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New treatment option for Intrahepatic Cholangiocarcinoma
Official title Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT06298968
What this study is testing
What is combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab?
combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The patient must be required to sign an informed consent form;
- Age 18-75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1;
- Child-Pugh score A;
- Histopathologically confirmed intrahepatic cholangiocarcinoma; consent to provide previously stored tumor tissue specimens or fresh biopsy tumor...
You likely can't join if
- Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer and other non-cholangiocarcinoma malignant tumor components;
- Patients who have received previous treatment with PD1 antibody, programmed death ligand -1 （PD-L1） antibody or cytotoxic T lymphocyte-associated...
- With other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
- Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis...
- Have an active, known or suspected autoimmune disease. people who require only hormone replacement therapy for hypothyroidism and skin diseases that...
- Previous interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy;
See the full eligibility criteria
- The patient must be required to sign an informed consent form;
- Age 18-75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1;
- Child-Pugh score A;
- Histopathologically confirmed intrahepatic cholangiocarcinoma; consent to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions;
- Advanced and unresectable ICC patients;
- The expected survival is longer than 12 weeks;
- At least 1 measurable liver lesion or non-liver lesion (according to RECIST 1.1);
- 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...
- Non-lactating or pregnant women, contraception during or after 3 months of treatment.
- Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer and other non-cholangiocarcinoma malignant tumor components;
- 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;
- With other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
- 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...
- Have an active, known or suspected autoimmune disease. people who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy may be enrolled;
- Previous interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy;
- Long-term systemic hormones (dose equivalent to \>10 mg prednisone/day) or any other form of immunosuppressive therapy are required. people using inhaled or topical corticosteroids may be enrolled;
- Severe cardiopulmonary and renal dysfunction;
- Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Abnormal blood coagulation (PT\>14s), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
- Hepatitis B virus （HBV） DNA\>2000 copies/ml, hepatitis C virus （HCV） RNA\>1000;
- Significant clinically significant bleeding symptoms or a clear tendency to appear within 6 months prior to enrollment;
- Active infections requiring systemic treatment;
- Human immunodeficiency virus (HIV) positive;
- History of psychotropic substance abuse, alcohol abuse or drug abuse;
- Has a history of allergy to platinum;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.