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

Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC (NCT06811844) is a Phase 2 interventional studying Nasopharyngeal Neoplasms and PD-1 Inhibitor, sponsored by The First Affiliated Hospital of Xiamen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Nasopharyngeal Neoplasms and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 208 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Nasopharyngeal Neoplasms subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Active, known, or suspected autoimmune conditions (where your immune system attacks your own body); - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06811844), the sponsor (The First Affiliated Hospital of Xiamen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06811844 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06811844?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06811844?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06811844. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06811844. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.