RecruitingPhase 2NCT05290194

Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma

Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial


Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Enrollment

28 participants

Start Date

Mar 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding targeted radiation (SBRT) to an ongoing immunotherapy and chemotherapy maintenance regimen improves outcomes in people with metastatic nasopharyngeal carcinoma (a type of head and neck cancer) that has responded to initial treatment. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with nasopharyngeal carcinoma confirmed by biopsy or lab test - Your cancer has spread (metastatic) and you have had 4–6 cycles of gemcitabine + cisplatin + PD-1 immunotherapy with at least stable disease - You have fewer than 5 distant organ metastases, and they are suitable for targeted radiation - You are in good general health (ECOG score 0–2) - Your blood counts, kidney, and liver function are within acceptable ranges **You may NOT be eligible if...** - You have more than 5 distant organ metastases - Your cancer progressed during initial treatment - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding 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

RADIATIONSBRT radiotherapy + Conventionally fractionated radiotherapy

Radiotherapy was performed 3-6 weeks after the end of first-line treatment, followed by conventional fractionated radiotherapy of the primary tumor and cervical lymph node metastases, SBRT radiotherapy of distant organ metastases 3-6 weeks later.

DRUGPD-1 inhibitor

Immunotherapy of PD-1 inhibitor is used during the whole time of this trial until subjects were withdrawn from the trial or the trial complete

DRUGCapecitabine

Capecitabine is treated for patients 3-6 weeks after radiotherapy, which combines with PD-1 inhibitor as the maintenance regimen in the trial.


Locations(1)

Fifth Affilliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

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NCT05290194


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