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New treatment option for Intrahepatic Cholangiocarcinoma (Icc)
Official title Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT06721286
What this study is testing
What is Teripalimab?
Teripalimab 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
- This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18, male or female;
- Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met...
- Can not received systemic treatment before participating in the study;
- ECOG PS score 0-1;
- The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and...
You likely can't join if
- Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such...
- Any other research drugs within 4 weeks before enrollment;
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis...
- Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
- Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within...
- Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug...
See the full eligibility criteria
- Age ≥ 18, male or female;
- Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met: 2.1 Single tumor, diameter greater than 5cm (T1b) 2.2 Single tumor with...
- Can not received systemic treatment before participating in the study;
- ECOG PS score 0-1;
- The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.
- Laboratory inspection shall meet the following requirements: Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of...
- The patient voluntarily participated and signed the informed consent form;
- It is expected that the compliance is good, and the how well it works and adverse reactions can be followed up according to the requirements of the scheme.
- Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);
- Any other research drugs within 4 weeks before enrollment;
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after...
- Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
- Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within one year, and clinically significant supraventricular or ventricular...
- Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause\>38.5 ° C occurred during...
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Live attenuated vaccine shall be inoculated within 4 weeks before the first administration or planned during the study period;
- Suffered from or accompanied by other system malignant tumors in the last 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
- Allergic to any test drug;
- Pregnant and lactating women, fertile people are unwilling to take effective contraceptive measures;
- Uncontrollable psychosis;
- Other situations that the researcher thinks are not suitable for inclusion. If the patient has central nervous system metastasis, has serious laboratory examination abnormalities, and is accompanied by family or social...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.