RecruitingPhase 2NCT06721286

Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma

Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma (ICC) With High Risk of Recurrence, Phase II, Single-center, Randomized Controlled Trial


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

70 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy (toripalimab) combined with gemcitabine and cisplatin chemotherapy before surgery can shrink liver bile duct cancer (intrahepatic cholangiocarcinoma) enough to make it easier to remove and improve long-term outcomes for patients with high-risk tumors. **You may be eligible if...** - You are 18 years or older - You have confirmed intrahepatic cholangiocarcinoma (a type of bile duct cancer inside the liver) that can be surgically removed - Your tumor meets at least one of the high-risk criteria: larger than 5 cm, has vascular invasion, penetrates through the liver lining, invades nearby organs, or has suspicious lymph nodes nearby - You have not had any prior systemic treatment - Your overall physical condition is good (ECOG 0-1) - Your major organ functions are normal **You may NOT be eligible if...** - You have received prior chemotherapy, immunotherapy, or radiation for this cancer - You have serious heart, lung, liver, kidney, or bone marrow problems - You are pregnant or unwilling to use contraception - You have active autoimmune disease or immunodeficiency 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTeripalimab

240mg intravenous injection, D1, q3w, for 9 weeks (3 cycles)

DRUGGemcitabine + Cisplatin

Gemcitabine 1000mg/m2 + cisplatin 25mg/m2, D1\&D8, q3w, for 9 weeks (3 cycles)

PROCEDURESurgery

Radical resection


Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06721286


Related Trials