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The survival of the refractory CRC is dismal and therapy options are limited ,the researchers aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in refractory MSS metastatic colorectal cancer in a real-world setting.
The invesgators conducted a retrospective single arm, single-center study in which patients with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed adenocarcinoma of the colon or rectum; with patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).The primary endpoint was overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | fruquintinib combined with anti-PD-1 antibodies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib combined with anti-PD-1 antibodies | Drug | Fruquintinib (3-5mg once daily for 21 days on/7 days off) anti-PD-1 antibodies (including sintilimab, toripalimab, pembrolizumab, tislelizumab, and nivolumab). |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Overall survival defined as the observed time from the treatment of the study until death due to any cause | assessed up to 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| progress-free survival (PFS) | the time from treatment initiation to the disease progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first. | assessed up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | The ORR was calculated as the sum of the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment | assessed up to 1 year |
| disease control rate (DCR) |
Inclusion Criteria:
Exclusion Criteria:
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Refractory MSS Metastatic Colorectal Cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | China |
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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 |
|---|---|
| D061026 | Programmed Cell Death 1 Receptor |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D000082102 | Immune Checkpoint Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061025 | Costimulatory and Inhibitory T-Cell Receptors |
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|
Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate, according to RECIST v 1.1 |
| assessed up to 1 year |
| Treatment-Related Adverse Events (TRAE) | Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs) | assessed up to 1 year |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000945 | Antigens, Differentiation, T-Lymphocyte |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D015415 | Biomarkers |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |