Actively Recruiting
Tislelizumab Combined with GEMOX (GOT) as Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma with High-risk Recurrence Factors
Led by Zhejiang Cancer Hospital · Updated on 2025-02-11
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment approach for patients with intrahepatic cholangiocarcinoma (ICC), a cancer arising from bile duct cells inside the liver. This trial focuses on those with resectable tumors who have high-risk factors for recurrence, such as large tumor size, multiple tumors, elevated preoperative CA19-9 levels, blood vessel invasion, or suspected lymph node metastasis. The study aims to evaluate the objective response rate, complete tumor removal rate (R0 resection), and survival outcomes after treatment. Participants receive a combination of Tislelizumab, an immune checkpoint inhibitor, with the chemotherapy drugs Gemcitabine and Oxaliplatin (GEMOX regimen). Treatment cycles last 3 weeks, with Tislelizumab given at 200 mg on day 1, Gemcitabine at 1000 mg/m2 on days 1 and 8, and Oxaliplatin at 135 mg/m2 on day 1. Up to six cycles of this regimen are administered as neoadjuvant therapy before surgery, aiming to shrink tumors and improve surgical outcomes. Throughout the study, patients undergo evaluations including imaging scans to measure tumor response according to RECIST criteria, pathology reports after surgery to assess resection success, and follow-up assessments for disease control, recurrence-free survival, and overall survival for at least 12 months after surgery. Safety and organ function are monitored to ensure participants can tolerate treatment and surgery. The total treatment period averages 18 to 20 weeks before surgery, with ongoing assessments to capture long-term outcomes.
CONDITIONS
Brief 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...
- Aged 18 to 75 years
- Pathologically confirmed intrahepatic cholangiocarcinoma
- No prior systemic therapy including chemotherapy, immunotherapy, targeted therapy, or other anti-cancer treatments
- Resectable ICC with at least one high-risk factor: tumor diameter greater than 5 cm or multiple tumors, preoperative CA19-9 > 200 U/mL, tumor invasion of adjacent blood vessels, suspected regional lymph node metastasis on imaging
- At least one measurable tumor lesion by CT or MRI according to RECIST v1.1
- ECOG performance status score of 0 before first drug administration
- Child-Pugh class A liver function
- Estimated overall survival greater than 16 weeks
- Adequate organ function to tolerate surgery and treatment as defined by specified blood counts and chemistry parameters
- Agreement to use effective contraception during the study if of reproductive potential
- Signed informed consent including agreement to provide tumor tissue specimens
You will not qualify if you...
- Diagnosis other than intrahepatic cholangiocarcinoma
- Anti-cancer therapy or surgery (except non-tumor surgeries and biopsies) within 28 days prior to first study dose
- Presence of distant metastasis
- Hepatitis B virus DNA > 2000 copies/ml or hepatitis C virus RNA > 1000
- Long-term use of systemic glucocorticoids or other immunosuppressive therapies
- Significant bleeding or bleeding disorders within 3 months prior to enrollment or on thrombolytic/anticoagulant therapy
- Complete or incomplete bowel obstruction requiring treatment (unless relieved by ostomy or stent)
- Active severe infections including tuberculosis or autoimmune diseases
- Uncontrolled diabetes mellitus or severe lung diseases affecting function
- Significant cardiovascular diseases or poorly controlled hypertension
- Receiving renal replacement therapy
- History of other cancers within 5 years except certain cured skin or cervical cancers
- Conditions preventing toleration of surgery
- Allergies to any study drug components
- Other conditions making participation unsuitable, including alcohol dependence, mental illness, pregnancy, or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of 3 weeks each)
Participants receive up to 6 cycles of tislelizumab combined with GEMOX (GOT) regimen as neoadjuvant therapy.
Up to 6 treatment visits every 3 weeks
Duration - Approximately 2 weeks
Participants undergo surgical resection after neoadjuvant treatment.
1 surgery visit
Duration - At least 12 months
Participants are monitored for recurrence and overall survival after surgery.
Regular follow-up visits for assessment of recurrence and survival
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
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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