Combination treatment for advanced intrahepatic cholangiocarcinoma and gallbladder cancer

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

This study is testing a new combination treatment for people with advanced bile duct and gallbladder cancer to see if it can help them respond better to therapy and possibly become eligible for surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (other)
• Drugs / interventions: toripalimab, lenvatinib, chemotherapy, immunotherapy
• Locations: 1 site (Tianjin, Tia)
• Trial ID: NCT06852287 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer that is deemed unresectable.

Not a fit: Patients with active autoimmune diseases, those requiring systemic anti-cancer drugs, or with significant immune dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with advanced intrahepatic cholangiocarcinoma and gallbladder cancer.

How similar studies have performed: While the combination of these specific treatments is novel, similar approaches using hepatic artery infusion chemotherapy have shown promise in other studies.

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

Where this trial is running

Tianjin, Tia

• 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

Conditions: Intrahepatic Cholangiocarcinoma, Gall Bladder Cancer, GemOX, Lenvatinib, Toripalimab