Actively Recruiting
GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence
Led by Zhejiang Cancer Hospital · Updated on 2025-02-11
20
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Pathologically confirmed intrahepatic cholangiocarcinoma with no prior systemic therapy
- Resectable ICC with high-risk recurrence factors including tumor larger than 5 cm or multiple tumors, elevated preoperative CA19-9 >200 U/mL, tumor invasion of adjacent blood vessels, suspected regional lymph node metastasis on imaging
- At least one measurable lesion by CT or MRI according to RECIST v1.1
- ECOG performance status score of 0
- Child-Pugh liver function classification class A
- Estimated overall survival greater than 16 weeks
- Adequate organ function meeting specified blood counts, liver and kidney function tests
- Agreement to use effective contraception during the study if of reproductive potential
- Signed informed consent and agreement to provide tumor tissue samples
You will not qualify if you...
- Non-intrahepatic cholangiocarcinoma diagnosis
- Anti-cancer therapy or surgery within 28 days before study start (except non-tumor surgeries and biopsies)
- Presence of distant metastasis
- High levels of hepatitis B or C virus DNA/RNA
- Long-term use of systemic steroids or other immunosuppressive treatments
- Significant bleeding or bleeding disorders within past 3 months or use of blood thinners
- Complete or unresolved bowel obstruction
- Active severe infections including tuberculosis or autoimmune disease
- Uncontrolled diabetes or severe lung disease
- Significant cardiovascular disease or uncontrolled hypertension
- Receiving renal replacement therapy
- History of other cancers within last 5 years except certain skin or cervical cancers
- Unable to tolerate surgery
- Allergic reactions to study drugs
- Other unsuitable conditions such as alcohol dependence, mental illness, pregnancy, or lactation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
1# Banshan East Rd. Zhejiang cancer hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
2
Jia Wu
Hanzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
C
Chaoqun Fei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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