Tislelizumab Combined With Lenvatinib and GEMOX Versus Ti... | NCT05620498

NCT05620498

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tislelizumab+lenvatinib+GMOX	Experimental	tislelizumab 200mg, Q3W, lenvatinib 8mg/kg, PO, qd, gemcitabine 1g/㎡, D1, D8, Q3W, oxaliplatin 100mg/㎡, D1, Q3W. Imaging evaluation was performed after 3 cycles. Patients who met surgical criteria will receive R0 resection and adjuvant therapy 4-8 weeks after surgery (tislelizumab 200mg, Q3W, lenvatinib 8mg/kg, PO, qd) for one year or until disease progression or toxicity became intolerable. Inoperable patients continue to receive ≤4 cycles of treatment, imaging evaluation every two cycles. Patients will receive R0 resection if meet surgical criteria and adjuvant therapy 4-8 weeks after surgery (Tislelizumab 200mg, Q3W, lenvatinib 8mg/kg, PO, qd,) for one year or until disease progression or toxicity became intolerable. Patients still unable to receive surgery, the experimental group will receive tislelizumab 200mg, Q3W, lenvatinib 8mg/kg, PO, qd for maintained treatment until disease progression or toxicity became intolerable.	Drug: tislelizumab+lenvatinib+GMOX
tislelizumab+GEMOX	Active Comparator	tislelizumab 200mg, Q3W, gemcitabine 1g/㎡, D1, D8, Q3W, oxaliplatin 100mg/㎡, D1, Q3W. Imaging evaluation was performed after 3 cycles. Patients who met surgical criteria will receive R0 resection and adjuvant therapy 4-8 weeks after surgery (tislelizumab 200mg, Q3W) for one year or until disease progression or toxicity became intolerable. Inoperable patients continue to receive ≤4 cycles of treatment, imaging evaluation every two cycles. Patients will receive R0 resection if meet surgical criteria and adjuvant therapy 4-8 weeks after surgery (Tislelizumab 200mg, Q3W) for one year or until disease progression or toxicity became intolerable. Patients still unable to receive surgery, the experimental group will receive tislelizumab 200mg, Q3W for maintained treatment until disease progression or toxicity became intolerable.	Drug: tislelizumab+GEMOX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tislelizumab+lenvatinib+GMOX	Drug	tislelizumab 200mg, Q3W Lenvatinib 4mg Po QD Gemcitabine 1g/m2 Oxaliplatin 100mg/m, D1, q3W2	tislelizumab+lenvatinib+GMOX

Measure	Description	Time Frame
Objective response rate (ORR)		6 months

Measure	Description	Time Frame
Progression-free survival (PFS)		18 months
Overall survival (OS)		24 months
R0 resection rate

Eligibility Module

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)

The hilar and retroperitoneal lymph nodes were considered for metastasis but could be resected completely.
Intrahepatic cholangiocarcinoma has multiple foci, but foci are less than three and limited to half of the liver.
Local progression of gallbladder carcinoma with colon or duodenal involvement.
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:

Previous treatment with tislelizumab or anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody, or any other therapy that regulates T cells
Received systemic corticosteroid or immunosuppressive therapy within 28 days before inclusion
Concurrent autoimmune diseases or a history of chronic or recurrent autoimmune diseases
A history of pleural adhesions or pericardium adhesions within 28 days prior to inclusion
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
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)
Brain or meningeal metastases (unless asymptomatic and do not require treatment)
and uncontrolled or severe cardiovascular disease.

Name	Role	Phone	Extension	Email
huikai Li, Doctor	Contact	18622228639		tjchlhk@126.com
Dongming Liu, Doctor	Contact	18502261477

ID	Term
D001661	Biliary Tract Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D005705	Gallbladder Diseases