Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06092957

Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy

Led by Sun Yat-sen University · Updated on 2023-12-15

504

Participants Needed

1

Research Sites

420 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

F

First Affiliated Hospital, Sun Yat-Sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.

CONDITIONS

Official Title

Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III).
  • Tumor stage III-IVA according to AJCC 8th edition, excluding T3N0.
  • Achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus immunotherapy, confirmed by MRI, PET-CT, endoscopic biopsy, and EBV DNA load of 0 copies/mL or lower.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate bone marrow function: neutrophil count ≥ 4 x 10^9/L, hemoglobin ≥ 90 g/L, platelet count ≥ 100 x 10^9/L.
  • Adequate liver and kidney function: ALT/AST ≤ 2.5 times upper limit of normal, bilirubin ≤ 2.5 times upper limit, creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5 times upper limit.
  • Provided informed consent after being informed about the investigational nature of the study.
Not Eligible

You will not qualify if you...

  • Not achieving complete response or having positive EBV DNA after 3 cycles of induction chemotherapy plus PD-1/PD-L1 blockades.
  • Laboratory values outside required standards within 7 days before enrollment.
  • Prior chemotherapy, immunotherapy, targeted therapy, or surgery (other than diagnostic treatment).
  • Previous treatment with anti-PD-1/PD-L1, anti-CTLA-4 antibodies, or anti-angiogenic drugs.
  • Active central nervous system metastases.
  • Grade 2 or higher epistaxis within 1 month before enrollment or significant hemoptysis/hematemesis.
  • Uncontrolled hypertension or significant heart disease, arrhythmia, or cardiac insufficiency.
  • Current use of anticoagulants or platelet inhibitors unless discontinued 10 days prior and coagulation criteria met.
  • Other malignancies except certain treated localized cancers.
  • History of interstitial lung disease or hypersensitivity to study drugs.
  • Active autoimmune disease or requiring immunosuppressive therapy, except specific exceptions.
  • Long-term use of immunosuppressive drugs or corticosteroids.
  • HIV positive, active hepatitis B or C infection.
  • Active tuberculosis within 1 year or ongoing anti-TB treatment.
  • Recent live vaccine, systemic glucocorticoid therapy, anti-infective vaccines, or Chinese anti-tumor herbs within 4 weeks.
  • Pregnancy or breastfeeding.
  • Any other condition deemed unsuitable by treating physicians.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

M

Ming-Yuan Chen, MD,PhD

CONTACT

R

Rui You, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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