Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
ID04376866

Toripalimab in Combination With Concurrent Chemoradiotherapy for Local-regional Recurrent Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

Led by Cancer Hospital of Guangxi Medical University · Updated on 2021-07-20

204

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating treatments for locoregionally recurrent nasopharyngeal carcinoma, a type of cancer common in parts of Asia and Africa. This phase 3, multicenter, randomized controlled trial evaluates the effectiveness and side effects of adding the PD-1 antibody Toripalimab to the standard cisplatin concurrent chemoradiotherapy compared to chemoradiotherapy alone. The study aims to improve survival and reduce toxicity in patients whose cancer has returned locally despite previous radiation treatment. Participants are assigned to one of two groups. One group receives Toripalimab 240 mg combined with cisplatin 100 mg/m2 every three weeks during intensity modulated radiotherapy (IMRT) given at a total dose of 60-66 Gy in fractions of 1.8-2.0 Gy, followed by nine cycles of Toripalimab every three weeks as additional immunotherapy. The other group receives cisplatin with IMRT alone, following the same dosing and schedule without Toripalimab. During the study, participants will have regular assessments including survival tracking up to five years, monitoring of disease progression, response to treatment at three months, adverse events over five years, and quality of life evaluation after one year. Researchers will conduct imaging and laboratory tests to monitor safety and effectiveness. The total participation period varies, but primary outcomes focus on long-term survival benefits and treatment tolerance.

CONDITIONS

Brief Title

Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with newly confirmed recurrent nasopharyngeal carcinoma by biopsy or imaging
  • Cancer staged as rT3-4N0-1M0 or rT1-4N2-3M0 according to the 8th AJCC edition
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 4×10⁹/L, hemoglobin ≥ 90 g/L
  • Normal liver function tests (ALT, AST ≤ 2.5× upper limit normal; total bilirubin ≤ 1.5× upper limit normal)
  • Normal kidney function (creatinine clearance ≥ 60 ml/min)
  • Signed informed consent form
  • Male participants and females who are not pregnant
Not Eligible

You will not qualify if you...

  • Age under 18 or over 65 years
  • Positive Hepatitis B surface antigen with HBV-DNA ≥ 200 IU/ml or 1000 cps/ml
  • Positive Hepatitis C antibody
  • Active or suspected autoimmune disease, except controlled hypothyroidism or skin diseases not requiring systemic therapy
  • History of interstitial lung disease
  • Use of immunosuppressive treatments equivalent to prednisone >10 mg/day within 28 days prior to consent
  • Receipt or planned receipt of live vaccine within 30 days prior to consent
  • Pregnant or breastfeeding women of child-bearing potential
  • History of malignant tumors within 5 years except certain in situ cancers
  • Hypersensitivity to macromolecular proteins or components of Toripalimab
  • HIV positive
  • Severe uncontrolled medical conditions or infections
  • Other diseases affecting safety or compliance, including heart failure symptoms, unstable angina, myocardial infarction, active systemic infections, mental illness, or social/family factors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3 months

Participants receive Toripalimab combined with concurrent chemoradiotherapy or chemoradiotherapy alone to treat local-regional recurrent nasopharyngeal carcinoma.

Multiple visits over the course of chemoradiotherapy and adjuvant immunotherapy

Follow-up

Duration - Up to 5 years

Participants are monitored for overall survival, progression-free survival, adverse events, and quality of life after treatment completion.

Periodic visits as scheduled by the study team

Trial Site Locations

Total: 1 location

1

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China, 530021

Actively Recruiting

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Research Team

S

Song Qu, PhD

Z

Zhong-Guo Liang, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.

Freddie Bray, Jacques Ferlay, Isabelle Soerjomataram...

https://pubmed.ncbi.nlm.nih.gov/30207593