RecruitingPhase 1NCT06886347

Metastatic Nasopharyngeal Carcinoma

Penpulimab Plus Gemcitabine and Anlotinib in the Treatment of Metastatic Nasopharyngeal Cancer, A Single Arm, Open-label, Phase Ib Clinical Trial

Sponsor

Chen Xiaozhong

Enrollment

47 participants

Start Date

Jul 7, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Nasopharyngeal Carcinoma

Summary

To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment regimen for people with metastatic nasopharyngeal carcinoma (NPC) — a cancer originating in the back of the nasal cavity/throat that has spread to other parts of the body — who have not yet received first-line chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed to have stage IVb NPC (spread to distant organs) by biopsy - You have not yet received platinum-based chemotherapy for metastatic disease - Your cancer has at least one measurable lesion on imaging - You are in good overall health (ECOG 0 or 1) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have had another cancer in the past 3 years (except certain cured skin or cervical cancers) - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You are enrolled in another drug 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

DRUGPenplimab Injection

Penplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle. Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.

DRUGAntitinib Hydrochloride Capsules

10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks.

DRUGGemcitabine

Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06886347

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