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Trial Title:
GOT Applied as Neoadjuvant Regimen for Patients of Resectable ICC With High-risk Factors of Recurrence
NCT ID:
NCT05557578
Condition:
Intrahepatic Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Recurrence
Gemcitabine
Oxaliplatin
Tislelizumab
Conditions: Keywords:
Tislelizumab
Gemcitabine
Oxaliplatin
cholangiocarcinoma
Neoadjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Patients of Resectable ICC With High-risk Factors of Recurrence
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab combined with GEMOX (GOT) regimen
Description:
Tislelizumab 200mg on day 1；Gemcitabine 1000mg/m2 on day 1、8；Oxaliplatin 135mg/m2 on day
1；cycle 3 weeks
Arm group label:
Experimental arm
Other name:
Gemcitabine
Other name:
Oxaliplatin
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.
Criteria for eligibility:
Criteria:
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;
6. Estimated overall survival is greater than 16 weeks;
7. 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 or
alanine aminotransferase≤5 upper limits of normal(ULN），alkaline phosphatase≤2.5
ULN，Serum albumin≥30g/L；serum creatinine<1.5 ULN；International normalized
ratios（INR）≤2 or Prothrombin time（PT）exceed ULN≤6s；Creatinine clearance≥60 mL/min.
8. Male and female subjects with potential fertility had to agree to the use of
effective contraceptive methods throughout the study period；
9. Sign an informed consent form agreeing to provide previously preserved specimens of
tumor tissue or fresh detection of tumor lesions.
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);
11. Patient who are receiving renal replacement therapy；
12. 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;
13. Others situations are not expected to tolerate surgical treatment；
14. People with allergic reactions to any component of the drug under study;
15. There are other unsuitable candidates for clinical trials, such as alcohol
dependence, mental illness, pregnancy (or lactation).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
1# Banshan East Rd. Zhejiang cancer hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuhua Zhang, M.D.
Phone:
+86-0571-88128058
Email:
drzhangyuhua@126.com
Contact backup:
Last name:
Jia Wu
Phone:
+86-0571-88128052
Email:
tkds123@qq.com
Facility:
Name:
Jia Wu
Address:
City:
Hanzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jia Wu
Phone:
086-0571-88128058
Email:
tkds123@qq.com
Start date:
May 5, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557578
