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Trial Title:
The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases
NCT ID:
NCT05877001
Condition:
Colorectal Liver Metastases
Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200mg, IV, Q3W
Arm group label:
HAIC combined with Tislelizumab and Regorafenib
Other name:
BGB-A317
Intervention type:
Drug
Intervention name:
Regorafenib
Description:
80 mg once daily for the first 3 weeks of each 4-week cycle
Arm group label:
HAIC combined with Tislelizumab and Regorafenib
Other name:
BAY73-4506
Intervention type:
Other
Intervention name:
HAIC
Description:
OXA 85mg/m2 IA 0-4h +5-Fu 2000mg/m2 IA 4-48h，CF 200mg/m2 IV 2-4h， Q3W
Arm group label:
HAIC combined with Tislelizumab and Regorafenib
Summary:
Tislelizumab is an anti-PD-1 monoclonal antibody with high binding affinity for PD-1 and
with minimized Fcγ receptor binding on macrophages. Regorafenib has been approved in mCRC
by CFDA. Hepatic arterial infusion chemotherapy has a high local control rate for liver
metastases. NCCN guidelines and several expert consensus recommend that regional hepatic
arterial infusion chemotherapy can be considered as a "rescue treatment" for patients
with colorectal cancer liver metastases who fail to receive first-line or second-line
systemic chemotherapy, which can significantly prolong the overall survival of patients.
Detailed description:
The investigators aimed to evaluated the safety and efficacy of HAIC combined with
Tislelizumab and Regorafenib in patients with advanced treated colorectal liver
metastases. This study is a prospective, open label, single-center clinical study and the
sample size is 20.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age≥18 years old
2. Histologically or cytologically confirmed colorectal cancer with unresectable or
surgical contraindicated liver metastases
- Extrahepatic metastases are allowed and the primary tumor load is assessed to
be intrahepatic by two or more attending physicians
- Whether liver metastases can be resected or not is determined by two or more
attending physicians according to the Chinese guidelines for the diagnosis and
comprehensive treatment of colorectal liver metastases
3. Patients with unresectable colorectal liver metastases after failed standard
second-line therapy
- Including, but not limited to, Oxaliplatin, Fluorouracil, and Irinotecan
- Treatment failure is defined as disease progression and intolerable toxicity
4. Patients who withdrew from standard therapy due to unacceptable toxicity, guaranteed
to discontinue treatment before disease progression and excluded treatment with the
same drug, are also allowed to be included in the study.
5. At least one measurable lesion according to RECIST 1.1 criteria
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
7. Subject life expectancy ≥12 weeks
8. Laboratory tests of bone marrow, hepatic and renal function and coagulation function
within 7 days before the first dose of medication meet the study requirements
- No blood transfusion, blood products, or correction with granulocyte
colony-stimulating factor or other hematopoietic stimulating factor within 7
days before laboratory testing.
9. Female patients of childbearing age must have a negative blood pregnancy test within
7 days before the first dose of medication and male or female patients of
childbearing age volunteered to take effective contraceptive measures during the
whole treatment and within 3 months after treatment
10. All patients must sign an informed consent form and follow the trial treatment
protocol and follow up plan
Exclusion Criteria:
1. ANC <1.5×109/L, or platelet count <80×109/L, or HGB < 9g/dL;
- Blood transfusion to meet enrollment criteria within 2 weeks before enrollment
is not allowed
2. serum total bilirubin>2.0 times upper limit of normal
3. AST and/or ALT>5.0 times upper limit of normal
4. Serum creatinine>1.5 times upper limit of normal, or creatinine clearance
rate<50ml/min(calculated according to the Cockcroft-Gault formula)
5. APTT or PT>1.5 times upper limit of normal
6. Clinically significant severe electrolyte abnormalities by the investigator
7. Urine protein test 2+ or more, or 24 hours urine protein quantitation ≥1.0g/24h
8. Hypertension that is not stably controlled by medications: systolic blood
pressure(SBP) >140mmHg or diastolic blood pressure(DBP) > 90mmHg
9. Patients with active gastric and duodenal ulcer, ulcerative colitis or other
gastrointestinal diseases or unresected tumors with active bleeding, or other
conditions that may cause gastrointestinal bleeding or perforation as judged by the
investigators; Or patients with previous gastrointestinal perforation or
gastrointestinal fistula, which is not cured after surgical treatment
10. History of arterial or deep-vein thrombosis within 6 months before enrollment or
evidence or history of bleeding tendency within 2 months before enrollment,
regardless of severity
11. History of troke or transient ischemic attack within 12 months before enrollment
12. History of heart disease within 6 months before enrollment, manifested as congestive
heart failure, acute myocardial infarction, severe/unstable angina, coronary artery
bypass grafting; impaired cardiac function in NYHA class 2 or above; left
ventricular ejection fraction (LVEF) <50%
13. Uncontrolled malignant pleural, ascites, or pericardial effusion
- defined as not being effectively controlled with diuretics or punctures
14. Clinically detectable second primary malignancy or history of other malignancies
within 5 years. Adequately treated nonmelanoma skin cancers, cervical carcinoma in
situ, and superficial bladder tumors [noninvasive tumors, carcinoma in situ, and T1
(tumor invasion of the lamina propria)] are excluded
15. Central nervous system (CNS) metastases or previous brain metastases
16. Clinically uncontrolled severe active infection
17. Pregnant or lactating women or women of childbearing age have a positive pregnancy
test before the first dose of medication; Or female participants themselves and
their partners who are unwilling to use strict contraception during the trial
18. Patients are considered by the investigator to have any clinical or laboratory
abnormalities or compliance issues that precluded participation in the trial
19. Serious psychological or psychiatric abnormalities
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhu Xu, M.D.
Phone:
0086-10-88196330
Email:
zhux387@263.net
Contact backup:
Last name:
Aiwei Feng, M.D.
Phone:
0086-10-88196330
Email:
ivyfeng_1026@163.com
Investigator:
Last name:
Zhu Xu, M.D.
Email:
Principal Investigator
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Zhu, M.D.
Phone:
861088196330
Email:
drzhuxu@163.com
Contact backup:
Last name:
Aiwei Feng, M.D.
Phone:
861088196330
Email:
ivyfeng_1026@163.com
Start date:
May 30, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05877001
