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Trial Title:
Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma
NCT ID:
NCT06298968
Condition:
Intrahepatic Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Gemcitabine
Lenvatinib
Conditions: Keywords:
Lenvatinib
Adebrelimab
gemcitabine
cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab
Description:
Gemcitabine (1000mg/m²) and cisplatin (25mg/m²) on day1 and 8 every 3 weeks, with a total
of 6 cycles.
Lenvatinib 8 mg once daily (QD) oral dosing, continuous use for 2 years. Adebrelimab
1200mg intravenously every 3 weeks, continuous use for 2 years.
Arm group label:
Combined therapy using GC, Lenvatinib and Adebrelimab
Summary:
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
Detailed description:
Most intrahepatic cholangiocarcinoma (ICC) patients are often accompanied by local or
distant metastases and lose the opportunity for surgical resection. For patients with
unresectable ICC who have been in stages IIIb and IV (AJCC/UICC, V2, 2018), the survival
time is less than 4 months, and there is currently no standard treatment. TheGC
chemotherapy (gemcitabine and cisplatin) has been used in the treatment of advanced
intrahepatic cholangiocarcinoma, but the efficacy is still unsatisfactory. Lenvatinib is
a small molecule multi-kinase inhibitor, the main targets including VEGFR1-3, fibroblast
growth factor receptor 1-4, PDGFRα, RET(ret proto-oncogene ), KIT(KIT proto-oncogene,
receptor tyrosine kinase), have anti-angiogenic effects, have been proven effective in
hepatocellular carcinoma. In recent years, immunological checkpoint inhibitors (ICIs)
have shown remarkable therapeutic effects in the treatment of various solid tumors.
Combined with other therapies such as chemotherapy and targeted drugs is an important
direction to improve the therapeutic effect of immunological checkpoint inhibitors. In
this study, the investigators aim to evaluate the efficacy and safety of GC chemotherapy
combined with Lenvatinib and immune checkpoint inhibitor PD-L1 antibody Adebrelimab for
patients with advanced and unresectable intrahepatic cholangiocarcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient must be required to sign an informed consent form;
2. Age 18-75 years old, male or female;
3. Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1;
4. Child-Pugh score A;
5. Histopathologically confirmed intrahepatic cholangiocarcinoma; consent to provide
previously stored tumor tissue specimens or fresh biopsy tumor lesions;
6. Advanced and unresectable ICC patients;
7. The expected survival is longer than 12 weeks;
8. At least 1 measurable liver lesion or non-liver lesion (according to RECIST 1.1);
9. Functional indicators of vital organs meet the following requirements a Neutrophils
≥1.5*109/L; platelets≥100*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; b Thyroid
stimulating hormone (TSH) ≤ 1 times the upper limit of normal value(ULN), T3, T4 are
in the normal range; c bilirubin ≤ 2 times ULN; Alanine aminotransferase （ALT） and
Aspartate aminotransferase （AST） ≤ 2 times ULN; serum creatinine ≤ 1.5 ULN,
creatinine clearance rate ≥ 60ml / min;
10. Non-lactating or pregnant women, contraception during or after 3 months of
treatment.
Exclusion Criteria:
1. Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer and other
non-cholangiocarcinoma malignant tumor components;
2. Patients who have received previous treatment with PD1 antibody, programmed death
ligand -1 （PD-L1） antibody or cytotoxic T lymphocyte-associated antigen-4 （CTLA4）
antibody;
3. With other malignant tumors, except for fully treated non-melanoma skin cancer,
cervical carcinoma in situ, and papillary thyroid carcinoma;
4. Active tuberculosis infection. Patients with active tuberculosis infection within 1
year prior to enrollment; had a history of active tuberculosis infection more than 1
year before enrollment, did not receive formal anti-tuberculosis treatment or
tuberculosis is still active;
5. Have an active, known or suspected autoimmune disease. Subjects who require only
hormone replacement therapy for hypothyroidism and skin diseases that do not require
systemic therapy may be enrolled;
6. Previous interstitial lung disease, or (non-infectious) pneumonia and need oral or
intravenous steroid therapy;
7. Long-term systemic hormones (dose equivalent to >10 mg prednisone/day) or any other
form of immunosuppressive therapy are required. Subjects using inhaled or topical
corticosteroids may be enrolled;
8. Severe cardiopulmonary and renal dysfunction;
9. Suffering from high blood pressure, and can not be well controlled by
antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure
≥90mmHg);
10. Abnormal blood coagulation (PT>14s), with bleeding tendency or receiving
thrombolytic or anticoagulant therapy;
11. Hepatitis B virus （HBV） DNA>2000 copies/ml, hepatitis C virus （HCV） RNA>1000;
12. Significant clinically significant bleeding symptoms or a clear tendency to appear
within 6 months prior to enrollment;
13. Active infections requiring systemic treatment;
14. Human immunodeficiency virus (HIV) positive;
15. History of psychotropic substance abuse, alcohol abuse or drug abuse;
16. Has a history of allergy to platinum;
17. Other factors that may influence the safety of the subject or the compliance of the
test by the investigator. Serious illnesses (including mental illness), severe
laboratory tests, or other family or social factors that require combined treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital of Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Mengya Zang
Phone:
86-20-62787430
Email:
zangmy@163.com
Start date:
April 26, 2024
Completion date:
February 25, 2027
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06298968
