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Trial Title:
Tislelizumab Combined With Lenvatinib and GEMOX Versus Tislelizumab Combined With GEMOX in Conversion Therapy of ICC and GBC.
NCT ID:
NCT05620498
Condition:
Potentially Resectable Locally Advanced Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Conditions: Official terms:
Cholangiocarcinoma
Gallbladder Neoplasms
Lenvatinib
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
tislelizumab+lenvatinib+GMOX
Description:
tislelizumab 200mg, Q3W Lenvatinib 4mg Po QD Gemcitabine 1g/m2 Oxaliplatin 100mg/m, D1,
q3W2
Arm group label:
tislelizumab+lenvatinib+GMOX
Intervention type:
Drug
Intervention name:
tislelizumab+GEMOX
Description:
tislelizumab+GEMOX
Arm group label:
tislelizumab+GEMOX
Summary:
This is an Open Phase II Clinical Study of Tislelizumab Combined with Lenvatinib and
GEMOX Versus Tislelizumab Combined with GEMOX in the Treatment of Locally Advanced
Intrahepatic Cholangiocarcinoma and Gallbladder Cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1：Intrahepatic cholangiocarcinoma and gallbladder carcinoma confirmed by histology or
cytology.
Potential resectable criteria: The first stage R0 resection cannot be guaranteed for
patients with cholangiocarcinoma admitted to our hospital, and there are the following
imaging characteristics (satisfy one or more)
1. The hilar and retroperitoneal lymph nodes were considered for metastasis but could
be resected completely.
2. Intrahepatic cholangiocarcinoma has multiple foci, but foci are less than three and
limited to half of the liver.
3. Local progression of gallbladder carcinoma with colon or duodenal involvement.
4. Hilar cholangiocarcinoma or lower segment of cholangiocarcinoma involving portal
vein or hepatic artery requires combined vascular resection or reconstruction. 2.
Patient age: 20-79 years 3. At least one measurable lesion as defined in RECIST
version 1.1 4. ECOG score was 0-1 5.Life expectancy of at least 90 days 6.Aspartic
aminotransferase and alanine aminotransferase ≤150 IU/L in patients with bile
drainage, and ≤100IU/L in patients without bile drainage Total bilirubin ≤3.0 mg/dL
in patients with bile drainage and ≤2.0 mg/dL in patients without bile drainage.
7.Creatinine ≤1.5 mg/dL was used in the single treatment cohort and ≤1.2 mg/dL was used
in the combination treatment cohort; Creatinine clearance [measured or estimated using
the Cockcroft-Gault equation]≥45mL/min for the single treatment cohort and ≥50mL/min for
the combination treatment cohort 8.Neutrophil ≥1500 cells /µL, hemoglobin ≥9.0g/dL,
platelet ≥100000/µL 9.PD-L1 expression analysis and microsatellite unstable state
analysis were performed on tumor tissue samples.
Exclusion Criteria:
1. Previous treatment with tislelizumab or anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4
antibody, or any other therapy that regulates T cells
2. Received systemic corticosteroid or immunosuppressive therapy within 28 days before
inclusion
3. Concurrent autoimmune diseases or a history of chronic or recurrent autoimmune
diseases
4. A history of pleural adhesions or pericardium adhesions within 28 days prior to
inclusion
5. Test positive for HIV antibody, human T-cell leukemia virus type 1 antibody,
hepatitis C virus antibody, hepatitis B surface protein antigen, hepatitis B surface
protein antibody, hepatitis B core protein antibody or any detectable hepatitis B
virus DNA
6. Multiple primary cancers (except completely resected basal cell carcinoma, stage I
squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial
bladder carcinoma, and any other cancer that has not recurred for at least 5 years)
7. Brain or meningeal metastases (unless asymptomatic and do not require treatment)
8. and uncontrolled or severe cardiovascular disease.
Gender:
All
Minimum age:
20 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Huikai Li, MD
Phone:
+862223340123
Phone ext:
3091
Email:
lihuikai@tjmuch.com
Start date:
September 8, 2022
Completion date:
March 31, 2024
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05620498
