Chemotherapy, Complete Response, Induction Therapy, Nasopharyngeal Neoplasms, PD-1 Inhibitor
Conditions
Brief 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.
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
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.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | At the end of Cycle 2 or Cycle 3 (each cycle is 21 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 years | Progression-free survival was measured from the day of the NPC diagnosis until disease recurrence and death from any cause. |
| Overall survival | 3 years | Overall survival was measured from the day of the NPC diagnosis until death due to any cause. |
Countries
China
Contacts
Primary ContactSan-Gang Wu, MD
Outcome results
None listed