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

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Complete response [Time frame: At the end of Cycle 2 or Cycle 3 (each cycle is 21 days)]

Secondary outcome measures (2)

• Progression-free survival [Time frame: 3 years]
• Overall survival [Time frame: 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 3 centers

• The First Affiliated Hospital of Xiamen University — Xiamen
• Zhangzhou Affiliated Hospital of Fujian Medical University — Zhangzhou
• Hainan General Hospital — Haikou

Identifiers

NCT: NCT06811844 · XMYY-2024KY230-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗