RecruitingPhase 2NCT06586242

Efficacy and Safety of Penpulimab Combined With Anlotinib and Chemotherapy

A Two Arm, Randomized, Prospective, Multicenter Study of Penpulimab Combined With Anlotinib Hydrochloride and Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Esophageal Cancer


Sponsor

Xijing Hospital

Enrollment

194 participants

Start Date

Apr 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a two arm, randomized, prospective, multicenter study on the perioperative treatment of locally advanced resectable esophageal cancer with penpulimab combined with anlotinib hydrochloride and chemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining an immunotherapy drug (penpulimab), a targeted anti-cancer drug (anlotinib), and chemotherapy before surgery can improve outcomes for people with locally advanced esophageal cancer that has not yet spread to distant organs. **You may be eligible if...** - You are between 18 and 75 years old - Your biopsy confirms esophageal cancer and your clinical staging is Stage II–IVA (locally advanced but not distant metastasis) - Your esophageal cancer is not located in the cervical (neck) region - Your major organ functions are within acceptable levels - Your overall health is rated 0–1 on standard performance scales **You may NOT be eligible if...** - You have received prior treatment for this esophageal cancer - You have another active cancer - You have uncontrolled infections or autoimmune conditions - You are pregnant or breastfeeding - You have serious heart conditions or uncontrolled high blood pressure 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

DRUGPenpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin

200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, Penpulimab:administered on the first day of each cycle Anlotinib:Body weight \<60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w


Locations(1)

The First Affiliated Hospital of the Air Force Medical University

Xi'an, Shaan'xi, China

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NCT06586242


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