Potentially Resectable Locally Advanced Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Conditions
Brief 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.
Interventions
DRUGtislelizumab+lenvatinib+GMOX
tislelizumab 200mg, Q3W Lenvatinib 4mg Po QD Gemcitabine 1g/m2 Oxaliplatin 100mg/m, D1, q3W2
DRUGtislelizumab+GEMOX
tislelizumab+GEMOX
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 18 months | — |
| Overall survival (OS) | 24 months | — |
| R0 resection rate | 6 months | — |
| AE | 24 months | Improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0) |
Countries
China
Contacts
Primary Contacthuikai Li, Doctor
Backup ContactDongming Liu, Doctor
Outcome results
None listed