Clinical trial NCT05620498: Tislelizumab Combined With Lenvatinib and GEMOX Versus Tislelizumab Combined With GEMOX in Conversion Therapy of ICC and GBC.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Potentially Resectable Locally Advanced Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 18 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: R0 resection rate
timeFrame: 6 months
measure: AE
timeFrame: 24 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
References: