- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05877001
The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases
An Open Label, Single-center Study on the Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib in Patients With Advanced Treated Colorectal Liver Metastases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xu Zhu, MD
- Phone Number: +86-10-88196001
- Email: drzhuxu@163.com
Study Contact Backup
- Name: Feng Aiwei, MD
- Phone Number: +86-10-88196330
- Email: ivyfeng_1026@163.com
Study Locations
-
-
-
Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Xu Zhu, M.D.
- Phone Number: 861088196330
- Email: drzhuxu@163.com
-
Contact:
- Aiwei Feng, M.D.
- Phone Number: 861088196330
- Email: ivyfeng_1026@163.com
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Zhu Xu, M.D.
- Phone Number: 0086-10-88196330
- Email: zhux387@263.net
-
Contact:
- Aiwei Feng, M.D.
- Phone Number: 0086-10-88196330
- Email: ivyfeng_1026@163.com
-
Principal Investigator:
- Zhu Xu, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age≥18 years old
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
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
- 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.
- At least one measurable lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Subject life expectancy ≥12 weeks
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.
- 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
- All patients must sign an informed consent form and follow the trial treatment protocol and follow up plan
Exclusion Criteria:
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
- serum total bilirubin>2.0 times upper limit of normal
- AST and/or ALT>5.0 times upper limit of normal
- Serum creatinine>1.5 times upper limit of normal, or creatinine clearance rate<50ml/min(calculated according to the Cockcroft-Gault formula)
- APTT or PT>1.5 times upper limit of normal
- Clinically significant severe electrolyte abnormalities by the investigator
- Urine protein test 2+ or more, or 24 hours urine protein quantitation ≥1.0g/24h
- Hypertension that is not stably controlled by medications: systolic blood pressure(SBP) >140mmHg or diastolic blood pressure(DBP) > 90mmHg
- 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
- 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
- History of troke or transient ischemic attack within 12 months before enrollment
- 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%
Uncontrolled malignant pleural, ascites, or pericardial effusion
- defined as not being effectively controlled with diuretics or punctures
- 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
- Central nervous system (CNS) metastases or previous brain metastases
- Clinically uncontrolled severe active infection
- 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
- Patients are considered by the investigator to have any clinical or laboratory abnormalities or compliance issues that precluded participation in the trial
- Serious psychological or psychiatric abnormalities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HAIC combined with Tislelizumab and Regorafenib
HAIC combined with Tislelizumab and Regorafenib until progression or death.
|
200mg, IV, Q3W
Other Names:
80 mg once daily for the first 3 weeks of each 4-week cycle
Other Names:
OXA 85mg/m2 IA 0-4h +5-Fu 2000mg/m2 IA 4-48h,CF 200mg/m2 IV 2-4h, Q3W
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety profiles by NCI-CTCAE version 5 .0
Time Frame: From the first patient enrolled to 15 months after the last patient enrolled.
|
The evaluation of adverse events , using NCI-CTCAE version 5.0.
|
From the first patient enrolled to 15 months after the last patient enrolled.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate(ORR)
Time Frame: up to 2 years
|
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
|
up to 2 years
|
Disease control rate(DCR)
Time Frame: Up to 2 years
|
The ORR is defined as the proportion of subjects with confirmed complete response, partial response, or stable disease according to RECIST v 1.1.
|
Up to 2 years
|
Duration of Response (DoR)
Time Frame: Up to 2 years
|
The time from the date of first documentation of a partial response or complete response to the date of first documentation of progressive disease (PD) or date of death due to any cause.
|
Up to 2 years
|
Response rate of intrahepatic lesions
Time Frame: Up to 2 years
|
Response rate of intrahepatic lesions defined as the proportion of intrahepatic lesions that achieved complete response or partial response, regardless of extrahepatic lesions.
|
Up to 2 years
|
Response rate of extrahepatic lesions
Time Frame: Up to 2 years
|
Response rate of extrahepatic lesions defined as the proportion of intrahepatic lesions that achieved complete response or partial response, regardless of intrahepatic lesions.
|
Up to 2 years
|
Quality of Life (QoL)
Time Frame: Up to 2 years
|
The patient's ability to perform daily living can be evaluated through specific questionnaire(EORTC QLQ-C30), so as to evaluate the effect of anti-tumor drug treatment.
|
Up to 2 years
|
Overall survival (OS)
Time Frame: Up to 2 years
|
Overall survival is defined as the time from the start of HAIC until death due to any cause.
|
Up to 2 years
|
Progression free survival (PFS)
Time Frame: Up to 2 years
|
Progression-free survival is defined as the time from the start of HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first.
|
Up to 2 years
|
Collaborators and Investigators
Investigators
- Study Chair: Xu Zhu, MD, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022KT98
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Liver Metastases
-
Humanitas Clinical and Research CenterCompletedColorectal Cancer | Liver Metastases | Immunotherapy | Colorectal Liver Metastases
-
Mayo ClinicRecruitingColorectal Cancer | Colorectal Liver MetastasesUnited States
-
Shanghai Changzheng HospitalNot yet recruiting
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Completed
-
Fudan UniversityNot yet recruitingColorectal Cancer Liver MetastasesChina
-
Vastra Gotaland RegionRecruitingColorectal Cancer | Liver Metastases | Colorectal Liver MetastasesSweden
-
Fudan UniversityUnknown
-
Sun Yat-sen UniversityRecruitingColorectal Cancer Liver Metastases | RegorafenibChina
-
Ye XuUnknownResected Liver Metastases From Colorectal CancerChina
-
University of ZurichCompletedColorectal Liver MetastasesSwitzerland, France, Spain
Clinical Trials on Tislelizumab
-
Peking University Cancer Hospital & InstituteRecruitingNon-small Cell Lung Cancer | Consolidation Immunotherapy | Radiotherapy or Sequential ChemoradiationChina
-
Jiangsu Yahong Meditech Co., Ltd aka AsierisRecruitingMuscle Invasive Bladder CancerUnited States, China
-
Fudan UniversityActive, not recruitingHepatocellular CarcinomaChina
-
Henan Cancer HospitalNot yet recruiting
-
Shanghai Gopherwood Biotech Co., Ltd.RecruitingAdvanced Solid TumorChina
-
GeneScience Pharmaceuticals Co., Ltd.RecruitingMalignant Solid TumorsChina
-
Fudan UniversityRecruitingRefractory Malignant AscitesChina
-
Peter MacCallum Cancer Centre, AustraliaRecruiting
-
Peking UniversityRecruitingGastric Cancer | Colo-rectal CancerChina
-
XIANG YANQUNRecruitingNasopharyngeal CarcinomaChina