RecruitingPhase 2NCT06852287

Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

33 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Gall Bladder Cancer Intrahepatic Cholangiocarcinoma (Icc)

Summary

For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects. This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of chemotherapy delivered directly into the liver (via the hepatic artery), along with two other drugs — lenvatinib and toripalimab — for people with advanced bile duct cancer or gallbladder cancer that cannot be surgically removed. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) or gallbladder cancer - Three independent surgeons agree the tumor cannot be surgically removed - You are in good general health with a life expectancy of at least 12 weeks - You are willing to participate and comply with follow-up visits **You may NOT be eligible if:** - You are receiving other cancer treatments - You have an active autoimmune disease (e.g., inflammatory lung disease, colitis, hepatitis) - You have HIV infection or another immune deficiency - You have uncontrolled heart disease - You had a serious infection within the past 4 weeks - You have had an organ transplant or bone marrow transplant - You had another cancer in the past 5 years (other than this one) 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

DRUGchemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.

Toripalimab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight\<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd) Chemotherapy by hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.