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New treatment option for Intrahepatic Cholangiocarcinoma (Icc)
Official title Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
ClinicalTrials.gov ID: NCT06852287
What this study is testing
What is chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.?
chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intrahepatic cholangiocarcinoma (icc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Use any systemic research anti-cancer drugs
- Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary...
- 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
See the full eligibility 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 how well it works and adverse reactions according to the protocol requirements.
- Use any systemic research anti-cancer drugs
- Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism...
- 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
- Other systemic malignant tumors in the past 5 years
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tia, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tia, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.