Actively Recruiting
Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-03-03
33
Participants Needed
3
Research Sites
154 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
J
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.
CONDITIONS
Official Title
Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Aged 18 to 75 years, any gender
- ECOG performance status score 0 or 1
- Pathologically or clinically diagnosed intrahepatic cholangiocarcinoma with high-risk factors
- High-risk factors include Stage 61b, single tumor larger than 5cm, multiple tumors in one lobe, vascular invasion, or lymph node involvement
- Locally advanced ICC assessed as surgically resectable by a surgeon
- Adequate organ function including neutrophils, platelets, hemoglobin, serum albumin, thyroid hormones, bilirubin, ALT, AST, and creatinine
- At least one measurable tumor lesion
- Fertile women must agree to effective contraception and have a negative pregnancy test before enrollment
- Male participants with fertile partners must agree to contraception and not donate sperm during the study period
You will not qualify if you...
- Diagnosis of hepatocellular carcinoma, mixed liver cancers, or non-cholangiocarcinoma tumors
- Prior systemic therapy or tumor-related surgery except biliary drainage; prior PD1/PDL1/CTLA4 antibody, Lenvatinib, or chemotherapy; participation in other trials within 30 days
- Other active or recent cancers except certain treated skin or thyroid cancers
- Active pulmonary tuberculosis within one year or untreated tuberculosis
- Active autoimmune diseases requiring systemic therapy
- Use of systemic immunosuppressive therapy or high-dose steroids
- Severe heart, lung, or kidney problems
- Poorly controlled high blood pressure
- Abnormal blood clotting or bleeding tendencies
- High levels of HBV DNA or HCV RNA
- Recent significant bleeding or infections needing treatment
- HIV positive
- History of substance abuse or drug allergy
- Any other conditions affecting safety or study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
2
West China Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
3
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315000
Actively Recruiting
Research Team
F
Feng Cheng, MD
CONTACT
J
Jianhua Rao, MD
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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