RecruitingPhase 2NCT05147844

Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

Antitumor Activity of Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma: A Single-arm, Multicenter Study


Sponsor

Xinqiao Hospital of Chongqing

Enrollment

40 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the study was to determine the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining toripalimab (an immunotherapy drug) with radiation therapy can help control metastatic nasopharyngeal carcinoma (NPC, a cancer in the back of the nose) in patients with a limited number of metastatic sites (called oligometastatic disease). This combination is for patients who are not able or willing to receive chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed nasopharyngeal carcinoma that has spread to 5 or fewer sites in 2 or fewer organs - You have not received any prior treatment for metastatic NPC - You are not suitable for or do not wish to receive chemotherapy - You are in good health (ECOG score 0–1) with an expected survival of at least 6 months - Your blood counts and organ function meet required minimums **You may NOT be eligible if...** - You have an active autoimmune disease - You are on high-dose steroids or immune-suppressing medications - You have HIV, uncontrolled hepatitis B or C, or active tuberculosis - You have had a recent heart attack, severe heart failure, or stroke - You have interstitial lung disease or pulmonary fibrosis - You are pregnant or breastfeeding - You are currently in another clinical trial 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

DRUGToripalimab

Toripalimab: 240mg, iv. Q3W for 1 year or until disease progression/intolerable toxicity Radiotherapy: Newly diagnosed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 70 Gy, pGTVnd 99Gy, pCTV1, 60 Gy, pCTV2, 54 Gy, 33 times, completed in 7 weeks. Relapsed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 60Gy, pGTVnd 60Gy, 20-25 times, completed in 4-5 weeks. Newly diagnosed and relapsed patients: SBRT for oligometastatic lesions, pGTV 25-40 Gy, 3-5 times, completed in 1-2 weeks.


Locations(2)

Xinqiao Hospital of Chongqing

Chongqing, Chongqing Municipality, China

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

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NCT05147844


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