To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab
NCT ID:
NCT06540326
Condition:
Colorectal Cancer Metastatic
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Cetuximab
Fluorouracil
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
irinotecan liposome (II)
Description:
irinotecan liposome (II) is a powerful chemotherapeutic agents, in the combination with
fluorouracil，and bevacizumab or cetuximab
Arm group label:
irinotecan liposome (II), fluorouracil in combination with bevacizumab
Arm group label:
irinotecan liposome (II), fluorouracil in combination with cetuximab
Other name:
irinotecan liposome (II) injection
Intervention type:
Drug
Intervention name:
fluorouracil
Description:
fluorouracil is a powerful chemotherapeutic agents, in the combination with irinotecan
liposome (II)，and bevacizumab or cetuximab
Arm group label:
irinotecan liposome (II), fluorouracil in combination with bevacizumab
Arm group label:
irinotecan liposome (II), fluorouracil in combination with cetuximab
Other name:
5-fluorouracil
Intervention type:
Drug
Intervention name:
cetuximab
Description:
cetuximab is a powerful targeted agents, in the combination with irinotecan liposome
(II)，and fluorouracil
Arm group label:
irinotecan liposome (II), fluorouracil in combination with cetuximab
Other name:
cetuximab injection
Intervention type:
Drug
Intervention name:
bevacizumab
Description:
bevacizumab is a powerful targeted agents, in the combination with irinotecan liposome
(II)，and fluorouracil
Arm group label:
irinotecan liposome (II), fluorouracil in combination with bevacizumab
Other name:
bevacizumab injection
Summary:
Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment
option for advanced second-line colorectal cancer, and this study explores the efficacy
and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination
with bevacizumab or cetuximab for the second-line treatment of patients with advanced
colorectal cancer.
Detailed description:
Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment
option for advanced second-line colorectal cancer. Liposomal irinotecan (II) compared
with ordinary irinotecan can improve efficacy and safety. This study explores the
efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in
combination with bevacizumab or cetuximab for the second-line treatment of patients with
advanced colorectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provide written informed consent to voluntarily enroll in this study.
2. Men or women aged 18-75 years.
3. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
4. Patients who have failed one prior systemic therapy.
5. Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
6. Life expectancy of at least 3 months.
7. Measurable lesions at baseline as assessed by the investigator by imaging (according
to RECIST 1.1), measurable lesions should not have received local treatment such as
radiotherapy (lesions located within the area of previous radiotherapy may also be
selected as target lesions if progression is confirmed to have occurred).
8. Function of vital organs in accordance with the following requirements (no
medication with any blood component, cell growth factor corrective therapy is
allowed within 14 days prior to the first administration of study drug); Absolute
neutrophil count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L; Haemoglobin ≥ 9 g/dL;
Serum albumin ≥ 2.5 g/dL; Total bilirubin ≤ 1.5 × upper limit of normal; alanine
aminotransferase, aspartate aminotransferase≤ 2.5 × upper limit of normal, and if
liver metastases are present, alanine aminotransferase, aspartate aminotransferase ≤
5 × upper limit of normal Serum creatinine ≤ 1.5 × upper limit of normal or
creatinine clearance > 60 mL/min (Cockcroft-Gault); Activated partial thromboplastin
time (APTT) and International Normalised Ratio (INR) ≤ 1.5 × upper limit of normal
(screened for use of stable doses of anticoagulant therapy such as low molecular
heparin or warfarin where the INR is within the expected therapeutic range of the
anticoagulant).
9. Female subjects of childbearing potential must have a negative serum pregnancy test
within 72 hours prior to initiation of trial drug administration and use effective
contraception (e.g., intrauterine device, birth control pills, or condoms) during
the trial period and for at least 3 months after the last dose of trial drug; for
male subjects whose partner is a female of childbearing potential, effective
contraception should be used during the trial period and for at least 3 months after
the last dose of trial drug. For male subjects whose partners are women of
childbearing potential
Exclusion Criteria:
1. Have received local radiotherapy within 4 weeks prior to the first dose of study
drug and have not recovered to baseline levels of adverse events due to
radiotherapy. Subjects who have had palliative radiotherapy to a peripheral site
(e.g., bone metastases) prior to 4 weeks may be admitted to the study, provided they
have recovered from any acute adverse events;
2. Known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Subjects previously treated for brain metastases may enter the study
provided they have stable brain metastases and have not been treated for brain
metastases with steroids for at least 28 days prior to study entry. This exception
does not include carcinomatous meningitis, as patients with carcinomatous meningitis
are excluded regardless of clinical stability;
3. Major surgery, open biopsy, or severe trauma 28 days prior to first dose;
4. Have a previous history of hypersensitivity to fluorouracil or irinotecan;
5. Subjects with hypertension that is not well controlled with antihypertensive
medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90
mmHg)
6. Subject has uncontrolled cardiovascular clinical symptoms or disease, including but
not limited to: (1) New York Heart Association Class II or higher heart failure (2)
unstable angina (3) myocardial infarction within 1 year (4) clinically significant
supraventricular or ventricular arrhythmia that is not clinically interfered with or
remains poorly controlled after clinical intervention.
7. Clinically significant bleeding symptoms or a definite bleeding tendency within 3
months prior to the first dose, e.g., gastrointestinal bleeding, bleeding gastric
ulcer, or vasculitis;
8. Arterial/venous thrombotic events within 6 months prior to the first dose, such as
cerebrovascular accidents (including temporary ischaemic attack, cerebral
haemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, with
superficial venous thrombosis being eligible for enrolment as determined by the
investigator;
9. Have another malignancy that is progressing or requires aggressive treatment, except
for non-melanoma skin cancer and cervical cancer in situ for which potential
treatment has been administered;
10. Women who are pregnant or breastfeeding;
11. Subjects who, in the judgement of the investigator, have other factors that may
cause them to be forced to terminate the study midway, such as other serious
illnesses (including psychiatric illnesses) that require comorbid treatment, grossly
abnormal laboratory test values, and family or social factors that may affect the
subject's safety or the collection of trial data
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 15, 2024
Completion date:
October 31, 2027
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06540326
