Actively Recruiting
D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma
Led by Fujian Provincial Hospital · Updated on 2025-06-26
37
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving D-TACE-HAIC (using the GEMOX regimen), Envafolimab, and Lenvatinib for people with unresectable intrahepatic cholangiocarcinoma. This prospective, single-arm, multicenter, phase II trial aims to assess how well this combined therapy works and its safety for patients who cannot undergo surgery. The study is led by Fujian Provincial Hospital and focuses on this specific liver cancer type with complex treatment needs. Participants will receive the combination therapy of D-TACE-HAIC alongside Envafolimab and Lenvatinib. The treatment plan involves administering these therapies together to target the cancer, with all patients placed in a single combination therapy group. The study will observe the effects of this combined approach over time, monitoring its impact on the disease. During the study, participants will be evaluated through imaging scans to measure tumor response four weeks after starting treatment. Researchers will also track overall survival and progression-free survival for up to 60 months and monitor any treatment-related side effects for up to 12 months. Other assessments include disease control rate and safety evaluations. The total participation period extends from enrollment through long-term follow-up to understand the treatment's outcomes and safety profile.
CONDITIONS
Brief Title
D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages between 18 and 75 years
- Child-Pugh liver function grade A or B
- ECOG performance status score of 1 or less
- Pathologically confirmed intrahepatic cholangiocarcinoma deemed unresectable by two senior hepatobiliary surgeons
- At least one measurable lesion per RECIST 1.1 criteria with diameter 10 mm or more, untreated by local therapies
- Expected survival time greater than 3 months
- No prior tumor-targeted therapy, immunotherapy, radiotherapy, or chemotherapy
- Adequate vital organ function including blood counts, liver, renal, and coagulation parameters meeting specified thresholds
- No history of severe arrhythmia, heart failure, severe lung dysfunction, or severe pulmonary infection
- Women of childbearing age must agree to contraception during treatment and for 6 months after; men must agree to contraception during study and for 6 months post-study
- Negative pregnancy test within 7 days prior to enrollment; must not be lactating
You will not qualify if you...
- Prior local anti-tumor treatments such as radiotherapy or radiofrequency ablation, except relapse allowed 6 months post-surgery; biliary drainage allowed
- Allergy to gemcitabine, oxaliplatin, envafolimab, lenvatinib, or their components
- History of other malignant tumors within past 5 years except cured basal cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma
- Previous or planned organ transplant
- Active autoimmune disease or expected recurrence including interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid disorders
- Immune deficiency or use of immunosuppressants/systemic hormones within 2 weeks prior to consent
- Known bleeding or clotting disorders; recent therapeutic anticoagulant or thrombolytic use (prophylactic low-dose aspirin or heparin allowed)
- Serious infections requiring hospitalization in past 4 weeks or signs of active infection within 2 weeks before treatment
- Mental illness, history of substance abuse, alcoholism, or drug use
- Pregnant or lactating women
- Any other condition judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive combination drug therapy including TACE-HAIC, Envafolimab, and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.
Visits whenever treatment-related adverse events occur and assessments at 4 weeks after initiation
Duration - Up to 60 months
Participants are monitored for overall survival and progression-free survival outcomes.
Periodic assessments until 60 months
Trial Site Locations
Total: 1 location
1
Fujian Provincial Hospital
Fuzhou, Fujian, China
Actively Recruiting
Research Team
M
Maolin Yan, Doctor
J
Junyi Wu, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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