RecruitingPhase 2NCT05430698

PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

PD-1 Antibody Plus Gemcitabine and Oxaliplatin (GEMOX) as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma Patients With Positively Metastatic Lymph Nodes : a Single Arm, Phase II Trial


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

62 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a PD-1 immunotherapy antibody with a chemotherapy regimen (GEMOX: gemcitabine and oxaliplatin) after surgery can help prevent bile duct cancer (perihilar cholangiocarcinoma) from coming back in patients who had surgery with clear margins but positive lymph nodes, suggesting a higher risk of recurrence. **You may be eligible if:** - You are between 18 and 75 years old - You have perihilar cholangiocarcinoma (bile duct cancer near the liver hilum) and have undergone surgery with clean surgical margins (R0 resection) - Your pathology confirmed cancer in nearby lymph nodes - You have not received any systemic treatment for 6 months - Your ECOG status is 0 or 1 and your liver (Child-Pugh A) and blood counts are acceptable **You may NOT be eligible if:** - Your cancer was not fully resected, or has already recurred or spread - You have had another cancer previously - You are pregnant or breastfeeding - Your liver, kidney, thyroid, or blood count values do not meet the required minimums 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

DRUGPD-1antibody plus GEMOX

1. PD-1 antibody,200mg,D1,intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : gemcitabine 1000mg/m2,D1,D8;oxaliplatin 100mg/m2,D1,intravenous infusion. 3. Three weeks is a course of treatment,a total of 6-8 courses.


Locations(1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05430698


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