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New treatment option for Intrahepatic Cholangiocarcinoma
Official title GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence
ClinicalTrials.gov ID: NCT05557578
What this study is testing
What is Tislelizumab combined with GEMOX (GOT) regimen?
Tislelizumab combined with GEMOX (GOT) regimen is an investigational medicine, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
Also referred to as Gemcitabine, Oxaliplatin.
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
- Intrahepatic cholangiocarcinoma (ICC) arises from the epithelial cells of bile ducts and occurs proximal to the segmental biliary ducts. ICC is highly aggressive, long-term survival only can be achieved in patients with R0 surgical resection.
- 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
- 18-75 yo;
- Patients of Pathological confirmed intrahepatic cholangiocarcinoma who has never received systemic therapy including chemotherapy, immunotherapy...
- Patients of resectable ICC with high risk recurrent factors: ①Maximum diameter greater than 5cm or multiple tumors. ②Preoperative CA19-9 greater than...
- Eastern Cooperative Oncology Group(ECOG)-Performance status(PS) score is 0 before first drug administration;
- Child-Pugh classification is class A;
You likely can't join if
- Patient with non-intrahepatic cholangiocarcinoma；
- Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation, interventions in 28 days prior to the first dose of the study (except...
- Distant metastasis；
- hepatitis B virus (HBV) DNA\>2000 copies/ml, hepatitis C virus (HCV) RNA\>1000;
- Long-term glucocorticoid users require long-term systemic hormones (equivalent to \>10 mg Prednisone/day) or any other form of immunosuppressive...
- Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy；
See the full eligibility criteria
- 18-75 yo;
- Patients of Pathological confirmed intrahepatic cholangiocarcinoma who has never received systemic therapy including chemotherapy, immunotherapy, target therapy and other anti-cancer therapy;
- Patients of resectable ICC with high risk recurrent factors: ①Maximum diameter greater than 5cm or multiple tumors. ②Preoperative CA19-9 greater than 200 Unit(U)/mL ③Tumors invaded adjacent blood vessels ④Preoperative...
- Eastern Cooperative Oncology Group(ECOG)-Performance status(PS) score is 0 before first drug administration;
- Child-Pugh classification is class A;
- Estimated overall survival is greater than 16 weeks;
- The level of organ function meets the criteria and can tolerate surgery before the first treatment. Main organs meet the criteria as below: haemoglobin≥90g/L，Neutrophil count≥1.5×10⁹/L，Platelet count≥100×10⁹/L；Aspartate...
- Male and female people with potential fertility had to agree to the use of effective contraceptive methods throughout the study period；
- Sign an informed consent form agreeing to provide previously preserved specimens of tumor tissue or fresh detection of tumor lesions.
- Patient with non-intrahepatic cholangiocarcinoma；
- Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation, interventions in 28 days prior to the first dose of the study (except for previous non-tumor-related surgeries and diagnostic biopsies)；
- Distant metastasis；
- hepatitis B virus (HBV) DNA\>2000 copies/ml, hepatitis C virus (HCV) RNA\>1000;
- Long-term glucocorticoid users require long-term systemic hormones (equivalent to \>10 mg Prednisone/day) or any other form of immunosuppressive therapy；
- Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy；
- Patients with complete bowel obstruction and incomplete intestinal obstruction that require treatment, but patients who have been relieved of obstruction by ostomy or stent placement can be enrolled；
- Active severe clinical infections (\> grade 2, NCI-CTCAE version 5.0), including active TB; Have a history of active TB infection at least 1 year before enrolment, have not received regular anti-tuberculosis (TB)...
- Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L), severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease). except for recovered radiation...
- Clinically significant cardiovascular diseases; With hypertension, antihypertensive drugs cannot be well controlled (systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
- Patient who are receiving renal replacement therapy；
- History of other malignancies in the last 5 years. With the exception of carcinoma of the skin basal cells that have been cured or carcinoma in situ in the cervix;
- Others situations are not expected to tolerate surgical treatment；
- People with allergic reactions to any component of the drug under study;
- There are other unsuitable candidates for clinical trials, such as alcohol dependence, mental illness, pregnancy (or lactation).
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
- Hanzhou, 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 Hangzhou, Zhejiang, China; Hanzhou, 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.