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RecruitingNCT06675214Updated Nov 5, 2024

Under Whole-course of Immunotherapy, Gradient Fractionated RT with CCT Versus CFRT with CCT for LANPC Who Achieved PR Post Induction Chemotherapy.

A Phase 3 interventional study of Full course of PD-1/PD-L1 blockades and Cisplatin-based induction chemotherapy in Nasopharyngeal Carcinoma and De-escalation Therapy, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2024, registered Nov 2024).
  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
586
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This prospective trial aims to enroll patients with stage III-IVA (AJCC 8th,) locoregionally advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved radiological partial response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1 ratio to receive gradient radiotherapy (reducing the irradiation dose of PET-CT areas without metabolic abnormalities, while maintaining adequate irradiation dose of areas with metabolic abnormalities) or standard dose radiotherapy with concurrent chemotherapy. It is expected to provide a new therapeutic option for locally advanced nasopharyngeal carcinoma at moderate risk.

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Conditions studied

  • Nasopharyngeal Carcinoma
  • De-escalation Therapy
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 586 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
  2. Tumor staged as III-IVA (AJCC 8th).
  3. Patients who achieved partial response according to the RECIST criteria on the basis of MRI, PET-CT and endoscopic biopsy after 3 cycles of induction therapy of platinum-based chemotherapy plus immunotherapy.
  4. Eastern Cooperative Oncology Group performance status ≤1.
  5. Age: 18-65 years old.

  6. Adequate organ function:

    Adequate marrow function: neutrocyte count≥4×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.

    Adequate liver and kidney function: Alanine Aminotransferase (ALT)/ Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 2.5×ULN.; creatinine clearance rate ≥ 60 ml/min or creatinine of no more than 1.5 times the upper normal limit.

  7. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are evaluated as CR or SD or PD after 3 cycles of induction therapy of platinum-based chemotherapy plus PD-1/PD-L1 blockades.
  2. The laboratory examination value does not meet the relevant standards within 7 days before enrollment.
  3. The images of PET-CT and enhanced MRI/CT before induction chemotherapy showed necrotic foci in the center of primary tumors or regional lymph nodes.
  4. The metabolic changes shown by PET-CT images after induction chemotherapy were inconsistent with the changes in the extent of tumor invasion shown by anatomical images such as enhanced MRI/CT.
  5. The primary and/or cervical metastases of patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (except diagnostic treatment).
  6. Has a known history of hypersensitivity to any components of the PD-1/PD-L1 blockades formulation or other monoclonal antibodies.
  7. Has a known or suspected history of autoimmune diseases, including dementia and seizures.
  8. Patients with recurrence, distant metastasis and other malignant tumors.
  9. Severe heart disease, lung dysfunction, heart function, lung function below grade 3 (including grade 3)
  10. Patients who underwent anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs.
  11. Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.
  12. HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive).
  13. Has a known history of allergic reactions to the drugs in the study (gemcitabine, cisplatin, docetaxel, abraxane, paclitaxel ).
  14. Has a known history of active TB (bacillus tuberculosis) within 1 year; anti-TB treatment is ongoing or within 1 year prior to screening.
  15. Has received a live vaccine; or a systematic glucocorticoid therapy ; or any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) ; any Chinese anti-tumor herbs within 4 weeks prior to enrollment.
  16. Pregnancy or breastfeeding.
  17. Other patients who were considered unsuitable by the treating physicians.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
586 participants (estimated)

Study arms

  • Active comparator
    Induction chemotherapy plus conventional concurrent chemoradiotherapy

    Drug: Full course of PD-1/PD-L1 blockades · Drug: Cisplatin-based induction chemotherapy · Radiation: Standard-dose IMRT · Drug: Concurrent Chemotherapy

  • Experimental
    Induction chemotherapy plus gradient fractioned radiotherapy and concurrent chemotherapy

    Drug: Full course of PD-1/PD-L1 blockades · Drug: Cisplatin-based induction chemotherapy · Radiation: Gradient Fractionated IMRT · Drug: Concurrent Chemotherapy

Interventions

  • DrugFull course of PD-1/PD-L1 blockades

    a) Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment.

  • DrugCisplatin-based induction chemotherapy

    Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy.

  • RadiationStandard-dose IMRT

    GTVnx/nd:69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82y CTV2: 54.12Gy/33Fr/1.64Gy

  • RadiationGradient Fractionated IMRT

    GTVresidue: 68Gy/30Fr/2.27Gy GTVmcr: 60Gy/30F/2Gy CTV1:54Gy/30F/1.8Gy CTV2: 48GY/30F/1.60Gy

  • DrugConcurrent Chemotherapy

    Cisplatin 100mg/m2 every 3 weeks for 2 cycles

06

What researchers measure

Primary outcomes

  1. Progress-Free Survival (PFS)

    Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

    Time frame: 3 years

Secondary outcomes

  1. Overall Survival (OS)

    Defined as the time interval from randomization to death due to any cause.

    Time frame: 3 years

  2. Locoregional Relapse-Free Survival (LRRFS)

    Defined as the time from randomisation to the date of first locoregional relapse.

    Time frame: 3 years

  3. Distant Metastasis-Free Survival (DMFS)

    Defined as the time interval from randomisation to the date of first distant metastases.

    Time frame: 3 years

  4. The proportion of patients with treatment related acute complications

    The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Time frame: 1 year

  5. The proportion of patients with treatment related late complications

    The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Time frame: 3 years

  6. Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

    Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

    Time frame: 3 years

  7. Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)

    Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • The Fifth Affiliated Hospital of Sun Yat-sen University
    Zhuhai, Guangdong 519000, China
    • Ming-Yuan Chen, MD,PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06675214
Lead sponsor
Sun Yat-sen University
Responsible party
Ming-Yuan Chen (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Nov 5, 2024
Start date
Jul 30, 2024
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Nov 5, 2024

Study contacts

Ming-Yuan Chen, MD,PhD
Contact
chenmy@sysucc.org.cn
+86-20-87343361
Rui You, MD,PhD
Contact
yourui@sysucc.org.cn
+86-13580439820
Ming-Yuan Chen, MD,PhD
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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