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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| irinotecan liposome injection combined with bevacizumab | Experimental | Patients will be treated with irinotecan liposome injection combined with bevacizumab. Treatment until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan Liposome | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival -1 | The time from initiation of maintenance therapy to first recording of PD or death, whichever occurs first. To investigate antitumor efficacy of study. | From initial medication to the date of first documented progression or end of medication, whichever came first . Assessed up to 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival -2 | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Qiu | Contact | 028-85423203 | qiumeng33@hotmail.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | 5mg/kg, d1, 14 days per cycle. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first). |
|
| Objective response rate |
To investigate antitumor efficacy of study. |
| From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 18 months |
| Disease control rate | To investigate the preliminary antitumor efficacy of study. | From initial medication to the date of first documented progression or end of medication , assessed up to 18 months. |
| Overall survival | To investigate antitumor efficacy of study. | From initial medication to the date of death from any cause, Assessed up to 30 months. |
| Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 | To assess the incidence and severity of adverse events in combination regimens. | Assessed up to 6 months. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |