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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Neoplasms; Chemotherapy; PD-1 Inhibitor; Induction Therapy; Complete Response
• Intervention / Treatment: Drug: Two-cycle induction chemotherapy + immunotherapy; Drug: Three-cycle induction chemotherapy + immunotherapy

Detailed Description

Currently, the recommended number of cycles for induction chemotherapy in nasopharyngeal carcinoma primarily suggests two-three cycles of induction therapy. However, several studies have found that three cycles of induction therapy did not improve patient survival and may further increase hematological toxicity and gastrointestinal toxicity compared to those treated with two cycles of induction therapy. Based on research from our center, three cycles of induction therapy also did not improve patient survival. The latest 2024 CSCO guidelines have recommended that immunotherapy can be incorporated into the induction therapy stage for locally advanced nasopharyngeal carcinoma. Therefore, based on these research findings, the investigators hypothesize that two cycles of induction chemotherapy combined with immunotherapy will not be inferior to three cycles in terms of tumor response rates and may have lower adverse reactions. The investigators aim to compare the complete response rates and long-term survival outcomes of two-cycle and three-cycle modified TPF regimens combined with camrelizumab in patients with locally advanced (T1-4N2-3M0) nasopharyngeal carcinoma, providing new options for toxicity-reduced treatment in nasopharyngeal cancer.

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: San-Gang Wu, MD; Phone Number: 865922139531; Email: wusg@xmu.edu.cn

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The first affiliated hospital of xiamen university
      • Contact: Dan-Ping Wang; Phone Number: 865922137569; Email: xdfyec@sina.com
    • Zhangzhou, Fujian, China, 363099
      • Recruiting
      • Zhangzhou Affiliated Hospital of Fujian Medical University
      • Contact: Gui-Ping Chen, MD; Phone Number: 8613599592455; Email: 754514055@qq.com
  • Hainan
    • Haikou, Hainan, China, 570311
      • Recruiting
      • Hainan General Hospital
      • Contact: Shi-Ping Yang, MD; Phone Number: 8618976460313; Email: shipingyang1982@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18-65 years old;
• Pathologically (including histology or cytology) confirmed nasopharyngeal carcinoma patients, with clinical staging T1-4N2-3M0 (according to the UICC/AJCC TNM staging system, 8th edition);
• No prior systemic treatment (surgery, radiotherapy, chemotherapy, etc.);
• At least one measurable lesion on imaging (as per RECIST criteria version 1.1);
• ECOG Performance Status (PS): 0-1;
• Expected survival ≥3 months;
• Male subjects and women of childbearing potential must use contraception from the first dose of study medication until 24 weeks after the last dose of study medication;
• Normal major organ function, with basic normal results in hematology, biochemistry, and coagulation tests;
• The investigator believes that the treatment will provide a survival benefit.

Exclusion Criteria:

• Active, known, or suspected autoimmune disease;
• Patients with hypertension that cannot be controlled to normal range despite antihypertensive medication (systolic BP >160 mmHg, diastolic BP >90 mmHg);
• History of hereditary bleeding tendency or coagulation dysfunction. Any clinically significant bleeding symptoms within 12 weeks prior to screening, or cumulative bleeding over 50 ml in 24 hours;
• Unwell-controlled cardiac clinical symptoms or diseases;
• Interstitial lung disease, drug-induced pneumonia, steroid-treated radiation pneumonitis, active pneumonia with symptoms, or severe pulmonary dysfunction;
• Active hepatitis B (HBV DNA ≥2000 IU/mL or 10^4 copies/mL), hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection of the assay);
• Allergy to any of the study drugs;
• Pregnant or breastfeeding women;
• Any other factors that, in the investigator's judgment, may cause premature termination of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Two-cycle; Two cycles induction chemotherapy + immunotherapy	Drug: Two-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.; Other Names: 2
Active Comparator: Three-cycle; Three cycles induction chemotherapy + immunotherapy	Drug: Three-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.; Other Names: 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response	Complete Remission after induction therapy means that all detectable signs of the tumor have disappeared, including all measurable and assessable diseases. This includes the absence of any tumor lesions in imaging studies.	At the end of Cycle 2 or Cycle 3 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival was measured from the day of the NPC diagnosis until disease recurrence and death from any cause.	3 years
Overall survival	Overall survival was measured from the day of the NPC diagnosis until death due to any cause.	3 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Physiological Effects of Drugs; Immunomodulating Agents; Immunologic Factors
• Other Study ID Numbers: XMYY-2024KY230-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No