Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma

NCT04143984 | Unknown Phase 2 DMC

• 1 other identifier: SPHIC-TR-HNCNS-2019-34
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to examine the role of camrezlizumab in addition to carbon-ion radiotherapy (CIRT) for patients with locally recurrent nasopharyngeal carcinoma. According to the plan, a total of 146 patients will be recruited and randomized into: 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group).

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.

  2-year

Secondary Outcomes (5)

• Overall survival

  2-year

• Local progression-free survival

  2-year

• Regional progression-free survival

  2-year

• Distant metastasis-free survival

  2-year

• Number of participants with adverse events

  2-year

Study Arms (2)

Arm-C

ACTIVE COMPARATOR

Patients will receive induction chemotherapy followed by carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE).

Drug: Induction chemotherapy; Radiation: Carbon-ion radiotherapy

Arm-CC

EXPERIMENTAL

Patients will receive induction chemotherapy followed by carbon-ion radiotherapy and camrelizumab. In details, patients will receive carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE); in addition, patients will also receive camrelizumab of 200 mg (IV.), every 2 weeks, started with carbon-ion radiotherapy for a maximal period of 1 year.

Drug: Induction chemotherapy; Radiation: Carbon-ion radiotherapy; Drug: Camrelizumab

Interventions

Induction chemotherapy DRUG

Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.

Arm-C; Arm-CC

Carbon-ion radiotherapy RADIATION

Accelerated carbon-ion beam with pencil beam scanning technique.

Arm-C; Arm-CC

Camrelizumab DRUG

An anti-PD-1 antibody.

Also known as: SHR-1210

Arm-CC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed a definitive course of intensity-modulated photon radiation therapy (IMRT) to a total dose of ≥ 66 Gy
• Recurrence at nasopharynx diagnosed more than 6 months after the initial course of IMRT
• Patients with neck lymphadenopathy should receive neck dissection before randomization
• With measurable lesion on contrast MR scan
• Age ≥ 18 and \< 70 years of age
• ECOG score: 0-1
• Leucocyte count ≥ 4000/µL, neutrocyte count ≥ 2000/µL, platelet count ≥ 100000/µL, hemoglobin ≥ 90g/L
• Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN), alkaline phosphatase \< 2.5×ULN, bilirubin ≤ ULN, serum creatinine ≤ ULN, creatinine clearance ≥ 60ml/min
• Willing to accept adequate contraception
• Ability to understand the nature of the clinical trial and sign the written informed consent

You may not qualify if:

• Presence of distant metastasis
• Previously received radioactive particle implantation
• Prior malignancy within 5 years before randomization, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer
• Patients who received local (such as surgery and cryotherapy) or systemic treatment, except for induction chemotherapy after diagnosis of recurrence
• With uncontrolled active infection
• With pneumonia
• With autoimmune disease
• With a known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
• Hepatitis B virus (HBV) DNA ≥ 500IU/mL for patients with positive HBV surface antigen, positive hepatitis C virus RNA for patients with positive HCV antigen
• Previously treated by immune checkpoint inhibitors
• Medical conditions requiring treatment of antibiotics and/or corticosteroid
• Treated with ≥ 5 days antibiotics one month before start of immunotherapy
• With known allergy to any of the study drugs
• Pregnant or lactating women
• Any severe intercurrent disease that may interfere with the current study

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201315, China

RECRUITING

Related Publications (1)

• Hu J, Huang Q, Hu W, Gao J, Yang J, Zhang H, Lu JJ, Kong L. A protocol for a randomized trial evaluating the role of carbon-ion radiation therapy plus camrelizumab for patients with locoregionally recurrent nasopharyngeal carcinoma. Cancer Med. 2024 Feb;13(3):e6742. doi: 10.1002/cam4.6742. Epub 2024 Jan 11.

  PMID: 38205914 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Induction Chemotherapy; Heavy Ion Radiotherapy; camrelizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction; Radiotherapy

Study Officials

• Jiade J Lu, MD

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiyi Hu, MD, PhD

CONTACT

+8602138296666; jiyi.hu@sphic.org.cn

Lin Kong, MD

CONTACT

+8602138296666; konglin@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: October 30, 2019
• Study Start: January 19, 2021
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 3 years after publication of the study.
• Access Criteria: Data mentioned in the plan description and relevant supporting files will be shared with radiation oncologist who are interested in conducting pooled analysis comparing carbon-ion radiotherapy with other treatment modalities (such as other radiation technique and systemic therapy) for patients with recurrent nasopharyngeal carcinoma. The IPD will only be shared after the study protocol is reviewed and approved by the principle investigator.

Locations

CN (1)