RecruitingPhase 2NCT06664021

Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma

Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma:A Prospective, Multicenter, Phase II Clinical Study


Sponsor

Anhui Provincial Hospital

Enrollment

60 participants

Start Date

Nov 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluating the efficacy and safety of treatment with Tislelizumab in combination with S-1 in patients with high-risk recurrent intrahepatic cholangiocarcinoma after radical surgery


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining the immunotherapy drug tislelizumab with an oral chemotherapy called S-1 after surgery can reduce the risk of intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) returning, in patients who had surgery but still have one or more high-risk features that make recurrence more likely. **You may be eligible if...** - You are between 18 and 75 years old - You have bile duct cancer inside the liver that was surgically removed (complete or near-complete removal) - You have at least one high-risk feature: positive margins, multiple tumor nodules, spread to lymph nodes, cancer invasion around nerves, tumor larger than 5 cm, or blood vessel invasion - You have not received any chemotherapy, radiation, or immunotherapy in the 3 months before your surgery - Your liver function and organ tests are within acceptable ranges **You may NOT be eligible if...** - Scans before surgery showed distant spread (metastasis) - You received prior cancer treatment within 3 months before the operation - Your liver function is too impaired to tolerate treatment - Your organ function tests (blood counts, kidney, liver) do not meet minimum requirements 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

DRUGTislelizumab combined with S-1

Tislelizumab:200mg q3w iv , lasts for one year. S-1:40mg, 50mg, or 60mg orally twice daily for 4 weeks, depending on body surface area, followed by 2 weeks of rest,lasts four cycles.


Locations(2)

No.2 People's Hospital of Fuyang city

Fuyang, Anhui, China

Anhui province hospital

Hefei, Anhui, China

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NCT06664021


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