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New treatment option for Intrahepatic Cholangiocarcinoma (Icc)
Official title A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC
ClinicalTrials.gov ID: NCT06925516
What this study is testing
What is Apatinib and Adebrelimab in Combination With chemotherapy?
Apatinib and Adebrelimab in Combination With chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intrahepatic cholangiocarcinoma (icc).
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
- The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)
- 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
- 1\. Provided informed consent and sign the informed consent form;
- 2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
- 3\. Histologically or cytologically confirmed ICC;
- 4\. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
- 5\. No previous systematic treatment for advanced ICC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy...
You likely can't join if
- 1\. Known hepatocellular carcinoma, Combined Hepatocellular and Intrahepatic Cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, fibrolamellar...
- 2\. Other active malignant tumor except ICC within 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin...
- 3\. Planning to or previously received organ or allogenic bone marrow transplantation;
- 4\. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;
- 5\. Previous treatment with Immune Checkpoint Inhibitors: Prior use of any antibody/drug targeting T-cell co-regulatory proteins (immune...
- 6\. Moderate-to-severe ascites with clinical symptoms, i.e., requiring therapeutic puncture or drainage, or Child-Pugh score \>2, except the people...
See the full eligibility criteria
Who can join
- 1\. Provided informed consent and sign the informed consent form;
- 2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
- 3\. Histologically or cytologically confirmed ICC;
- 4\. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
- 5\. No previous systematic treatment for advanced ICC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not...
- 6\. Have at least one measurable lesion (in accordance with RECIST v1.1, major diameter ≥ 10 mm of the measurable lesion in spiral CT scan or short diameter of swollen lymph node ≥ 15 mm; the lesion with previous local...
- 7\. Child-Pugh class: Grade A;
- 8\. ECOG-PS score: 0-1;
- 9\. With a life expectancy of ≥ 12 weeks;
- 10\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;
- 11\. If people have active hepatitis B (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be \< 500 IU/mL (or must be \< 2500 copy/mL if copy/mL is the only unit available in the study site) and are willing to...
- 12\. Women of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug...
- 13\. Men with female partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last...
What rules you out
- 1\. Known hepatocellular carcinoma, Combined Hepatocellular and Intrahepatic Cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, fibrolamellar carcinoma of liver;
- 2\. Other active malignant tumor except ICC within 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in...
- 3\. Planning to or previously received organ or allogenic bone marrow transplantation;
- 4\. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;
- 5\. Previous treatment with Immune Checkpoint Inhibitors: Prior use of any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints), including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies...
- 6\. Moderate-to-severe ascites with clinical symptoms, i.e., requiring therapeutic puncture or drainage, or Child-Pugh score \>2, except the people with small amount of ascites in radiological examination but free from...
- 7\. History of gastrointestinal bleeding within 6 months prior to the start of study treatment or clear tendency of gastrointestinal bleeding;
- 8\. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment;
- 9\. Known genetic or acquired hemorrhage (e.g., coagulation dysfunction) or thrombotic tendency, for example, subject with hemophilia; current or recent (within 10 days prior to the start of study treatment) use of...
- 10\. Current or recent (within 10 days prior to the start of study treatment) use of aspirin (\> 325 mg/day, maximum dose for antiplatelet) or dipyridamole, ticlopidine, clopidogrel and cilostazol;
- 11\. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment, for example, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction)...
- 12\. Cardiac clinical symptom or disease that is not well controlled;
- 13\. Hypertension that cannot be well controlled through antihypertensive drugs, allowing to reach the above parameters by the use of antihypertensive therapy; previous hypertensive crisis or hypertensive encephalopathy;
- 14\. Major vascular disease within 6 months prior to the start of study treatment (for example, aortic aneurysm requiring surgical repair or peripheral arterial thrombosis in recent days); Serious, unhealed or splitting...
- 15\. Evidence on intraperitoneal pneumatosis that can not be explained by puncture or recent surgery;
- 16\. Previous or current presence of metastasis to central nervous system; Metastatic disease involving main airway or blood vessels (e.g. Vena cava tumor invasion or complete occlusion of the major portal vein due to...
- 17\. History of hepatic encephalopathy; Current interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease which required hormonal therapy, or other pulmonary...
- 18\. Active autoimmune disease or history of autoimmune disease and may relapse (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis...
- 19\. Use of immunosuppressive medication within 14 days prior to the start of study treatment, or systemic corticosteroid therapy to achieve the objective of immunosuppression (Prednisone at the dose of \>10mg/day or...
- 20\. Known history of hypersensitivity to the active substance or to any other components of each investigational medicinal product;
- 21\. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic...
- 22\. Congenital or acquired immunodeficiency (e.g., HIV infection);
- 23\. Hepatitis B and hepatitis C co-infection;
- 24\. Attenuated live vaccine therapy administered within 28 days prior to the start of study treatment, or are expected to receive such vaccines during Adebrelimab treatment or within 60 days after the last dose of...
- 25\. Other factors that may affect the study results or lead to early study termination as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring...
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.