Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06313450

De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma

Led by Sun Yat-sen University · Updated on 2024-03-19

112

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with stage II-III nasopharyngeal carcinoma to evaluate whether reducing radiation doses after immunochemotherapy affects local tumor control and late radiation side effects. The study focuses on using neoadjuvant chemotherapy combined with immunotherapy to improve treatment responses and potentially allow lower radiation doses. This approach aims to balance tumor control with fewer long-term toxicities over a three-year period. Participants receive three cycles of induction therapy with gemcitabine, cisplatin, and Toripalimab. Those whose tumors shrink by over 75% and have no detectable Epstein-Barr virus DNA will receive a lower radiation dose of 60 Gy along with additional cycles of Toripalimab and cisplatin during radiotherapy. Others will undergo conventional radiation therapy at 70 Gy with concurrent cisplatin. If needed, extra radiation may be given to remaining tumor areas. Throughout the study, patients will be monitored with imaging and blood tests to assess tumor response and viral DNA levels. Researchers will track tumor control rates, survival, and radiation side effects up to three years after treatment. Participants will have regular clinical visits, laboratory tests, and assessments to evaluate both effectiveness and safety of the treatment approaches.

CONDITIONS

Brief Title

De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed nasopharyngeal carcinoma with no prior anti-cancer therapy
  • ECOG performance status score of 0 or 1
  • Age between 18 and 70 years
  • Stage II-III nasopharyngeal carcinoma except T2N0M0 (AJCC 8th edition)
  • Neutrophil count ≥ 1.5 × 10^9/L, hemoglobin ≥ 90 g/L, and platelet count ≥ 100 × 10^9/L
  • Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times upper normal limit, bilirubin ≤ 1.5 times upper normal limit, creatinine clearance ≥ 60 ml/min
  • Ability and willingness to comply with study visits, treatment, and tests with signed informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 or over 70 years
  • Positive for HBsAg with HBV DNA ≥ 1 × 10^3 copies/ml
  • Positive for HCV antibody
  • Active or suspected autoimmune diseases except controlled type 1 diabetes, hypothyroidism on hormone replacement, or skin conditions not requiring systemic therapy
  • History of interstitial lung disease
  • Use of systemic sex hormones or immunosuppressive therapy equivalent to ≥ 10 mg prednisone/day within 28 days before consent
  • Live vaccines received within 30 days before consent
  • Pregnant or breastfeeding women
  • Other cancers within 5 years except certain treated skin or thyroid cancers
  • Known allergy to Toripalimab or its components
  • HIV infection
  • Conditions affecting safety or compliance such as symptomatic heart failure, unstable angina, recent myocardial infarction, active infection needing treatment, mental illness, or social issues

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)

Neoadjuvant Therapy

Duration - Approximately 9 weeks

Participants receive three courses of induction therapy with gemcitabine and cisplatin, along with Toripalimab before radiotherapy.

3 treatment cycles, each 3 weeks long

Radiotherapy

Duration - Duration of radiotherapy treatment (not specified)

Participants receive radiotherapy to the primary tumor. Those with tumor regression over 75% and no detectable EBV DNA receive de-escalated radiotherapy with concurrent Toripalimab and cisplatin. Others receive conventional radiotherapy with cisplatin.

Concurrent cisplatin every three weeks for two cycles; Toripalimab every three weeks for three cycles in de-escalated group

Follow-up

Duration - Up to 3 years after radiotherapy

Participants are monitored for treatment response and potential radiation-induced toxicities.

Periodic visits for up to 3 years

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

P

Puyun Ouyang

F

Fangyun Xie

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Endoscopic surgery compared with intensity-modulated radiotherapy in resectable locally recurrent nasopharyngeal carcinoma: a multicentre, open-label, randomised, controlled, phase 3 trial.

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https://pubmed.ncbi.nlm.nih.gov/33600761

The Tumour Response to Induction Chemotherapy has Prognostic Value for Long-Term Survival Outcomes after Intensity-Modulated Radiation Therapy in Nasopharyngeal Carcinoma.

Hao Peng, Lei Chen, Yuan Zhang...

https://pubmed.ncbi.nlm.nih.gov/27099096

The feasibility of reduced-dose radiotherapy in childhood nasopharyngeal carcinoma with favorable response to neoadjuvant chemotherapy.

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https://pubmed.ncbi.nlm.nih.gov/36375563

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E1308: Phase II Trial of Induction Chemotherapy Followed by Reduced-Dose Radiation and Weekly Cetuximab in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx- ECOG-ACRIN Cancer Research Group.

Shanthi Marur, Shuli Li, Anthony J Cmelak...

https://pubmed.ncbi.nlm.nih.gov/28029303

Deep learning-based precise prediction and early detection of radiation-induced temporal lobe injury for nasopharyngeal carcinoma.

Pu-Yun OuYang, Bao-Yu Zhang, Jian-Gui Guo...

https://pubmed.ncbi.nlm.nih.gov/37090437

Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma: A Randomized Clinical Trial.

Ling-Long Tang, Rui Guo, Ning Zhang...

https://pubmed.ncbi.nlm.nih.gov/35997729

Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial.

Yuan Zhang, Lei Chen, Guo-Qing Hu...

https://pubmed.ncbi.nlm.nih.gov/35709465