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

NCT06811844 | Recruiting Phase 2 DMC

• 1 other identifier: XMYY-2024KY230-03
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 3

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.

Conditions

Nasopharyngeal Neoplasms; PD-1 Inhibitor; Induction Therapy; Complete Response; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival

  3 years

• Overall survival

  3 years

Study Arms (2)

Two-cycle

EXPERIMENTAL

Two cycles induction chemotherapy + immunotherapy

Drug: Two-cycle induction chemotherapy + immunotherapy

Three-cycle

ACTIVE COMPARATOR

Three cycles induction chemotherapy + immunotherapy

Drug: Three-cycle induction chemotherapy + immunotherapy

Interventions

Two-cycle induction chemotherapy + immunotherapy DRUG

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.

Also known as: 2

Two-cycle

Three-cycle induction chemotherapy + immunotherapy DRUG

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.

Also known as: 3

Three-cycle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (3)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Zhangzhou Affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, 363099, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, 570311, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Pathologic Complete Response

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

San-Gang Wu, MD

CONTACT

865922139531; wusg@xmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 6, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)