Actively Recruiting
Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-02-28
33
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or above
- Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
- Tumor judged unresectable by three independent surgeons
- Expected lifespan of at least 12 weeks
- ECOG Performance Status score of 0-1
- Voluntary participation with signed informed consent
- Ability to comply with follow-up for efficacy and adverse reaction monitoring
You will not qualify if you...
- Use of any systemic research anti-cancer drugs
- Active autoimmune diseases or history of autoimmune diseases such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, or thyroid disorders
- Asthma requiring bronchodilator treatment
- Congenital or acquired immune dysfunction, including HIV infection
- Clinical symptoms or uncontrolled heart disease
- Severe infection within 4 weeks before starting treatment
- History of allogeneic organ or hematopoietic stem cell transplantation
- Vaccination with live attenuated vaccine within 4 weeks before treatment
- Other systemic malignant tumors within the past 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tia, China, 300060
Actively Recruiting
Research Team
T
Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer
CONTACT
W
wei zhang, surgical chief physician, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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