Fruquintinib is already the standard third-line treatment for metastatic colorectal cancer, but the efficacy of fruquintinib in neoadjuvant and conversion therapy for locally advanced/advanced colorectal cancer has not yet been reported. This study aims to observe the efficacy and safety of fruquintinib combined with chemotherapy in neoadjuvant or conversion therapy for colorectal cancer patients in the real world.
Age ≥18 years and ≤75 years;
Either gender;
Patients with histologically confirmed colorectal cancer. For the neoadjuvant treatment cohort: Rectal cancer is limited to high rectal cancer, but patients with mid to low rectal cancer who are unwilling or unsuitable for neoadjuvant chemoradiotherapy can also be included.
Neoadjuvant treatment cohort: Clinically staged as stage II (T3-4N0M0) or stage III (T1-4N1-2M0) and initially resectable; patients with clinical stage M1 but initially resectable can also be included in the neoadjuvant treatment cohort, such as patients with stage IV liver oligometastasis. Conversion treatment cohort: Patients with initially unresectable but potentially resectable locally advanced or advanced distant metastatic colorectal cancer (according to AJCC 8th), and patients with locally advanced low rectal cancer who are unsuitable or unwilling to undergo chemoradiotherapy can also be included.
History of other primary malignant tumors, except: (1) complete remission of malignant tumors at least 2 years before enrollment and no need for other treatment during the study period; (2) adequately treated non-melanoma skin cancer or malignant melanoma without evidence of disease recurrence; (3) adequately treated in situ carcinoma.
dMMR/MSI-H.
Female patients who are pregnant or lactating.
Known allergy (Grade 3 or higher allergic reaction) or contraindication to anti-angiogenic drugs or chemotherapy drug components.
Colorectal cancer who have received chemotherapy and fruquintinib as neoadjuvant or conversion treatment.
Cohort
Retrospective
corhot1: chemotherapy combined with fruquintinib
Combination productChemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: mFOLFOX6 or CAPEOX. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.
corhot2: chemotherapy combined with fruquintinib
Combination productChemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: mFOLFOX6 or CAPEOX. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.
Corhot1: Pathological Complete Response Rate (pCR)
Pathological Complete Response Rate (pCR), defined as no residual tumor cells in the surgical specimen of the primary tumor and lymph nodes (ypT0N0); corresponds to TRG grade 0.
Corhot2: R0 surgical conversion rate
R0 surgical conversion rate：The proportion of subjects who achieve complete R0 resection of both the primary gastric lesion and any metastases among all subjects receiving the conversion therapy regimen.
Corhot1: R0 resection rate
R0 resection rate: Defined as the proportion of subjects achieving negative margins among those who underwent surgical treatment.
Corhot1: Event-Free Survival (EFS)
Event-Free Survival (EFS): Time from initiation of neoadjuvant study treatment until first documented progression, recurrence/metastasis, or death from any cause (whichever occurs first, without progression/recurrence at the time of death).
Corhot1: 1-year Event-Free Survival (EFS) rate
1-year Event-Free Survival rate: Survival rate of patients who, from initiation of neoadjuvant study treatment, have not experienced progression, recurrence/metastasis, or death from any cause at 12 months.
Corhot1 and Corhot2: Overall Survival (OS)
Overall Survival (OS): Time from the first study treatment until death from any cause.
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