RecruitingPhase 2NCT06770270

Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)

Pucotenlimab Combined With Radiotherapy and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Single-Arm Clinical Study(PUCRT)

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

68 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer

Summary

Colorectal cancer is a common gastrointestinal tumor, with rising incidence in China. Rectal cancer accounts for nearly half of new cases, and many patients are diagnosed at a locally advanced stage. Neoadjuvant chemoradiotherapy (nCRT) is the standard treatment, but only 20-30% achieve a complete response, with many experiencing recurrence or metastasis. Immunotherapy, particularly PD-1/PD-L1 inhibitors, has shown promise in improving outcomes, especially in dMMR/MSI-H patients. However, most rectal cancer patients have MSS, where combining immunotherapy with nCRT has shown moderate success in clinical trials. This project aims to explore the safety and efficacy of PD-1 inhibitor (pucotenlimab) combined with nCRT for locally advanced rectal cancer, potentially offering new treatment options.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called pucotenlimab to standard radiation therapy and chemotherapy before surgery improves outcomes for people with locally advanced esophageal squamous cell carcinoma (cancer of the food pipe that has grown into nearby tissue). **You may be eligible if...** - You are 18–75 years old with confirmed esophageal squamous cell carcinoma - Your cancer is at a locally advanced stage (not yet spread to distant organs) - You have not yet received treatment for this cancer - Your general health is good enough to tolerate combined treatment - Your organ function (heart, liver, kidneys, blood) is adequate **You may NOT be eligible if...** - You have cancer that has spread to distant organs (metastatic disease) - You have active autoimmune disease - You have active hepatitis B, hepatitis C, or HIV - You have severe heart or lung disease - 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

DRUGPucotenlimab

Pucotenlimab combined with long-course concurrent chemoradiotherapy, followed by two cycles of pucotenlimab combined with chemotherapy, and then based on tumor response, TME surgery or a "watch and wait" strategy will be adopted.

Locations(1)

Second Affiliated Hospital Of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06770270

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