Metastatic Colorectal Cancer
Conditions
Brief summary
To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer.
Interventions
70 mg/m\^2 , d1, 14 days per cycle. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).
DRUGBevacizumab
5mg/kg, d1, 14 days per cycle. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18\ 85 years old. * Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma. * pMMR or MSS. * CR, PR, or SD (according to RECIST v1.1 criteria) achieved after 12-16 weeks of intensive treatment with a first-line chemotherapy regimen containing irinotecan/fluorouracil or a three-drug chemotherapy regimen containing oxaliplatin/irinotecan/fluorouracil plus bevacizumab. * If previously received neoadjuvant or adjuvant therapy, the time interval between initiation of systemic first-line therapy and the date of last dosing must be at least 6 months. * ECOG 0\ 1, patients ≥75 years old need an ECOG score of 0. * Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10\^9/L, platelets (PLT) ≥75×10\^9/L, hemoglobin (Hb) ≥85g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10\^9/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; The total bilirubin level doesn't exceed the upper limit of the agency's normal range; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated according to Cockroft-Gault). * Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form.
Exclusion criteria
* Known or suspected central nervous system metastasis. * Had received surgery or other treatment for tumors other than intensive treatment (including chemotherapy, radiotherapy, research treatment, etc., within 4 weeks prior to enrollment, if the interval between the current treatment was longer than 5 drug half-lives, could be included). * Previous treatment-related toxicity did not return to NCI-CTCAE v5.0 I or below (except for alopecia, peripheral neuropathy). * The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment. * The presence of severe gastrointestinal dysfunction or gastrointestinal perforation, intraperitoneal abscess, and fistula. * Intestinal obstruction, signs and symptoms of intestinal obstruction, or the stent has been previously implanted and the stent has not been removed before the screening period. * Interstitial lung disease. * Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding). * Patients with fluid accumulation that couldn't reach a stable state but small amount of ascites on imaging without clinical symptoms could be enrolled. * Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc. * Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer. * Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding. * The researchers didn't consider it appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival -1 | From initial medication to the date of first documented progression or end of medication, whichever came first . Assessed up to 18 months. | The time from initiation of maintenance therapy to first recording of PD or death, whichever occurs first. To investigate antitumor efficacy of study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival -2 | The time from the start of first-line treatment to the maintenance of PD treatment or death, whichever occurs first. Assessed up to 24 months. | The time from the start of first-line treatment to the maintenance of PD treatment or death, whichever occurs first. To investigate antitumor efficacy of study. |
| Objective response rate | From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 18 months | To investigate antitumor efficacy of study. |
| Disease control rate | From initial medication to the date of first documented progression or end of medication , assessed up to 18 months. | To investigate the preliminary antitumor efficacy of study. |
| Overall survival | From initial medication to the date of death from any cause, Assessed up to 30 months. | To investigate antitumor efficacy of study. |
| Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 | Assessed up to 6 months. | To assess the incidence and severity of adverse events in combination regimens. |
Contacts
Primary ContactMeng Qiu
Outcome results
None listed