RecruitingPhase 2NCT04830267

The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC

A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma


Sponsor

Chongqing University Cancer Hospital

Enrollment

39 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining the immunotherapy drug camrelizumab with stereotactic body radiotherapy (SBRT) — a very precise, high-dose form of radiation — improves outcomes for people with nasopharyngeal cancer (a cancer behind the nose) that has returned or spread after prior treatment. **You may be eligible if...** - You are 18 years or older - You have histologically confirmed metastatic or recurrent nasopharyngeal carcinoma - You have at least two tumor lesions, one of which can be safely targeted with radiation - You are in reasonably good health (ECOG score 0–2) - Any prior radiation to a target lesion was given at least 6 months ago **You may NOT be eligible if...** - You have only one lesion - Your lesions cannot be safely irradiated - Your general health is too poor to tolerate treatment - You have had recent immunotherapy that conflicts with the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab

Camrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity.

RADIATIONStereotactic body radiotherapy

Image guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab).


Locations(3)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Chongqing University Three Gorges Hospital

Wanzhou, Chongqing Municipality, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

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NCT04830267


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