- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04924179
Tislelizumab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With Advanced CRC
August 15, 2022 updated by: Xianglin Yuan, Huazhong University of Science and Technology
A Phase II, Single-arm, Open-label, Single Center Study of Tislelizumab Combined With Fruquintinib and SBRT as A Third-line and Posterior Line Treatment in Patients With Advanced Colorectal Cancer
A Phase II Study to Assess the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and SBRT as A third-line and Posterior Line Treatment in Patients With Advanced Colorectal Cancer
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430000
- Huazhong University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of written Informed Consent Form (ICF) prior to any study specific procedures
- Age ≥ 18 years, ≤75 years
- Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer
- One or more organs metastases, and the metastases are suitable for SBRT according to the evaluation of the researchers;
- At least two or more standard systemic therapies prior treatment (based on Fu, oxaliplatin, irinotecan, bevacizumab and cetuximab) of cytotoxic chemotherapy, treatment failure or intolerable toxicities
- ECOG 0-1
- Patients must have measurable lesions
- Expected overall survival ≥12 weeks
- AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN),Serum bilirubin ≤ 1.5 x ULN,creatinine<ULN
- Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
- Patients are allowed to have received radiotherapy, but the time from entering the group must be more than 4 weeks, and the currently selected radiotherapy lesions and evaluable lesions must be lesions that have not received radiotherapy
- Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment
Exclusion Criteria:
- Patients have received anti-PD-1 / PD-L1 immunotherapy or other immunoexperimental drugs
- Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc
- Risk factors of intestinal perforation: active diverticulitis, abdominal abscess, gastrointestinal obstruction, abdominal cancer or other known risk factors of intestinal perforation
- Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia patients
- Aspirin (> 325 mg / day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel (≥ 75 mg) and cilostazol are currently used or have been used recently (within 10 days before the start of study treatment)
- Thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) and pulmonary embolism occurred within 6 months before the start of the study
- The researchers believe that the patient has a lesion and needs emergency palliative radiotherapy / emergency surgery (spinal cord compression, brain hernia, pathological fracture)
- Known active infection and active tuberculosis infection were not included in the group; However, patients with hepatitis B virus (HBV) and hepatitis C virus (HCV) infection can be included in the group if their condition is stable after antiviral treatment;
- There is evidence of pneumoperitoneum that cannot be explained by puncture or recent surgery;
- Patients with history of hepatic encephalopathy;
- Participated in the clinical trials of other drugs that have not been approved or marketed in China and received the corresponding experimental drug treatment within 2 weeks before enrollment
- systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs
- Patients have untreated central nervous system metastasis
- Received any operation or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment
- Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE v5.0) Grade of 0 or 1, except for alopecia and oxaliplatin induced neurotoxicity ≤ 2 , and the previous surgery did not recover completely
- Dysphagia or known malabsorption of drugs
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI
- Have evidence or history of bleeding tendency within 2 months after enrollment, the researcher assessed that moderate or severe bleeding tendency was not suitable for enrollment
- Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
- Pregnant or lactating women
- Allergic to Surufatinib/Vinorelbine
- History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation
- Patients with acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before admission; Or a history of arterial thrombosis or deep venous thrombosis
- There are concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect the completion of the study, or any laboratory abnormalities that are not suitable for participating in the clinical trial according to the judgment of the researcher
- Active autoimmune disease or history of autoimmune disease with possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism);
- Immunosuppressive agents or systemic hormones were used 14 days before the start of the study to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones)
- Known to have a history of severe allergy to any monoclonal antibody or antiangiogenic target drug
- Serious psychological or mental disorders that may affect the compliance study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Tislelizumab plus Fruquintinib and SBRT
|
Fruquintinib:5mg ,qd,po, d1-d14, 21 days for a cycle;Tislelizumab Injection:200mg,IV,d1,21 days for a cycle;SBRT:8-10Gy×5F,qod,in 10 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: up to 16 months
|
To assess the efficacy of Tislelizumab Combined With Fruquintinib and SBRT for patients with advanced colorectal cancer by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
|
up to 16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: up to 16 months
|
CR + PR rate according to the RECIST version 1.1 guidelines.
|
up to 16 months
|
Disease control rate (DCR)
Time Frame: up to 16 months
|
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
|
up to 16 months
|
Overall survival (OS)
Time Frame: up to 36 months
|
The time interval between the start date of study drug and the date of death (any cause)
|
up to 36 months
|
AEs
Time Frame: up to 36 months
|
Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.
|
up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
June 3, 2021
First Submitted That Met QC Criteria
June 7, 2021
First Posted (Actual)
June 11, 2021
Study Record Updates
Last Update Posted (Actual)
August 17, 2022
Last Update Submitted That Met QC Criteria
August 15, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMPL-013-FLAG-C113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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