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New treatment option for Intrahepatic Cholangiocarcinoma
Official title Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
ClinicalTrials.gov ID: NCT06208462
What this study is testing
What is Adebrelimab?
Adebrelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
Also referred to as SHR-1316.
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
- Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.
- 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 sign the informed consent;
- Age 18-75 years old, male and female;
- ECOG Physical status Score (PS score) 0 or 1;
- Patients with ICC who have been pathologically diagnosed (histopathological and/or cytological examination) or clinically diagnosed as having...
- Patients with untreated and resectable locally advanced ICC who have been assessed by the surgeon as surgically resectable;
You likely can't join if
- Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;
- Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);Patients who relapse after surgery, have received PD1...
- Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary...
- Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of...
- Have an active, known, or suspected autoimmune disease. people with hypothyroidism requiring hormone replacement therapy and skin conditions that do...
- Long-term acceptance of systemic sex hormones (doses equivalent to \> 10mg prednisone per day) or any other form of immunosuppressive therapy...
See the full eligibility criteria
- The patient must sign the informed consent;
- Age 18-75 years old, male and female;
- ECOG Physical status Score (PS score) 0 or 1;
- Patients with ICC who have been pathologically diagnosed (histopathological and/or cytological examination) or clinically diagnosed as having high-risk factors; Risk factors are defined as follows: Stage ≥Ib, single...
- Patients with untreated and resectable locally advanced ICC who have been assessed by the surgeon as surgically resectable;
- The functional indicators of vital organs meet the following requirements ① Neutrophils ≥1.5\ 109/L; Platelet ≥80\ 109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl;② Thyroid stimulating hormone (TSH) ≤ 1 times the upper...
- The subject has at least one measurable lesion (according to RECIST1.1);
- Fertile women: must agree to abstain from sex (abstain from heterosexual intercourse) or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final...
- For male people whose partner is a fertile woman, they must agree to abstain from sex or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final...
- Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;
- Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);Patients who relapse after surgery, have received PD1 antibody, PDL1 antibody or CTLA4 antibody, Lenvatinib, chemotherapy in the...
- Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
- Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of active tuberculosis infection more than 1 year before enrollment, had...
- Have an active, known, or suspected autoimmune disease. people with hypothyroidism requiring hormone replacement therapy and skin conditions that do not require systemic therapy are eligible;
- Long-term acceptance of systemic sex hormones (doses equivalent to \> 10mg prednisone per day) or any other form of immunosuppressive therapy. Participants using inhaled or topical corticosteroids may be enrolled;
- Severe cardiopulmonary and renal dysfunction;
- Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Abnormal coagulation function (PT\> 14s), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy;
- HBV DNA\> 2000IU/ml, HCV RNA\> 1000 IU/ml;
- Had clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
- Active infections that require systemic treatment;
- Human immunodeficiency virus (HIV, HIV1/2 antibodies) positive;
- Have a history of psychotropic substance abuse, alcohol abuse or drug use;
- Have a history of drug allergy;
- Other factors, as determined by the investigator, that may affect the subject's safety or compliance with the test. Such as a serious illness (including mental illness) requiring co-treatment, serious laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Chengdu, Sichuan, China
- Ningbo, Zhejiang, 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 Nanjing, Jiangsu, China; Chengdu, Sichuan, China; Ningbo, Zhejiang, 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.