surgery, radiation, or chemotherapy) - You have at least one tumor that can be measured on imaging - Your general health score (ECOG) is 0 or 1 and your major organs are functioning normally **You may NOT be eligible if...** - You have already received any treatment for this cancer - Your cancer has spread to distant organs - Your organ function is significantly impaired - You cannot use contraception during the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTwo-cycle induction chemotherapy + immunotherapy

Two cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area \[BSA\] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA \>1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle.

DRUGThree-cycle induction chemotherapy + immunotherapy

Three cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area \[BSA\] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA \>1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle.


Locations(3)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhangzhou Affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, China

Hainan General Hospital

Haikou, Hainan, China

View Full Details on ClinicalTrials.gov

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NCT06811844


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