Recruiting

Testing a new immunotherapy drug with radiation and chemotherapy for recurring throat cancer

Plain-English translation of NCT04453813 on ClinicalTrials.gov ↗ · Source last updated September 2020 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing whether adding a medication called toripalimab to standard cancer treatment (radiation combined with chemotherapy) works better than radiation and chemotherapy alone. Toripalimab is an immunotherapy drug designed to help your immune system recognize and fight cancer cells. You would be randomly assigned to receive either the standard treatment or the standard treatment plus this medication.

Nasopharyngeal cancer that comes back after initial treatment is very difficult to treat, and current options are limited. Researchers believe that adding an immunotherapy drug to standard radiation and chemotherapy might help more patients respond to treatment and live longer.

Do you qualify?

You likely qualify if…

you have been diagnosed with nasopharyngeal cancer that has recurred (come back) more than 12 months after your first radiation treatment
your cancer is considered unresectable, meaning it cannot be safely removed by surgery
you are in reasonably good overall health with a Karnofsky performance score of at least 70 (able to care for yourself and do light activities)
your blood, liver, and kidney function are normal or only mildly abnormal on recent blood tests
you have measurable disease that can be seen on CT or MRI scans

You likely don't qualify if…

you have severe damage to your throat tissues, brain injury from radiation, or scarring of the neck that makes a second round of radiation unsafe
you have a known allergy to large protein-based drugs or any component of the study medications
you have a history of autoimmune disease (like lupus, rheumatoid arthritis, or Crohn's disease) or active autoimmune conditions
you have a history of HIV, active tuberculosis, or viral hepatitis (hepatitis B or C)
you have received any immunotherapy drugs (PD-1 inhibitors or similar treatments) before

What participation looks like

You will receive concurrent radiation and chemotherapy as the foundation of your treatment. Depending on which group you are randomly assigned to, you may also receive the immunotherapy medication toripalimab during your radiation and chemotherapy, and continue it for several months afterward as maintenance treatment. You will have regular clinic visits to receive treatment, have blood tests, and be monitored for side effects. The trial compares how well the two groups do over time in terms of cancer control and safety.

AI-generated summary from trial data · Jun 25, 2026 · Not medical advice

Trial locations(6 sites)

China

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong

Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong

Yuebei People's Hospital, Shaoguan, Guangdong

Zhongshan People's Hospital, Zhongshan, Guangdong

The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong