NCT06852287RecruitingPhase 2
Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Source: ClinicalTrials.gov · Last updated 28 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 20 Oct 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06852287
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 1 Sept 2024 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe infection within 4 weeks before the first use of medication
- Vaccination with attenuated live vaccine within 4 weeks before treatment
Other illness
- 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 (which may include hormone replacement therapy)
- Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
- Clinical symptoms or uncontrolled heart disease
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- Other systemic malignant tumors in the past 5 years
Other
- Asthma requires the use of bronchodilators for medical intervention
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.