Actively Recruiting
Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-07-03
38
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma
CONDITIONS
Official Title
Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 18 and 75 years, male or female
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
- Child-Pugh liver function score A
- Histopathologically confirmed intrahepatic cholangiocarcinoma
- Advanced and unresectable intrahepatic cholangiocarcinoma
- Expected survival longer than 12 weeks
- At least one measurable liver or non-liver lesion per RECIST 1.1 criteria
- Adequate vital organ function including neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL, serum albumin ≥3 g/dL
- Thyroid function normal: TSH ≤ upper limit of normal, T3 and T4 normal
- Bilirubin ≤ 2 times upper limit of normal
- ALT and AST ≤ 2 times upper limit of normal
- Serum creatinine ≤ 1.5 times upper limit of normal and creatinine clearance ≥ 60 ml/min
- Non-lactating or non-pregnant women; agree to use contraception during and for 3 months after treatment
You will not qualify if you...
- Diagnosis of hepatocellular carcinoma, mixed liver cancer, or other non-cholangiocarcinoma malignant tumors
- Prior treatment with PD1, PD-L1, or CTLA-4 antibody therapies
- Presence of other malignant tumors except fully treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma
- Active tuberculosis infection within 1 year before enrollment or untreated past tuberculosis
- Active or suspected autoimmune disease requiring systemic therapy (except hormone replacement for hypothyroidism or non-systemic skin diseases)
- History of interstitial lung disease or pneumonia requiring steroid treatment
- Long-term systemic steroid or immunosuppressive therapy (inhaled or topical steroids allowed)
- Severe heart, lung, or kidney dysfunction
- Uncontrolled high blood pressure (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Abnormal blood clotting or bleeding tendency or on blood thinning therapy
- Hepatitis B virus DNA > 2000 copies/ml or hepatitis C virus RNA > 1000
- Significant bleeding or bleeding risk within 6 months prior to enrollment
- Active infections requiring systemic treatment
- HIV positive status
- History of substance, alcohol, or drug abuse
- Allergy to platinum-based drugs
- Other serious illnesses or social factors that may affect safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
M
Mengya Zang
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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