Actively Recruiting
Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Prospective, Single-arm Phase II Trial
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-07-03
38
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment approach for patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC), a type of liver cancer with poor survival rates and limited treatment options. This phase 2 study aims to assess the safety and effectiveness of combining gemcitabine and cisplatin chemotherapy with Lenvatinib, a targeted therapy, and Adebrelimab, an immune checkpoint inhibitor. Participants will receive gemcitabine and cisplatin chemotherapy every 3 weeks for a total of 6 cycles. Lenvatinib is taken orally once daily at 8 mg, and Adebrelimab is given intravenously every 3 weeks at 1200 mg. Both Lenvatinib and Adebrelimab treatments continue for up to 2 years. This combined therapy is being studied as a single treatment arm in this trial. During the study, participants will be monitored for tumor response and disease progression using objective response rates and other measures such as disease control rate and survival times, assessed for up to approximately 3 years. Safety will be closely followed by tracking treatment-related adverse events. The study involves regular clinical evaluations, laboratory tests, and imaging to assess treatment effects and participant health over time.
CONDITIONS
Brief 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 18 to 75 years, male or female
- ECOG performance status score of 0 or 1
- Child-Pugh score A liver function
- Histologically confirmed intrahepatic cholangiocarcinoma
- Advanced and unresectable disease
- Expected survival longer than 12 weeks
- At least one measurable liver or non-liver lesion
- Adequate organ function including neutrophils ≥1.5x10⁹/L, platelets ≥100x10⁹/L, hemoglobin ≥9 g/dl, serum albumin ≥3 g/dl
- Thyroid function within normal limits
- Bilirubin and liver enzymes ≤ 2 times upper limit of normal
- Serum creatinine ≤1.5 times upper limit of normal with creatinine clearance ≥60 ml/min
- Non-pregnant, non-lactating women using 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 tumors
- Previous treatment with PD1, PD-L1, or CTLA-4 antibodies
- Other active malignant tumors except certain treated skin, cervical, or thyroid cancers
- Active tuberculosis infection within 1 year or untreated past tuberculosis
- Active or suspected autoimmune disease requiring systemic therapy
- History of interstitial lung disease or pneumonia needing steroid treatment
- Need for long-term systemic corticosteroids or immunosuppressants
- Severe heart, lung, or kidney dysfunction
- Uncontrolled high blood pressure
- Abnormal blood clotting or bleeding disorders
- High levels of hepatitis B or C virus
- Clinically significant bleeding within 6 months
- Active infections needing systemic treatment
- HIV positive
- History of substance abuse
- Allergy to platinum-based drugs
- Other serious illnesses or factors affecting safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive combined therapy consisting of gemcitabine and cisplatin chemotherapy every 3 weeks for a total of 6 cycles, daily oral dosing of Lenvatinib continuously for up to 2 years, and intravenous Adebrelimab every 3 weeks for up to 2 years.
Chemotherapy and Adebrelimab infusions every 3 weeks, daily oral Lenvatinib dosing
Trial Site Locations
Total: 1 location
1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
M
Mengya Zang
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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