Actively Recruiting
Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma
Led by Tongji Hospital · Updated on 2024-11-05
36
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of hepatic artery infusion chemotherapy combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.
CONDITIONS
Official Title
Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed intrahepatic cholangiocarcinoma.
- Age 18 years or older.
- ECOG performance status score of 0 or 1.
- Not suitable for radical surgery after expert evaluation, including if complete tumor removal is not feasible.
- For patients without cirrhosis, normal liver volume less than 30%; with cirrhosis, less than 40%, or ICG-R15 >15%.
- More than one tumor lesion.
- No prior systemic anti-tumor treatment for intrahepatic cholangiocarcinoma.
- At least one measurable lesion or a lesion that has progressed after local treatment according to RECIST v1.1.
- Patients with certain types of portal vein and hepatic vein tumor thrombus as specified.
- Patients with up to three metastatic lesions in no more than two organs outside the liver, each no larger than 3 cm.
- Child-Pugh score of 7 or less.
- Adequate organ and bone marrow function within 7 days before inclusion.
- Estimated life expectancy of 12 weeks or more.
- Use of effective contraception during treatment and for 6 months after last medication if of childbearing potential.
- Signed informed consent and able to comply with study procedures.
You will not qualify if you...
- Sarcomatoid intrahepatic cholangiocarcinoma or mixed hepatocellular carcinoma.
- History of hepatic encephalopathy or liver transplantation.
- Symptomatic pleural effusion, ascites, or pericardial effusion needing drainage.
- Active hepatitis B or C infection above specified viral load levels.
- Central nervous system metastases.
- Recent serious bleeding events or high bleeding risk.
- Recent arterial or venous thromboembolic events.
- Recent use of high-dose aspirin or platelet inhibitors.
- Uncontrolled high blood pressure or history of hypertensive crisis.
- Unresolved toxicities from previous treatments above grade 1.
- Symptomatic heart failure or significant arrhythmias.
- Severe bleeding disorders or currently on thrombolytic therapy.
- Recent gastrointestinal perforation, fistula, obstruction, or inflammatory bowel disease.
- Recent radiotherapy with unresolved toxicities.
- Severe lung diseases or active tuberculosis.
- HIV or syphilis infection requiring treatment.
- Active serious infections or autoimmune diseases requiring systemic treatment.
- Recent immunosuppressive drug use except certain corticosteroids.
- Recent live attenuated vaccine.
- Recent major surgery or unhealed wounds.
- Recent local treatment for hepatocellular carcinoma.
- Recent use of traditional Chinese medicine with anti-tumor or immunomodulatory effects.
- Uncontrolled metabolic or systemic diseases increasing medical risk.
- Other malignancies within 5 years except certain skin cancers.
- Previous treatment with PD-1/PD-L1 or other immunotherapies or certain targeted therapies.
- Known allergies to study drugs or severe reactions to monoclonal antibodies.
- Diagnosed vascular aneurysms related to major arteries.
- Participation in other clinical trials within 4 weeks.
- Pregnant or breastfeeding women.
- Extensive metastases or tumor thrombi involving critical vessels.
- Other acute or chronic conditions making participation unsafe or unreliable.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Z
Ze-yang Ding
CONTACT
H
Han Gao
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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