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GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence | Clinical Trials | Clareo Health

RECRUITINGPHASE2

GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence

Tislelizumab Combined with GEMOX (GOT) Applied As Neoadjuvant Regimen for Patients of Resectable Intrahepatic Cholangiocarcinoma with High-risk Factors of Recurrence: a Single Arm, Single Center, Prospective, Explorative Clinical Trail.

NCT05557578•Zhejiang Cancer Hospital

View on ClinicalTrials.gov

Summary

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. Large diameter of tumor, multiple tumors, preoperative carbohydrate antigen(CA)19-9 elevated, tumors invaded adjacent blood vessels and preoperative radiology hints suspected regional lymph node metastasis were considered as high-risk factors of recurrence in the previous study. Chemotherapy can trigger antigen release and induces strong anti-tumor effects of T cells due to cytotoxic cell death. Immune checkpoint inhibitors can relieve tumor immunosuppressive microenvironment. Hence, we aim to investigate objective response rate and R0 resection rate and survival rate of patients with high-risk factors of recurrence who receives Tislelizumab combined with GEMOX regimen(GOT) as a neoadjuvant therapy.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-75 yo;
•2. Patients of Pathological confirmed intrahepatic cholangiocarcinoma who has never received systemic therapy including chemotherapy, immunotherapy, target therapy and other anti-cancer therapy;
•3. 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 radiology hints suspected regional lymph node metastasis.
•⑤Tumor tissues confirmed by CT or MRI, at least one measurable lesion exists according to RECIST v1.1.
•4. Eastern Cooperative Oncology Group(ECOG)-Performance status(PS) score is 0 before first drug administration;
•5. Child-Pugh classification is class A;
+5 more criteria

Exclusion Criteria

•1. Patient with non-intrahepatic cholangiocarcinoma；
•2. 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)；
•3. Distant metastasis；
•4. hepatitis B virus (HBV) DNA\>2000 copies/ml, hepatitis C virus (HCV) RNA\>1000;
•5. Long-term glucocorticoid users require long-term systemic hormones (equivalent to \>10 mg Prednisone/day) or any other form of immunosuppressive therapy；
•6. Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy；
•7. 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；
•8. 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) treatment or are still active; active, known or suspected autoimmune disease;
•9. 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 pneumonia);
•10. Clinically significant cardiovascular diseases; With hypertension, antihypertensive drugs cannot be well controlled (systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
+5 more criteria

Locations (2)

1# Banshan East Rd. Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Jia Wu

Hanzhou, Zhejiang, China

Key Dates

Start Date

May 5, 2023

Primary Completion Date

November 30, 2025

Completion Date

December 1, 2025

Last Updated

February 11, 2025

Enrollment

ESTIMATED participants

Conditions

Intrahepatic Cholangiocarcinoma

Interventions

Tislelizumab combined with GEMOX (GOT) regimen

DRUG

Contacts

Chaoqun Fei

CONTACT

+086-0571-88122564 ec@zjcc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence

Inclusion Criteria

Exclusion Criteria

HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)

Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers

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