Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalim… (NCT06852287) | Clinical Trial Compass
RecruitingPhase 2
Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
China33 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 or above
. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
. A tumor that cannot be removed by three independent surgeons.
. Expected lifespan ≥ 12 weeks
. ECOG PS score 0-1 points
. The patient voluntarily participates and signs an informed consent form;
. Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT06852287
SponsorTianjin Medical University Cancer Institute and Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-09-01
Contact for this trial
Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer
. 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)
. Asthma requires the use of bronchodilators for medical intervention
. Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
. Clinical symptoms or uncontrolled heart disease
. Severe infection within 4 weeks before the first use of medication
. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
. Vaccination with attenuated live vaccine within 4 weeks before treatment