Actively Recruiting
D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC
Led by Fujian Provincial Hospital · Updated on 2025-06-26
37
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.
CONDITIONS
Official Title
D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Child-Pugh liver function grade A or B
- ECOG performance score of 0 or 1
- Pathologically confirmed unresectable intrahepatic cholangiocarcinoma evaluated by two senior hepatobiliary surgeons
- At least one measurable lesion of 10 mm or larger on CT or MRI, untreated by local therapies
- Expected survival time longer than 3 months
- No prior tumor-related therapies such as targeted therapy, immunotherapy, radiotherapy, or chemotherapy
- Adequate organ function including neutrophil count ≥1.5x10^9/L, hemoglobin ≥9.0 g/L, platelets ≥75x10^9/L; total bilirubin ≤1.5 times ULN (≤2.5 times ULN after biliary drainage for obstructive jaundice); ALT and AST ≤5 times ULN; albumin ≥30 g/L; serum creatinine ≤1.5 mg/dL; creatinine clearance ≥60 ml/min; INR and APTT ≤1.5 times ULN
- No history of severe arrhythmia, heart failure, severe ventilation dysfunction, or severe pulmonary infection
- Women of childbearing age must agree to use contraception during treatment and for 6 months after; negative pregnancy test within 7 days before enrollment; non-lactating; men must agree to contraception during and 6 months after the study
You will not qualify if you...
- Previous local anti-tumor treatments like radiotherapy or radiofrequency ablation, except relapse allowed 6 months after surgery and biliary drainage procedures
- Allergy to gemcitabine, oxaliplatin, Envafolimab, Lenvatinib, or their components
- History of other cancers within 5 years except cured basal cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma
- Prior or planned organ transplant
- Active autoimmune disease or expected recurrence of autoimmune conditions
- History of immune deficiency or recent use of immunosuppressants or systemic steroids within 2 weeks
- Known bleeding or clotting disorders or recent therapeutic anticoagulant or thrombolytic use (low-dose aspirin or low-molecular-weight heparin allowed)
- Serious infections requiring hospitalization within 4 weeks or active lung inflammation or infection needing antibiotics within 2 weeks before treatment
- Mental illness or history of substance abuse, alcoholism, or drug use
- Pregnant or breastfeeding women
- Any other reason judged by the investigator to exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Provincial Hospital
Fuzhou, Fujian, China
Actively Recruiting
Research Team
M
Maolin Yan, Doctor
CONTACT
J
Junyi Wu, Doctor
CONTACT
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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