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Trial Title:
Second-line Treatment of Metastatic Colorectal Cancer
NCT ID:
NCT06242067
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Trifluridine
Irinotecan
Conditions: Keywords:
colorectal cancer
bevacizumab
trifluridine-tipiracil/TAS-102
irinotecan
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:
Trifluridine/tipiracil
Description:
patients received biweekly Trifluridine/tipiracil (30 mg/m2 twice daily; days 1-5),
irinotecan (150 mg/m2; day 1) and bevacizumab (5 mg/kg; day 1).
Arm group label:
Irinotecan,Trifluridine-tipiracil in combination with Bevacizumab
Other name:
Irinotecan
Other name:
Bevacizumab
Summary:
The goal of this multicenter, single-arm, observational cohort study is to investigate
the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and
bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based
chemotherapy (including 5-FU/capecitabine/S-1) exposure in the metastatic setting or
within 12 months of recurrence.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. All subjects are required to sign an informed consent form before starting the
study-related procedure
2. Age 18-75 years old, male or female.
3. have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, life
expectancy >3 months.
4. Histologically or cytological proven metastatic or recurrent adenocarcinoma of the
colon or rectum.
5. Prior treatment with a fluoropyrimidine (5-fluorouracil [5-FU] or capecitabine) and
oxaliplatin with bevacizumab or cetuximab targeted therapy as the first-line
regimen.
6. Recurrence or metastasis within 12 months after completion of adjuvant/neoadjuvant
therapy with oxaliplatin and fluoropyrimidine-based drugs is also considered as the
failure of first-line chemotherapy.
7. At least one measurable metastatic lesion, as defined by Response Evaluation
Criteria in Solid Tumors (RECIST) 1.1.
8. Adequate organ function: bone marrow, kidney, liver function (within 7 days before
treatment start) Absolute neutrophil count ≥ 1.5×109/L Platelet count ≥ 100×109/L
Hemoglobin≥ 90g/L (no history of blood transfusion within 7 days); Creatinine
clearance≥ 60 ml/min (Cockcroft-Gault formula) Bilirubin ≤ 1.5 x the upper limit of
normal (ULN) Glutamate aminotransferase (AST)/ alanine aminotransferase (ALT) levels
≤2.5 x ULN or =< 5 x ULN if with hepatic metastases; Alkaline phosphatase (AKP) ≤
2.5 x ULN or =< 5 x ULN if with hepatic metastases;
9. Urine protein <1+ or 24-hour urine protein <1 gram;
10. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN or within
the range if receiving anticoagulant therapy;
11. Participants of child-bearing potential must agree to use adequate contraceptive
methods (e.g., hormonal or barrier method of birth control; abstinence; IUDs, etc)
during the study period and within 90 days of the last study medication. All female
patients will be considered fertile unless they have spontaneous menopause,
artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnexectomy,
or radiation ovarian irradiation).
Exclusion Criteria:
1. First-line treatment with irinotecan;
2. Patients with KRAS/NRAS/BRAF wild-type and not treated with cetuximab in the first
line.
3. Patients with dMMR/MSI-H (deficient mismatch repair/microsatellite instability-high)
status;
4. Symptomatic brain or meningeal metastases (except for brain metastases that have
undergone local radiotherapy or surgery for more than 6 months and stable disease
control)
5. Previous or current severe bleeding (bleeding >30ml within 3 months), coughing up
blood (>5ml of fresh blood within 4 weeks) or cerebrovascular accident (excluding
lacunar cerebral infarction, minor cerebral ischemia or transient ischemic attack,
etc.) within half a year before the first use of the study drug, myocardial
infarction, unstable angina, poorly controlled arrhythmias (including QTc interval
≥450 ms for men and 470 ms for women≥) (QTc interval is calculated by Fridericia
formula). According to the New York College of Cardiology (NYHA) standard class III
or IV cardiac insufficiency or cardiac ultrasound: left ventricular ejection
fraction (LVEF) < 50%.
6. Uncontrolled hypertension: systolic blood pressure >140mmHg, diastolic blood
pressure > >90mmHg;
7. Digestive tract diseases or states that the investigator determines may affect drug
absorption, including but not limited to active gastric and duodenal ulcers,
ulcerative colitis and other digestive tract diseases or active bleeding in
unresected gastrointestinal tumors, or other conditions that the investigator
determines may cause gastrointestinal bleeding or perforation or obstruction;
8. History of second primary malignancy within 5 years prior to enrollment, excluding
basal cell skin carcinoma or in-situ cervical carcinoma after radical resection;
9. Have known active infection, including but not limited to human immunodeficiency
virus (HIV) infection, a history of liver disease known to be significant, including
but not limited to hepatitis B virus (HBV) infection and HBV DNA positive
(≥1×104/ml); hepatitis C virus infection (HCV) with positive HCV RNA (≥1×103/ml), or
cirrhosis, etc.
10. Unresolved toxicities from prior therapy of > grade 1, excluding alopecia; Any other
disorders, metabolic abnormality, physical examination abnormality, or laboratory
abnormality which has reason to suspect that the patient not suitable for the study
or will affect the interpretation of the results. Any condition which in the
investigator's opinion deems the participant an unsuitable candidate to receive
study drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
xiangling Wang, Dr.
Phone:
8653182169841
Email:
xlwang71@163.com
Investigator:
Last name:
Jing Hao
Email:
Principal Investigator
Start date:
April 23, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Qianfoshan Hospital
Agency class:
Other
Collaborator:
Agency:
Binzhou People's Hospital
Agency class:
Other
Collaborator:
Agency:
Binzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Yantai Yuhuangding Hospital
Agency class:
Other
Collaborator:
Agency:
Linyi Tumour Hospital
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06242067
