Combination treatment for advanced intrahepatic cholangiocarcinoma and gallbladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a novel treatment approach for patients with advanced and unresectable intrahepatic cholangiocarcinoma and gallbladder cancer. It combines hepatic arterial infusion chemotherapy using gemcitabine and oxaliplatin with the tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The goal is to enhance treatment efficacy while minimizing systemic toxicity, potentially allowing for surgical options in the future. The study will evaluate the objective response rate as the primary endpoint, alongside secondary endpoints such as surgical resection rates and overall survival.

Why it matters

Who can join: the full rules

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

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tia, China Recruiting

Study contacts

• Study coordinator: Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer
• Email: zhang.wei@tmu.edu.cn
• Phone: 86-2223340123

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• Combining toripalimab with GemCis for treating resectable intrahepatic cholangiocarcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.