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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced intrahepatic cholangiocarcinoma (a type of bile duct cancer) and gallbladder cancer that cannot be surgically removed. The researchers are combining a specific type of chemotherapy delivered directly to the liver with medications that help the body's immune system fight cancer. The goal is to see if this combination can improve treatment effectiveness, potentially allowing some patients to undergo surgery later on.

To participate in the trial, patients need to be at least 18 years old and have a confirmed diagnosis of either intrahepatic cholangiocarcinoma or gallbladder cancer that cannot be removed by surgery. They should also be in relatively good health, as determined by a score that assesses their ability to carry out daily activities. Participants will receive the study treatment and will be monitored for how well it works and for any side effects. This trial aims to find better ways to treat these difficult-to-treat cancers and improve survival rates for patients.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Age 18 or above
• • 2. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
• • 3. A tumor that cannot be removed by three independent surgeons.
• • 4. Expected lifespan ≥ 12 weeks
• • 5. ECOG PS score 0-1 points
• • 6. The patient voluntarily participates and signs an informed consent form;
• • 7. Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.
• Exclusion criteria:
• • 1. Use any systemic research anti-cancer drugs
• • 2. Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)
• • 3. Asthma requires the use of bronchodilators for medical intervention
• • 4. Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
• • 5. Clinical symptoms or uncontrolled heart disease
• • 6. Severe infection within 4 weeks before the first use of medication
• • 7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• • 8. Vaccination with attenuated live vaccine within 4 weeks before treatment
• • 9. Other systemic malignant tumors in the past 5 years